Asian Journal of Pharmaceutical Research and Development
Asian Journal of Pharmaceutical Research and Development (AJPRD) is a new online international journal allowing free unlimited access to abstract and Full text. The journal is devoted to the promotion of pharmaceutical sciences and related disciplines. It seeks particularly (but not exclusively) to encourage pharmaceutical and allied research of tropical relevance and to foster multidisciplinary research and collaboration among scientists, the pharmaceutical industry and health the health care professionals. It will also provide an international plate form for the communication and evaluation of data, methods and findings in pharmaceutical sciences and related disciplines. Although primarily devoted to original research papers, the journal welcomes reviews on current topics of special interest and relevance.
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS: Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
Ethosomal Drug Delivery Systems for Enhanced Topical Delivery of Antiviral and Anti-Inflammatory Drugs
Ethosomal drug delivery systems have emerged as advanced vesicular carriers designed to enhance the topical and transdermal delivery of therapeutic agents, particularly in the management of dermatological conditions such as herpes simplex and herpes zoster. Conventional topical formulations often face significant limitations due to the barrier function of the stratum corneum, which restricts drug penetration and reduces therapeutic efficacy. To overcome these challenges, vesicular systems have been extensively explored, among which ethosomes have demonstrated notable advantages. Ethosomes are distinguished by their high ethanol content combined with flexible phospholipid bilayers, which facilitate deeper skin penetration and improved drug permeation. These systems enhance drug entrapment efficiency, increase bioavailability, and enable sustained drug release compared to traditional carriers like liposomes and niosomes. Their unique mechanism involves ethanol-induced fluidization of skin lipids along with vesicle deformability, allowing efficient transport of active compounds across skin layers. Various aspects of ethosomal systems, including their composition, classification, preparation techniques, and characterization parameters such as vesicle size, zeta potential, morphology, entrapment efficiency, in vitro release, and stability, are critical in determining their performance. Additionally, ethosomes provide a versatile platform for combination therapy by enabling co-delivery of antiviral and anti-inflammatory agents. For instance, simultaneous incorporation of drugs like acyclovir and triamcinolone acetonide offers synergistic benefits by targeting both viral replication and associated inflammation. Overall, ethosomal systems represent a promising and efficient approach for targeted and controlled topical drug delivery. Their ability to enhance permeability, improve therapeutic outcomes, and support combination therapy highlights their potential as superior alternatives to conventional formulations, paving the way for future advancements in pharmaceutical and clinical applications.
Copyright (c) 2026 Dikshita S. Sawarkar, Nitin N. Padole, Pankaj R. Dhapke, Nilakshi N. Dhoble, Jagdish R. Baheti http://creativecommons.org/licenses/by-nc/4.0
Efficacy and Safety of Major Antihypertensive Drug Classes in Adults with Hypertension: A Systematic Review
Background: Hypertension (HTN) remained a major global health concern and a leading risk factor for cardiovascular morbidity and mortality, with many patients requiring more than single-drug therapy to achieve optimal blood pressure control. Objective: This study aimed to evaluate and compare the efficacy and safety of commonly used antihypertensive drug classes, with a focus on different combination therapy strategies. Methods: A systematic review was conducted using PubMed and Google Scholar to identify relevant clinical trials and supporting studies in adult patients with HTN. Studies were selected based on predefined eligibility criteria using the Population, Intervention, Comparison, Outcome (PICO) framework. Data extraction included systolic blood pressure (SBP), diastolic blood pressure (DBP), overall blood pressure control, nighttime blood pressure control, sustained effects, and safety outcomes such as adverse effects, electrolyte changes, and heart rate (HR). A structured comparative approach was used to analyze monotherapy, dual therapy, and multi-drug combinations. Results: The included studies showed that all major antihypertensive drug classes contributed to reductions in SBP and DBP; however, combination therapy demonstrated more consistent and effective overall blood pressure control compared to monotherapy. Differences were observed among drug classes in terms of specific effects, including HR reduction and electrolyte changes. Conclusion: The findings suggested that combination therapy played an important role in achieving better blood pressure control, and a structured comparison of different drug classes and their combinations provided a clearer understanding of their relative efficacy and safety.
Copyright (c) 2026 Amar M. Raval, Aryan Rakesh Verma, Dhruva Shaileshbhai Prajapati http://creativecommons.org/licenses/by-nc/4.0
Nasal In situ Gel Systems For Enhanced Drug Delivery: A Comprehensive Review
Intranasal delivery has emerged as a promising alternative route for drug administration due to its non-invasive nature, rapid absorption, and ability to bypass hepatic first-pass metabolism. In recent years, nasal in-situ gel systems have gained considerable interest as they offer improved retention time and controlled drug release within the nasal cavity. These systems are designed to be administered as low-viscosity liquids that convert into gels upon contact with physiological conditions such as temperature, pH changes, or ions present in nasal secretions. This sol-to-gel transition enhances mucoadhesion, minimizes the chances of formulation drainage, and ensures prolonged interaction of the drug with the nasal mucosa, thereby increasing therapeutic efficiency. Different polymers such as Poloxamers, Carbopol, Gellan gum, and Sodium alginate are widely used in these formulations due to their stimuli-responsive gelling properties and biocompatibility. The ideal nasal in-situ gel should possess optimal viscosity for easy administration, suitable gel strength for retention, and must maintain clarity, stability, sterility, and uniform drug content. Such formulations have demonstrated significant potential in delivering a broad range of therapeutic agents including analgesics, anti-inflammatory drugs, peptides, vaccines, and central nervous system (CNS) active compounds, especially where rapid and sustained action is desired. Evaluation of nasal in-situ gels involves assessing parameters like gelling capacity, viscosity, gel strength, drug release behavior, isotonicity, sterility, and stability studies to ensure safety and effectiveness. Overall, nasal in-situ gel technology offers a versatile and patient-friendly platform capable of improving drug bioavailability and enhancing clinical outcomes for various therapeutic applications.
Copyright (c) 2026 Pahurkar A. Ashwin, Dr. Nishan N. Bobade, Dr. Shrikant D. Pande, Dr.Pravin Wakte , Dr. Sandeep C Atram, Dr. Vikrant P. Wankhade http://creativecommons.org/licenses/by-nc/4.0
A Comprehensive Review of Polycystic Ovary Syndrome (PCOS): Pathophysiology, Diagnosis and Management
Polycystic Ovary Syndrome (PCOS) is one of the most prevalent endocrine and metabolic disorders affecting women of reproductive age worldwide. It is characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. Beyond reproductive abnormalities, PCOS is strongly associated with insulin resistance, obesity, dyslipidemia, and chronic low-grade inflammation, predisposing affected individuals to type 2 diabetes mellitus, cardiovascular disease, and endometrial hyperplasia. The pathophysiology of PCOS is multifactorial, involving genetic predisposition, neuroendocrine dysregulation, metabolic disturbances, and environmental influences. Diagnosis is primarily based on the Rotterdam consensus criteria. Management strategies include lifestyle modification, pharmacological therapy tailored to symptom profile, and fertility-directed interventions where required. This review comprehensively summarizes the epidemiology, mechanisms, clinical manifestations, diagnostic criteria, therapeutic approaches, and emerging trends in PCOS management.
Copyright (c) 2026 Pankti Bhavik kumar Patel, Amar M. Raval, Helly Bhupendrabhai Patel, Krisha Hiteshbhai Patel, Patel Poorv, Purva Ajesh Kumar Vaidya, Krishna Hiteshkumar Kahar http://creativecommons.org/licenses/by-nc/4.0
Review on QBD Approaches to HPLC Method Development and Validation on Tirzepatide
Tirzepatide, a novel dual GIP and GLP-1 receptor agonist, requires highly sensitive and robust analytical methods for quality control. This study describes a systematic Quality by Design (QbD) approach for the development and validation of a stability-indicating RP-HPLC method. The Analytical Target Profile (ATP) was defined to ensure a short runtime with high resolution. Critical Quality Attributes (CQAs), including the tailing factor (T \leq 1.5) and resolution (Rs > 2.0), were monitored against Critical Method Parameters (CMPs) such as mobile phase composition (Acetonitrile percentage), flow rate, and buffer pH. Using a Central Composite Design (CCD), the design space was established to identify the Method Operable Design Region (MODR). Forced degradation studies under acidic, alkaline, and oxidative conditions confirmed the method’s stability-indicating nature, as degradants were well-resolved from the Tirzepatide peak. The results indicate that the proposed QbD-based method is cost-effective, robust, and highly suitable for routine pharmaceutical analysis.
Copyright (c) 2026 Ravina Mule, Dr Vinayak Gaware http://creativecommons.org/licenses/by-nc/4.0
An essential component of the entire drug development process is pharm acovigilance. Pharmacovigilance is the ongoing observation, assessment, and interpretation of possible side effects or other problems pertaining to medications. By weighing the advantages and disadvantages of particular medications, this promotes patient safety. Pharmacovigilance has been more effective with the use of information technology, allowing for improved monitoring and clinical safety procedures. It is essential to ensuring the cost-effectiveness, safety, and efficacy of medications over their entire lifecycle, from research to postmarketing monitoring. ICH GCP, USFDA standards, and other regulatory g uidelines regulate the clinical trial procedure.The evidence underpinning for regulatory judgments about safe and effective medications is provided by clinical studies. A crucial part of every stage of the drug development life cycle is safety evaluation A crucial part of every stage of the drug development life cycle is safety evaluation. The ultimate objective of pharmacovigilance in clinical trials is to monitor and evaluate the test product's safety profile.
Copyright (c) 2026 Shelke Nikita, Shelke Harshal B, Sathe Dipti B, Sangale Vaibhavi S. http://creativecommons.org/licenses/by-nc/4.0
Revolutionary Aspects of Artificial Intelligence in Drug Discovery and Development
The pharmaceutical sector is shifting with the help of artificial intelligence (AI), which has enhanced the accuracy of drug development and discovery. AI enables predictive modeling of bioactivity and toxicity, accelerates virtual screening and lead optimization, enhances the processing of complex biological data sets, and streamlines clinical trial design and patient recruitment. To analyze how AI has transformed the pharmaceutical sector, enhanced product life cycle management, and facilitated data-informed decision-making from target candidate selection to market, this research includes high-impact studies. We also address operational, ethical, and regulatory challenges as well as what needs to be done to ensure that AI delivers its promise of creating better, faster, and cheaper cures.
Copyright (c) 2026 Neetu Dharu N, Iram Fatema Siddique, Dr. Gautam B. Sonara, Dr. Manish B. Goyani http://creativecommons.org/licenses/by-nc/4.0
Artificial Intelligence in Pharmacy and Healthcare: Applications in Drug Discovery, Precision Medicine, Clinical Practice, and Future Perspectives
Artificial intelligence (AI) is revolutionizing pharmaceutical sciences and healthcare by enabling predictive analytics, automation, precision therapeutics, and real-time clinical decision support. The integration of machine learning (ML), deep learning (DL), natural language processing (NLP), and generative AI across drug discovery, pharmaceutical manufacturing, clinical practice, pharmacovigilance, and regulatory science has transformed traditional workflows. AI-driven molecular modelling accelerates target identification and de novo drug design, while advanced analytics optimize clinical trials and manufacturing processes. In clinical settings, AI enhances diagnostic accuracy, patient risk stratification, and medication safety monitoring. However, challenges including algorithmic bias, data privacy concerns, regulatory uncertainty, and explainability remain significant barriers to widespread adoption. This review provides a comprehensive overview of AI applications in pharmaceutical sciences and healthcare (2020–2025), discusses regulatory and ethical frameworks, and outlines future directions including explainable AI, federated learning, and digital twins. Responsible integration of AI technologies holds transformative potential for improving healthcare efficiency, therapeutic precision, and patient outcomes globally. .
Copyright (c) 2026 Amar M. Raval, Dr Twinkle Rana, Srushti Yogeshbhai Joshi, Dr Switi Buch, Dr Bhoomi Arora, Vishwa S. Patel http://creativecommons.org/licenses/by-nc/4.0
Gastro-Retentive Floating Drug Delivery System: A Comprehensive Review
Floating Drug Delivery Systems are an advanced gastroretentive approach designed to improve the bioavailability and therapeutic efficacy of drugs that have a narrow absorption window or are unstable in the intestinal environment. These systems remain buoyant in gastric fluids due to their low density or gas-generating mechanisms, allowing prolonged gastric retention and controlled drug release at the desired site. FDDS are broadly categorized into effervescent and non-effervescent systems, including bilayer tablets, raft-forming systems, and colloidal gel barrier formulations. Various formulation and physiological factors such as polymer type, tablet size, gastric motility, and fed or fasted state significantly influence the gastric retention time and drug release behavior. Among the preparation techniques, direct compression, wet granulation, and effervescent methods are widely employed. FDDS offer distinct advantages like enhanced bioavailability, reduced dosing frequency, and improved patient compliance, though they are unsuitable for drugs unstable in acidic media.
Copyright (c) 2026 Malpani P. Shraddha, Dr. Nishan N. Bobade, Dr. Shrikant D. Pande, Dr. Sandeep C. Atram, Dr.Vikrant P. Wankhade http://creativecommons.org/licenses/by-nc/4.0
Phytochemical Constituents and Antidiabetic Potential of Swertia Chirayita: A Review of Pharmacological and Therapeutic Applications
Artificial intelligence (AI) is revolutionizing pharmaceutical sciences and healthcare by enabling predictive analytics, automation, precision therapeutics, and real-time clinical decision support. The integration of machine learning (ML), deep learning (DL), natural language processing (NLP), and generative AI across drug discovery, pharmaceutical manufacturing, clinical practice, pharmacovigilance, and regulatory science has transformed traditional workflows. AI-driven molecular modelling accelerates target identification and de novo drug design, while advanced analytics optimize clinical trials and manufacturing processes. In clinical settings, AI enhances diagnostic accuracy, patient risk stratification, and medication safety monitoring. However, challenges including algorithmic bias, data privacy concerns, regulatory uncertainty, and explainability remain significant barriers to widespread adoption. This review provides a comprehensive overview of AI applications in pharmaceutical sciences and healthcare (2020–2025), discusses regulatory and ethical frameworks, and outlines future directions including explainable AI, federated learning, and digital twins. Responsible integration of AI technologies holds transformative potential for improving healthcare efficiency, therapeutic precision, and patient outcomes globally.
Copyright (c) 2026 Mali Devyani R, Mene Arpita P, Mandlik Shraddha E, Mankar Prerana D, Kotkar Vaishnavi D http://creativecommons.org/licenses/by-nc/4.0
Niosomal Nanovesicular Spray Systems for Topical Drug Delivery: Formulation Strategies, Characterization, and Therapeutic Applications
Topical drug delivery is commonly used for localized therapy, but conventional gels, creams, and ointments often face limitations in skin penetration and consistent therapeutic response. Niosome-based nanosprays provide an advanced alternative by encapsulating both hydrophilic and lipophilic drugs in non-ionic surfactant vesicles with a bilayer structure. Key formulation factors affecting performance include surfactant type, cholesterol content, vesicle size and surface properties, and drying methods. Converting liquid dispersions into dry nanospray powders enhances stability, handling, and storage while preserving vesicle integrity. Preclinical studies show that niosomalnanosprays penetrate deeper skin layers, extend dermal retention, and improve therapeutic outcomes for dermatological and inflammatory conditions compared with traditional topical systems. Despite these advantages, challenges remain in scaling up production, ensuring long-term stability, and validating clinical efficacy. Employing quality-by-design strategies and optimizing formulations are essential for translating niosome-based nanosprays into commercially viable and effective therapeutic products.
Copyright (c) 2026 Shaikh Zoya Fatema, Vaidya Vijay D, Borkar Shilpa S, Baheti Jagdish http://creativecommons.org/licenses/by-nc/4.0
Nanotechnology-Enabled Niosomal Nasal Sprays: Unlocking New Therapeutic Avenues for Alzheimer’s Disease
To determine the viability of using niosome-based nasal sprays as a new delivery method for therapeutic use in Alzheimer’s disease. Through searches of current peer-reviewed publication materials through study of nanotechnology drug delivery systems, intranasal delivery and therapeutics used in the treatment of Alzheimer’s. Relevance to niosomal formulations, pathway of nose-to-brain administration and previous or ongoing studies (preclinical)/clinical studies on therapeutics developed to treat Alzheimer’s.Alzheimer’s is a progressive neurodegenerative disorder with limited options for therapy, due largely to the inability of drug molecules to effectively pass through the blood-brain barrier (BBB). Intranasal administration provides non-invasive delivery of therapeutics, eliminating the need for crossing through the BBB (via olfactory/trigeminal nerves). Niosomes formulated from non-ionic surfactants and cholesterol provide improved stability, bioavailability and sustained-release of active ingredients. Niosomal form would improve delivery of therapeutics into the brain, decrease the incidence of systemic adverse effects from drugs used to treat Alzheimer’s and enhance therapeutic effectiveness in an Alzheimer’s patient. Preliminary clinical trials for the use of niosomes demonstrate improved pharmacokinetics of the drug, cognitive improvement for patients receiving niosomal therapy and greater safety of niosomal therapies over traditionally formulated products.The use of niosomal nasal sprays for the targeted administration (i.e., brain) of therapeutics for treating Alzheimer’s represents a powerful and innovative approach to address Alzheimer’s disease and will require additional clinical evidence and methods to support large-scale niosome production.
Copyright (c) 2026 Charde Yugali, Dhapake Pankaj, Dhoble Nilakshi, Padole Nitin, Baheti Jagdish http://creativecommons.org/licenses/by-nc/4.0
NMR Libraries of Natural and Synthetic Monosaccharides
Nuclear Magnetic Resonance (NMR) spectroscopy is a cornerstone analytical technique for the structural elucidation of monosaccharides, which are the fundamental building blocks of complex carbohydrates. Due to their structural diversity, including variations in stereochemistry, ring forms (furanose and pyranose), and functional group modifications, accurate identification of monosaccharides remains a significant challenge in glycoscience. To address this, NMR libraries of natural and synthetic monosaccharides have been developed, providing reference spectra for a wide range of sugar molecules under standardized conditions. These libraries typically include both 1D (¹H, ¹³C) and 2D (COSY, HSQC, HMBC, TOCSY) NMR data, enabling comprehensive structural comparisons. Such databases are essential tools for rapid identification, quality control in carbohydrate synthesis, and the interpretation of complex biological mixtures, such as plant extracts or glycoproteins. Synthetic monosaccharides, often labeled or derivatized, are especially useful in expanding NMR libraries to include rare or unstable structures not readily found in nature. Moreover, computational tools and software are now integrated with these spectral databases, improving automated peak assignments and structure prediction. These resources facilitate the study of carbohydrate-related biological processes, such as pathogen recognition, cell signaling, and energy metabolism. The development and continuous updating of NMR libraries not only streamline structural analysis but also contribute to standardization efforts in carbohydrate research. As the demand for glycan-based therapeutics and diagnostics grows, the role of comprehensive NMR libraries becomes increasingly vital in supporting both fundamental research and applied sciences.
Copyright (c) 2026 Pushpraj Singh http://creativecommons.org/licenses/by-nc/4.0
Review on The Multifunctional Role of Flaxseed (Linum Usitatissimum) in Pharmacotherapeutics: Bioactive Constituents and Clinical Evidence
Linum usitatissimum, commonly known as flaxseed, is one of the most important medicinal plants that has been traditionally used for its wide-ranging health and nutritional benefits. Owing to its rich chemical composition, flaxseed has attracted considerable scientific interest as a functional food with significant pharmacological potential. This review summarizes the major bioactive constituents of flaxseed, including alpha-linolenic acid, lignans, dietary fibers, proteins, vitamins, and minerals, and highlights their pharmacological relevance supported by experimental and clinical evidence. Flaxseed exhibits multiple biological activities, such as antioxidant, anti-inflammatory, estrogenic and anti-estrogenic, laxative, and antibacterial effects, which collectively contribute to its therapeutic value. Both whole flaxseeds and flaxseed oil are among the richest plant-based sources of omega-3 fatty acids, particularly alpha-linolenic acid, which plays a crucial role in maintaining cardiovascular and metabolic health. Regular consumption of flaxseeds has been associated with the prevention and management of a wide range of chronic disorders, including cardiovascular diseases, neurodegenerative conditions, obesity, diabetes mellitus, polycystic ovary syndrome, and gout. In addition, flaxseed intake has been reported to support liver and kidney function and to reduce the risk of diseases associated with oxidative stress. Its phytoestrogen content has shown beneficial effects in alleviating postmenopausal symptoms and improving bone health in osteoporosis. Furthermore, flaxseed has demonstrated positive effects in gastrointestinal disorders such as irritable bowel syndrome, diarrhea, and constipation, as well as in conditions like dry eye disease and cystic fibrosis. Notably, increasing evidence suggests that flaxseed and its bioactive components may exert protective effects against certain hormone-dependent cancers, particularly breast and prostate cancer, underscoring its importance in preventive and therapeutic healthcare strategies.
Copyright (c) 2026 Suraj Hirekar, Solanke Sohani, Katre Bhumika, Chaudhari Tanuja, More Ankita, Pawar Siddhi http://creativecommons.org/licenses/by-nc/4.0
A Comprehensive Review of Antibiotic Resistance: Mechanisms, Causes, and Novel Therapeutic Approaches
Antibiotic resistance is a major global health concern that threatens the effective treatment of bacterial infections. The misuse and overuse of antibiotics in human medicine and agriculture have accelerated the emergence of resistant bacterial pathogens such as Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa. Various mechanisms, including genetic mutations and horizontal gene transfer, contribute to the spread of antimicrobial resistance. This review discusses the causes and mechanisms of antibiotic resistance as well as emerging strategies to combat it, including bacteriophage therapy, antimicrobial peptides, and advanced genomic technologies. Strengthening antimicrobial stewardship, improving surveillance systems, and developing new therapeutic approaches are essential to control the spread of antibiotic resistance and ensure effective treatment in the future.
Copyright (c) 2026 Prit Sunilbhai Patel, Amar M. Raval, Patel Annavi Ashish Kumar, Patel Poorv Dharmendra Kumar, Prajapati Tushar Ghanshyam, Patel Pankti bhavikkimar http://creativecommons.org/licenses/by-nc/4.0
Recent Insights into Breast Cancer Metastasis: Molecular Pathways, Prognostic Markers and Novel Therapies
Breast cancer metastasis remains a major challenge, contributing significantly to its high mortality rate despite progress in early diagnosis and localized treatments. This review consolidates recent advancements in three crucial areas: molecular mechanisms underlying metastatic progression, prognostic biomarkers for disease prediction, and emerging therapeutic strategiestargetingmetastasis. Keysignaling pathways, including MAPK,PI3K/AKT/mTOR, and Wnt/β-catenin, as well as tumor microenvironment interactions and epithelial-mesenchymal transition, are explored for their role in tumor dissemination and colonization of distant organs. The discovery of prognostic markers such as circulating tumor cells (CTCs), exosomal micro RNAs, cell-free DNA, and genetic alterations like BRCA1/2 mutations and HER2 amplification has revolutionized precision oncology by enabling real-time disease monitoring and patient stratification. Additionally, advancements in transcriptomic and proteomic profiling have introduced novel biomarkers that enhance metastaticrisk assessment and therapeutic decision-making. In parallel, innovative treatment approaches offer new prospects for managing metastatic breast cancer. Immunotherapy strategies, including cancer vaccines, immune checkpoint inhibitors, and adoptive cell therapies, are reshaping treatment paradigms, while targeted small-molecule inhibitors, such as PARP and CDK4/6 inhibitors, alongwith nanotechnology-based drug delivery systems, are improving therapeutic efficacy while minimizing adverse effects. However, challenges such as tumor heterogeneity, resistance to therapy, and variable patient responses highlight the need for further research and clinical trials. By bridging molecular insights with clinical applications, this review aims to provide a comprehen sivere source on the evolving land scape of metastatic breast cancer, focusing on molecular mechanisms, prognostic advancements, and novel therapeutic developments.
Copyright (c) 2026 Bhadange Jyoti A, Dr. Shekhar V. Kokate, Netra Mhatre, Kashish Gaikwad, Rakesh Yadav, Manasi Chogale http://creativecommons.org/licenses/by-nc/4.0
A Critical Appraisal of Lc–Ms/Ms Bioanalytical Method Validation for Cilostazol According To USFDA and ICH M10
Cilostazol is a phosphodiesterase III inhibitor widely used for the treatment of intermittent claudication and prevention of thrombotic events. Accurate quantification of cilostazol in biological matrices is essential for pharmacokinetic evaluation, bioequivalence assessment, and therapeutic monitoring. Liquid chromatography coupled with tandem mass spectrometry has become the gold standard analytical technique due to its superior sensitivity, selectivity, and robustness. Regulatory authorities such as the United States Food and Drug Administration and the International Council for Harmonisation have established comprehensive guidelines to ensure reliability and reproducibility of bioanalytical data. The present review critically evaluates LC–MS/MS bioanalytical method validation for cilostazol with particular emphasis on regulatory expectations outlined in USFDA guidance and ICH M10. Method development strategies, validation parameters, matrix effects, stability considerations, incurred sample reanalysis, data integrity, and lifecycle management are discussed in depth. The article also highlights challenges encountered in real laboratory settings and provides perspectives on harmonization and future trends in bioanalytical science.
Copyright (c) 2026 Srushti Chame, Shrikrishna Baokar, Rajendra Patil, Mansingh Rajput http://creativecommons.org/licenses/by-nc/4.0
A Review on: Advances in colon targeted drug delivery system for oral site specific Therapeutics
The delivery of the drug into the eye has always been a big problem because of the organs and physiological peculiarities of the eye: the eye is blinking, tears are flowing, and nasolacrimal drainage. The traditional dosage delivery methods such as eye drops and eye ointments are usually associated with poor bioavailability and poor therapeutic potential. In order to address these constraints, in situ gels in the eye have become one of the promising ones to provide long residence time, greater compliance, and regulated drug delivery in patients. These formulations are embedded as low-viscosity solutions undergoing a sol-to-gel transition to environmental stimuli, e.g. pH, temperature, or ionic strength in the ocular cavity. Some of the polymers that are used as either natural or synthetic polymers such as chitosan, carbopol, poloxamer, and gellan gum are very important in giving the gelling property and biocompatibility. The design of ophthalmic in situ gels entails rather sensitive areas such as viscosity, clarity, drug entrapment capacity, gelation capacity, and sterility that have direct influence on therapeutic performance. Rheology, gel strength, in vitro release studies, and ocular irritation tests are the methods of characterization that are important to evaluate the quality of the formulations. This review outlines the latest progress in the design of strategies to be used in the formulation of ophthalmic in situ gel, the criteria of evaluation, and the therapeutic use and outlines how it can be used as an efficient substitute to the traditional methods of ocular delivery systems.
Copyright (c) 2026 Switi S. Naktode, Dr. Shrikant P. Pande, Shrushti P. Wagh, Shrirang A. Virkhare, Sidhhi P. Kalbande http://creativecommons.org/licenses/by-nc/4.0
A Review on Phytosomes for Effective Topical Drug Delivery
In recent years, there has been growing interest in the therapeutic potential of medicinal herbs and the bioactive compounds they contain for treating various health conditions. However, challenges such as poor bioavailability and limited targeting ability may reduce their effectiveness in clinical applications. As a result, enhancing the bioavailability of these compounds has become a critical focus to maximize their therapeutic impact. Phytosome-based nanotechnology offers a promising solution, especially for improving the topical delivery of herbal bioactives. Phytosomes, which are lipid-based nanoparticles, significantly enhance the absorption and penetration of phytochemicals across biological barriers, such as the skin. This review examines how encapsulating phytochemicals in a phytosome—a complex of plant compounds and phospholipids—can enhance their absorption, bioavailability, and ability to penetrate the skin.
Copyright (c) 2026 Ajay Prakash Nemade, Dr. Sandeep C. Atram, Dr. Vikrant P. Wankhade, Nishan N. Bobade, Dr. Shrikant D. Pande http://creativecommons.org/licenses/by-nc/4.0
Sustained Release Microspheres in Drug Delivery: Formulation Strategies, Characterization, and Therapeutic Application
Sustained release microspheres have emerged as a promising and versatile drug delivery system capable of improving therapeutic efficacy, patient compliance, and overall treatment outcomes by providing controlled and prolonged drug release. These microspheres, typically composed of biodegradable and biocompatible polymers such as PLGA, PLA, chitosan, and alginate, are designed to encapsulate a wide range of drugs, including small molecules, peptides, and proteins, and release them at a predetermined rate over extended periods. Various formulation strategies such as solvent evaporation, spray drying, ionic gelation, coacervation, and advanced techniques like microfluidics have been extensively explored to optimize particle size, drug loading, and release characteristics. Comprehensive characterization of microspheres, including particle size analysis, surface morphology, encapsulation efficiency, thermal behavior, and in vitro drug release studies, plays a critical role in ensuring formulation stability and performance. Drug release from microspheres is governed by mechanisms such as diffusion, degradation, swelling, and erosion, which can be effectively, modeled using kinetic approaches like zero-order, Higuchi, and Korsmeyer peppas models. These systems have demonstrated significant potential across diverse therapeutic areas, including cancer therapy, diabetes management, cardiovascular diseases, infectious diseases, hormone delivery, vaccine delivery, and central nervous system disorders, with several formulations already approved for clinical use. Furthermore, recent advancements in targeted delivery, stimuli responsive systems, and nanostructured microspheres, along with integration of Quality by Design (QbD) and artificial intelligence approaches, have further expanded their application scope. Despite challenges such as burst release, scale-up difficulties, and regulatory considerations, sustained release microspheres continue to represent a cornerstone in modern pharmaceutics, offering innovative solutions for controlled and site-specific drug delivery.
Copyright (c) 2026 Tusara Kanta Behera, Santosh Kumar Dash, Jyotirmaya Parida, Khagesh Bhoi, Lokesh Kumar Barik, Madhusudan Behera, Jitu Rout, Kandarpa Rana, Kundan Bishi http://creativecommons.org/licenses/by-nc/4.0
An Antihyperlipidemic Agents Review for Atherosclerosis Treatment
Elevated levels of one or more plasma lipids, including triglycerides, cholesterol, cholesterol esters, phospholipids, and/or plasma lipoproteins, including very low-density lipoprotein and decreased levels of high-density lipoprotein are indicative of a medical condition called hyperlipidemia. This elevation in plasma lipids is one of the primary risk factors for cardiovascular diseases.Statins and fibrates remain the main antihyperlipidemic drugs for the treatment of elevated plasma cholesterol and triglycerides, respectively, at the cost of major negative effects on the liver and muscles. Hyperlipidemia is the main risk factor for coronary heart disease.
Copyright (c) 2026 Rutuja Talekar, Nanasaheb Gorade, Sachin Jadhav, Pratiksha Chormage, Shivani Gadekar, Swati H.Tarkase, Dr.Gajanan Sanap http://creativecommons.org/licenses/by-nc/4.0
Review on Carbon Nanotubes in Drug Therapy
Carbon nanotubes have gained considerable attention as advanced Nano carriers in drug therapy owing to their distinctive structural, physiochemical and biological characteristics. Their exceptionally large surface area, nanoscale size and efficient cellular internationalization facilitate high drug-loading capacity and targeted delivery of diverse therapeutic agent, including small molecules, proteins and nucleic acid. Surface modification of CNTs through covalent or non-covalent functionalization significantly improves their aqueous dispensability, biocompatibility and targeting efficiency, while simultaneously minimizing intrinsic toxicity. CNT-based drug delivery platforms enable controlled and sustained drug release, enhance bioavailability and reduce off-target effects with particular relevance in cancer treatment.
Copyright (c) 2026 Pavithra.T.K, Mahalakshmi.C.R, Hummera.R, Shashikala.V, Shwetha.T.L http://creativecommons.org/licenses/by-nc/4.0
Floating Bilayered Tablets: A Novel Approach in Gastro-Retentive Drug Delivery System
Floating bilayered tablets represent an advanced gastro-retentive drug delivery approach designed to enhance the bioavailability of drugs that exhibit narrow absorption windows or poor solubility in alkaline environments. This review provides an in-depth overview of recent progress in the design, formulation, and evaluation of EFBTs. The effervescent mechanism relies on acid–base interactions, typically involving sodium bicarbonate and citric acid, which generate carbon dioxide to achieve rapid buoyancy and prolonged gastric residence. The bilayer configuration combines a floating or immediate-release layer with a sustained-release layer, ensuring controlled drug release and improved pharmacokinetic performance. Various studies have demonstrated floating lag times of less than one minute, sustained release over 12–24 hours, and marked enhancement in relative bioavailability and patient compliance. Drugs such as eplerenone, levofloxacin, nicotinamide, and clarithromycin have shown significant therapeutic benefits when formulated as FBTs. Key formulation aspects—including polymer selection, gas-generating agents, and matrix integrity—play vital roles in optimising drug release kinetics and buoyancy characteristics. Furthermore, the review discusses critical evaluation parameters, stability profiles, and regulatory considerations that influence the successful translation of laboratory findings into commercial dosage forms. Overall, effervescent floating bilayered tablets offer a versatile and patient-friendly platform for achieving sustained gastric retention, controlled release, and enhanced therapeutic efficacy in oral drug delivery.
Copyright (c) 2026 Ishika Bijore, Vikrant Wankhede, Shrikant Pande, Abhishek Mankar, Saurabh Bodke, Shrirang Virkhare http://creativecommons.org/licenses/by-nc/4.0
Fabrication and Evaluation of Polyherbal Diaper Rash Gel
Diaper rash is a common dermatological condition affecting infants and young children, causing inflammation, discomfort, and potential bacterial or fungal infections. Current synthetic formulations often contain chemical irritants and pose the risk of adverse effects. This research presents the formulation, fabrication, and comprehensive evaluation of a novel polyherbal diaper rash gel incorporating natural botanicals with proven dermatological properties. The gel formulation was developed using Aloe vera (soothing and antimicrobial), Calendula officinalis (anti-inflammatory and wound healing), Chamomilla recutita (calming and protective), and Zinc oxide (protective barrier). The gel was prepared using optimized concentrations of herbal extracts, thickening agents, and preservatives. Physicochemical evaluation included appearance, pH testing, viscosity measurement, spreadability assessment, and antimicrobial activity testing against Staphylococcus aureus and Candida albicans. Stability testing was performed under accelerated conditions (40°C ± 2°C, 75% ± 5% RH for 90 days). The optimized formulation demonstrated excellent physical properties with pH 6.5 ± 0.2, appropriate viscosity for topical application, and superior spreadability. The gel exhibited significant antimicrobial activity against both test organisms, demonstrating MIC values of 62.5µg/mL and 125µg/mL respectively. Stability studies showed consistent physicochemical parameters throughout the testing period. The polyherbal gel formulation presents a safe, efficacious, and cost-effective alternative to conventional diaper rash products, offering dual benefits of soothing relief and antimicrobial protection without adverse effects associated with synthetic ingredients.
Copyright (c) 2026 Deepak Prashar, Sakshi Binta, Niharika, Pallavi, Sahil http://creativecommons.org/licenses/by-nc/4.0
LC–MS/MS Bioanalysis of Gabapentin in Human Plasma: Method Development, Validation, and Regulatory Perspectives under USFDA and ICH M10 Guidelines
Gabapentin, a structural analogue of gamma-aminobutyric acid, is widely used in the treatment of epilepsy, neuropathic pain, and related neurological disorders. Reliable quantification of gabapentin in human plasma is critical for pharmacokinetic, bioavailability, and bioequivalence studies. However, due to its high polarity, zwitterionic nature, and lack of strong chromophores, conventional analytical methods such as HPLC and UV spectroscopy often exhibit limited sensitivity and selectivity. In this context, liquid chromatography–tandem mass spectrometry (LC–MS/MS) has emerged as the method of choice for gabapentin bioanalysis owing to its superior sensitivity, selectivity, and robustness. This review provides a comprehensive evaluation of LC–MS/MS methods developed for the quantification of gabapentin in human plasma, with particular emphasis on bioanalytical method development strategies and validation requirements as per United States Food and Drug Administration (USFDA) and International Council for Harmonisation (ICH M10) guidelines. Critical aspects including sample preparation techniques, chromatographic optimization, mass spectrometric parameters, and internal standard selection are systematically discussed. A comparative assessment of reported methods highlights variations in extraction efficiency, matrix effect evaluation, analytical sensitivity, and regulatory compliance. Furthermore, this review identifies key limitations in existing methods, such as inadequate assessment of matrix effects, incomplete stability studies, lack of appropriate internal standards, and insufficient evaluation of carryover, dilution integrity, and incurred sample reanalysis. These gaps may affect the regulatory acceptability and reproducibility of bioanalytical data. In conclusion, although LC–MS/MS offers a highly effective platform for gabapentin bioanalysis, strict adherence to harmonized regulatory guidelines and implementation of a lifecycle-based validation approach are essential to ensure method reliability, reproducibility, and global regulatory acceptance. This review aims to serve as a practical reference for the development of robust and compliant bioanalytical methods for gabapentin.
Copyright (c) 2026 Ashvini Pawar, Shrikrishna Baokar, Rajendra Patil, Mansingh Rajput http://creativecommons.org/licenses/by-nc/4.0
A Survey on Awareness on Pregnancy Related Complications and Associated Factors
Pregnancy related complications are a major health concern in our country. Awareness of these complication is essential for early detection of complication and prevention of maternal mortality. The purpose of this study was to analyze the awareness regarding the pregnancy related complications and associated factors in pregnant and parous women. It was questionnaire based survey conducted in pregnant and parous women contains both open-ended and close ended questions covering the knowledge of complication like, anemia, gestational hypertension, gestational diabetes, pre-eclampsia, ectopic pregnancy, preterm birth. Finding of the survey indicates that the women had general awareness about complications but more awareness is still needed. high educational status, regular antenatal care attendance and exposure to health information can reduce the incidence of complications. the survey asses the role of ANC in prevention of complications and reduce the maternal health risk.
Copyright (c) 2026 Ankita Dongare, Tejas Deshmukh, Bhavika Bahekar, Akanksha Patil, Prachi Shivankar, Dr. Nitin Indurwade http://creativecommons.org/licenses/by-nc/4.0
Development and Evaluation of Multifunctional Co-Processed Excipients for Fast Dissolving Tablet Formulation
Fast dissolving tablets (FDTs) are novel oral solid dosage forms designed to disintegrate rapidly in saliva without the need for water. They improve patient compliance, especially in pediatric, geriatric, and dysphagic patients. The present study aimed to formulate and evaluate co-processed excipients for fast dissolving tablets using the wet granulation method. Different batches of co-processed excipients were prepared using Crospovidone, microcrystalline cellulose, sodium starch glycolate, mannitol, talc, magnesium stearate, and PVP K30. Pre-compression parameters such as bulk density, tapped density, Carr’s index, Hausner ratio, and angle of repose were evaluated to determine flow properties. Post-compression studies included hardness, disintegration time, wetting time, and water absorption ratio. The results demonstrated that co-processed excipients significantly improved the flowability and compressibility compared to physical mixtures. Among all formulations, batch F5 showed optimum performance with excellent flow properties, compressibility, rapid disintegration time (40.58 sec), and wetting time (26 sec). The study concluded that co-processed excipients are an effective approach for improving the overall performance of fast dissolving tablets.
Copyright (c) 2026 Amar M. Raval, Pandya Foram Utpalkumar, Pandya Vipra Utpalkumar, Bhavsar Prathmesh Ratnakar http://creativecommons.org/licenses/by-nc/4.0
Development and Evaluation of PolyherbalTopical Cream for Wound Healing Applications Using Alum, Turmeric, and Aloe Vera
Background: Hypertension (HTN) remained a major global health concern and a leading risk factor for cardiovascular morbidity Wound healing is a complex biological process involving hemostasis, inflammation, proliferation, and tissue remodeling. Herbal formulations have gained significant interest due to their safety, effectiveness, and reduced adverse effects compared to synthetic products. The present study aimed to formulate and evaluate a polyherbal wound healing cream containing alum, turmeric, and aloe vera using an oil-in-water emulsion base. Different batches (F1, F2, and F3) were prepared by varying the concentration of excipients such as stearic acid, cetyl alcohol, glycerin, and herbal extracts. The prepared formulations were evaluated for appearance, pH, spreadability, homogeneity, greasiness, phase separation, washability, skin irritation, and stability. The results indicated that all formulations showed acceptable physical characteristics. Batch F3 demonstrated superior properties with good spreadability, light yellow appearance, pleasant odor, no phase separation, and excellent stability. The study concluded that the developed polyherbal cream possesses promising potential for wound care applications.
Copyright (c) 2026 Amar M. Raval, Rathod Jainish Maneklal, Makwana Utsav Dilipbhai http://creativecommons.org/licenses/by-nc/4.0