DETAILED REVIEW ON 3D PRINTING TECHNOLOGY IN DRUG DELIVERY
By , Komal R. Jankar, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.3586
Three-dimensional printing (3DP) is an emerging additive manufacturing technology with significant potential to transform pharmaceutical manufacturing and drug delivery systems. It enables the layer-by-layer fabrication of drug-loaded dosage forms with precise control over their geometry, drug loading, and release characteristics. This review provides an overview of major 3D printing techniques used in drug delivery, including inkjet-based printing, fused deposition modeling (FDM), stereolithography (SLA), selective laser sintering (SLS), and binder jetting. Various materials employed in pharmaceutical 3D printing, such as polymers, ceramics, hydrogels, and chitosan, are also discussed. Particular emphasis is placed on the application of 3DP for personalized drug dosing, controlled and targeted drug release, pediatric formulations, dosage forms for visually impaired patients, rapidly disintegrating formulations, and transdermal drug delivery using 3Dprinted microneedles. The integration of artificial intelligence (AI) with 3Dprinted dosage forms further provides opportunities for optimizing formulation design, drug release profiles, printing parameters, and quality control. Despite these advantages, challenges related to material availability, process reproducibility, mechanical properties, scalability, product quality, regulatory requirements, and standardization continue to limit widespread clinical implementation. Recent advances in bioprinting and customized drug delivery demonstrate the promising future of this technology. Overall, 3D printing represents a promising approach toward patient-centric and personalized medicine, with continued technological and regulatory development required for its broader application in pharmaceutical drug delivery.
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PHARMACIST'S ROLE IN CHRONIC DISEASE MANAGEMENT A REVIEW
By , Ankita Yuvraj Gorad, Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9176
Objective: The objective of this research was to gather physicians' perception of pharmacists providing chronic disease management and identify trends in physicians' characteristics that could potentially impact their comfort level collaborating with pharmacists.
Method: Physicians practicing in the outpatient setting in the state of Washington were invited to participate in a voluntary, anonymous survey. Physicians practicing in a large multidisciplinary outpatient clinic in the Southwest Washington and Seattle areas were included. For Likert scale questions, median values were reported. Physicians' characteristics were also correlated with their willingness to collaborate with pharmacists in the provision of clinical services.
Results: Results were analyzed using descriptive statistics to summarize the data collected to determine which pharmacist-provided clinical services physicians would like to collaborate on. Physicians were most comfortable with pharmacists reviewing patients' medications, followed by pharmacist provision of disease-state education, and least comfortable with pharmacists initiating therapy. Physicians who had worked with pharmacists in the past were more likely to collaborate with pharmacists compared to those who had never worked with one. Furthermore, pharmacists' ability to bill patients' medical insurance did not influence physicians' likelihood of collaboration.
Conclusion: This information will be used to aid in determining future directions for the implementation of additional clinical services within the community pharmacy setting. It is anticipated that pharmacists will be able to utilize this information to initiate conversations with physicians in an effort to collaborate on new pharmacist-provided clinical services and to improve patient outcomes by increasing access to healthcare providers, including pharmacists.
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A REVIEW ON PATIENT COUNSELLING: IMPORTANCE IN IMPROVING MEDICATION ADHERENCE
By , Irfan H. Mulla, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.3832
A common issue that costs billions of dollars annually is pharmaceutical non-adherence, which happens when patients do not take their prescriptions as prescribed. According to estimates (Ho, Bryson & Rumsfeld, 2009; Costa et al., 2015; Laufs, Rettig-Ewen & Böhm, 2011), the average adherence rate in the industrialised world is between 50 and 80%. Disease progression, hospitalisation of patients when such an outcome might be prevented, increased mortality, and significant financial costs are all consequences of medication non-adherence. Patient education, sometimes referred to as counselling, is a face-to-face discussion between a patient and a chemist, nurse, doctor, or other specialist in which the patient is informed about the rationale for the drug prescription, how to use the medication properly, and the rate of adherence.
The purpose of this review is to summarise the evidence from systematic reviews, randomised controlled trials, and position papers on medication adherence in patients with rheumatoid arthritis, cardiovascular disease, COPD, hypertension, and chronic diseases in general that counselling can improve patient knowledge and adherence to medications.
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TELEPHARMACY: CURRENT TRENDS AND FUTURE SCOPE
By , Sahil N. Hagavne, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.2095
Telepharmacy – the practice of delivering pharmaceutical services via telecommunications and IT technologies in the absence of physical proximity of the pharmacist and the patient – has transitioned from being a temporary measure aimed at solving pharmacist shortage into being a regular technological element of the digital delivery of healthcare services. The current narrative review provides the overview of evidence on telepharmacy models, clinical advantages, implementation obstacles and trends, based on twenty articles published between 1999 and 2026, including scoping reviews, systematic reviews of reviews, retrospective service evaluation, cohort studies of state-level policy, pharmacist perception research, and industry market analysis.
The existing trends include expanding the scope of telepharmacy to chronic disease management through mHealth technologies, greater integration with EHR and wearables, increasing interest in applying AI solutions to clinical decision-making, regulatory changes that were introduced during the COVID-19 pandemic and commercial growth of the telepharmacy market worldwide. The reported advantages of telepharmacy include increased access in rural areas, reducing pharmacy desertification, cost savings, increased medication adherence and better glycaemic and blood pressure control in chronic disease patients. Obstacles remain as the inconsistency in regulation and licensure across states and countries, technological and connectivity problems, lack of digital literacy among users, uncertain reimbursement policies, and lack of security of personal health information.
The possible trends in the future include the transition towards AI-based, personalized and hybrid telepharmacy models, facilitated by regulatory and reimbursement policies. Realizing this potential will require joint efforts in terms of infrastructural development, workforce education and policy harmonization.
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HOME MEDICATION: REVIEW CONCEPT AND BENEFITS
By , Rudrakshi S .Kore, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.2200
Home medication review (HMR) sends a pharmacist into a patient's own home to go through everything they are taking, with thegoalofcatching medication problemsearly, helping patientsstick to theirregimens, and getting the patient, pharmacist, and prescriber talking to one another. Over the past thirty years the idea has taken on quite different shapes depending on where it is practiced — the United Kingdom, Australia, Canada, the United States, and parts of the Middle East all run some version of it, from the fairly informal “brown bag” review done at the pharmacy counter to fully government-funded home-visit schemes. This narrative review pulls together seven primary studies and thirteen supporting references to lay out what HMR actually is, how it developed in different countries, and what the evidence says about its clinical, humanistic, economic, and educational value. Taken together, the studies make a strong case that HMR is good at surfacing things that would otherwise stay hidden — medicationerrors, adverse drug reactions, missed doses—and patients and pharmacists both seem to appreciate the unhurried, one-on-one setting it creates. Where the picture gets murkier is on the outcomes that matter most tohealthsystems:thelandmark HOMERtrialactuallyfoundmorehospitaladmissionsamongpatientswhoreceiveda home review, not fewer, and a follow-up economic analysis judged the service unlikely to be cost-effective by conventional standards. Recurring problems across the literature include poor communication at referral,prescribers who never quite follow up on a pharmacist's recommendations, patients who are not always sure why a pharmacist is at their door in the first place, and funding rules that do not always target the people most likely to benefit. The overall conclusion is that HMR has real value for optimizing medicines use and putting the patient at the centre of care, but that it needs better design, sharper targeting, and closer integration with primary care before it can live up to its promise.
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ANTIMICROBIAL STEWARDSHIP PROGRAMS IN HOSPITALS: A NARRATIVE REVIEW OF STRATEGIES, OUTCOMES, AND IMPLEMENTATION CHALLENGES
By , Santosh B. Thorat, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.2852
One of the most urgent problems in the field of public health worldwide is antimicrobial resistance (AMR). It is greatly caused by improper usage of antimicrobial agents in hospitals. An antimicrobial stewardship program (ASP) is a multidisciplinary effort aimed at optimizing the process of prescription of antibiotics with the purpose of achieving better treatment outcomes, decreasing toxicity and CDI, limiting the development of AMR, and lowering the cost of healthcare services. This narrative review uses data from fourteen sources, including systematic reviews, scoping review, meta-analysis of over fifty sources, survey of multiple US hospitals, and studies about implementation of ASPs conducted in Spain and Saudi Arabia to identify the key elements of hospital ASPs, main strategies used in them (education and implementation of guidelines, restriction and preauthorization, prospective audit and intervention, computer decision support, and antibiotic cycling), and their effect on antimicrobial use, expenditure, LOS, mortality, readmission, and resistance patterns. Data shows that ASPs lead to reduction of inappropriate prescription of antimicrobials (almost all of the studies show that), antimicrobial cost (9 out of 10 studies), and are often associated with decreased incidence of CDI, VAP, and CLABSI, without having negative impact on clinical outcomes. Meta-analysis of 52 studies including over 1.7 million patients showed 10% decrease in antibiotic prescriptions and 28% decrease in antibiotic consumption in total after ASPs were implemented. Those ASPs which used comprehensive approach, audit and support from pharmacists, especially collaborative "handshake stewardship" approach, proved to be the most effective. Hospital ASPs for pediatric population, communities, small hospitals, and low- and middle-income countries received relatively little attention and face different problems of resources shortage and workforce inadequacy. Among the problems of ongoing research on ASPs are heterogeneity in methodology and measures of effectiveness, absence of cost reports, lack of long-term data on resistance and mortality, and uneven distribution of research geographically. More resources should be invested into leadership engagement, availability of pharmacist and infectious diseases specialist expertise, IT solutions, standardized outcome measurements, and benchmarking.
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A REVIEW ON INDUSTRIAL SAFETY IN PHARMACEUTICAL MANUFACTURING
By , Aarti D.Patil, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.4726
Pharmaceutical manufacturing is unique among the process industries in that it involves all of the chemical, biological, mechanical, and psychosocial risks inherent in heavy industry, along with a specific patientrelated requirement to protect product quality and sterility. This paper provides a summary of recent scientific literature on industrial hazards and industrial safety in pharmaceutical manufacturing in terms of (i) classification of industrial hazards, (ii) modes of occupational exposure, (iii) chemical and microbial contamination, (iv) use of quality risk management methodologies like Failure Mode and Effects Analysis (FMEA) integrated with Fuzzy TOPSIS, (v) threshold-of-toxicological-concern method for setting exposure and cleaning limits, and (vi) hierarchy of controls and regulation governing industrial safety in pharmaceutical manufacturing.
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A REVIEW ON FUTURE TRENDS IN BIOSIMILARS AND BIOPHARMACEUTICALS
By , Madhura D. Patil, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.1820
Biologic drugs, being highly targeted therapies based on large and complex molecules that cannot be produced by ordinary chemistry, revolutionized the treatment of oncological, autoimmune, and genetic disorders . As the patents on first-generation biologic drugs begin to lapse, biosimilars, defined as biotherapeutic products that have been proven to be highly similar to a licensed reference biologic and having no clinically significant differences regarding safety, purity, and potency, appear to be the main driver of biosimilar development. This review aims to summarize recent findings related to the history, regulatory framework, manufacturing process, and market dynamics of biosimilar medicines, with a special focus on the major trends likely to determine future biosimilar science. These trends include the development of regulatory guidelines in the USA, the European Union, India, and the United Arab Emirates; the role of AI and digital health tools in biosimilar analysis, research, and post-marketing surveillance; advances in continuous bioprocessing and engineering of mammalian cell lines; evolving standards for interchangeability and automatic substitution of biosimilars; and extending the reach of biosimilars into advanced classes of biologics, such as monoclonal and bispecific antibodies. Challenges, such as immunogenicity, manufacturing variability, fragmentation of payment systems, and non-convergence of global regulations will be discussed as well. The conclusion is drawn that future biosimilar science will be shaped by the combination of technological innovations, regulatory simplification, and international harmonization, which can contribute to the accelerated adoption of biosimilars around the world and transform the economy of biologics.
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A DETAILED REVIEW ON FUNDAMENTAL OF PHARMACOVIGILANCE
Pharmacovigilance (PV), which refers to detecting, assessing, understanding and preventing adverse drug reactions (ADRs), has progressed from being largely case-report-based in its methodology to using causality algorithms, population-level databases, risk management methodologies, audits and increasingly artificial intelligence (AI) techniques. The current narrative review summarises evidence from six recently published sources from all of these areas: a theoretical exposition of the "signal-alert-alarm-action" process and the relative strengths of case-based versus exposure-based pharmacoepidemiology designs [2]; conference-abstract evidence on the aggregation and completeness of medicine-exposure data in periodic safety update reports and reporting of additional risk-minimisation measures (aRMMs) [12]; audit-based evidence on compliance with regulatory requirements and ethical principles (beneficence, non-maleficence, autonomy and justice) for PV activities [16]; a review of the principles, challenges and reporting framework for pharmacovigilance in Ayurveda [19]; and a review of the applications, advantages and limitations of AI and machine learning (ML) - NLP, automated case processing, predictive analytics and explainable AI - in modern PV [21]. Taken together, the six recent sources reveal that PV is converging on a set of unresolved issues: inadequate and inconsistently standardised exposure denominators, inconsistent and inadequately evaluated risk-minimisation measures, persistent underreporting and reporting biases, deficiencies that consistently come up during audits and an increasing reliance on artificial intelligence tools whose data quality and regulatory acceptance remain unfinished work in progress. The review concludes with recommendations for enhancing exposure data reporting, aligning regulatory audit and ethical principles, applying PV principles to traditional medicine and implementing AI tools in an ethically responsible way along with continuous human oversight.
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TRANSDERMAL DRUG DELIVERY SYSTEMS: A CONCISE REVIEW OF DESIGN, COMPONENTS, EVALUATION AND EMERGING TECHNOLOGIES
By , Sandesh Sharad More, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9242
A proven, non-invasive method of delivering pharmaceuticals through the skin and into the bloodstream is provided by transdermal drug delivery devices (TDDS). In addition to vesicular carriers (liposomes, niosomes, and transfersomes) created to increase the permeability of hydrophilic medications and macromolecules, patch design has evolved to reservoir, matrix, drug-in-adhesive, and micro-reservoir kinds since the first patch (scopolamine) was approved in 1979. The fundamental obstacle is still the lipoidal "bricks-and-mortar" structure of the stratum corneum, which typically prevents passive delivery of strong, lipophilic medications below about 500 Da. The range of deliverable pharmaceuticals has been expanded by the use of both active physical tactics (iontophoresis, electroporation, sonophoresis, microneedles, thermal/radiofrequency ablation, needle-free injection) and passive strategies (chemical enhancers, prodrugs, vesicular carriers). The patch adheres to the skin equally
crucial because adhesive failure jeopardizes safety and effectiveness. The anatomy of the skin and the permeation pathway, the justification for transdermal distribution, patch components and architectures, preparation and assessment techniques, adhesion testing, commercial products, and future prospects for active delivery systems are all summarized in this review.
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A REVIEW ON PHARMACOTHERAPEUTIC APPROACHES IN MIGRAINE MANAGEMENT
Migraine is one of the most frequent forms of primary headache disorder with the worldwide prevalence ranging between 10% and 15% of population and the disorder ranking among the main causes of years lived with disability (1,13). It is characterized by the trigeminovascular system activation, release of vasoactive neuropeptides, predominantly calcitonin gene-related peptide (CGRP), and disturbance in central pain modulation (4,5). Migraine treatment involves both acute and preventive approaches and consists of pharmacological and non-pharmacological treatments such as analgesics, NSAIDs, triptans, ditans, ergots, novel CGRP-targeting monoclonal antibodies and gepants, nutraceuticals, behavioral therapy, acupuncture, and neuromodulation (6). Current real-world evidence shows that triptans and NSAIDs are still the main prescribed acute treatments for the disorder, whereas non-pharmacological treatments remain underutilized in comparison with the available evidence base (2). Besides, migraine is accompanied with various comorbidities including depression, anxiety, stroke, epilepsy, and obesity, which makes the treatment of the disorder complicated due to the need for therapeutic independence rather than combination therapy (3). This paper provides the summary of the current literature on pharmacological and non-pharmacological treatment of the migraine and describes the novel therapeutic approaches for the disease based on the CGRP and PACAP targeting.
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A COMPRESSIONSIVE REVIEW ON ENVIRONMENTAL IMPACT OF PHARMACEUTICAL INDUSTRIES.
By , Rakesh A. Mane, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.2494
The pharmaceutical sector occupies a contradictory position with respect to environmental sustainability: it exists to protect human health, yet the manufacturing, use and disposal of its products generate ecological burdens that remain under-reported relative to sectors such as energy and transport. This review synthesises evidence from open-access peer-reviewed articles, systematic reviews and industry reports to examine four interrelated dimensions of pharmaceutical-industry sustainability: the carbon footprint of manufacturing and the wider healthcare sector; the discharge of active pharmaceutical ingredients (APIs) into surface water, groundwater, soil and sediment; the industry's contribution to antimicrobial resistance (AMR) through untreated antibiotic-manufacturing effluent; and lifecycle interventions aimed at reducing these impacts. The reviewed evidence indicates that pharmaceutical manufacturing is more emissions-intensive than the automotive industry, and that hundreds of pharmaceutical substances have been detected in the environment across more than seventy countries. Discharge from antibiotic manufacturers has been linked to resistant bacteria near production sites in India and China, compounding an AMR burden projected to cause ten million deaths annually by 2050. The review highlights promising interventions — green chemistry, enzymatic and continuous manufacturing, extended producer responsibility, eco-prescription and take-back schemes — while identifying regulatory fragmentation, inconsistent emissions reporting and limited life-cycle transparency as persistent obstacles. It concludes with policy and research recommendations.
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DNA VACCINES: CURRENT STATUS AND FUTURE PROSPECTS
By , Sanjana D. Todkar, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.3133
DNA vaccines deliver a gene encoding a pathogen- or tumour-derived antigen on a bacterial plasmid, relying on the host cell's own transcriptional and translational machinery to generate the immunogen in situ. First conceived in the early 1990s, the platform generated exceptional enthusiasm because, unlike protein or polysaccharide vaccines, it could reliably induce both antibody and cytotoxic T-lymphocyte (CTL) responses in small-animal models while avoiding the safety liabilities of live or inactivated pathogens. Three decades of research have clarified the molecular mechanisms underlying this dual immunogenicity, including antigen presentation via the classical MHC class I pathway, cross-presentation, and innate immune sensing of plasmid DNA through Toll-like receptor 9 (TLR9) and the cGAS–STING axis. However, the striking potency observed in mice has translated poorly to humans and other large animals, and improving immunogenicity has become the central challenge of the field. This review synthesises the composition and mechanism of action of DNA vaccines; strategies used to enhance their potency, including molecular (cytokine and chemokine) adjuvants and physical delivery platforms such as electroporation, gene guns, jet injection and microneedle arrays; their record of safety across three decades of clinical testing; and their current translational status, culminating in the 2021 emergency-use authorisation of ZyCoV-D, the first DNA vaccine licensed for human use. We conclude by outlining the delivery, formulation and regulatory advances that are likely to shape the next generation of DNA vaccines for infectious disease, oncology and personalised medicine.
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SYSTEMATIC REVIEW AND CLINICAL EVALUATION OF CAUSALITY ASSESSMENT METHODS FOR ADVERSE DRUG REACTIONS (ADRS) IN PHARMACOVIGILANCE
Adverse Drug Reactions (ADRs) present a massive challenge to global healthcare systems, leading to escalating morbidity, prolonged hospital stays, and extensive socioeconomic burdens. Assessing whether a suspected drug is clinically responsible for an adverse medical event remains the foundational pillar of robust post-market surveillance. This systematic review delivers an exhaustive, critical comparison of traditional and contemporary causality appraisal frameworks, including expert clinical judgment schemas (WHO-UMC system), standardized algorithmic checklists (Naranjo Scale, Liverpool tool, and organ-specific RUCAM framework), and multi-layered probabilistic models (Bayesian networks). The study expands on operational vulnerabilities such as inter-rater variance, data-entry bottlenecks, and linguistic ambiguity. Furthermore, it incorporates standard regulatory reporting workflows (CDSCO, FDA, EMA) and offers real-world step-by-step clinical scoring simulations. Finally, we highlight the paradigm shift toward integrating automated, No-Code Artificial Intelligence (AI) and Large Language Models (LLMs) to ensure optimized, objective, and real-time patient safety networks across modern pharmacy ecosystems.
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A COMPREHENSIVE REVIEW ON FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY
Fourier transform infrared (FTIR) spectroscopy has emerged as one of the most commonly utilized vibrational-spectroscopic techniques in modern-day analytical science owing to its speed, non-destructiveness, and applicability to solids, liquids, and gaseous samples without prior extensive preparation. This review seeks to bring together results obtained in five representative areas of lignin biochemistry, pharmaceutical drugs analysis, phytochemical composition of traditional herbal medicines, thin-layer chromatography coupled impurities detection and catalysis/chemical engineering to give an overall perspective on the use of FTIR in these diverse fields. The discussion will be focused on representative applications of this technique, specifically (i) mathematical band fitting analysis of softwood lignin spectra to determine structural changes occurring due to isolation and degradation; (ii) qualitative and chemometric (partial least squares [PLS], principal components regression +) quantitation of active pharmaceutical ingredients and polymorphs, hydrates and counterfeits detection; (iii) functional group fingerprinting of bioactive phytoconstituents in medicinal plants; (iv) HPTLC-FTIR on-line detection of degradation impurities in a benzodiazepine drug product; and (v) operando FTIR analysis of catalytic surfaces and reaction intermediates in chemical engineering research. Analytical issues, present limitations (poor DRIFTS signal, band overlapping, vacuum-/pressure-induced artifacts) and future perspectives (chemometric coupling, time-resolved/operando measurements) are briefly considered in conclusion section. Overall, the versatility of FTIR, its relatively low cost as compared to hyphenated mass-spectrometric techniques and compatibility with quantitative chemometric modeling are likely to ensure its leading role in structural characterization and quality control in chemistry, pharmacy and engineering.
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A REVIEW ON QUALITY ASSURANCE OF STERILE PHARMACEUTICAL PRODUCT
By , Shejal. D. Patil, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.8653
The quality risk management (QRM) and quality control (QC) processes are fundamental in the prevention of patient injury throughout the life-cycle of pharmaceutical manufacturing process, which includes dispensing of raw materials, sterilization, packaging, storing, and compounding at point of use. The present review synthesizes findings from four recent primary papers, two Failure Mode and Effects Analysis (FMEA) case studies of sterile injection manufacturing based on International Council for Harmonisation (ICH) Q9 [1,2], a framework of SOP of in-pharmacy chemical quality control of an extemporaneous sterile solution [3], and quantitative study of pharmaceutical QC compliance and public health outcomes among 150 manufacturing facilities in the United States [4]. In addition, the review considers the supporting literature, including regulatory and methodological considerations [5,25]. A consistent pattern is revealed within these primary and secondary sources: data-driven QRM results in a significant reduction in Risk Priority Numbers (RPN) and rates of product recalls, adverse events, and warning letters, which is achieved mainly through improvement in the detectability of failures and not in their intrinsic severity. The review makes a comparison between the methodological approaches (10-point versus 5-point FMEA scale), synthesizes the quantitative risk-reducing effects of QRM and QC measures, and draws convergences between micro-level (process-based) and macro-level (industry-wide) findings. The review shows that FMEA-based QRM, in-process and in-pharmacy QC and regulatory enforcement work as a complementary but not as substitutable components of a unified pharmaceutical safety system, and suggests priorities for further research, which includes real-time release testing, artificial-intelligence-assisted quality monitoring, and harmonization of RPN scoring systems.
At present, the various treatments available are almost entirely dependent on inhibiting the renin–angiotensin–aldosterone system; such inhibitors reduce systemic blood pressure and glomerular hyperfiltration, which in turn results in a decrease in proteinuria and the prevention of functional decline. At present, the various treatments available are almost entirely dependent on inhibiting the renin–angiotensin–aldosterone system; such inhibitors reduce systemic blood pressure and glomerular hyperfiltration, which in turn results in a decrease in proteinuria and the prevention of functional decline. Many medications undergoing clinical trials focus on inflammatory pathways, such as certain cytokines (such CC-chemokine ligand 2 (CCL2)) or signaling molecules (like Janus kinase (JAK)). These medications may be therapeutically beneficial in later stages of the disease when inflammation is a major symptom.1The development of new CKD treatments and the identification of patients who will respond to particular medications may be aided by precision medicine techniques based on particular genetic or protein biomarkers.
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GOOD HOUSEKEEPING IN THE PHARMACEUTICAL INDUSTRY: PRINCIPLES, REGULATORY EXPECTATIONS AND CHALLENGES OF MODERNITY A COMPREHENSIVE REVIEW
By , Harshada H. jadhav, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.2206
Good housekeeping forms the basis of quality assurance in the manufacture of pharmaceutical products. Good housekeeping includes daily cleaning, sanitation, organization, personnel hygiene, waste disposal, and documentation necessary to keep a facility contamination-free between and during manufacturing operations. While good housekeeping may seem like an obvious background task, inspection results have shown that failures in cleaning, sanitation schedules, material storage organization, and documentation of these aspects form some of the most common causes for GMP deviations, recalls, and warning letters. The present review summarizes key aspects of good housekeeping practice in the modern pharmaceutical industry described in GMP literature, microbial contamination control literature, aseptic processing, engineering controls, guidance on good documentation practice, quality management systems, and pharmaceutical data integrity guidelines. The regulatory bodies providing GMP expectations related to good housekeeping (USFDA, WHO, EMA, CDSCO/Schedule M, ICH), the basic elements of good housekeeping practice (personnel hygiene, cleaning and sanitation, premises and equipment maintenance, contamination control, waste and pest management, and organized material storage), the connection of housekeeping with documentation, data integrity, and quality management systems is discussed. Common GMP housekeeping failures, the associated regulatory consequences, and modern digital and risk-based approaches to housekeeping and sanitation management are also addressed.
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A DETAILED REVIEW MRNA VACCINES TECHNOLOGY AND APPLICATIONS
By , Aniket. A. Kharade, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.6802
Due in great part, though not entirely, to their remarkable performance in recent years against the global pandemic COVID-19, mRNA vaccines have emerged as a very effective techniques in the prophylaxis and treatment of diseases. Despite minor issues with design, fabrication, and mode of administration, the pharmaceutical and biotechnology industries are encouraged to expand the use of mRNA vaccines to a wide range of diseases due to their enormous superiority in terms of efficacy, safety, and large-scale manufacturing.
Over the past ten years, the development of messenger RNA (mRNA) vaccines for therapeutic and preventive uses has advanced quickly. The mRNA vaccine has demonstrated therapeutic efficacy in a number of areas, including cancer, immunotherapy, infectious diseases, genetic disorders, and regenerative medicine. Numerous RNA vaccines have entered clinical trials, and a few have received FDA approval.
Millions of people have been infected and killed by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) that produced the coronavirus disease-19 (COVID-19) pandemic. Generating vaccines typically requires years of development and safety and efficacy testing. However, the creation and implementation of two mRNA vaccines took less than a year. The most promising vaccination candidates in the fight against the pandemic are mRNA vaccines with spotlights because of their quick production time, affordability, adaptability in vaccine design, and clinically demonstrated capacity to elicit humeral and cellular immune responses.
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REVIEW ON ARTIFICIAL INTELLIGENCE IN PHARMACOVIGILANCE: APPLICATIONS, EVALUATION AND FUTURE SCOPE
By , Ankita V. Sawant, Dr. Prasad V. Patrekar, Saurabh D. Joshi, Poonam A. Mane- Patil, Shrirang V. Kharmate, Dipak R. Phalle, Satyajeet R. Jagdale, Omkar V. Kamble
https://doi-doi.org/101555/ijpcr.4644
Pharmacovigilance is the science of detecting, assessing, and preventing the adverse effects of medicines once they reach patients. For decades this work has leaned on manual case review and classical disproportionality statistics, both of which struggle to keep pace with the sheer volume of safety data generated today from spontaneous reports, electronic health records, clinical literature, and social media. Artificial intelligence, spanning machine learning, natural language processing, and rule-based expert systems, is increasingly layered onto these traditional workflows to read unstructured case narratives, flag statistically unusual drug-event pairs earlier, and reduce the routine burden on safety teams. This review draws together current literature on how AI is being applied across the pharmacovigilance lifecycle, the methods used to evaluate whether these tools genuinely work, a snapshot of tools and platforms already in use in industry, and the regulatory and practical hurdles that still stand in the way of wider adoption. The evidence to date suggests that AI improves speed, sensitivity, and consistency in signal detection and case processing, while human expert oversight remains indispensable to every stage of the pharmacovigilance lifecycle.
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A REVIEW ON NUCLEAR MAGNETIC RESONANCE (NMR) SPECTROSCOPY IN PHARMACEUTICAL RESEARCH
Since its discovery in the 1940s, nuclear magnetic resonance (NMR) spectroscopy has developed into one of the most useful instruments available to analytical and medicinal chemists. Current viewpoints on the underlying physical principles governing NMR measurements, the equipment used to get spectra, and the one- and multi-dimensional experiments that enable the technology to resolve complicated molecule structures are all included in this overview. Quantitative NMR (qNMR), which uses the direct proportionality between signal intensity and the number of resonating nuclei to assess the potency, purity, and composition of medicinal compounds without the need for compound-specific calibration curves, receives special emphasis. Multiple-microcoil probes, spatiotemporally encoded ultrafast experiments, and multi-receiver, multi-FID supersequences like NOAH and PANACEA are examples of recent developments in parallelized data acquisition that are discussed as methods for cutting experiment duration while maintaining or even improving sensitivity. The study summarizes the technical specifications and uses of liquid chromatography–NMR (LC–NMR) and LC–MS–NMR for the analysis of complex mixtures and drug metabolites. It also takes NMR into consideration as a hyphenated approach. The range of current NMR practice is demonstrated by representative applications from pharmaceutical potency testing, metabolomics, natural product elucidation, and pharmacopeial quality control. The technique's benefits and enduring drawbacks are discussed throughout. The overview ends with a summary of new developments that will probably influence the next wave of NMR applications, such as computer-assisted structure elucidation, benchtop apparatus, and hyperpolarization.
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A DETAILED REVIEW ON PHARMACOTHERAPY OF HEART FAILURE
By , Tanishka D. Tasgonkar, Dr. Prasad V. Patrekar, Saurabh D. Joshi, Poonam A. Mane- Patil, Shrirang V. Kharmate, Dipak R. Phalle, Satyajeet R. Jagdale, Omkar V. Kamble
https://doi-doi.org/101555/ijpcr.5564
Recent breakthroughs in medical therapy have dramatically enhanced outcomes for patients with heart failure and reduced ejection fraction (HFrEF).The foundation of current care relies on four established therapeutic pillars:
B-blockers, angiotensin-Converting enzyme inhibitors Or angiotensin receptor- neprilysin inhibitors, Mineralocorticoid receptor antagonists and Sodium-glucose Contransporter 2 inhibitors. However, these foundational therapies are merely the baseline for Contemporary heart failure Management. Recent advancements have introduced novel medications, innovative medical devices & optimized diuretic protocols. This review highlights the latest clinical developments in HFrEF treatment. While these innovation offer promising. Clinical outlooks ,the text also addresses the Critical, unresolved challenges in managing HEYEF-a Syndrome that remains al leading global driver of mortality, morbidity, diminished quality of of life, & escalating healthcare expenditures.
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A REVIEW ON GREEN MANUFACTURING IN PHARMCEUTICAL INDUSTRIES
By , Vaishnavi.V. Sawant, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.7932
Green manufacturing is a priority in developing sustainable and eco-friendly approaches to pharmaceutical production. This review provides an insight into the most prominent environmental issues related to the pharmaceutical manufacturing process. The main negative effects of pharmaceutical production on the environment are connected with hazardous waste, solvents, water, energy, and active pharmaceutical ingredients (API). Applying green chemistry and engineering principles in various contexts of the pharmaceutical industry can lead to significant improvements in terms of waste minimization, efficient use of resources, and reduction of hazardous materials.
The set of green chemistry and engineering metrics that can be applied to assess pharmaceutical manufacturing includes E-factor, atom economy, Process Mass Intensity (PMI), Reaction Mass Efficiency
(RME), Effective Mass Yield (EMY), green solvents, and solvent guides (for instance, GSK Solvent Guide). Proper pharmaceutical waste minimization, recycling, water and energy conservation, biocatalysis, continuous manufacturing process, and chemical engineering and process safety are the key ways to make pharmaceutical production more environmentally friendly and sustainable. The Life Cycle Assessment (LCA) is the critical tool for analyzing the potential environmental impacts of a product throughout its life cycle. The latest technologies, including Artificial Intelligence, IoT, and Process Analytical Technology, can be successfully employed to optimize and make pharmaceutical production more eco-friendly. In general, there are several ways to make the pharmaceutical industry more sustainable, profitable, safer, and competitive.
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COLD CHAIN MANAGEMENT OF VACCINES
By , Tejasvini Vishvanath Sisale, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.2455
Vaccines are temperature-sensitive biological products and their quality depends on maintaining recommended storage and transport conditions throughout the supply chain. The vaccine cold chain is an end-to-end temperature-controlled system extending from manufacture and central storage through distribution, transportation, health-facility storage and final administration. This review discusses the principles and components of vaccine cold-chain management, temperature requirements, equipment, temperature monitoring, vaccine vial monitors, transportation, temperature excursions, inventory management, standard operating procedures, personnel training, quality assurance, controlled temperature chain approaches, digital technologies and operational challenges. Particular attention is given to preventive maintenance, temperature mapping, documentation, contingency planning and rapid response to excursions. Modern electronic monitoring and remote-alert systems can improve visibility and response, while resilient infrastructure and competent personnel remain essential. Effective cold-chain management can reduce potency loss, avoidable wastage, unnecessary revaccination and financial losses and can support safe, effective and equitable immunization. Vaccine-specific decisions must always be based on current product information, manufacturer instructions and applicable national or programme guidance.
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OSMOTIC DRUG DELIVERY SYSTEM: A REVIEW OF TYPES, ADVANTAGES AND FORMULATION CONSIDERATION
By , Sajiya Shaikh, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade, Saurabh D. Joshi
https://doi-doi.org/101555/ijpcr.1492
Osmotic drug delivery systems are regulated drug delivery methods intended to administer drugs in a consistent and long-lasting manner. These devices regulate medication release and water inflow by using osmotic pressure produced by an osmogen over a semipermeable membrane. Implantable pumps, basic osmotic pumps, push-pull systems, sandwich systems, and monolithic osmotic systems are among the several varieties. Important components in formulation include cellulose acetate, osmogens, surfactants, wicking agents, and plasticizers. Near zero-order drug release, less variation in drug concentration, and predictable administration are all possible with osmotic methods. However, dose dumping, cost, delivery-orifice size, and coating flaws are significant constraints.
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RATIONAL USE OF ANTIBIOTICS
By , Sadiya Shaikh, Dr. Prasad V. Patrekar, Saurabh D. Joshi, Poonam A. Mane- Patil, Shrirang V. Kharmate, Satyajeet R. Jagdale
https://doi-doi.org/101555/ijpcr.2939
Antibiotics have greatly enhanced modern healthcare and are vital medications used to treat bacterial infections. Antimicrobial resistance, however, develops and spreads as a result of irrational use, which includes needless prescription, self-medication, improper dosage and duration, and use without a prescription. Using antibiotics rationally entails choosing the right medication, dosage, route, and duration based on the patient's condition and recommended course of therapy. The mechanics and consequences of antibiotic resistance, the factors encouraging irrational antibiotic use, and tactics to support rational antibiotic therapy are all covered in this review. Antimicrobial stewardship, prescribing standards, healthcare professional education, public awareness, and appropriate antibiotic disposal are all necessary to maintain antibiotic efficacy.
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DETAILED REVIEW ON MONOCLONAL ANTIBODIES IN MODERN THERAPY
By , Arya K . Mali, Dr. Prasad V. Patrekar, Saurabh D. Joshi, Poonam A. Mane- Patil, Shrirang V. Kharmate, Dipak R. Phalle, Satyajeet R. Jagdale
https://doi-doi.org/101555/ijpcr.7135
Monoclonal antibodies (mAbs) have evolved over five decades from being merely a scientific technique involving the fusion of antibody-producing B cells with myeloma cells into one of the fastest-growing and largest classes of therapeutics . This review will bring together results of analysis done through six recent review articles in connection with the relevant primary literature cited, providing an overview of antibody structure, mechanism of action, production techniques, clinical pharmacology, applications of mAbs for the treatment of oncological diseases, autoimmune conditions and infectious diseases including COVID-19, as well as emerging engineered antibodies such as bispecific antibodies, nanobodies , ADCs, and antibody mimetics . The efficacy of mAbs is achieved thanks to target specificity, prolonged half-life due to recycling by neonatal Fc receptor (FcRn) and diverse mechanisms of action including ADCC (antibody-dependent cellular cytotoxicity) and CDC (complement-dependent cytotoxicity) . Despite the existence of more than 100 approved products there are still a number of issues including expensive manufacturing, immunogenicity, lack of oral bioavailability and accessibility in low-resource areas facing mAb industry. This review will provide the synthesis of relevant historical, technical, pharmacological and clinical literature in order to orient researchers and clinicians to the current developments in the area of antibody therapies.
The methodical observation of the safety of medications used in children and adolescents is known as pediatric pharmacovigilance. Because children are a diverse population with constantly changing growth, organ maturation, body composition, and developmental pharmacology, it is especially crucial. Drug exposure, responsiveness, and the clinical manifestation of adverse drug reactions (ADRs) can all be impacted by these variations. Furthermore, off-label and unlicensed medication use, age-inappropriate dosage forms, and weight-based dosing are still often used in general practice, and children clinical studies are frequently smaller than adult trials. These elements may raise the possibility of medication errors and fail to address crucial safety concerns at the time of marketing. 1–4
The burden of medication-related damage is not fully captured by spontaneous reporting alone, according to data from pediatric pharmacovigilance research. Electronic medical-record triggers found 280 adverse drug reactions (ADRs) in a pediatric hospital study, but only 21 ADRs were voluntarily reported in the same year. A further comparison of spontaneous EudraVigilance reports and systematic KiDSafe surveillance revealed significant disparities in the kinds of safety issues recorded, with 845 reports compared to 697. 5, 6 Signal detection is also aided by large databases. 1,198,560 pediatric reports, including 1,585 death incidents, were found in a WHO VigiBase review between 2010 and 2019; the majority of these reports included children between the ages of 28 days and 23 months. 7
The significance of pediatric pharmacovigilance, developmental factors, ADR patterns, off-label use, medication errors, spontaneous and active surveillance, electronic health records, real-world evidence, signal detection, causality assessment, serious cutaneous reactions, the role of caregivers and healthcare professionals, underreporting, neonatal safety, adolescent pharmacovigilance, and emerging digital approaches are all covered in this review. An integrated, age-sensitive strategy is anticipated to offer a more comprehensive view of medication safety and assist in translating safety data into workable risk-reduction strategies.
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DETAILED REVIEW ON RECENT ADVANCES IN UV-VISIBLE SPECTROPHOTOMETRY IN PHARMACEUTICAL ANALYSIS
UV-Vis spectrophotometry is a common technique in pharmaceutical analysis owing to its easy nature, affordability, and accessibility, even in poorly-equipped laboratories. The present paper reviews the latest developments on UV-Vis method development, validation, and application that involve the principle of absorption, Beer-Lambert's Law, instrumentation and validation guidelines based on ICH Q2(R1)/Q2(R2) and Q1 . Examples of single component analysis involving ciprofloxacin [1] and paracetamol represent standard uses whereas multicomponent and fixed-dose combinations analysis demonstrate the major limitations associated with this type of techniques including spectral interference, lack of specificity, absorptivity/dosage issues, linearity restrictions and matrix effect. Possible solutions include the use of simple mathematical equations, double wavelength method, derivative spectrophotometry, ratio spectra manipulation and multivariate calibrations such as PCR and PLS . Strategy selection based on a severity scale is considered along with the latest developments involving the use of chemometric-based UV spectroscopy, microfluidics and miniaturized spectrophotometers and future developments such as the use of machine learning in spectral decomposition.
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A REVIEW ON MUCOADHESIVE DRUG DELIVERY SYSTEMS
By , Varad S. Pol, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.4229
Mucoadhesive drug delivery systems are based on the capacity of certain hydrophilic polymers to adhere to the mucus gel layer covering epithelial surfaces, thereby enhancing their residence time in the application or absorption sites. This occurs through two steps, namely, contact and consolidation, where polymer chains entangle in the mucin meshwork. Six theories, namely, electronic, adsorption, wetting, diffusion, fracture, and mechanical, account for the wide variety of adhesive properties. Factors affecting mucoadhesion include an array of polymer-related, environmental, and biological parameters. The present review covers the development from nonspecific, first-generation mucoadhesives to site-specific second-generation lectins and thiomers, dosage forms such as tablets, films, gels, micro/nanoparticles, and multiparticulates for the buccal, nasal, ocular, gastrointestinal, vaginal, and rectal routes, enhancement strategies and evaluation procedures. A patent survey indicates that the area is far beyond the proof-of-concept phase, with reproducibility of residence time and macromolecular permeation being major issues. In addition, an updated comparison of mucoadhesive systems with transdermal drug delivery systems is provided within the context of patient compliance of noninvasive dosage platforms.
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A COMPREHENSIVE REVIEW ON PHARMACOTHERAPY OF PEPTICULCER
An imbalance between aggressive forces and mucosal defence mechanisms results in peptic ulcer disease, a common gastrointestinal illness. NSAID use and Helicobacter pylori infection are significant contributors to the development of ulcers. H2-receptor antagonists, proton pump inhibitors, antacids, prostaglandin analogues, ulcer-protective medications, and antibiotics for H. pylori eradication are examples of pharmacotherapy. Standard triple and quadruple regimens are frequently employed, although the efficacy of treatment is impacted by rising antibiotic resistance. Potassium-competitive acid blockers, such vonoprazan, which offer quick and long-lasting acid suppression, are examples of recent developments. Hemostatic gel emulsions and the creation of new antibacterial targets against H. pylori are examples of future strategies that could enhance ulcer management and prevention.
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PHARMACEUTICAL WASTE DISPOSAL: CURRENT PRACTICES
By , Prachi s Patil, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.6447
A specific category of chemical-waste is pharmaceutical waste, including medicinal products, active pharmaceutical ingredients (APIs) and other contaminated materials that are no longer able to be used medicinally. Although its use has increased and there is uncontrolled disposal in homes, most jurisdictions only control it under biomedical-waste regulations that focus on infection control. The present review critically compares the existing disposal methods in the light of pharmacy perspective. The different methods evaluated for destruction efficiency, applicable waste categories and environmental cost, do not dominate, they have been tumbled one against the other. Global monitoring of rivers and instructive ecological research all show that population-level damage occurs at realistic concentrations of APIs, whilst the manufacturing effluent is the highest-concentration point source, and antimicrobial residues are shown to exert environmental selection pressure, but the causal chain from highest concentration point sources to end-to-end clinical resistance is not established. Positive attitudes of professionals and public in relation to correct disposal routes are never matched in practice and pharmacists lack their own knowledge of the correct disposal route. Pharmacists hold the key to the critical process of segregation (destruction of API) as well as to procurement, inventory and counselling (waste generation). In the next ten years it is the take-back, extended producer responsibility, quantification and evaluation of pharmacist interventions that will be priorities.
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A REVIEW ON PEPTIDE-BASED DRUG DELIVERY SYSTEM: MECHANISMS, APPLICATIONS, AND FUTURE PERSPECTIVE
By , Amruta V. Palkar, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.7835
Peptides, comprising amino acids with a molecular weight below 10kDa, offer therapeutic advantages over larger biologics, including higher activity, better tissue penetration, reduced immunogenicity, and lower manufacturing costs. They can be sourced naturally from the body, dietary items, or environmental extraction, as well as synthetically produced in laboratories for medical applications. Peptides play a crucial role in cell signaling and can function as hormones, modulators, or disease biomarkers. In drug delivery systems, peptides are valued for their biocompatibility and ability to be engineered for targeted treatment, enhancing efficacy and minimizing side effects. Cell-penetrating peptides (CPPs) are a notable type, facilitating drug entry into cells via endocytosis or direct translocation.
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A BRIEF REVIEW ON MASS SPECTROMETRY IN DRUG IDENTIFICATION
Mass spectrometry is an important analytical technique used for the identification and analysis of drugs and pharmaceutical substances. It is known for its high sensitivity and accuracy and can provide useful information about a compound's molecular weight and structure. This review focuses on the role of mass spectrometry in drug identification and its applications in pharmaceutical and clinical fields. An overview of the basic principles of mass spectrometry, including affinity mass spectrometry and its application in the study of interactions between drugs and biological targets. This review also describes the main components of a mass spectrometer and describes the basic concepts of mass spectrometry imaging that can study the distribution of drugs and their metabolites in tissues. Additionally, we will discuss the use of mass spectrometry for sample identification and analysis of tablets and powders. Clinical applications in the detection and analysis of drugs and related compounds are also highlighted. Overall, mass spectrometry provides a reliable and sensitive approach for drug identification and analysis. With continuous improvements in equipment and analytical techniques, this method is becoming increasingly useful in pharmaceutical research, quality control, and clinical analysis.
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A REVIEW ON MICROSPHERES AS VERSATILE CARRIERS IN CONTROLLED DRUG DELIVERY
By , Harshad S. Patil, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.4731
The conventional oral or parenteral administration routes for the medications have several drawbacks such as fluctuation of the plasma level of the drug, frequent dosing and decreased compliance. Microspheres - free-flowing particles with the size of 1-1000 µm, wherein the drug can be distributed or entrapped in the polymeric matrix or shell - offer the opportunity to achieve the control of the drug release rate and site. The review presents an overview of the optimal properties, classification (bioadhesive/mucoadhesive, magnetic, floating, radioactive and polymeric microspheres), selection of the appropriate polymers (natural, semi-synthetic and synthetic) as well as drug entrapment methods and fabrication techniques (emulsification–solvent evaporation, spray drying/congealing, coacervation, ionic gelation, polymerization and novel microfluidic techniques). The drug release mechanisms, evaluation parameters and case studies - Quality by Design (QbD)-optimized microspheres with antidiabetic effect, surface engineered PLGA microspheres for intra-articular administration of the corticosteroid, magnetic microspheres for delivery of chemotherapeutic agents, floating gastro retentive tablets and environmentally friendly herbal/colon-targeted microspheres - will be highlighted.
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A REVIEW ON MANAGEMENT OF BRONCHIAL ASTHMA
By , Nityanand Sawashe, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9908
Bronchial asthma is fluctuating respiratory symptoms and fluctuating expiratory airflow limitation are hallmarks of bronchial asthma, a diverse chronic airway illness. Sustained symptom control, avoiding exacerbations, maintaining pulmonary function, reducing side effects from treatment, and preserving quality of life are all goals of effective management. An integrated approach that combines pharmaceutical treatment, environmental and trigger management, monitoring, patient education, adherence support, and customized therapy adjustment is supported by the literature evaluated in the uploaded material. While leukotriene receptor antagonists, long-acting muscarinic antagonists, inhaled corticosteroid/long-acting β2-agonist combinations, and certain biologic therapies offer additional options based on disease characteristics, inhaled corticosteroids continue to be the mainstay of long-term anti-inflammatory treatment. Written asthma action plans can improve adherence, self-management, and the ability to react quickly to worsening symptoms.Prompt severity assessment, proper bronchodilator and systemic corticosteroid medication, and specific adjuvant interventions in severe attacks are necessary for acute exacerbations. Although causality has not been proven, recent submitted data has linked low serum magnesium to acute exacerbation and worse lung function. Phenotype- and endotype-directed therapy, steroid-sparing techniques, and better inhaler use are becoming more and more important in emerging management. In general, asthma treatment should be customized, gradual, and constantly reevaluated, with the patient's active involvement and frequent expert evaluation.
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A REVIEW ON SUSTAINABLE WASTE MANAGEMENT PRACTICES IN THE PHARMACEUTICAL INDUSTRY
By , Sadanand Patil, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9781
Although the pharmaceutical sector produces a variety of waste streams during research, manufacture, formulation, packaging, distribution, and use, it is crucial to public health. Products that have been rejected or expired, chemical residues, solvents, active pharmaceutical ingredients (APIs), contaminated materials, packaging debris, sludge, and wastewater are examples of these streams. Conventional end-of-pipe disposal is not enough to achieve pharmaceutical-sector sustainability, according to the literature provided for this review. APIs, solvents, intermediates, catalysts, and other resistant materials may be present in pharmaceutical wastewater, and environmentally significant compounds may not be entirely eliminated by traditional biological treatment. Therefore, a hierarchy that puts prevention and source reduction first, followed by segregation, reuse, recycling, recovery, and proper treatment/disposal, is necessary for sustainability.
Complementary elements of an integrated strategy include cleaner production, green chemistry, life-cycle thinking, green supply chains, employee engagement, sustainable packaging, reverse logistics, and enhanced wastewater treatment. While maintaining patient safety and efficacy as the fundamental requirements, recent work on greener medicines further expands the approach upstream by taking environmental fate, biodegradability, persistence, and risk into account during drug creation. An integrated pharmaceutical waste-management system based on prevention, measurement, segregation, resource recovery, treatment, monitoring, and continuous improvement is proposed in this study, which summarises the available knowledge.
Immunization remains one of the most cost-effective public health interventions available, preventing millions of deaths every year from vaccine-preventable diseases (VPDs). India operates the world's largest Universal Immunization Programme (UIP), providing free vaccination against twelve VPDs to nearly 26–29 million infants and 29–30 million pregnant women annually. Since the launch of the Expanded Programme of Immunization (EPI) in 1978 and its reorganization as the UIP in 1985, India's immunization landscape has evolved considerably, expanding the vaccine basket, strengthening cold-chain and supply-chain logistics, and adopting digital platforms such as the Electronic Vaccine Intelligence Network (eVIN), CoWIN, and U-WIN. Landmark achievements include the eradication of smallpox (1977), polio (2014), and maternal and neonatal tetanus (2015). Government-led catch-up campaigns, particularly Mission Indradhanush (2014) and its successive Intensified phases (IMI 1.0–5.0), have narrowed immunity gaps and reduced the number of zero-dose children from an estimated 2.9 million in 2020 to about 0.9 million in 2024. The COVID-19 pandemic severely disrupted routine immunization services worldwide, and India mounted one of the largest COVID-19 vaccination drives globally using the indigenously built CoWIN platform, while simultaneously restoring routine services through IMI 3.0–5.0. Despite these gains, India continues to face challenges including vaccine hesitancy, geographic and socio-cultural barriers, healthcare workforce shortages, cold-chain limitations, rapid urbanization, and climate-related disruptions to service delivery. This review synthesizes the current status of India's immunization program, its historical evolution, technological innovations, coverage trends, persistent challenges, and future directions in the context of the Immunization Agenda 2030.
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A DETAILED REVIEW ON A SIGNAL DETECTION IN PHARMACOVIGILANCE
Pharmacovigilance plays an important role in patient safety through a process of detecting analysing interpreting, and disseminating information about adverse effects of drugs after licensure. Although safety data from clinical trials are the first lines of evidence that is crucial still limitations like small sample size, relatively homogeneous patient pool, short duration of exposure, highly restricted study environment etc. are often pointed out as reasons why rare, delayed or actual-world adverse drug reactions are being missed. That's why, monitoring of the marketed medicines has been recognized as one of the main ways through which a number of new safety signals and the balance between benefit and risk are determined. Considering Really spontaneous reports mostly from health professionals and patients still constitute the mainstay for pharmacovigilance, the recognition of infrequent (very rare), uncommon delayed and drug-drug interactions etc. which are quite a challenge for spontaneous reports may need large scale data collection. The availability of individual case safety (ICS) reports will provide an opportunity for pharmacovigilance to be a bit more organized at least and for having a more systematic way to identify safety signals in a timely manner. The use of signal detection methods such as the Bayesian Confidence Propagation Neural Network (BCPNN) and the Reporting Odds Ratio (ROR) have demonstrated usefulness in the identification of false-positives and/or spurious drug event associations. The advent of large-scale databases, implementation of electronic health records, the adoption of data-quality practices and mechanisms for duplication of reporting, data-mining programs, new statistical techniques are all aspects surrounding complex machine learning which appear to be great means for getting a hold on how quick and how precisely safety concerns are recognized. In this way, combining classical approaches alongside newly developed ones could be an effective way of elevating the clinical value and efficiency of pharmacovigilance operations, health care system, clinicians reliance on the scientifically valid evidence, and citizens' trust in the medical field.
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POLYPHARMACY IN GERIATRIC PATIENTS: CHALLENGES AND MANAGEMENT
By , Sanika B. Mane, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.3720
The concurrent use of five or more medications is known as polypharmacy, and it is a significant clinical problem in older persons, especially given the growing number of people 65 and older. The accumulation of medications in older people is caused by multimorbidity, disease-focused treatment, and longer life expectancy. Inappropriate polypharmacy may raise the risk of adverse drug reactions, drug-drug and drug-disease interactions, poor adherence, falls, frailty, cognitive impairment, functional decline, hospitalisation, and other geriatric syndromes. However, polypharmacy may be appropriate when all medications have obvious therapeutic benefits. Ten peer-reviewed publications that address the epidemiology, mechanisms, clinical management, and policy aspects of polypharmacy are summarised in this review. Studies on adverse drug responses, the Drug Burden Index, medication reviews, deprescribing, the SIMPATHY effort, and the Scottish Polypharmacy Program are among the evidence. It also takes into account the viewpoints of patients and healthcare professionals from other nations. The Beers criterion, STOPP/START criterion, and Medication Appropriateness Index are crucial instruments for spotting possibly improper dosing. Medication-related dangers can be decreased with a methodical, step-by-step medication review and deprescribing procedure. Artificial intelligence and digital health combined with patient-centered care could enhance pharmaceutical administration even further. In general, a potential strategy for managing polypharmacy is customised medication evaluation and deprescribing based on patients' clinical circumstances, preferences, and care objectives.
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A REVIEW ON APPLICATIONS OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) IN PHARMACEUTICAL QUALITY CONTROL
HPLC separates analytes from a sample using a pressurized mobile phase flowing through a packed column; the separation process translates differences in interphase interactions into differences in elution time. As a medicine is an API with excipients, process residues, degradants, stereoisomers and preservatives, this resolution process prior to measurement is the reason why chromatography is such an important tool for pharmaceutical quality control (QC). This review links the literature for 2020-2025 with the quality problems solved by HPLC: assay, impurity and stability indicating testing, dissolution and content uniformity, preservatives/excipient determination, chiral purity, bioanalysis and herbal fingerprinting. Method development according to ICH Q14, method validation according to ICH Q2(R2) and recent developments (UHPLC, LC-MS/MS, 2D-LC, green chemistry, automation and machine learning) will be covered, along with practical aspects (sample preparation, troubleshooting, method transfer, data integrity), concluding with HPLC's regulatory framework, its limitations and advice for resource-limited laboratories.
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A DETAILED REVIEW ON NANOPARTICLES IN DRUG DELIVERY
By , Snehal Subhash pingale, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.1728
Nanoparticle-based drug administration has emerged as an important area of pharmaceutical research due to conventional dosage forms’ poor water solubility, fast disintegration, low bioavailability, non-specific distribution, and dose-related toxicity. Nanoparticles can serve as carriers for an active pharmacological ingredient, increasing its apparent solubility, altering pharmacokinetics, and releasing the medicine in a controlled manner. Their small size and customizable surface features allow either passive or active targeting, as well as delivery via difficult-to-manage pathways. Recent work highlights polymeric nanoparticles, lipid nanoparticles, solid lipid nanoparticles, nanostructured lipid carriers, metallic nanoparticles, dendrimers, polymeric micelles, and Nano suspensions as essential medicinal delivery platforms..1,2,3,4 This study outlines the fundamental concept of nanoparticles in drug delivery, key nanoparticle systems, preparation methods, drug loading and release processes, targeting techniques, therapeutic uses, benefits, limitations, safety concerns, and future prospects. The 2018 literature is highlighted, with a focus on the transition of nanomedicine from proof-of-concept research to clinically relevant formulations. The review also highlights why particle size, surface charge, shape, composition, and protein-corona formation should be treated in tandem rather than as separate formulation factors.
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CURRENT PHARMACOTHERAPY FOR DIABETES MELLITUS: A REVIEW
Diabetes mellitus (DM) is an endocrine disease characterized by hyperglycemia caused by either deficient production of insulin, insufficient action of insulin, or both. This condition has become one of the fastest growing healthcare issues around the world. Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of the pancreatic beta cells leading to insufficient insulin production. On the other hand, type 2 diabetes mellitus (T2DM) is caused by the body's inability to respond to insulin, or beta-cell dysfunction, and constitutes 90% of all diabetes cases. Significant development has been achieved in the management of T2DM through the years. While earlier management was solely based on the use of insulin and first-generation sulfonylurea’s, currently, there are many drug types used for treatment. Such drugs include biguanides, second-generation sulfonylurea’s, meglitinides, thiazolidinediones, alpha-glycosidase inhibitors, incretions, including glucagon-like peptide-1 receptor agonist and dipeptidyl peptidase-4 inhibitors, amylin mimetic, bile acid sequestrates, and sodium-glucose cotransporter-2 inhibitors. Choice of therapy is based on the effectiveness, mode of action, safety and individual needs of the patient. Other than medical therapy, lifestyle modification which includes healthy eating habits, physical exercise, body mass regulation and other behavioral modifications is also crucial in the management of T2DM. Increasing prevalence of T2DM in children and adolescents has created the need for safer and more efficacious treatment options. This article reviews the history of development, mode of action, efficacy and safety of commonly used anti-diabetic drugs with special focus on lifestyle modification, T2DM in children and withdrawn antidiabetic drugs due to safety issues.
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A REVIEW SOLVENT RECOVERY AND RECYCLING IN PHARMACEUTICAL MANUFACTURING
By , Sanskruti. S. Mali, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9770
Organic solvents are a key component of pharmaceutical manufacturing and constitute 50-90% of the total mass of non-active substances employed in the production of active pharmaceutical ingredients (APIs). Although solvents are not usually used as such in the reaction, their high consumption leads to huge amount of wastes being generated, which makes the pharmaceutical manufacturing the most wasteful branch of the chemical industry with the E-factors of 25-100 kg of waste per kilogram of the product. Traditionally, only 28% of the waste pharmaceutical solvents were being recovered and reused whereas the rest of the waste was burnt, which led to enormous energy consumption, generation of greenhouse gases, and expenses. Solvent recovery methods include batch and continuous distillation, azeotropic and pressure-swing distillation, pervaporation, organic solvent nanofiltration, and adsorption. In addition, the paper discusses physical and chemical properties which define solvent separation, solvent design guidelines, and quality of the solvent recovery process required for successful implementation of the solvent recovery process in the pharmaceutical process. Examples of case studies of industry leaders such as Pfizer, Bristol-Myers Squibb, and Novartis provide evidence of the environmental and economic benefits of the solvent recovery. Life-cycle emission reduction is reported at 74-98% and the cost savings of 69-99% for a particular waste stream. Payback periods of the solvent recovery systems for several solvent streams recovery are 1.8-4.5 years, which guarantees internal rate of return exceeding investment hurdle rates. Consequently, solvent recovery and recycling are efficient approaches to reduce pharmaceutical wastes, energy consumption, emissions, and the cost of pharmaceutical production.
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A COMPREHENSIVE REVIEW ON RECOMBINANT PROTEIN THERAPEUTICS
Numerous advantageous proteins have restricted natural availability, frequently limiting their supply and consequently diminishing their potential for therapeutic or industrial applications. The emergence of recombinant DNA (rDNA) technology allows for the use of various microbes as alternative hosts to aid in the production of these proteins. This microbial technology keeps evolving and merging with contemporary advancements to create more efficient methods for boosting the output of recombinant biopharmaceuticals. These approaches include fermentation techniques, metabolic manipulation, the use of potent promoters, innovative vector components like inducers and enhancers, protein tags, secretion signals, synthetic biology, high-throughput cloning tools, and process evaluation.
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A DETAILED REVIEW ON PHARMACOVIGILANCE OF HERBAL MEDICINE
Systematic data on the negative effects of traditional medicine is lacking because complicated problems like multi-ingredient products, inadequate standardization, and a lack of clinical trials, manufacturing variations Better conventional medicine and Phyto-medicine Formulations are now widely accepted; contamination, adulteration, and incorrect identification of herbs. Pharmacovigilance's goal is to identify, evaluate, and comprehend a Most people agree that herbal products are safe, eco-friendly, and becoming more used by the public without a prescription to avoid any negative consequences or other potential drug-related issues with complementary, traditional, and herbal remedies .Herbal medicine pharmacovigilance is still in its early stages, and keeping an eye on the security of natural Due to the particular difficulties that products present, preparations are offered from a variety of variety of sources where there aren't many competent medical professionals. The ethico-Medical regulations and legal concerns differ from nation to nation. Additionally, this essay clarifies the degree of difficulties related to herbal Pharmacovigilance aimed at enhancing herbal medicine safety monitoring in the future.
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A BRIEF REVIEW OF PRINCIPLES & APPLICATIONS OF GREEN ANALYTICAL CHEMISTRY
The goal of the multidisciplinary field of “green chemistry” is to reduce dangerous materials and encourage environmentally friendly substitutes for traditional chemical processes and products. With a focus on its contribution to the advancement of sustainable chemical synthesis, analytical techniques and industrial practices, this review offers a thorough examination of the basic ideas, historical evolution and real-world application of green chemistry. Inspired by Rachel Carson’s “silent spring”, environmental activism of green chemistry, which was formally established in the 1990s by Paul Anastas and john C. warner’s 10 principles. These guidelines place a strong emphasis on using renewable raw materials, cutting back on dangerous chemicals, preventing waste, and the atomic economy. Green chemistry has a big impact on industries like education, cosmetics, and pharmaceuticals. It encourages more ecologically friendly analytical techniques in the pharmaceutical sector. Biodegradable materials are advantageous to the cosmetics industry, and educational institution use sustainable laboratory and waste management techniques.
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MEDICATION ADHERENCE: ASSESSMENT AND IMPROVEMENT STRATEGIES
By , Pratiksha. D. Khandagale, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.8611
When managing both acute and chronic illnesses, medication adherence is a key factor in determining treatment success. Intentional choices, inadvertent obstacles, or a confluence of patient, treatment, healthcare system, socioeconomic, and condition-related factors can all contribute to non-adherence. Treatment failure, illness progression, needless hospitalization, decreased quality of life, and higher healthcare costs are all consequences of poor adherence. A change in perspective from considering non-adherence as a straightforward patient behavior issue to a multifaceted clinical condition necessitating comprehensive assessment and tailored care is supported by current evidence. The main ideas of drug adherence, factors that contribute to non-adherence, evaluation techniques, and evidence-based improvement measures are all summarized in this review.
Although they can be expensive and unfeasible, direct measurements like medication concentrations and biologic markers offer objective information. Self-report scales, pill counts, pharmacy refill records, medicine possession ratio, percentage of days covered, electronic monitoring, and digital records are examples of indirect methods that are more practical yet have different levels of accuracy and interpretation. According to available data, there isn't a single approach that works for everyone; integrating complementing measurements could result in a more accurate evaluation.
Patient education, collaborative decision-making, simplifying regimens, reminder systems, behavioral and motivational therapies, pharmacist-led services, cost-cutting measures, family and social support, and digital health technology are examples of improvement techniques. Personalized and multifaceted interventions seem to be more beneficial than simple reminders. Identifying adherence hurdles, improving therapy, promoting proper drug usage, and organizing follow-up are all crucial tasks for pharmacists. In order to preserve patient privacy and reduce treatment burden, future methods should incorporate digital monitoring, patient-reported barriers, objective adherence measurement, and individualized behavioral support.
Rheumatoid arthritis (RA) is a chronic systemic autoimmune inflammatory disease characterized by synovitis, pain, stiffness, progressive joint damage and functional impairment. The supplied literature consistently presents early recognition and disease-modifying treatment as central to preventing irreversible structural damage and disability.
Symptomatic medicines such as analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) may reduce pain, while glucocorticoids can provide rapid control during active disease or while slower disease-modifying antirheumatic drugs (DMARDs) take effect. Conventional synthetic DMARDs, particularly methotrexate (MTX), form the core of pharmacological management, with biologic DMARDs and targeted synthetic DMARDs providing additional options when response is inadequate or treatment is not tolerated.
RA management extends beyond inflammation. Pain may persist despite good inflammatory control because mechanical pain, fibromyalgia, neuropathic mechanisms and psychosocial factors can contribute. RA is additionally associated with generalized and local bone loss and increased fracture risk. Obesity may worsen disease activity and treatment response, while weight reduction has been associated with lower disease activity in patients with obesity. Patient perceptions of DMARD efficacy and adverse effects can influence treatment experience and adherence, and pharmacoeconomic analysis further highlights the importance of rational medicine selection and resource use.
Overall, the evidence assembled supports a multidimensional, treat-to-target approach in which early diagnosis, appropriate DMARD therapy, monitoring, management of pain and comorbidities, and attention to patient preferences are combined to improve long-term outcomes.
50
REVIEW ON INJECTABLE DRUG DELIVERY SYSTEMS
By , Saniya Yajid Jamadar, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.8294
Injectable systems for drug delivery are an important component of modern pharmaceutical systems for drug delivery because they allow drugs to be injected directly into the body and thus achieve fast and predictable therapeutic effects. These are especially useful for drugs with poor oral bioavailability, gastrointestinal degradation or rapid action. Conventional injection formulations are solutions, suspensions, emulsions and injection powders. Advanced systems for controlled and prolonged drug release include microspheres, nanoparticles, liposomes, lipid depots and in situ-forming systems.
Injectable pharmaceutical delivery systems are enable the administration of therapeutic agents directly into the body via parenteral routes. They have many advantages over conventional oral administration such as rapid onset of action, improved bioavailability, avoidance of gastrointestinal degradation and hepatic first-pass metabolism and the delivery of poorly absorbed orally drugs. The main forms of conventional injectable preparations administered intravenously, intramuscularly, subcutaneously, intradermally and intraperitoneally are solution, suspension, emulsion and powders for injection. Traditional injectable systems, however, have drawbacks such as pain, invasiveness, risk of infection, frequent administration and requirement for skilled staff.
This review, gives an insight of conventional and advanced injectable drug delivery methods, their major routes of administration, formulation approaches, advantages, limitations, recent developments and pharmaceutical applications. Particular attention is given to the possibilities of sophisticated injectable systems to improve therapeutic efficacy, patient compliance and controlled drug delivery.
51
A REVIEW ON FIRE SAFETY MEASURES IN PHARMACEUTICAL INDUSTRIES
By , Pranali Shivaji Narute, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.7788
Fire safety is an important aspect of the pharmaceutical industry because the manufacture, handling and storage of combustible materials, chemicals, electrical equipment and flammable substances all pose serious fire and explosion hazards. Fire incidents at a pharmaceutical firm can lead to worker injuries, damage to buildings and equipment, loss of pharmaceutical products, and production stoppages. This overview discusses the main fire hazard reasons in the pharmaceutical industry and contributing factors. It includes the classification of hazardous areas, risk assessment, fire detection and alarm systems, fire prevention strategies, firefighting equipment, emergency planning and regulatory requirements. Good Manufacturing Practices (GMP), safe storage and handling of combustible materials, electrical safety, ventilation, housekeeping and personnel training all help to reduce the danger of fire. Management of fire safety should include systematic identification of hazards, assessment of risks, suitable preventative and protective measures, ongoing surveillance and training. The assessment stresses the need to incorporate fire safety into pharmaceutical quality and safety management systems to safeguard staff, premises, equipment and pharmaceutical products.
52
REVIEW ON THERAPEUTIC PROTEIN: APPLICATION AND CHALLENGES
Protein-based drugs are now one of the fastest-expanding areas of pharmaceutical development, spanning enzymes, hormones, monoclonal antibodies, clotting factors, cytokines, recombinant vaccines, and engineered fusion proteins [1]. Compared with conventional small-molecule drugs, they tend to act with far greater target specificity and cause less off-target toxicity, which has made them central to treating metabolic disease, cancer, autoimmune disorders, and infection. At the same time, several biological and manufacturing hurdles keep proteins from reaching patients as easily as a typical tablet or capsule would: they can provoke unwanted immune responses [3], they lose structural integrity fairly easily [2], they clear from the bloodstream quickly [5], they are poorly absorbed when swallowed [4], and they are expensive and technically demanding to manufacture [6]. This review walks through the major classes and uses of therapeutic proteins, examines the challenges that continue to limit their development and delivery, and summarizes the strategies currently being used to work around them.
53
REVIEW ON CONSUMER REPORTING OF ADVERSE DRUG REACTION
A novel idea in pharmacovigilance that helps improve current drug safety procedures is consumer adverse drug reaction reporting. Currently, 44 nations have consumer adverse medication reaction reporting systems in place, accounting for 9% of all adverse drug reaction reports. Methods Adults who have taken medication in Australia were asked to complete a cross-sectional online survey. A structured questionnaire that was pretested for face validity and included multiple choice or Likert scale responses, as well as a free-text response option, was employed.
The chi-square test or Fisher's exact test, along with descriptive statistics, were used to examine consumer characteristics, knowledge, and ADR reporting behaviours. One of the main challenges in the PV system is underreporting. According to research, the absence of an established ADR reporting system in many parts of the world and a lack of knowledge and awareness among healthcare personnel are the main causes of underreporting the research on ADR under-reporting scenarios is reviewed in this article, with an emphasis on the causes of this PV barrier.
The goal of this review is to find out how the healthcare sector can use automation and digital tools to increase the volume and Caliber of ADR reporting. Topics covered: The importance of ADR underreporting was examined in this review. Future research is required to assess how well this ADR reporting approach is working to improve patient outcomes and shorten the time it takes to find new safety problems. Critical analysis is done on issues with ADR reporting, including underreporting, reporting bias, and problems with causality assessment. Additionally covered is the effect of erroneous or partial information on risk assessment and signal detection. This narrative review highlights the significance of pharmacovigilance in guaranteeing patient safety and maximizing medication therapy by examining current procedures and difficulties in reporting Adverse Drug Reactions (ADRs).
54
A DETAILED REVIEW ON A HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY (HPTLC) AND ITS APPLICATIONS
High-Performance Thin Layer Chromatography (HPTLC) is a technique used for analyzing substances in chemical testing. Such efficient and complex methods of separation have completely changed analytical chemistry industry with their accuracy, trustworthiness, and broad applicability. HPTLC itself is an improvement on the traditional kind of thin layer chromatography, and that means has a number of good features, like simple sample preparation, analysis of one sample with multiple detection methods, and high cost-effectiveness. The method has found its way into many different areas mainly in pharmaceutical analysis, botanical product investigations, and food quality control. It is a high-performance analytical method that features resolution, sensitivity, and capabilities for automation. The technique, because of this, plays an essential role in lots of sectors, from pharmaceutical to environmental, including biochemical analyses. The system works by separating substances using different mechanisms: reverse, normal Phases chromatography modes or ion exchange that permit the separation of complex mixtures with precision. Recent technical advancements have resulted in ultra-high performance liquid chromatography (UHPLC) with even better speed and resolution. Both techniques are complementary and are used in an analytical laboratory - while HPTLC serves for quick screening, HP offers precise quantitative determination ultimately. The development of analytical technologies continues to enhance both ways through new technological discoveries which, because of this, makes sure that their role remains one of the central ones in contemporary analytical chemistry.
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A REVIEW ON OPTHALMIC DRUG DELIVERY SYSTEM RECENT IN ADVANCE
By , Zeba S. Mulla, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.4706
Ophthalmic drug delivery is a significant area of pharmaceutical study since it is difficult to transport medications to the eye effectively because of blinking, nasolacrimal drainage, fast tear drainage, and other anatomical and physiological barriers. Conventional eye drops often have low ocular bioavailability and a short drug residence time, necessitating repeated administration. Enhancing drug retention, controlled release, ocular targeting, and patient compliance have been the main goals of recent developments in ophthalmic drug administration. Nanoparticles, liposomes, nanoemulsions, nanomicelles, hydrogels, in-situ gels, drug-eluting contact lenses, ocular implants, microneedles, iontophoresis, and stimuli-responsive delivery systems are examples of novel techniques. These technologies can deliver drugs to the anterior and posterior parts of the eye in a sustained and focused manner. Systems based on nanotechnology are especially promising since they can enhance the solubility, permeability, stability.
56
A DETAILED REVIEW DRUG INFORMATION SERVICES IN HOSPITAL PHARMACY
By , Shreya B. Bile, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9697
The Drug Information Center (DIC) plays a vital role in the healthcare settings by providing evidence-based unbiased drug information to healthcare professionals such as physicians and pharmacists. As drug therapies and guidelines become increasingly complex, DICs provide a way to help close the gap between the rapid evolution of the drug literature and patient care. Studies have shown that DICs answer questions of drug identification, dosage, adverse reactions, and drug interactions and that there are many important questions from the patient. The process of providing information is structured including documentation, literature search and evidence evaluation. The challenges faced include declining use and information retrieval issues, but the opportunities presented by telepharmacy and digital services provide opportunities for improved accessibility and patient education in future DIC operations. DICs are generally important for promoting safe and effective medication practices in hospitals.
57
OCCUPATIONAL HEALTH HAZARDS IN PHARMACEUTICAL MANUFACTURING
By , Ruchita. U. Shinde, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.8060
Pharmaceutical manufacturing brings together chemical synthesis, potent active pharmaceutical ingredients (APIs), solvents, powders, process intermediates, biological materials and specialised processing equipment, all within the same workplace. As a result, workers can be exposed to chemical, pharmacological, biological, physical, ergonomic and psychosocial hazards at essentially every stage of production, from dispensing and synthesis through to formulation, filling, cleaning, maintenance and waste handling. The literature published since 2018 has moved steadily towards a more systematic way of managing these risks: identifying hazards early, characterising toxicology properly, assessing exposure quantitatively, deriving health-based exposure limits, and then choosing controls that genuinely reduce risk rather than simply appearing to. The rise of biopharmaceutical manufacturing has added further complexity, since proteins, peptides, nucleic-acid therapeutics and other advanced modalities do not always behave like conventional small-molecule APIs, and this has pushed occupational-hygiene practice to develop new assessment tools. This review draws together recent literature to summarise the major hazards, the routes by which workers are exposed, the resulting health effects, current thinking on occupational exposure limits (OELs) and health-based exposure limits (HBELs), risk-assessment approaches, control strategies, monitoring practices, medical surveillance, and the priorities that are likely to shape occupational health programmes going forward.[1,2,16,22]
58
A REVIEW ON BIOSIMILARS: REGULATORY ASPECTS & CHALLENGES
Biosimilars are biologic medicinal products designed to be highly similar to an already approved biological drug.Since the first biosimilar (somatropin) was approved by the European Medicines Agency (EMA) in 2006 and the first US biosimilar (filgrastim-sndz) was licensed by the US Food and Drug Administration (FDA) in 2015, biosimilars have grown in popularity because they are essential for expanding patient access to costly biologic drugs while reducing healthcare costs.
. However, more than 50 national and regional regulatory frameworks have been introduced over this period, but heterogeneity remains in many areas of nonclinical and clinical development, requirements for interchangeability, substitution, labeling, pharmacovigilance and others. This review will analyze the current state of affairs based on the evidence from regulatory scientific perspective papers, results of international surveys (e.g., a survey across 20 countries conducted by WHO and BRICS-TM survey across 6 countries) and the existing biosimilar legislation[7,2] mandatory versus conditional requirement for in vivo nonclinical toxicity studies, acceptance of foreign-originated reference biologics, interchangeability and automatic substitution policies, nomenclature and traceability schemes, and patent dispute resolution procedures such as the US "patent dance" are examples of divergent aspects.
[1,6,4]The paper will discuss opportunities for regulatory harmonization such as reliance, joint reviews, WHO prequalification of biosimilars, artificial intelligence supported analytical comparability and others, which could increase efficiency of the process and ensure equitable access to biosimilar drugs. Therefore, we suggest that there is a need for coordinated, science-based and gradually harmonized regulatory regime for biosimilars.
59
A COMPREHENSIVE REVIEW ON LIPOSOMES AS NOVEL DRUG DELIVERY SYSTEMS
By , Sudesh. U. Mane, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.8175
Phospholipids organized in one or more bilayers around an aqueous core make up the majority of liposomes, which are spherical vesicular drug delivery vehicles. Because they can include both hydrophilic and lipophilic medicines, they are significant new drug delivery methods. Liposomal encapsulation can extend drug circulation, alter pharmacokinetic behavior, increase drug solubility and stability, and lessen undesired exposure to healthy tissues. For use in pharmacological and therapeutic applications, a variety of liposome varieties have been produced, including conventional, uniflagellar, multilamellar, PEGylated, targeted, and stimuli-responsive liposomes.
Liposomes are prepared using a variety of techniques, including thin-film hydration, reverse-phase evaporation, ethanol injection, and microfluidic techniques. Particle size, polydispersity index, zeta potential, morphology, encapsulation efficiency, and drug-release behaviors are significant characterisation criteria. Liposomes have been extensively studied for regulated and targeted medication administration, especially for pulmonary disorders, cancer, fungal infections, pain management, and nucleic acid delivery. Clinical use has been achieved for a number of liposomal formulations, including Doxia®, Ambi some®, Oneyda®, Vyxeos®, Marqibo®, and Arikayce®. Physical and chemical instability, drug leakage, manufacturing complexity, scale-up, and variable targeting efficiency are still issues, nevertheless. Future uses of liposomal drug delivery are anticipated to grow because to recent developments in stimuli-responsive liposomes, active targeting, microfluidic production, and RNA delivery.
60
PHARMACOVIGILANCE PROGRAMME OF INDIA (PVPI): AN OVERVIEW
The field of Pharmacovigilance (PV) has changed dramatically worldwide over a few decades as there are quite a few advancements in the field. In this article we would focus on the status of the PV system of India, highlighting its history of development, challenges and measures for the improvement of the system in addition. Under the Pharmacovigilance Program of India (PvPI ) a major effort has been made to collect drug safety related information and make such information available to the world health organization as well which is a WHO database. The PvPI system is one of the minimum requirements to run a national PV system based on WHO. Indian Pharmacopoeia Commission (IPC) is the national coordination centre under PvPI. In India adverse drug events first and foremost get reported through a spontaneous mechanism. A significant issue for PV in India is the extent of under-reporting.Along with patient safety, the programme is trying to create the trust and understanding between the physician and the patient as well as increase the people's confidence in the country's health system, apart from detecting substandard drugs and errors in prescribing, dispensing, and administration. The IPC-PvPI has recently been recognized by WHO as a Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services. Despite these major successes, challenges have remained for the PvPI, mainly monitoring generic drugs, generic similarity products of original biopharmaceuticals and detection of disease-specific ADR to antidiabetic agents, cardiac drugs, antipsychotic agents etc and, above everything, awareness creation, a never ending process. Besides these efforts, there are other challenges being dealt with by the PvPI such as counterfeit medicines, antimicrobial resistance and surveillance during large-scale vaccinations and other national programmes.
61
A DETAILED REVIEW ON A BIOMEDICAL WASTE MANAGEMENT IN HEALTHCARE FACILITIES
By , Aniket Arun Shinde, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9171
Hospitals, health care centres, research laboratories, blood banks etc. are the major sources of waste generation. Improper disposal of the biomedical wastes can create hazards to many mankind. They can be severely affected by the hazards created by the biomedical wastes; we have summarized the different operations involved in handling these wastes like collection storing transporting and final disposal of biomedical waste in our present paper. There are 4 categories of biomedical wastes like Pathological(human as well as animal tissues, blood and body fluids, products containing A B C & D viruses of hepatitis B C H, I; Contagious body fluids including blood plasma serum urine stool, etc; wastes with detailed others aspects of waste handling methods. In our present paper, we have also statistically studied the R i.e. reducing reusing recycling principles. It elaborates beyond the segregation of wastes from the point of generation by providing the information for the major waste disposal and treatment methods including incineration combustion microwave, micro-waving, landfill etc. and how these can be operational. In our present attempt, we also try to highlight some of the various other issues like Biomedical Waste Management Rules 2016, whether these rules are being followed or not, and the recommendations of the competent authorities of India on this subject. To sum up, the main objective of the paper was to have a safe and environment friendly system of waste management at the hospital level which in turn is a big step towards prevention of the communicable diseases and pollution altogether leading to a healthy community and an improved health care environment.
62
A COMPREHENSIVE REVIEW ON ARTIFICIAL INTELLIGENCE IN PHARMACEUTICAL ANALYTICAL TECNIQUES
By , M. Sajid R. Sayyad, Dr. Prasad V. Patrekar, Dipak R. Phalle, Omkar V. Kamble, M. Chitra G. Rajput, Mrudula P. More
https://doi-doi.org/101555/ijpcr.7569
The merging of traditional instrumental approaches with artificial intelligence (AI) and machine learning (ML) is driving a fundamental shift in pharmaceutical analytical chemistry. Traditional chemometric techniques find it difficult to fully utilize the large, high-dimensional, and frequently noisy datasets produced by spectroscopic techniques (ultraviolet-visible, infrared, near-infrared, Raman, and nuclear magnetic resonance), chromatographic separations (HPLC, UPLC, GC), and mass spectrometry. This review summarizes recent research on the use of AI and ML in the main pharmaceutical analytical workflows, including deep architectures (artificial neural networks, convolutional neural networks, recurrent networks, and transformers), supervised learners (SVM, random forest, k-NN), and classical chemometrics (PCA, PLS). We look at real-time process analytical technology (PAT), predictive quality control, impurity and stability profiling, automated peak detection and deconvolution in chromatography, structure elucidation from combined spectroscopic data, AI-enabled spectral preprocessing and baseline correction, and analytical method development under Quality by Design (QbD) frameworks. In comparison to manual or purely statistical methods, representative case studies from Raman spectroscopy, NMR, chromatography, and mass spectrometry show quantifiable improvements in accuracy, throughput, and reproducibility. Along with outlining emerging directions like generative and foundation models for spectral data, autonomous self-driving laboratories, federated learning, and the integration of AI with green analytical chemistry, the review also takes into account the main obstacles to broader adoption, such as data scarcity and quality, the interpretability of "black-box" deep learning models, regulatory validation requirements, and workforce readiness. All things considered, the data shows that AI is transforming pharmaceutical analysis from a reactive, expertise-bound field into a predictive, automated, and data-driven science. However, it also emphasizes that strong validation, explainability, and regulatory alignment are still necessary for its responsible adoption.
63
A COMPREHEHENSIVE REVIEW ON PHARMACOTHERAPY OF HYPERTENSION
Around 8–42% of premature babies suffering from chronic lung disease of prematurity, known as bronchopulmonary dysplasia (BPD), experience pulmonary hypertension (PH). Infants with BPD-PH have shockingly elevated mortality rates reaching as high as 47%. There is a critical need for effective pharmacotherapies targeted at PH for these infants. Despite the frequent use of various PH-targeted pharmacotherapies for treating BPD-PH, all existing applications are considered off-label. Furthermore, all existing guidelines for the administration of any PH-targeted treatment in infants with BPD-PH rely on expert opinions and consensus declarations. Randomized Control Trials (RCTs) are essential to assess the effectiveness of PH-focused therapies in premature infants either diagnosed with or prone to BPD-PH. Before conducting efficacy RCTs, it is essential to carry out studies to gather pharmacokinetic, pharmacodynamic, and safety information for any pharmacotherapy utilized in this vulnerable and under-researched patient group. This review will examine existing and necessary treatment strategies, highlight knowledge gaps, and outline both the obstacles to address and the methods to adopt in order to create effective pharmacotherapies aimed at improving outcomes for premature infants with or at risk of developing BPD-PH.
64
A COMPREHENSIVE REVIEW ON STERILE MANUFACTURING PRACTICES IN PHARMACEUTICAL INDUSTRIES
By , Rutuja. B. Yamgar, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.9845
The pharmaceutical sector relies heavily on sterile production, especially for items like vaccines, biological products, ophthalmic preparations, injections, and other sterile dosageformFor these products to be safe, highquality, sterile, and stable, microbial and particle contamination must be strictly controlled.The main procedures in sterile manufacturing are covered in this study, including aseptic processing, cleanroom and environmental control, HEPA filtration, staff gowning and hygiene, cleaning, sanitization, and sterilization.
65
A REVIEW ON MEDICATION ERRORS: CAUSES, PREVENTION AND REPORTING
By , Harshad. S. Patil, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.3059
Medication errors are preventable events that may arise at multiple points in the medication use process, including prescribing, transcription, dispensing, preparation, administration and monitoring. Evidence in the uploaded literature shows that errors are multifactorial and reflect interactions between individual performance, clinical conditions, communication, workload, technology, workflow and organizational systems. Different clinical settings and detection methods produce different patterns of observed errors. Prevention is therefore best approached through layered safeguards rather than reliance on individual vigilance. Education and competency development, standardized processes, medication reconciliation, pharmacist involvement, appropriate verification, information technology, automated dispensing, high-alert medication safeguards and reduction of avoidable workload and interruptions are repeatedly represented in the reviewed evidence. Reporting is essential because incident and near-miss information can reveal weaknesses that are otherwise difficult to detect. However, under-reporting remains a major limitation because of fear of punishment or blame, workload and time constraints, unclear definitions, inadequate reporting systems and lack of feedback. A non-punitive, learning-oriented safety culture is therefore necessary to turn reports into preventive learning. Overall, medication safety requires coordinated responsibility across nurses, pharmacists, physicians, administrators and other members of the multidisciplinary healthcare team.
66
A DETAILED REVIEW ON VACCINE DELIVERY TECHNOLOGIES
By , Tanmay S.Waghmare, Dr. Prasad V. Patrekar, Shrirang V. Kharmate, Satyajeet R. Jagdale, Pradeep C. Patil, Pratibha P. Shingade
https://doi-doi.org/101555/ijpcr.1200
Vaccine delivery technologies have progressed from conventional needle-and-syringe administration toward advanced systems designed to improve antigen protection, intracellular delivery, immunogenicity, patient acceptability and mucosal protection. Recent developments include lipid nanoparticles (LNPs) for messenger RNA (mRNA), microneedles and microarray patches for minimally invasive skin delivery, and nanoparticle-based oral, buccal, intranasal and inhaled systems. This review evaluates recent peer-reviewed literature published from 2022 onward. Particular attention is given to formulation principles, delivery mechanisms, advantages, limitations, safety, stability and manufacturing. LNPs have become an important enabling technology for mRNA because they protect RNA and facilitate cellular uptake and intracellular release. Microneedles and microarray patches may reduce pain, sharps waste and dependence on trained personnel. Oral and intranasal systems aim to stimulate mucosal immunity at pathogen-entry sites. Despite rapid progress, stability, dose uniformity, biological barriers, scale-up and regulatory requirements remain important challenges. Future vaccine delivery will require integration of formulation science, nanotechnology, device engineering and manufacturing.