Current Drug Research Reviews - Online First
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1 - 20 of 24 results
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Formulation Development of Low Soluble Drugs: Integrating Solubility, Dissolution, and PK-PD Stand Points through AI-Driven Strategies
Available online: 03 September 2025More LessA key challenge during drug development is getting the low-solubility molecules from the drug discovery phase to the formulation phase. The low bioavailability of a drug is typically correlated with its low solubility, which may negatively impact the drug’s effectiveness and its ability to act. Traditionally, the problem of low solubility was resolved by employing empirical trial-and-error methodologies to ascertain the best available technologies for achieving the drug's desired bioavailability. However, these traditional methods are time-consuming and require the use of more resources, posing a challenge to developmental timelines and budgets. With the progress of artificial intelligence (AI) and machine learning (ML), it is possible to accurately predict the appropriate drug-excipient mixtures and solubility enhancement technologies for drug development. This review aims to present intelligent modeling that supports knowledge generation, problem solving, and decision making. It highlights various AI-based strategies applied across the drug development pipeline - from solubility prediction and selection of excipient(s) to formulation optimization, solid dispersion evaluation, and real-time monitoring of drug release. Furthermore, it examines the role of AI in modeling pharmacokinetic (PK) and pharmacodynamic (PD) behaviors, thereby enabling more accurate predictions of in vivo outcomes. By leveraging intelligent algorithms, pharmaceutical scientists can accelerate development timelines, enhance decision-making, and improve the efficiency of formulation design. The pharmaceutical industry has tremendous opportunities to improve patient care and drug development processes through ongoing AI research and applications.
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Advancements in Analytical Techniques for Preservative Identification in Pharmaceuticals
Authors: Shefali Mehla, Anjali Sharma, Vishnu Mittal and Devkant SharmaAvailable online: 02 September 2025More LessIntroductionPreservatives are widely used chemical agents that inhibit microbial growth and extend the shelf life of food and pharmaceutical products. However, growing concerns over the potential adverse effects of synthetic preservatives, such as parabens and benzoates, have emphasized the need for precise and reliable analytical methods for their detection and quantification.
MethodsThis review evaluates and compares various analytical techniques employed for preservative analysis in pharmaceutical formulations, including chromatographic (HPLC, GC-MS), spectroscopic (UV-Vis), electrophoretic (CE), and electrochemical methods. Parameters such as sensitivity, accuracy, separation efficiency, and applicability in complex matrices were assessed across different techniques.
ResultsHigh-performance liquid chromatography (HPLC) demonstrated superior sensitivity with detection limits as low as 0.01 µg/mL and excellent linearity (R2 > 0.999), making it the most widely adopted method. Capillary electrophoresis (CE) provided rapid analysis within 10 minutes and high recovery rates (>98%). UV-Vis spectroscopy, although economical, faced challenges in analyzing complex samples due to spectral overlapping. Gas chromatography–mass spectrometry (GC-MS) excelled in identifying volatile preservatives through enhanced structural elucidation.
DiscussionHPLC emerged as the gold standard for routine preservative analysis due to its high precision (RSD < 2%), versatility, and ability to quantify multiple preservatives concurrently. While GC-MS offers detailed structural insight, it is more suited for specific applications. Emerging methods like UPLC and CE are gaining attention for their speed and reduced solvent usage, aligning with green analytical chemistry principles.
ConclusionRobust and sensitive analytical techniques are essential for the accurate determination of preservatives to ensure pharmaceutical safety and regulatory compliance. Continued innovation and optimization in analytical methodologies enhances the reliability of preservative monitoring and contributes significantly to public health risk assessment.
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Navigating Global Cosmetics Compliance: A Comparative Analysis of India's Cosmetics Rules 2020 with International Standards
Authors: Afifa Akram, Indu Singh and Shikha Baghel ChauhanAvailable online: 01 September 2025More LessThe Indian cosmetics industry has undergone a significant transformation with the implementation of the Cosmetics Rules 2020, which seek to align the country's regulatory framework with international standards, address local challenges, and ensure consumer safety. These rules cover registration and licensing, labeling and packaging, and stringent safety standards, ensuring the production of high-quality, safe products. This review provides a detailed comparative analysis of India's new regulations with those in major markets, including the European Union (EU), the United States (US), and Japan, as well as emerging markets such as China, Brazil, and Southeast Asia. The analysis highlights key similarities and differences, identifies areas for further reform, and offers insights into global regulatory dynamics. The review examines critical aspects such as registration and licensing requirements, which are essential for market entry. It also scrutinizes labeling and packaging regulations, which promote consumer transparency. Safety standards are a focal point, given their importance in protecting consumers. The impact of these regulations on India's cosmetics industry is explored, emphasizing the growing importance of sustainable practices, digital labeling, and traceability systems. These technologies enhance consumer access to product information and ensure product authenticity and safety throughout the supply chain. Furthermore, this review provides a future outlook, suggesting areas for regulatory improvement to support continued industry growth and consumer protection by examining current regulations and emerging trends.
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Revolutionizing Drug Delivery: The Promise of Self-emulsifying Systems in Overcoming Bioavailability Challenges
Authors: Sonia Dhiman, Ashi Mannan, Maneesh Mohan and Thakur Gurjeet SinghAvailable online: 25 August 2025More LessIntroductionThe oral route is a preferred method for drug administration; however, lipophilic drugs often suffer from poor water solubility, significantly limiting their therapeutic effectiveness. Traditional approaches like complexation, micronization, and solid dispersion have been explored, but each comes with inherent limitations.
MethodsSelf-Emulsifying Drug Delivery Systems (SEDDS) have emerged as a promising strategy to address solubility challenges. These systems incorporate drug molecules into a mixture of oils, surfactants, and cosolvents to enhance solubility. Ternary phase diagrams are frequently utilized to determine optimal component ratios for effective formulation.
ResultsSEDDS maintain drugs in a solubilized form within gastrointestinal fluids and protect peptide drugs from enzymatic degradation-a common issue in conventional formulations. They also facilitate the formation of stable emulsions at the target site, enhancing drug absorption. Additionally, the ability of SEDDS to traverse the blood-brain barrier (BBB) increases their applicability in treating neurological disorders.
DiscussionThe findings emphasize the utility of SEDDS in overcoming the solubility and stability challenges faced by poorly water-soluble drugs. Their capacity to enhance drug absorption and protect bioactive molecules from degradation aligns with current efforts to improve oral drug delivery systems. However, formulation complexities and variability in in vivo performance remain areas requiring further investigation.
ConclusionThis review outlines the formulation strategies, characterization methods, and evaluation techniques for SEDDS, emphasizing their potential in enhancing the bioavailability of poorly soluble drugs, particularly those aimed at the central nervous system. SEDDS offer a promising platform for improving therapeutic outcomes across diverse clinical settings.
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Exploring the Therapeutic Potential of SGLT-2 Inhibitors in Managing Metabolic Syndrome: A Narrative Review
Available online: 22 August 2025More LessMetabolic syndrome, a cluster of interconnected metabolic risk factors such as central obesity, insulin resistance, hypertension, and dyslipidemia, significantly increases the risk of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Despite its rising prevalence and serious health consequences, metabolic syndrome remains underdiagnosed and undertreated. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, initially developed for T2DM management, have demonstrated promising therapeutic potential for addressing multiple components of metabolic syndrome. These drugs lower blood glucose levels by promoting glycosuria and exhibit additional benefits, including weight loss, reduced blood pressure, improved lipid profiles, and cardioprotective effects. The impact of SGLT-2 inhibitors on the five metabolic syndrome criteria listed by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)—central obesity, triglycerides, HDL cholesterol, blood pressure, and fasting glucose levels-is evaluated in this narrative review, which combines results from meta-analyses and clinical trials. Reduced waist circumference, better lipid profiles, lower blood pressure, and improved glycaemic management are some of the main outcomes. Diuresis, natriuresis, enhanced insulin sensitivity, and AMP-activated protein kinase (AMPK) activation are the processes that underlie these effects. Although SGLT-2 inhibitors have a good safety record, they can cause uncommon diabetic ketoacidosis and urinary tract infections, which can be avoided with careful management. The study highlights that more research is necessary to understand long-term effects, optimize dosing regimens, and assess real-world applicability. According to these findings, SGLT-2 inhibitors are essential therapies for managing metabolic syndrome holistically, and they hold great promise for lowering the disease's worldwide burden and related health hazards.
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Pharmacological Activity of Scopoletin: Deciphering the Potential of Coumarins in Cognitive Dysfunction
Authors: Pranay Wal, Shaili Vadera, Namra Aziz, Prashant1, Rajesh KS, Chennu MM Prasada Rao and Mukesh Chandra SharmaAvailable online: 21 August 2025More LessNumerous therapeutic and culinary species produce scopoletin, a coumarin that is essential for treating a wide range of illnesses as a curative and chemopreventive agent. Globally, chronic illnesses are regarded as a major public health concern. Atypical regulation of various signalling pathways is the primary cause of most of these illnesses, which include cancer, as well as cardiovascular, metabolic, and neurological disorders. In Alzheimer’s disease (AD), amyloid β (Aβ) peptide aggregates are deposited in the CNS, forming plaques. The investigation assessed the capacity of scopoletin to modify the disease to several AD-related factors. It activated the release of insulin in the β cell of the pancreas. Additionally, it has been noted that most currently approved treatments for these illnesses are mono-targeted and related to the development of chemoresistance, which limits their utility and prevents them from demonstrating prolonged efficacy. Conversely, the molecules originating from plants exhibit a multi-targeted nature, which has led to widespread interest in these phytochemicals due to their few adverse effects. The purpose of this review is to summarise the possible consequences of scopoletin. An outline of scopoletin pharmacology, pharmacokinetics, and toxicity is given in this review. In addition, this chemical is non-toxic and has good pharmacokinetic properties, so more research in clinical settings is necessary to develop it as a possible medication. The findings from the investigation could aid in the prevention and management of illnesses as well as the understanding of the benefits of plants containing scopoletin.
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Exploring Compound Kushen Injection’s Anticancer Properties in Hepatocellular Carcinoma: An Integrated Approach of Network Pharmacology, Bioinformatics, and Experimental Validation
Authors: Changce Wei, Chunjuan Zhang, Shuyang Wang, Mingrui Yang, Jingxiao Wang, Miao Jiang and Cuiyan MaAvailable online: 06 August 2025More LessBackgroundHepatocellular carcinoma (HCC), commonly referred to as primary liver cancer, is a malignant neoplasm that originates within the liver. Conventional treatment modalities frequently result in less than satisfactory outcomes, primarily attributed to the intricate physiological and pathological contexts. Compound Kushen Injection (CKI), formulated from the botanicals Sophora flavescens and Atractylodes macrocephala, is employed as a supplementary therapy in the treatment of advanced-stage malignant tumors, including HCC.
ObjectiveOur study combined network pharmacology, bioinformatics, GeneMANIA-based functional association (GMFA), and experimental validation to elucidate CKI's therapeutic targets and mechanisms.
MethodsSTRING was used to build a protein-protein interaction network, and GO and KEGG analyses were performed with DAVID and ShinyGO on the overlapping targets of CKI and HCC. Hub targets were identified using CytoHubba and their clinical relevance was confirmed with GEPIA2. GMFA and TIMER assessed the functions of key hub genes. The findings were further verified through significant KEGG analysis, molecular docking, and experimental validation.
Results10 hub targets were identified for CKI against HCC and analyzed for their impact on HCC patient survival and gene expression. GMFA confirmed four key hub genes, and TIMER assessed the correlation between SRC expression and immune infiltration. Significant KEGG analysis highlighted SRC's role in cell proliferation and migration through the MMP/EGFR-PI3K/AKT pathway. Molecular docking showed interactions between SRC and desmethylanhydroicaritin or resokaempferol. Experiments in HepG2 cells confirmed CKI's inhibitory effect on tumor cells.
ConclusionCKI’s anti-HCC effects may be exerted by regulating SRC via active compounds desmethylanhydroicaritin and resokaempferol.
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Bioactive Compounds and their Therapeutic Potential in Gastrointestinal Disease
Authors: Rudra Pratap Singh and Shashank SoniAvailable online: 31 July 2025More LessThe gastrointestinal tract (GIT) is inhabited by an extensive range of microorganisms known as the human gut microbiota, which includes fungi, bacteria, viruses, algae, and parasites. Through its relationships with the host and other bacteria, this microbiota generates an intricate ecosystem that is essential to preserving human health. The gastrointestinal microbiota is necessary for many physiological functions, including immune system regulation, nutrition metabolism, vitamin synthesis, medication and xenobiotic processing, gut mucosal barrier integrity, and pathogen defense. An immune system's response to tissue damage or injury caused by infections, physical and chemical stress, immune system deviations, or genetic factors is inflammation. Chronic inflammation is a condition that is fueled by the activity of immune cells and has been linked with several diseases. While lifestyle adjustments, dietary alterations, and medicines are now used to reduce inflammation, these strategies frequently prove ineffective. Beyond the basics of nutrition, bioactive compounds (BCs), known as nutritional ingredients found in small quantities in foods and plant extracts, give additional benefits for health. Their anti-inflammatory, anticancer, anti-metabolic syndrome, antioxidant, and antimicrobial properties make them an excellent choice for addressing a variety of GIT disorders. By adjusting inflammatory mediators, bioactive compounds can lessen the negative effects of inflammation. Although medications, dietary changes, and changes in behavior are now employed to lower inflammation, these tactics usually fail to succeed. BCs, occasionally referred to as nutritious elements present in trace amounts in foods and plant extracts, provide additional health benefits beyond the essentials of nutrition. Bioactive substances may reduce the adverse effects of inflammation by modifying mediators of inflammation.
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Efficacy of Herbal Remedies in Menopause: Bridging Traditional Medicine and Modern Therapeutics
Authors: Megha Chavda, Lata Mansukhbhai Manani and Chandni ChandaranaAvailable online: 31 July 2025More LessIntroductionMenopause is a natural physiological transition marked by hormonal changes that can lead to a range of physical, emotional, and psychological symptoms, often impacting a woman's quality of life. This review aims to evaluate the effectiveness of herbal remedies as alternative or complementary options to conventional treatments, particularly hormone replacement therapy (HRT), in managing menopausal symptoms.
MethodsAn extensive literature review was conducted, focusing on commonly used herbs such as black cohosh, red clover, Dong Quai, and chaste tree berry. The review assessed the phytoestrogenic and adaptogenic properties of these herbs, exploring their mechanisms of action, clinical efficacy, safety profiles, and potential interactions. Comparisons were made with HRT and other conventional therapies. Non-hormonal pharmacological options and lifestyle interventions, including yoga and dietary changes, were also examined.
ResultsHerbal remedies, particularly black cohosh and red clover, demonstrated moderate effectiveness in alleviating menopausal symptoms, attributed to their phytoestrogenic and adaptogenic actions. Clinical evidence supports their safety, though individual responses and drug interactions vary. Additionally, non-hormonal treatments and lifestyle modifications, such as yoga and dietary adjustments, contribute to symptom relief.
DiscussionThe findings underscore the potential of herbal remedies as viable alternatives or adjuncts to HRT. While generally safe and moderately effective, the variability in individual response and the need for awareness of possible interactions are important considerations. Integrating herbal approaches with evidence-based medical practices may offer more personalized and holistic menopause care.
ConclusionHerbal therapies present a promising, well-tolerated option for managing menopausal symptoms. When combined with conventional or lifestyle-based interventions, they broaden the spectrum of therapeutic choices available to women, enabling individualized, integrative care during menopause.
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Functional Effects of Cromakalim on Aortic Tissue in STZ-Diabetic Rats: Impact of Insulin Treatment
Available online: 30 July 2025More LessIntroductionK+ channels play a key role in the development of the vasodilation response, which is compromised in diabetes.
MethodsIn this study, the effects of the potassium channel activator cromakalim on aortic function were investigated in streptozotocin (STZ)-diabetic rats at short (1 week), medium (8 weeks), and long-term (14 weeks) durations, including a group treated with insulin for 14 weeks.
ResultsCompared with the control group, cromakalim-induced concentration-dependent vasodilation was reduced in the aortas of 8 and 14-week streptozotocin-diabetic rats (p < 0.05). Daily insulin treatment during the long-term (14 weeks) durations normalized the vasodilation response to cromakalim in the aortas of 14-week streptozotocin-diabetic rats.
DiscussionStudies with cromakalim on diabetic rat aortic K+ channels are limited. Dose-dependent cromakalim-induced vasodilation was investigated in 8- and 12-week STZ-diabetic rat aortas and was found to be reduced. The impaired vasodilation responses were improved in the STZ-diabetic group with chronic insulin treatment. The results of these studies were similar to those of our study.
ConclusionThese findings indicate that potassium channel activity and vascular vasodilation ability decrease in the aortas of streptozotocin-diabetic rats depending on the duration of diabetes. In contrast, potassium channel activity and vascular vasodilation ability return to normal with insulin treatment in 14-week streptozotocin-diabetic aortas.
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Efficacy and Safety of Ionic Contra-viral Therapy (Digoxin-Furosemide) in the Treatment of Multiple Cutaneous Warts: A Systematic Review, Meta-analysis, and Trial Sequential Analysis
Authors: Madhusudan Prasad Singh, Manisha Maheshwari and Juhi SinghAvailable online: 24 July 2025More LessIntroductionThe primary objective of this systematic review was to evaluate the therapeutic efficacy and safety profile of intralesional Ionic Contra-Viral Therapy (ICVT)-a combination of digoxin and furosemide-in the treatment of multiple cutaneous warts.
MethodsThis meta-analysis was conducted in accordance with PRISMA guidelines and was prospectively registered in PROSPERO (CRD42024544551). A comprehensive literature search was performed up to April 2024 across PubMed, MEDLINE, Scopus, Cochrane CENTRAL, ClinicalTrials.gov, and Google Scholar. Eligible studies included randomized controlled trials involving adults with ≥2 cutaneous warts treated with intralesional digoxin and furosemide, assessing outcomes, such as complete and partial clearance, wart size reduction, and adverse events. Exclusion criteria included case reports, reviews, and preclinical studies. Data extraction was performed independently by two reviewers, with discrepancies resolved through consensus. The Cochrane RoB 2 tool was used for risk of bias assessment. Meta-analyses were conducted using a random-effects model, and heterogeneity was evaluated using the I2 statistic. The quality of evidence was graded using the GRADE framework.
ResultsSeven randomized trials, including a total of 391 patients, were analyzed. The ICVT group demonstrated significantly higher complete wart clearance compared to placebo (56.8% vs. 2.8%; RR = 13.27, 95% CI = 2.93-60.17; p = 0.0018). Partial response was lower in the ICVT group (5.08% vs. 10%; RR = 0.66, 95% CI = 0.09-5.09; p = 0.69). Adverse events occurred more frequently in the ICVT group (85% vs. 58.8%; RR = 1.33, 95% CI = 0.47-3.79; p = 0.59; I2 = 97%). Pain during injection was also more commonly reported in the ICVT group (96.6% vs. 63.3%; RR = 1.45, 95% CI = 0.29-7.22; p = 0.65; I2 = 99%). The certainty of evidence was rated as very low for complete clearance, moderate for partial response, and low for adverse events and injection pain. Trial Sequential Analysis (TSA) indicated that the required information size was not met for any of the outcomes.
DiscussionWhile the results suggest that ICVT may be effective in achieving complete clearance of multiple cutaneous warts, the current evidence is limited by small sample sizes, methodological heterogeneity, and potential biases. The higher incidence of adverse events and injection-related pain raises safety concerns. The low to very low certainty of evidence, coupled with the TSA findings, underscores the need for more rigorous investigation. Variability in trial design, dosing protocols, and outcome reporting further limits the applicability of current findings.
ConclusionIntralesional ICVT shows promise as a therapeutic option for multiple cutaneous warts, particularly in achieving complete clearance. However, due to the limited certainty of available evidence and inconsistent safety data, further large-scale, high-quality randomized controlled trials are necessary to validate these findings and establish standardized treatment protocols.
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Role of Antioxidants in Diseases and its Impact on Mitochondria with A Focus on Diabetes: An Overview
Authors: Junmoni Nath, Bhargab Deka and Bhanu P SahuAvailable online: 23 July 2025More LessIntroductionThis review focuses on the various natural and synthetic antioxidants which affect cellular signalling and mitochondrial dynamics for managing diabetes and its complications including other variety of diseases or traumas.
MethodsInformation in the current review was gathered from electronic scientific resources like google scholar, science direct, springer link and via the PubMed website using the Boolean Method and a variety of keywords.
ResultsThe results of the present study revealed that a number of 110 antioxidants have been identified to improve mitochondrial health, offering potential treatments for diabetes and a spectrum of other diseases. Naturally occurring antioxidants such as polyphenols and flavonoids present in fruits and plants, have demonstrated the ability to attenuate oxidative stress and enhance mitochondrial performance thereby helps in the management of diabetes and various other health complications. From among the polyphenol’s resveratrol, mitoQ, quercetin and curcumin has been discussed in the review.
DiscussionThe analysis indicates a strong correlation between antioxidant activity and mitochondrial function, underscoring their role in disease prevention and therapy. These antioxidants not only reduce oxidative damage but also regulate signalling pathways involved in inflammation and energy metabolism. Their dual action makes them promising agents in managing diabetes and potentially other chronic diseases.
ConclusionThe conclusion offers a concise yet comprehensive overview for researchers and industries in highlighting the therapeutic promise of antioxidant interventions in addressing diverse health conditions through enhanced mitochondrial function.
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The Pharmacoeconomics and its Evaluation in Enhancing the Indian Healthcare System
Authors: Uma Agarwal, Garima Kapoor, Khushboo Singhal and Rajiv Kumar TonkAvailable online: 04 July 2025More LessIntroductionEscalating healthcare costs and increasing demands on healthcare systems have increased the need for efficient resource allocation. Pharmacoeconomics is a vital field that quantifies and compares the value of therapeutic drugs or treatments. It provides a systematic framework for decision-makers in the pharmaceutical industry, government, and private sectors to optimize healthcare delivery and spending. This review aimed to explore the role of pharmacoeconomic models in assessing the economic and clinical value of therapies. It emphasizes the importance of cost-effectiveness, cost-utility, cost-benefit, and cost-minimization analyses in balancing costs with outcomes and guiding healthcare resource allocation.
MethodsPharmacoeconomic methodologies focus on assessing the costs, processes, and outcomes associated with therapeutic interventions. Key methods include cost-minimization, cost-effectiveness, cost-utility, and cost-benefit analyses. These approaches are critical in regulatory compliance, reimbursement decisions, cost assessments, and sustaining pharmaceutical models.
ResultsThis review reveals that pharmacoeconomic approaches such as Cost-Effectiveness Analysis (CEA), Cost-Utility Analysis (CUA), and Cost-Benefit Analysis (CBA) are widely used to guide healthcare policy decisions, particularly in resource-constrained settings. CEA is the most commonly applied method due to its simplicity, while CUA is gaining traction in advanced policy frameworks like Health Technology Assessment (HTA). In India, pharmacoeconomic research is emerging but faces barriers such as limited access to real-world data, the absence of national reimbursement systems, and high out-of-pocket costs. Innovative methods like machine learning and pharmacogenomics are being explored to improve the relevance and precision of these evaluations.
DiscussionWhile pharmacoeconomic models offer valuable insights for healthcare decision-making, their real-world impact is limited by inconsistencies in data quality and variations in implementation standards. In India, fragmented governance, low public health spending, and a lack of coordination among stakeholders further hinder effective application. Addressing systemic challenges-such as establishing interoperable data systems, standard treatment guidelines, and equitable healthcare access-is crucial. Tailored approaches, including localized utility values and digital health initiatives, are essential to make pharmacoeconomics a practical and influential tool in policy formulation and resource allocation in India and similar settings.
ConclusionPharmacoeconomic studies evaluate clinical efficacy, adverse effects, and production costs while incorporating perspectives from patients, providers, payers, and communities. For India, unique challenges such as limited rural healthcare access, infrastructure disparities, and high out-of-pocket expenses necessitate tailored adaptations. Strategies such as integrating accessibility metrics, localized data, equity considerations, preventive care, tiered pricing, and public-private partnerships can enhance healthcare delivery. Pharmacoeconomic models are essential for improving health outcomes, ensuring equitable resource allocation, and addressing the diverse needs of India.
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Navigating Global Regulatory Divergence in Over-the-counter Drugs: Addressing Emerging Risks and Harmonization Challenges
Authors: Simran Nayan, Ankit Kolay, Shikha Baghel Chauhan and Indu SinghAvailable online: 03 July 2025More LessThe worldwide market for over-the-counter (OTC) medications is quickly developing, providing consumers with increased self-medication options while facing substantial regulatory issues due to varied approval procedures, labeling regulations, and safety standards between nations. Despite efforts to standardize regulatory frameworks, differences in component classification, dosage limitations, and risk assessment standards impede producers, healthcare professionals, and lawmakers. This analysis looks at the regulatory environment of over-the-counter pharmaceuticals in major countries, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and regulatory organizations in Asia-Pacific and developing economies, highlighting notable disparities in approval procedures, marketing authorization, and pharmacovigilance. Consumer safety is one of the most important problems in regulatory divergence, since differences in authorized active ingredients, warnings, and recalls can lead to abuse, adverse medication responses, and cross-border product availability anomalies. Furthermore, the lack of standardized testing and quality control procedures hampers international trade and public health policy. Emerging threats, such as antimicrobial resistance (AMR), counterfeit OTC goods, and digital health breakthroughs, necessitate a more integrated and adaptable global regulatory framework. This assessment also looks at continuing harmonization efforts by organizations such as the International Council for Harmonization (ICH) and the World Health Organization (WHO), as well as best practices for expediting global regulatory procedures. Addressing regulatory divergence with data-driven decision-making, digital pharmacovigilance, and risk-based categorization frameworks can help enhance consumer safety, market efficiency, and public health outcomes. The future of over-the-counter medication regulation lies in collaborative policymaking, real-time safety monitoring, and rapid adaptability to changing healthcare concerns.
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Platelet-rich Plasma: A Tour d’horizon for its Application in Rheumatoid Arthritis
Available online: 27 June 2025More LessRheumatoid Arthritis (RA) is one of the most common inflammatory diseases, affecting millions of people worldwide, out of which 40% show poor clinical response while 5-20% do not respond to current medications, including biologic and targeted therapies. Platelet-Rich Plasma (PRP), an autologous blood-derived product enriched with growth factors, has emerged as a new orthobiologic for the treatment of such non-responsive patients. The growth factors present in PRP influence various fundamental processes, including inflammation, angiogenesis, cell migration, and metabolism in RA. PRP alleviates the inflammatory response via suppression of nuclear factor-κβ beta and phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT) signalling pathway. It also modulates the intra-articular environment of the affected joints, characterised by the suppression of oxidative stress and synovial hyperplasia, and promotion of angiogenesis and chondrogenesis, thereby attenuating the arthritic changes in the synovium and cartilage. Till now, there appears to be a gap regarding uniformity in dosage regimens and treatment protocols among the studies demonstrating the efficacy of PRP in RA, and well-planned studies are required to explore the therapeutic potential of this new orthobiologic treatment.
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Nanotherapeutics Mediated Intranasal Delivery for Therapeutic Effect on Parkinson’s Disease: Balancing Advancements and Challenges
Authors: Pankaj Popli, Barika Rana, Sonia Dhiman, Indu Singh, Rajan Swami and Thakur Gurjeet SinghAvailable online: 25 June 2025More LessManaging Parkinson's Disease (PD) presents formidable challenges due to the impermeability of the Blood-Brain Barrier (BBB), which severely restricts effective drug delivery. Traditional treatment modalities often prove inadequate, prompting the exploration of intranasal drug delivery as a novel and promising alternative. This innovative approach provides direct access to the central nervous system while bypassing the Blood-Brain Barrier (BBB). Recent advancements in nanotechnology, particularly the development of polymeric and lipidic Nanoparticles (NPs), significantly enhance this delivery method by improving mucoadhesion and drug uptake, resulting in elevated drug concentrations in the brain and improved symptomatology. Furthermore, the unique properties of NPs enable sustained drug release, maintaining effective pharmacological levels while minimizing systemic side effects. However, challenges such as potential toxicity, formulation stability, and scalability persist. This review elucidates the role of NPs in surmounting BBB obstacles and underscores the necessity for continued research to optimize their design and ensure long-term safety. As the field advances, intranasal delivery systems hold the promise of becoming pivotal tools in PD management, offering more effective and less invasive therapeutic options for patients.
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Advances in Piperazine-based Compounds for Antimicrobial Drug Development: Design, SAR, and Therapeutic Potential
Authors: Shagun Aggarwal, Divya Jain, Parminder Kaur and Kuldeep SinghAvailable online: 19 June 2025More LessThe rise of antimicrobial resistance has intensified the need for novel therapeutic agents to combat infectious diseases. Among various heterocyclic scaffolds, piperazine has emerged as a promising nucleus in drug discovery due to its structural versatility and ability to enhance bioactivity. This review explores the role of piperazine-based compounds in antimicrobial drug development, focusing on design strategies, Structure-Activity Relationships (SAR), and therapeutic applications. Structural modifications of piperazine derivatives, including the incorporation of electron-withdrawing groups (Cl, Br, NO2), have demonstrated enhanced antibacterial activity, whereas electron-donating groups and certain ring substitutions (e.g., pyridine, furan) often reduce potency. Molecular docking studies have provided valuable insights into the binding interactions of piperazine derivatives with microbial enzymes and proteins, validating their mechanism of action. Additionally, the integration of computational techniques and medicinal chemistry approaches has facilitated the rational design of more potent derivatives with improved pharmacokinetic properties. The therapeutic potential of piperazine-based antimicrobials extends to bacterial infections caused by multidrug-resistant (MDR) pathogens, making them strong candidates for next-generation antimicrobial agents. This review provides a comprehensive analysis of recent advancements in piperazine-based antimicrobial drug discovery and highlights future directions for medicinal chemists in the fight against drug-resistant microorganisms.
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A Novel, Stability-indicating Method for Analyzing Degradation Impurities in Hydrochlorothiazide and Irbesartan Tablets Using RP-HPLC
Authors: Tusharkumar Shah, Smriti Sharma and Jayesh DhalaniAvailable online: 22 May 2025More LessIntroductionWell-known antihypertensive medications, hydrochlorothiazide and irbesartan, are sometimes taken as a low-dose combination in a single pill.
AimsThe aim of this research is to create and verify a standard screening test for identifying process-related degradation in tablets containing irbesartan and hydrochlorothiazide. The objective of the study was to report the quality and robust method of HPLC for impurities in the mentioned drugs.
Materials and MethodsSeparation was accomplished using a Kromasil L7 column (250 x 4.6 mm 5 μ). Furthermore, a 50 x 4.6 mm ghost-busting column was set up. 0.1% orthophosphoric acid was used in mobile phase A, and acetonitrile was used in mobile phase B. Infinity 1290 was used to conduct the analysis at a fixed flow rate of 1.2 mL/minute. At 220 nm, detection was carried out. The temperature in the column oven was kept at 30°C.
ResultsFor eight impurities, regression analyses show a correlation coefficient value greater than 0.999. The approach was to demonstrate superior recoveries for impurities linked to hydrochlorothiazide and irbesartan (89.7-108.9%), and the limit of quantification for hydrochloro thiazide Related Compound-A is 0.248 ppm, chlorothiazide 0.251 ppm, chloro hydrochlorothiazide 0.252 ppm, irbesartan related compound-A 1.214 ppm, triphenyl methanol 1.210 ppm, IB-23 1.198 ppm, trityl methyl ether 1.204 ppm and KL-2 1.196 ppm.
ConclusionThe recommended method was well evaluated and can be used for routine examination of the drug impurity studies and mixtures.
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Diabetic Wound Healing: Mechanism and Treatment Strategies with a Special Focus on Angiogenesis
Authors: Ankita Wal, Nidhi Singh, Pranay Wal, Rakesh Verma, S Gowrish, Rahul Subhash Buchade, Mohd Imran and Amin GasmiAvailable online: 24 April 2025More LessDue to the numerous comorbidities associated with diabetes mellitus (DM), its complications of poor wound healing, persistent ulceration, and subsequent limb amputation, DM is becoming a major global health concern. The need for research attention increases due to delayed and compromised healing. We provide an overview of the latest developments in our knowledge of the pathophysiology of diabetic wounds in this review, with a particular emphasis on impaired angiogenesis, suboptimal chronic inflammatory response, and barrier disruption. We also discuss potential future directions for treating the various pathologies linked to diabetic wounds. The emphasis of this study is diabetic wound healing, with particular attention to the abnormalities reported in the wound angiogenesis proliferative, remodelling, and maturation phases. This evaluation also considers therapies that might hold the key to improved wound healing results. Future treatment options must address many causes of delayed healing in diabetic wounds, given the worrying rise in the prevalence of diabetes and, consequently, diabetic wounds.
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The Potential of Coenzyme Q10 in Alzheimer's Disease: Reducing IL-17 Induced Inflammation and Oxidative Stress for Neuroprotection
Available online: 24 April 2025More LessAlzheimer's disease (AD) is a progressive neurodegenerative disorder primarily marked by amyloid-beta (Aβ) plaque accumulation and neurofibrillary tangles, which lead to cognitive decline. Oxidative stress and neuroinflammation are key contributors to the disease's progression, with elevated production of Reactive Oxygen Species (ROS) exacerbating neuronal damage. Coenzyme Q10 (CoQ10), a naturally occurring antioxidant, has been identified for its potential neuroprotective effects due to its roles in mitochondrial function, energy production, and antioxidant defense. The cytokine interleukin-17 (IL-17) is also implicated in AD, promoting neuroinflammation by disrupting the blood-brain barrier (BBB) and activating glial cells. This review explores the impact of CoQ10 on neuroinflammation and oxidative stress in AD, focusing on its role in mitigating IL-17-mediated pathways. Preclinical studies indicate that CoQ10 reduces Aβ plaques, improves cognitive functions, and restores mitochondrial stability. However, clinical trials have yielded mixed results, often limited by bioavailability challenges. This research highlights the necessity of further human trials better to understand CoQ10's therapeutic potential in AD management.
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