International Journal of Pharmaceuticals and Health Care Research
The International Journal of Pharmaceuticals and Health Care Research (IJPHR) is a peer-reviewed, Quarterly official international journal allowing access to abstracts and full-text. The journal is devoted to the promotion of pharmaceutical sciences, Health care, Public health and other related multi disciplines. Multi - Disciplines follows: Pharmacotherapy, Drug delivery systems, Drug Analysis, Hospital Pharmacy, Chemical Moieties, Pharmacology, Docking studies, Clinical studies, Traditional medicines, Immunology, Radiopharmaceuticals, Nuclear medicines, Nursing, Microbiology, Biotechnology, Industrial trials, Physiotherapy, Psychotherapy, Ophthalmology, Physiology, Biochemistry, Environmental and occupational health, Community medicine, Endermologie, Epidemiology and biostatistics, Human nutrition, Reproductive health, Health service management, Health informatics, Sociology & Social works, Biomedical engineering sciences, Molecular biology, Natural & computational sciences, Veterinary medicines, Plant biological studies. ISSN: 2306 - 6091 International Journal of Pharmaceuticals and Health Care Research seeks to foster multidisciplinary research and collaboration among scientists, pharmaceutical industries and healthcare sector as well as provide an international forum for the communication and evaluation of data, methods and opinions in pharmaceutical sciences and other related inter multi disciplines. Although primarily devoted to original research papers, the journal particularly welcomes reviews on current topics of special interest and relevance. All manuscripts will be subjected to rapid peer review. Those of high quality (not previously published and not already under consideration for publication) will be published without delay.
Glycerosomes: Recent Advancements, Therapeutic Applications, and Patents
Glycerosomes are innovative vesicular drug delivery systems composed of phospholipids, water, and high concentrations of glycerol (20–50%), which confer exceptional membrane flexibility and deformability. Originally introduced as advancement over classical liposomes and trans-fersomes, glycerosomes have emerged as versatile platforms for transdermal, topical and dermal drug delivery owing to their superior skin permeation capabilities, biocompatibility, and capacity to encapsulate both hydrophilic and lipophilic drugs. This review comprehensively summarizes recent advancements in glycerosome research spanning 2018–2025, including innovations in formulation strategies, physicochemical characterization, in vitro and in vivo evaluation, therapeutic applications across dermatology, oncology, and pain management, and the rapidly growing patent landscape. Relevant patents filed and granted internationally are catalogued and analyzed. The review also addresses current challenges, regulatory perspectives, and future directions for glycerosome based drug delivery. Key findings confirm that glycerosomes significantly improve drug permeation flux, reduce systemic side effects, and offer formulation advantages such as stability, scalability, and compatibility with biologics. The cumulative evidence positions glycerosomes as next generation carriers with strong clinical and commercial potential.
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Formulation and Evaluation of Vilazodone Microspheres
The aim of the study was to prepare Vilazodone microspheres using Solvent evaporation method using different polymer ratio. FT-IR studies revealed that there was no chemical interaction between the drug and polymer. The average particle size of the optimized formulation was found to be 166 μm. The in-vitro release behavior from all the Vilazodone microspheres was found to be Higuchi drug release kinetics and produced a sustained release over a period of 12 hours with better entrapment efficiency.
The Rise of Precision Medicine and Genomic Health Care
Precision medicine is a modern healthcare approach in which medical treatment and prevention methods designed according to an individual person’s genes. Precision medicine is the providing right treatment to the right patient at the right time. Precision medicine focuses on understanding individual differences to improve diagnosis, prevention, and treatment outcomes. Genomic healthcare also helps in the early detection of diseases, reducing side effects from medications and improving the overall quality of patient care. Precision medicine studies how each person is different and then providing the personalized healthcare. Precision medicine is widely used in areas like: cancer treatment, genetic disorders, and heart diseases also for drug therapies. Challenges in precision medicine and healthcare include high treatment and testing costs, limited accessibility in developing regions, it concerns about genetic data privacy and security. These challenges must be addressed to ensure safe and affordable and equal access to personalized healthcare for all patients.
Telemedicine: Transforming Healthcare Access in Rural Communities
Telemedicine is an innovative healthcare approach that uses information and communication technologies to deliver remote medical services, particularly in rural and underserved regions. It addresses barriers such as geographic isolation, limited medical workforce, economic constraints, and inadequate infrastructure. The study highlights the evolution, service models, technological tools, regulatory framework, advantages, and limitations of telemedicine. “Key modalities include real-time consultations, store-and-forward systems”, remote patient monitoring, and provider-to-provider communication. Technologies such as cloud-based platforms, mobile health applications, electronic health records, and wearable devices enhance accessibility, continuity of care and clinical decision-making. Despite its benefits in improving healthcare access and reducing costs, challenges remain, including poor internet connectivity, digital literacy gaps, data privacy concerns, regulatory complexity, and infrastructure limitations. Strengthened policies, standardized guidelines and improved digital infrastructure are essential for sustainable implementation. Telemedicine has strong potential to enhance healthcare equity and service delivery in resource-limited settings.
Formulation and Evaluation of Herbal Spray Using Tephrosia purpurea
Tephrosia purpurea (Linn.) Pers., commonly known as Sharpunkha, is a traditional medicinal plant with diverse pharmacological properties including antimicrobial, anti-inflammatory, and antioxidant activities. This research article presents the formulation and evaluation of herbal spray using Tephrosia purpurea extract. The herbal spray formulation was developed using standardized leaf extracts, appropriate carriers, and surfactants to enhance bioavailability and efficacy. Various physicochemical parameters were evaluated including pH, viscosity, particle size, spray pattern, and content uniformity. The antimicrobial activity was assessed against selected bacterial and fungal species, demonstrating significant activity (MIC range: 10-50 μg/mL). Stability studies conducted at accelerated conditions (40°C ± 2°C, 75% RH ± 5%) for three months showed acceptable stability with minimal changes in active constituents. The herbal spray exhibited promising potential for topical applications in respiratory infections and skin conditions, with improved patient compliance and targeted drug delivery.
Formulation and Evaluation of Transdermal Gel with Wound Healing and Anti-inflammatory Properties Derived from Calendula officinalis
Calendula officinalis (pot marigold) has been traditionally used in folk medicine for its prominent wound healing and anti-inflammatory properties. This study aimed to formulate and evaluate transdermal gel formulations (F1-F5) containing standardized Calendula officinalis extract. Five different formulations were prepared using various gelling agents and carriers to optimize the physicochemical and biological properties. The gels were evaluated for appearance, pH, viscosity, spreadability, in vitro permeation, stability, and anti-inflammatory activity. Results demonstrated that formulation F3, containing Carbopol 940 as the gelling agent, exhibited superior performance with optimized viscosity, spread ability, and consistent drug release profile. In vitro wound healing assay revealed significant fibroblast proliferation with F3 formulation, while anti-inflammatory studies showed inhibition of TNF-α and IL-6 cytokine production comparable to standard anti-inflammatory agents. Stability studies confirmed the robustness of the formulations under accelerated storage conditions. The findings validate the potential of Calendula derived transdermal gel as a promising therapeutic agent for topical wound healing and inflammatory skin conditions.
MOLECULAR TARGETS OF NATURAL POLYPHENOLS IN OXIDATIVE STRESS-MEDIATED NAFLD
Non-alcoholic fatty liver disease (NAFLD) is a major global cause of chronic liver disease, ranging from simple hepatic steatosis to non-alcoholic steatohepatitis (NASH), which may progress to fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). NASH is now one of the fastest-growing indications for liver transplantation. Despite its increasing prevalence, no approved pharmacological therapy exists, and lifestyle modification remains the primary treatment strategy. Oxidative stress plays a central role in NAFLD pathogenesis by disrupting the balance between reactive oxygen species (ROS) and antioxidant defenses, leading to cellular damage and disease progression. Natural polyphenols, plant-derived bioactive compounds with strong antioxidant and anti-inflammatory properties, have emerged as potential therapeutic agents. These compounds may improve hepatic steatosis by modulating lipid metabolism, insulin resistance, oxidative stress, and inflammatory pathways. This review focuses on oxidative stress-mediated mechanisms in NAFLD progression and highlights the molecular targets of natural polyphenols that may offer promising therapeutic strategies for its management.
Design and Evaluation of Nano spheres for Gastro retentive Drug Delivery System in Selected Hypertensive Drug
Hypertension is an ongoing heart condition that requires long-term pharmacotherapy so as to achieve the optimal blood pressure by removing associated complications such as heart attack, stroke, and kidney failure. Although oral drug delivery is the most preferable route of antihypertensive therapy, the majority of the traditional dosage delivery routes are constrained by the following factors: low bioavailability of gastrointestinal absorption, low GIT residence, high first-pass metabolism, and high dosage frequency. The gastro retentive drug delivery systems (GRDDS) have a number of antihypertensive agents that have a narrow absorption profile in the upper gastrointestinal tract with short biological half-lives. [1–3] [4–6] One of the potential solutions to these problems suggested is the use of the gastro retentive nanosphere-based drug delivery system that could extend gastric retention, enhance the solubility of the drug, and deliver it under controlled and sustained methods. Among the advantages of nanospheres, whose diameter ranges between 10 and 1000 nm, is the fact that they are typified by high surface area, high mucoadhesive property, high drug loading capacity, and protection of the drug contained in the nanoparticle against adverse gastric conditions.[10] [11] [12] [13] This review is a general discourse on the design principles, formulation methodology, and characterization schemes in the design of nanospheres to enable gastro retentive delivery of selected hypertensive drugs. It lays emphasis on the methods of preparation, polymer-drug complexes, the particle size, surface morphology, encapsulation efficiency, dynamics of drug release in vitro, mucoadhesive force, and stability measurements.
TARGETING URAT 1 AND GLUT 9 FOR HYPERURICEMIA MANAGEMENT: IMPORTANCE OF PRECLINICAL EVALUATION
Hyperuricemia is marked by elevated serum uric acid levels. It is the primary risk factor for gout and several related complications. Urate homeostasis involves balancing uric acid production and renal excretion. Urate transporters, such as urate transporter 1 (URAT1) and glucose transporter 9 (GLUT9), play crucial roles. Evidence suggests that dysfunction or genetic variation in these transporters contributes to abnormal urate accumulation and disease progression. This review summarises knowledge of uric acid metabolism, renal urate handling, and the physiological roles of URAT1 and GLUT9 in urate balance. It discusses the involvement of these transporters in hyperuricemia and gout, as well as therapeutic strategies targeting urate transporters, including uricosuric drugs and emerging transporter-specific inhibitors. The importance of preclinical evaluation using animal models and cell-based transporter assays for the discovery and development of novel antihyperuricemic agents is highlighted. Understanding the molecular mechanisms and pharmacological modulation of urate transporters may help develop more effective therapies for hyperuricemia and gout.
Molecular Insights in to the Gastro protective Potential of Marmin and Imperator in: A Phytochemical and Mechanistic Perspective
Peptic ulceration of the stomach continues to represent a common digestive system pathology distinguished by epithelial injury arising from disequilibrium between harmful elements including gastric acidity, reactive oxygen species, and inflammatory processes, and the protective systems of the gastric lining. Although established treatment modalities exist, encompassing proton pump inhibitors and H₂-receptor antagonists, prolonged administration frequently correlates with undesirable consequences and disease recurrence, creating demand for investigating more secure and efficacious therapeutic options. Within this framework, naturally derived coumarins have attracted substantial interest owing to their varied pharmacological attributes. Marmin and imperatorin, two notable furanocoumarins obtained from therapeutic plants including Aegle marmelos and Angelica species, demonstrate considerable gastric protective capabilities. This analysis thoroughly examines the phytochemical features, pharmacokinetic characteristics, and fundamental action mechanisms of marmin and imperatorin in gastric ulcer prevention and treatment. Data from laboratory and animal investigations indicate that these substances provide protective benefits via numerous mechanisms, encompassing antioxidant function, suppression of inflammatory factors, strengthening of mucosal protection, and regulation of gastric acid production. Furthermore, their possible anti-Helicobacter pylori properties additionally validate their clinical significance. The analysis emphasizes existing constraints, safety aspects, and developing formulation approaches designed to enhance bioavailability. In summary, marmin and imperatorin constitute encouraging prospects for developing innovative gastroprotective compounds. Additional clinical research is required to confirm their effectiveness and safety in human subjects and to enable their progression toward therapeutic implementation.
Neonatal Jaundice (Neonatal Hyperbilirubinemia): Clinical Aspects and Recent Advancements in Treatment
Neonatal jaundice (neonatal hyperbilirubinemia) is one of the most common clinical conditions encountered in newborn care, affecting approximately 60% of term neonates and up to 80% of preterm neonates during the first week of life. While physiological jaundice is typically benign and self-limiting, pathological hyperbilirubinemia carries a significant risk of bilirubin-induced neurological dysfunction (BIND), including the devastating complication of kernicterus. This review article comprehensively covers the epidemiology, pathophysiology, clinical classification, diagnostic criteria, and contemporary management strategies for neonatal jaundice. We discuss recent advancements in phototherapy technology, pharmacological interventions, transcutaneous bilirubin monitoring, and emerging molecular therapies. Four illustrative clinical cases are presented to highlight key diagnostic and management challenges. The article concludes with a synthesis of current evidence and future directions in the management of this prevalent neonatal condition.
Evaluation of Artificial Intelligence and Algorithms in Drug Discovery
The integration of Artificial Intelligence (AI) and advanced algorithms has significantly transformed the drug discovery process by enabling faster, cost-effective, and data-driven approaches. Traditional drug development is time-consuming, expensive, and characterized by high failure rates, necessitating innovative solutions. AI techniques, including machine learning, deep learning, natural language processing, and reinforcement learning, play a crucial role in various stages of drug discovery such as target identification, virtual screening, lead optimization, and clinical development. Algorithms like Naïve Bayes, Support Vector Machines, Decision Trees, Random Forest, and boosting methods enhance predictive accuracy and decision-making capabilities. Additionally, deep learning models such as Convolutional Neural Networks, Recurrent Neural Networks, and Graph Neural Networks facilitate the analysis of complex biological and chemical data. Despite these advancements, challenges such as data quality, model interpretability, and integration into existing pharmaceutical frameworks remain significant barriers. Overall, AI-driven methodologies hold great promise in improving efficiency, reducing costs, and accelerating the development of safe and effective therapeutic agents.
Phytochemical Characterization and In Vivo Efficacy of a Novel Hyptis suaveolens Vaginal Gel
The objective of the present investigation was to design, develop, and evaluate a novel vaginal gel formulation incorporating petroleum ether extract of Hyptis suaveolens, along with its phytochemical characterization and in vivo therapeutic assessment. The plant extract was obtained through Soxhlet extraction [1] and subjected to qualitative phytochemical screening [2,9,11], which revealed the presence of several bioactive compounds such as flavonoids, terpenoids, tannins, and steroids. Multiple gel formulations were prepared using different polymers, including Carbopol 934P, HPMC K100, Pemulen TR-1, Pemulen TR-2, Lutrol F127, and xanthan gum [12,14]. These formulations were evaluated for key physicochemical parameters such as pH, viscosity, spreadability, extrudability, and drug content uniformity [5,13]. The optimized formulation was further subjected to in vivo evaluation using an experimental animal model to assess antimicrobial and anti-inflammatory efficacy [20]. Statistical analysis was carried out using one-way ANOVA, demonstrating significant differences between treated and control groups (p < 0.05) [13]. The results indicated that the formulated gel exhibited excellent physicochemical properties and substantial therapeutic effectiveness. The study highlights the potential of Hyptis suaveolens as a natural and effective alternative in the management of vaginal infections.
Fast dissolving tablets are among the most commonly used dosage forms and are often administered in emergency situations. They serve various drugs as a route of administration due to their proven safety, convenience, and cost-effectiveness. Research and development focus on fast dissolving tablets aim to enhance patient adherence and ease of use. These tablets dissolve quickly and can be swallowed without the need for chewing or extra water. They are particularly beneficial for individuals who have difficulty swallowing (dysphagia), such as paediatric and geriatric patients. Fast dissolving tablets possess several ideal characteristics, advantages, and distinct features, as well as various technological advancements. They are utilized in treating conditions like Parkinson’s disease, neurological disorders, and schizophrenia. Additionally, fast dissolving tablets are referred to as mouth dissolving tablets. One of the key benefits of fast dissolving tablets is advantage of oral liquid dosage forms. There are restrictions on the oral dose. Form and administration of different drugs, such as first pass metabolism, mental patients, immobile patients, and unwilling patients.
Novel Drug Delivery Systems for Vulvovaginal Candidiasis: A Systematic Review
Vulvovaginal candidiasis (VVC) is a prevalent fungal infection affecting approximately 75% of women at least once during their lifetime. Conventional antifungal therapies are hampered by poor drug bioavailability, rapid vaginal clearance, and emerging resistance. Novel drug delivery systems (NDDS) offer promising alternatives by enhancing drug retention, permeation, and therapeutic efficacy. Objective: This systematic review critically evaluates current NDDS including liposomes, niosomes, solid lipid nanoparticles (SLN), nano emulsions, polymeric nanoparticles, in situ gels, microemulsions, vaginal films, cyclodextrin complexes, and dendrimers developed for the treatment of VVC. Methods: A comprehensive literature search was conducted across PubMed, Scopus, Web of Science, and Google Scholar (2010–2024) using MeSH terms including 'vulvovaginal candidiasis', 'novel drug delivery', 'vaginal nanoparticles', and 'antifungal formulation'. Patent databases including USPTO, EPO, and WIPO were also searched. Results: A total of 27 primary research articles and 10 relevant patents were reviewed. Nanoparticle-based formulations demonstrated superior antifungal activity with significant improvements in MIC values (2–8-fold reduction), prolonged drug release (24–72 h), and enhanced vaginal retention compared to conventional formulations. In situ gelling systems and mucoadhesive platforms showed the greatest promise for patient compliance and sustained therapeutic effect. Conclusion: NDDS represent a significant advancement in the management of VVC, offering improved drug bioavailability, reduced dosing frequency, and potential to overcome antifungal resistance. Further clinical translation and regulatory studies are required.
Exploring the Pharmacogenetic Standard Bioactive Potential Tagetes Erect
Marigold is a hardy annual plant native to Southern Europe and widely cultivated in tropical countries like India and China. Marigold (Tagetes species) has been used for centuries in traditional medicine and more recently in modern therapeutic applications. It produces brightly colored, fragrant flowers most commonly yellow which are edible and used as natural colouring agents and spices. Medicinal benefits of Calendula officinalis include wound healing, anti-inflammatory, antimicrobial, skin protective, menstrual supportive, oral care, and digestive protective properties. According to phytochemical analysis, carotenoids, flavonoids, terpenoids, thiophenes, essential oils. Different parts of the plant contain important phytochemicals such as lutein, quercetin, quercetagetin and its glucoside, syringic acid, thienyl compounds, terpenes, and various phenolic compounds. Various pharmacological properties include, wound healing, anti-inflammatory, antimicrobial, skin protective, menstrual supportive, oral care, and digestive protective properties.
COMPREHENSIVE REVIEW ON HERBAL TOPICAL GELS FOR THE MANAGEMENT OF VARICOSE VEINS
Varicose veins represent a chronic venous disorder characterized by dilated, tortuous superficial veins resulting from venous valve dysfunction and impaired blood return. The condition affects a significant proportion of the adult population worldwide and is associated with pain, edema, inflammation, heaviness of legs, and cosmetic concerns that may progress to chronic venous insufficiency if untreated. Conventional management strategies include compression therapy, sclerotherapy, pharmacological agents, and surgical interventions; however, these approaches may be expensive, invasive, or associated with adverse effects. Increasing attention has therefore shifted toward herbal-based topical formulations, particularly gels, due to their enhanced patient compliance, localized drug delivery, minimal systemic toxicity, and improved therapeutic outcomes. Herbal topical gels incorporate plant-derived bioactive compounds possessing anti-inflammatory, venotonic, antioxidant, and microcirculatory enhancing properties that directly target pathological mechanisms involved in venous disorders. This review comprehensively discusses the scientific basis of herbal topical gels in varicose vein management, including anatomical considerations, pathophysiology, causative factors, symptomatology, commonly used medicinal plants, formulation advantages, and therapeutic potential. Emphasis is placed on phytoconstituents capable of improving vascular tone, reducing edema, and protecting endothelial integrity. The article aims to provide a consolidated scientific framework supporting the development of effective, safe, and evidence-based herbal topical therapies for chronic venous diseases.
Herbal medicine as an emerging approach polycystic ovarian syndrome: A systematic review
Background: Polycystic ovarian syndrome (PCOS) is a a complex neuroendocrine and metabolic disorder condition that is frequently linked to irregular menstrual cycles. Although synthetic pharmacological agents are widely used and show clinical efficacy in managing PCOS, many patients increasingly prefer natural therapies because of their favorable therapeutic outcomes and the adverse effects or limitations linked to conventional allopathic treatments. Considering the rising interest in herbal medicine, this review highlights the potential role of various medicinal plants for the management of (PCOS). Methods: An extensive literature review was conducted, and relevant data were extracted from databases including Scopus, PubMed, Crossref, Google Scholar and Hinari to assess the efficacy of herbal interventions in the management of PCOS. Result: This review outlines the therapeutic significance of selected herbal medicines in PCOS, with emphasis on their phytochemical composition, mechanisms of action, and pharmacological effects. Conclusion: The findings presented in this review provide valuable insights and serve as a useful reference for researchers investigating the therapeutic potential of herbal interventions and approaches in PCOS.
Evaluation of Clinical Pharmacy Services on Antihypertensive Drug Prescribing Patterns and Compelling Indications in a Teaching Hospital
Hypertension is a prevalent cardiovascular disorder and a significant risk factor for various life-threatening conditions, including congestive heart failure, ischemic heart disease, chronic kidney disease, and stroke. The present study was undertaken to assess the impact of clinical pharmacy interventions on prescribing patterns of antihypertensive medications and their compelling indications in a tertiary care teaching hospital. This prospective observational study involved the review and analysis of inpatient records of individuals diagnosed with hypertension. Patient demographic characteristics, such as age and sex, were systematically documented. Among the 450 hypertensive patients included in the study, a total of 387 potential drug–drug interactions were identified. The findings underscore the critical role of clinical pharmacy services in optimizing antihypertensive drug therapy. Additionally, the results highlight the necessity of improving patient education related to medication adherence and lifestyle modifications to enhance blood pressure control in hospital-based care settings.
CASSIA FISTULA IN TRADITIONAL MEDICINE: PHYTOCHEMICAL PROFILING, THERAPEUTIC USES AND ANTIFUNGAL ACTIVITY
Medicinal plants have played a pivotal role in the origin and advancement of traditional herbal medicine systems worldwide. Species belonging to the genus Cassia are of considerable therapeutic importance due to their rich phytochemical diversity and wide range of pharmacological activities. These plants contain numerous bioactive secondary metabolites, including tannins, flavonoids, glycosides, anthraquinones, oxyanthraquinones, carbohydrates, and fatty acids, which contribute to their therapeutic efficacy. Cassia fistula Linn., commonly known as the Golden Shower tree, is one of the most extensively used medicinal plants in Ayurvedic, Unani, and other traditional medicine systems. Native to India and widely distributed in tropical and subtropical regions, C. fistula has been traditionally employed for the management of gastrointestinal disorders, skin diseases, liver ailments, respiratory disorders, fever, rheumatism, and metabolic diseases. Various plant parts, including the leaves, roots, bark, flowers, fruits, and seeds, have been reported to exhibit laxative, purgative, hepatoprotective, anti-inflammatory, analgesic, antimicrobial, antioxidant, antidiabetic, antitumor, antifertility, and wound-healing properties. Experimental studies further indicate its effectiveness against bacterial infections, hypercholesterolaemia, and oxidative stress, along with notable hypoglycaemic and central nervous system activities. Despite its long-standing traditional use and documented biological potential, many of the therapeutic claims associated with Cassia fistula require systematic clinical validation. This review critically compiles and evaluates available literature on the phytochemistry, ethnomedicinal uses, and pharmacological properties of Cassia fistula, highlighting its therapeutic relevance and identifying gaps for future scientific research.
NANOENCAPSULATION TECHNOLOGY: ADVANCING THE DEVELOPMENT OF MORE EFFECTIVE FOOD PRESERVATIVES
Food preservation represents a critical challenge in modern food systems, where conventional preservatives often face limitations in efficacy, stability, and bioavailability. This comprehensive review examines how nanoencapsulation technology serves as a transformative approach to enhance the effectiveness of food preservatives through improved delivery mechanisms, controlled release kinetics, and enhanced antimicrobial potency. By encapsulating bioactive compounds including natural antimicrobials, essential oils, and plant extracts within nanoscale carrier systems, nanoencapsulation addresses fundamental barriers that limit conventional preservative performance. This paper synthesizes current research on encapsulation technologies (liposomes, polymeric nanoparticles, nanoemulsions, and nanostructured lipid carriers), mechanisms of action in food matrices, application methodologies, and comparative efficacy studies demonstrating 2-4 log reductions in pathogenic microorganisms. Furthermore, we examine stimulus responsive delivery systems that intelligently release preservative agents in response to environmental triggers, the regulatory landscape governing nanomaterial food applications, and critical safety considerations essential for market adoption. The intersection of nanotechnology and food science creates unprecedented opportunities to develop preservative systems that are simultaneously more effective at lower concentrations, environmentally sustainable, and safer for consumers. This review provides stakeholders including food scientists, regulatory professionals, and technology developers with an integrated framework for understanding, implementing, and advancing nanoencapsulation-based preservation strategies in contemporary food systems.
Development of Duloxetine hydrochloride Orodispersible Films for Rapid Onset of Antidepressant Action
This study aimed to formulate fast-dissolving orodispersible films (ODFs) containing Duloxetine HCl to expedite beginning of action and augment patient adherence, especially in individuals with dysphagia. Films were fabricated by the solvent-casting method, employing HPMC E15 as the principal film-forming polymer, with sodium starch glycolate (SSG) and croscarmellose sodium (CCS) integrated as superdisintegrants to enhance wetting and disintegration. Seven formulations (DL1–DL7) were assessed for physicomechanical characteristics, content uniformity, FTIR compatibility, and in vitro dissolution. All films demonstrated sufficient flexibility, satisfactory surface pH, consistent thickness, and assay results within the range of 95–105%. Dissolution studies revealed swift drug release, with DL4 (9% SSG) and DL6 (4% CCS) attaining approximately 80–85% release in 10 minutes and nearly total release within 20 minutes. Kinetic modeling aligns most effectively with the Korsmeyer–Peppas model, suggesting the presence of anomalous diffusion. Stability testing verified the absence of substantial alterations in assay or performance. Ultimately, DL4 and DL6 were identified as optimal formulations.
Formulation and Evaluation of Mouth Dissolving Tablets of Nebivolol HCL for Treatment of Hypertension
The present study was aimed at the formulation and evaluation of mouth dissolving tablets (MDTs) of Nebivolol HCl for the effective treatment of hypertension, enhancing patient compliance and ensuring rapid onset of action. Nebivolol HCl, a β1-selective adrenergic blocker, suffers from poor aqueous solubility, which limits its bioavailability. To address this, mouth dissolving tablets were formulated using different super disintegrants — Polyplasdone XL, Solutab, and Explotab — in varying concentrations to optimize disintegration time and drug release profile. A Total of Nine formulations (F1 to F9) were prepared by direct compression method and evaluated for pre-compression and post-compression parameters such as hardness, friability, weight variation, disintegration time, wetting time, and in vitro drug release. Among all the formulations, Formulation F3, containing an optimized concentration of Polyplasdone XL, demonstrated the most desirable results with 99.24% drug release within 30 minutes, fastest disintegration time, and excellent tablet characteristics. The study concluded that the use of suitable super disintegrants significantly improved the dissolution rate and patient acceptability of Nebivolol HCl MDTs. Formulation F3 was identified as the optimized formulation and holds potential for rapid and effective hypertension management through improved bioavailability and patient compliance.
Formulation and Evaluation of Sustained Release Matrix Tablets of Theophylline Using Natural Polymer
The present study focuses on the formulation and evaluation of sustained release matrix tablets of Theophylline using natural polymers such as Guar Gum, Fenugreek, and Karya Gum. The aim was to develop a cost-effective and biocompatible drug delivery system that could provide prolonged therapeutic effects, reduce dosing frequency, and enhance patient compliance. A total of nine formulations were prepared using varying concentrations of the selected natural polymers by the Direct compression method. All pre-compression and post-compression parameters, including hardness, friability, weight variation, thickness, and drug content, were found to be within acceptable limits as per IP standards, indicating the suitability of the formulations. In-vitro drug release studies were carried out for 12 hours, and the release profiles showed a sustained release pattern. Among the nine formulations, F6 was identified as the optimized formulation as it exhibited a drug release of 99.72% at the end of 12 hours, following a controlled release mechanism. The results suggest that natural polymers can be effectively utilized for the formulation of sustained release tablets of Theophylline.
Formulation and Evaluation of Extended-Release Matrix Tablets of Salbutamol Sulphate Using Natural Polymers
The present study involves the formulation and evaluation of extended release matrix tablets of Salbutamol Sulphate using natural polymers such as Guar Gum, Locust Bean Gum, and Gum Damar. The primary objective was to develop a sustained release formulation that could maintain therapeutic drug levels over an extended period, thereby reducing dosing frequency and improving patient compliance. A total of nine formulations were prepared using varying concentrations of the selected natural polymers. All formulations were subjected to pre-compression and post-compression evaluations, and the results were found to be within the acceptable limits as per IP standards. Among all, formulation F6 was identified as the optimized batch, as it exhibited the most desirable drug release profile, achieving 99.08% drug release over 12 hours. The study concludes that natural polymers can effectively be used in the formulation of extended release tablets of Salbutamol Sulphate, offering a promising and sustainable alternative to synthetic polymers in controlled drug delivery systems.
Targeted Drug Delivery Systems for Breast Cancer Therapy: Advances in Nanomedicine
Breast cancer remains one of the leading causes of cancer-related morbidity and mortality among women worldwide, despite significant advances in early detection and systemic therapy. Conventional chemotherapy is often limited by poor tumor selectivity, dose-limiting toxicity, multidrug resistance, and inadequate intracellular drug accumulation. Targeted drug delivery systems enabled by nanomedicine have emerged as a transformative strategy to overcome these barriers by improving pharmacokinetics, enhancing tumor localization, and enabling molecularly guided therapy. This review critically examines the design principles, mechanistic foundations, and translational progress of nanotechnology-based targeted drug delivery systems for breast cancer therapy. Passive targeting through the enhanced permeability and retention effect and active targeting using ligand–receptor interactions are discussed in relation to tumor microenvironment heterogeneity, vascular permeability, and cellular internalization pathways. Major nanocarrier platforms, including liposomes, polymeric nanoparticles, dendrimers, inorganic nanostructures, and biomimetic systems, are analyzed with respect to drug loading capacity, release kinetics, biocompatibility, and clinical scalability. Particular attention is given to receptor-specific targeting strategies directed against HER2, estrogen receptors, folate receptors, and CD44, as well as emerging stimuli-responsive and theranostic systems. Recent preclinical and clinical evidence highlights meaningful improvements in therapeutic index, reduced systemic toxicity, and enhanced treatment personalization. Remaining challenges related to immunogenicity, manufacturing reproducibility, regulatory pathways, and long-term safety are critically evaluated. Overall, nanomedicine-based targeted delivery offers a compelling pathway toward precision breast cancer therapy and supports the continued integration of advanced materials science with molecular oncology for improved patient outcomes.
A Review of Phytochemical and Pharmacological Overview on
In traditional medicine, Celosia cristata (Family: Amaranthaceous) is frequently used to treat a variety of illnesses. Because the blossom resembles the head of a rooster (cock), Celosia cristata, a member of the genus Celosia, is frequently referred to as cockscomb. Numerous delicate components were separated from various plant sections. The plant exhibited a variety of pharmacological actions, according to current research. This review discussed Celosia cristata's pharmacological properties and chemical components.
Surgical and Non-Surgical Strategies in Intervention of Orthopedics
Orthopedic interventions encompass a broad range of surgical and non-surgical approaches designed to diagnose, manage, and treat disorders of the musculoskeletal system. This review article provides a comprehensive overview of current orthopedic practices, focusing on advancements in surgical techniques, bio-materials, minimally invasive procedures, and postoperative rehabilitation strategies. The article synthesizes findings from recent clinical studies and meta-analyses to evaluate the efficacy, safety, and long-term outcomes of common orthopedic interventions such as joint arthroscopy, fracture fixation, spinal surgery, and arthroscopy. Emerging technologies, including computer-assisted navigation and biological, are also discussed for their potential to enhance surgical precision and patient recovery. By critically analyzing the literature, this review aims to inform clinical decision-making, identify gaps in current research, and propose directions for future investigation in the evolving field of orthopedic care.
Artificial Intelligence–Enabled Pharmacovigilance: A New Paradigm in Drug Safety Surveillance
Pharmacovigilance (PV) has historically relied on manual intake and clinical review of spontaneous adverse event reports, constrained by under-reporting, variable data quality, duplicate cases, and operational latency. Over the last decade, the digitalization of Individual Case Safety Reports (ICSRs) and the maturation of machine learning (ML), natural language processing (NLP), and “augmented intelligence” workflows have enabled a shift from document-centric, manual processing toward data-centric, semi-automated surveillance. This review synthesizes the evolution from manual safety reporting to AI-enabled PV across the ICSR lifecycle: intake and triage, data extraction and normalization, coding (MedDRA/WHO Drug), case processing and medical assessment support, duplicate detection, signal detection and validation, and regulatory submission. We summarize the enabling regulatory/technical standards (e.g., ICH E2B (R3), EMA GVP), global surveillance ecosystems (FAERS, EudraVigilance, VigiBase), and contemporary guidance (e.g., CIOMS Working Group XIV) that shape responsible AI adoption. We present publication-ready tables describing (i) the PV technology timeline, (ii) AI methods mapped to PV tasks with validation metrics and risks, and (iii) an implementation governance checklist. A figure proposes an end-to-end AI-enabled PV operating model with human oversight and audit ability. We conclude that the most durable value arises from targeted automation (coding, extraction, prioritization) combined with robust governance data quality management, bias monitoring, explain ability, and continuous performance verification rather than full replacement of expert judgment.
Immunometabolism: Linking Cellular Energy Pathways with Immune Responses in Health and Disease
Immunometabolism, the interdisciplinary nexus between cellular metabolism and immune regulation, has emerged as a pivotal field in understanding how metabolic cues shape immune cell fate, function, and pathogenicity. Beyond merely supporting energy demands, metabolic pathways actively reprogram immune cells by modulating signaling cascades, transcriptional networks, and epigenetic landscapes. During immune activation, immune cells dynamically transition between metabolic states, such as glycolysis, oxidative phosphorylation, fatty acid oxidation, and glutaminolysis, to meet distinct functional requirements. Dysregulation of these pathways has been implicated in chronic inflammation, autoimmune disorders, cancer progression, metabolic syndromes, and infectious diseases. Recent advances in single-cell technologies, metabolomics, and imaging have expanded our understanding of how nutrient availability and metabolic checkpoints govern immunity. Moreover, therapeutic targeting of immunometabolic pathways, ranging from glycolytic inhibition to mitochondrial bioenergetic enhancement, offers promising interventions for diverse clinical conditions, including cancer immunotherapy and metabolic inflammatory diseases. This review consolidates current insights into the metabolic regulation of innate and adaptive immune responses, emphasizing physiological homeostasis and pathological alterations, while also exploring emerging translational opportunities in immunometabolic therapeutics.
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ANALYTICAL METHOD VALIDATION FOR ASSAY OF ALPROSTADIL BY HPLC USING INTERNAL STANDARD
An isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the assay of Alprostadil using an Internal Standard. The successful separation of from its synthetic impurities and degradation products formed under stress conditions was achieved using 4.6mm x 25cm, Packing L1 or equivalent maintained at 25°C with a mobile phase of Methanol, acetonitrile and 0.1 M mono basic potassium phosphate (2:1:2) adjust with phosphoric acid to pH of 3.0. The mobile phase flow rate was 1.0 mL/min, and the detection wavelength was 200 nm. The developed HPLC method was validated with respect to linearity, accuracy, precision, specificity, and robustness. The developed HPLC method to determine the assay of alprostadil can be used to evaluate the quality of regular production samples. It can be also used to test the stability samples of Alprostadil.
A Review on Comprehensive Comparative Study about Kefir, Yogurt, Buttermilk with their Health Benefits
Fermented milk products have played an integral role in human nutrition across cultures for centuries. Among the most widely consumed are kefir, yogurt, and buttermilk, each possessing unique microbial compositions, fermentation processes, sensory characteristics, and health benefits. This paper presents a comparative study of kefir, yogurt, and buttermilk, examining their origins, production methods, physicochemical properties, nutritional profiles, microbial diversity, and therapeutic implications. The analysis also considers their commercial and cultural significance and highlights the growing interest in probiotic-rich functional foods. Findings suggest that while all three share fundamental probiotic benefits, kefir demonstrates the highest microbial diversity and strongest potential for gastrointestinal and immune health, while yogurt and buttermilk retain distinctive advantages in texture, taste, and culinary versatility.
The Power of Data: How Clinical Data Management Shapes Modern Clinical Research
Clinical Data Management (CDM) plays a crucial role in ensuring the accuracy, reliability, and integrity of data collected during clinical trials. As clinical research expands globally and generates large volumes of data, CDM provides a structured process for data collection, validation, cleaning, and storage. The use of Electronic Data Capture (EDC) systems, cloud platforms, and automated validation tools has improved efficiency, reduced errors, and enabled real-time monitoring. CDM ensures that clinical trial data is compliant with regulatory standards such as ICH-GCP, FDA 21 CFR Part 11, and CDISC guidelines, which promote data traceability and patient confidentiality. By supporting high-quality data, CDM strengthens scientific conclusions and facilitates faster regulatory approvals. Moreover, advancements such as artificial intelligence and decentralized trial designs further enhance data accuracy and patient accessibility. Overall, CDM transforms raw clinical data into meaningful evidence, aiding drug development decisions, improving patient safety, and contributing significantly to modern healthcare innovation.
Formulation and Evaluation of Paclitaxel Controlled Release Tablets
The aim of the present study was to develop Paclitaxel controlled release tablets to maintain constant therapeutic levels of the drug for over 12 hrs. Carbopol974P, Xanthan Gum and HPMC K 15M were used as polymers. All the formulations were passed various physicochemical evaluation parameters such as Bulk Density, Tapped Density, Carrs Index, Hausners Ratio, Angle of Repose, Weight Variation, Hardness, Thickness, Friability and Drug Content. From the dissolution studies it was evident that the formulation F5 showed better and desired drug release pattern i.e., 99.16 % in 12 hours. It contains the Xanthan Gum as polymer. It followed peppas order release kinetics.
Formulation and in Vitro Evaluation of Mouth Dissolving Tablets of Amisulpride Using Novel Super Disintegrants
The present investigation was aimed at the formulation and in vitro evaluation of mouth dissolving tablets (MDTs) of Amisulpride using novel super disintegrants to enhance patient compliance and improve the drug’s onset of action. Amisulpride, an atypical antipsychotic agent, suffers from drawbacks such as delayed dissolution and swallowing difficulties in conventional dosage forms, making MDTs a suitable alternative. Various formulations were prepared by direct compression method using different concentrations of novel super disintegrants. The prepared tablets were evaluated for pre-compression parameters (angle of repose, bulk density, tapped density, Carr’s index, Hausner’s ratio) and post-compression parameters (hardness, friability, weight variation, wetting time, disintegration time, drug content, and in vitro dissolution studies). The results revealed that all formulations complied with pharmacopeial limits. Among the developed batches, the optimized formulation exhibited a minimum disintegration time, rapid wetting time, and maximum drug release within a short period, demonstrating the effectiveness of the selected super disintegrants. The incorporation of novel super disintegrants significantly enhanced the dissolution profile of Amisulpride compared to conventional formulations. In conclusion, the study established that mouth dissolving tablets of Amisulpride formulated with novel super disintegrants can serve as a promising dosage form, providing improved patient convenience, faster onset of therapeutic action, and enhanced bioavailability.
Formulation and Evaluation of Duloxetine Hydrochloride Enteric Coated Tablets
Objective of the current study is to develop colon targeted drug delivery systems for Duloxetine Hydrochloride. Sodium alginate and Carbopol 940 is used as polymers in this drug delivery system. The colon targeted tablet was prepared by direct compression technique. Study of the preformulation characteristics and FTIR studies indicates that there was no interaction between Duloxetine Hydrochloride and excipients used. The formulated tablets were tested for both pre-compression parameters and post compression parameters as per requirements of standards. Pre-compression parameters such as bulk density, tapped density, compressibility index, Hausner’s ratio and compressibility index. The results obtained indicate that it has good flow property for direct compression. From among the entire batches, formulation F4 showed 98.81% drug release at 24 hrs. Since it provide greater protection to the core under acidic condition while at the same time show the fastest drug release under intestinal pH. So the trial F4 was considered as best formulation.
Formulation and Evaluation of Immediate-Release Tablets of Cenobamate
The objective of this study was to formulate and evaluate immediate-release (IR) tablets of Cenobamate, an anticonvulsant drug, to enhance its bioavailability and therapeutic efficacy. Cenobamate, being poorly soluble in water, poses formulation challenges. Various excipients and approaches were employed to improve the drug's solubility and facilitate its rapid release. Immediate-release tablet formulations were prepared using direct compression, incorporating different concentrations of superdisintegrants Crospovidine (CP) , Croscarmellose sodium (CCS) and Sodium starch glycolate (SSG)) and fillers microcrystalline cellulose to optimize disintegration time, dissolution rate, and drug release profile. The tablets were characterized by physical parameters such as hardness, friability, weight variation, and content uniformity. In vitro dissolution studies were conducted to assess the release characteristics of cenobamate tablets, aiming for a rapid release in the first 30 minutes. The formulated tablets met pharmacopoeial standards for uniformity of weight, content, and dissolution, with a marked improvement in drug release compared to conventional tablet forms. The results indicated that the immediate-release cenobamate tablets have the potential to provide rapid onset of action, contributing to more efficient management of seizure disorders. This formulation offers an effective approach to enhance the bioavailability and clinical performance of cenobamate for better therapeutic outcomes.
Development and in-Vitro Evaluation of Raltegravir Sustain Release Tablets
The present study focuses on the development and in-vitro evaluation of sustained release tablets of Raltegravir, an antiretroviral drug used in the treatment of HIV. The aim was to enhance therapeutic efficacy and patient compliance by reducing the frequency of drug administration through sustained drug release. Various formulations were prepared using different polymers, among which Karya gum was selected as the natural polymer for sustained release. A total of several batches was formulated, and formulation R4, containing 100 mg of Karya gum, was found to be the optimized batch based on evaluation parameters. All pre-compression and post-compression parameters, including hardness, friability, weight variation, and drug content, were within acceptable limits. In-vitro dissolution studies revealed that formulation R4 exhibited a sustained drug release of 99.57% over a period of 12 hours. The drug release kinetics of the optimized formulation followed a sustained release pattern, indicating its potential in maintaining consistent plasma levels and improving therapeutic outcomes. Hence, R4 formulation using Karya gum can be considered a promising sustained release system for Raltegravir.
The Future of Drug Safety: AI-Driven Detection and Prediction of Adverse Drug Reactions
Pharmacovigilance (PV) is pivotal in ensuring drug safety and minimizing adverse drug reactions (ADRs). With the growing complexity of drug development, rising ADR-related morbidity, and the proliferation of real-world and digital health data, traditional PV systems face significant challenges, including underreporting, signal latency, and heterogeneous data integration. Recent advances in artificial intelligence (AI) offer transformative potential to enhance ADR detection, signal management, and personalized risk prediction. This review explores the evolution of pharmacovigilance, from early frameworks to modern AI-enabled systems, examining core concepts, regulatory landscapes, and the integration of machine learning, deep learning, natural language processing, and predictive modeling into PV practice. The study also evaluates digital data sources such as electronic health records, social media, and real-world evidence, highlighting AI-driven tools for real-time surveillance and automated signal detection. Ethical, legal, and regulatory considerations, along with challenges in implementation, transparency, and data quality, are discussed. Finally, emerging technologies including multi-omics integration, blockchain, digital twins, and predictive pharmacovigilance in drug development are considered, emphasizing the shift from reactive to proactive drug safety monitoring. This comprehensive analysis underscores the opportunities and future directions for AI in improving patient safety and advancing global pharmacovigilance systems.
Hydrodynamically Balanced Systems using Famotidine: Influence of natural and synthetic polymers
This study focuses on the development and evaluation of floating sustained-release tablets of Famotidine using the Hydrodynamically Balanced System (HBS) approach to prolong gastric retention and enhance bioavailability for the management of peptic and duodenal ulcers. Floating tablets were formulated via wet granulation employing both synthetic (HPMC 15cps, HPMC 100M, Carbopol) and natural polymers (Chitosan, Psyllium husk), along with gas-generating agents to achieve buoyancy. All prepared formulations were assessed for drug-polymer compatibility, pre-compression parameters, and post-compression characteristics, including in-vitro buoyancy and drug release. Infrared spectroscopy confirmed the compatibility between Famotidine and the polymers. The synthetic polymer-based formulations demonstrated superior performance compared to those with natural polymers. Among all, formulation SPF5, containing HPMC 15cps, was identified as the optimized batch. It exhibited an excellent floating lag time of 15 seconds, a total floating time of over 23 hours, a high swelling index (68.38%), and sustained drug release over 12 hours in simulated gastric fluid. The drug release from SPF5 followed zero-order kinetics (R²=0.964) and the Higuchi model, indicating a diffusion-based, Non-Fickian release mechanism. Stability studies confirmed the formulation's robustness over time. In conclusion, the successful development of Famotidine HBS tablets presents a promising strategy for controlled drug delivery, offering improved therapeutic efficacy over conventional dosage forms.
AI Language Models in Pharmaceutical R&D: Regulatory Compliance and Ethical Considerations
The integration of AI language models such as GPT, BERT, and other transformer-based systems is transforming pharmaceutical R&D by enhancing drug discovery, clinical trial design, regulatory documentation, and pharmacovigilance through automation of literature mining, protocol drafting, and safety reporting. Their ability to analyze vast unstructured data accelerates decision-making and shortens time-to-market for new therapies. However, adoption in regulated pharma environments faces challenges including lack of harmonized validation guidelines, risks of data hallucination, limited transparency, and compliance uncertainties due to the absence of specific frameworks from regulatory bodies like the FDA, EMA, and ICH. Ethical concerns such as algorithmic bias, patient data privacy, and accountability further complicate deployment. To overcome these issues, hybrid human-AI workflows, explainable AI (XAI), and ethical oversight are recommended, along with domain-specific model training, risk-based regulatory classifications, and global harmonization of standards. Ultimately, the future of AI in pharma depends on balancing innovation with compliance to ensure patient safety, equity, and trust.
Comparative Study of New Drug Application Procedure in US, EU and India
This topic aims at reviewing the drug filing and different aspects of obtaining United States Food & Drug Administration (USFDA) and European Medicines Agency (EMA) approval for a drug in order to get a Marketing Authorization in US & Europe and their effective role in improving the standards laid down by them. All new / generic drug products must be approved by the respective regulatory agency governing the respective market before a particular product can be introduced into the market. By law, all new drugs must first be shown to be safe and effective before they can be approved by the respective regulatory agency for marketing. USFDA is the regulatory agency which is responsible for safety regulation of the food and drug products in US. EMA is the regulatory agency decentralized body which is responsible for safety regulation of the food and drug products in Europe. Drug approval process in USFDA involves submitting of an Investigational New Drug Application, followed by submission of New Drug Application. The applications are reviewed and agency officials examine the drug’s safety and efficacy data and the drug is approved. EU establishes 4 different drug approval processes: 1) Centralized Procedure 2) Decentralized Procedure 3) National Procedure 4) Mutual Recognition Procedure.
Review and Approval Procedures for Promotional Materials
A survey study was conducted in Addis Ababa, Ethiopia, to examine current drug promotional practices and assess how promotional material gifts influence prescribing behavior. A total of 200 health professionals participated, including 100 drug promoters and 100 drug prescribers from both public and private institutions. Data were collected through structured questionnaires and supported by secondary sources. Findings revealed that most respondents preferred prescribing by generic name rather than brand name. Almost all promoters (99%) had contacted prescribers, and 97% of both groups believed promotional materials provided full and relevant drug information. While most participants agreed that promotion and material gifts are necessary, they felt the monetary value of such gifts should remain small. The study concluded that promotional activities accompanied by material gifts significantly influence prescribing behavior, particularly in private institutions. These findings highlight the need for stricter regulation and ethical oversight of drug promotion in Ethiopia to prevent biased prescribing and rising medication costs.
Challenges in Designing Anda for Parenteral Products
Quality by Design (QbD) is a systematic approach that focuses on understanding and controlling product quality through the integration of scientific principles, risk management, and regulatory requirements. This abstract provides a comprehensive overview of the application of QbD principles in the development of parenteral drug formulations, which are administered via injections, infusions, or implants. Employing Quality by Design (QbD) during the development of parenteral drug formulations yields substantial advantages as it facilitates a thorough comprehension of the interplay amongst formulation variables, process parameters, and critical quality attributes (CQAs). By employing a proactive and science-based approach, manufacturers can optimize product quality, reduce batch failures, and enhance patient safety and efficacy. The QbD approach in parenteral drug formulations involves several key elements. The first step is to identify and define the Critical Quality Attributes (CQAs) that are crucial to ensure the safety and effectiveness of the drug product. These attributes include parameters such as potency, purity, stability, and drug release profiles. Secondly, QbD encourages the establishment of a design space, which defines the acceptable ranges of formulation and process parameters that ensure product quality within the desired CQA specifications. Furthermore, QbD promotes a lifecycle approach, encompassing the entire product lifecycle from development to post-approval changes. This involves continuous process verification, ongoing monitoring of product performance, and the implementation of quality control strategies to ensure consistency and reliability. In conclusion, the application of QbD principles in parenteral drug formulations offers a robust and science-based approach to ensure product quality, safety, and efficacy. By leveraging these principles, manufacturers can optimize formulations, control critical parameters, and enhance process.
Role of ICH in Harmonizing Drug Regulations
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. Harmonisation of regulatory requirements was initiated by the European Community (EC), in the 1980s, the EC moved towards the development of a single market for pharmaceuticals. ICH regulatory authorities are among the first to evaluate new chemical entities and new products obtained from biotechnology. ICH provides various guidelines which are categorised into four category, Quality guidelines, safety guidelines, efficacy guidelines and multidisciplinary guidelines. These guideline give special concern for the patient population, large-scale human clinical trials lasting up to one year can begin in the absence of completed carcinogenicity studies in rodents.
International Regulatory Framework (IRF)
This study examines whether companies can comply with corporate reporting laws using de facto standards such as the International Integrated Reporting Framework (IRF) to meet the requirements of Directive 2014/95/EU on non-financial and diversity disclosure. An interpretivist research approach was adopted, using secondary data from professional reports, regulatory publications, and corporate registers. Findings reveal that for a private framework to achieve de facto standard status, it must gain strong regulatory endorsement and support from influential policymakers to ensure national-level adoption and diffusion. Without such backing, voluntary reporting frameworks struggle to become widely accepted. The study highlights that current practices often prioritize financial value creation and stock market capitalism over social and environmental sustainability, limiting their broader societal impact. It questions the continued relevance of both the IRF and the EU Directive in the post-COVID-19 era, emphasizing the need for reporting systems that move beyond compliance façades toward genuine accountability and sustainable value creation.
Hydrogel Systems for Clinical Research emerging trends in Therapeutics
This abstract summarizes current trends in hydrogel design and translational strategies that are advancing clinical research in therapeutics. It emphasizes responsive chemistries, device–drug combination pathways, and application niches with promising near-term clinical applications. Hydrogels are water-based polymer networks that can change their mechanical and transport properties. In the last ten years, they have quickly moved from research labs to real-world applications. Hydrogels are useful for several purposes: they can provide localized drug delivery, act as carriers for cells and genes, and serve as scaffolds for healing wounds and regenerating tissues. They are also effective in transdermal microneedle systems, which allow for painless drug administration. Hydrogels are becoming important platforms in clinical settings, effectively connecting biologics, small molecules, and cell therapies. They are particularly useful for local treatments, chronic wound repair, osteoarticular injections, and minimally invasive vaccine delivery. Early strategic engagement on chemistry, manufacturing, and controls (CMC) as well as regulatory pathways for combination products, along with the design of imaging-enabled endpoints, will help accelerate first-in-human studies and enhance the therapeutic impact.
Predictive Biopharmaceutics. Role of In-silico models in Drug Development
Predictive biopharmaceutics has become a vital tool in contemporary drug development, offering a theoretical framework to predict drug candidates' In- vivo performance based on their formulation and physicochemical properties. Predictive biopharmaceutics speeds up decision-making and lessens the cost of experiments by incorporating computational techniques to enable early identification of absorption, distribution, metabolism, and excretion (ADME) profiles. Quantitative structure–activity relationship (QSAR) analysis, physiologically based pharmacokinetic (PBPK) modelling, and molecular simulations are examples of in-silico models that are essential to this paradigm. These models provide highly accurate predictions of drug solubility, permeability, dissolution, and bioavailability under a variety of physiological circumstances. Using In-silico methods and predictive biopharmaceutics reduces late-stage failures while promoting cost-effectiveness, regulatory acceptance, and logical formulation design. When used in tandem, these instruments are transforming the drug development process by bridging the gap between clinical results and laboratory results, ultimately guaranteeing patients safer and more effective treatments.
Next Generation Biopharmaceutics Bridging Molecular Design with Clinical Success
Drug discovery and development remain lengthy and costly, often requiring over a decade and billions of dollars per approved therapy, with high attrition rates in clinical trials. Recent advances in artificial intelligence (AI) and machine learning (ML) are transforming this landscape by enabling predictive modelling, virtual screening, and generative molecular design. Techniques such as deep learning architectures (CNNs, RNNs and transformer models) and generative frameworks (GANs, VAEs, reinforcement learning) are accelerating drug–target interaction prediction, de novo compound generation, and optimization of biologics. These innovations significantly reduce development timelines, improve candidate selection, and enhance reliability compared to traditional trial-and-error methods. Integration of AI with organ-on-chip systems, biomarker-guided study designs, and digital simulations further bridges preclinical research with clinical translation. By fostering model-informed and data-driven development, next-generation biopharmaceutics emphasizes precision, safety, and cost-effectiveness. While regulatory, ethical, and technical challenges persist, AI-driven pipelines are poised to deliver a paradigm shift in pharmaceutical sciences, ensuring faster bench-to-bedside translation and shaping the future of personalized medicine.
Breast Cancer Management: Integrating Genomics, Targeted Therapy, and Immuno-Oncology
Breast cancer remains one of the most prevalent malignancies worldwide, contributing substantially to cancer-related morbidity and mortality among women. Over the past two decades, advances in genomics, molecular profiling, and translational oncology have transformed breast cancer management from a conventional, histology-driven approach to one increasingly guided by precision medicine. The integration of genomic technologies has enabled the identification of actionable mutations, predictive biomarkers, and molecular subtypes that inform both prognosis and therapeutic decision-making. Targeted therapies, particularly those directed against HER2, PI3K/AKT/mTOR signaling, and cyclin-dependent kinases, have reshaped the therapeutic landscape by improving survival outcomes and minimizing systemic toxicity. More recently, immuno-oncology strategies, including immune checkpoint inhibitors, tumor-infiltrating lymphocyte therapies, and cancer vaccines, have expanded therapeutic possibilities, especially in triple-negative breast cancer (TNBC), a traditionally hard-to-treat subtype. This manuscript provides a comprehensive review of breast cancer management, focusing on the integration of genomics, targeted therapy, and immuno-oncology within clinical practice. It highlights current standards of care, key molecular insights, translational research, and ongoing clinical trials while also emphasizing future perspectives for achieving durable responses and personalized cancer therapy.