Regulatory Frameworks and Filing Discrepancies in Generic Drug Approvals: A Cross-Regional Study with Analysis of FDA ANDA Deficiencies.

Objectives: This research aims to analyse the regulatory frameworks for generic drug applications in the US, EU, India, Japan, and China comparing their filing requirements to identify gaps and areas for harmonization. Additionally, it focuses on examining common deficiencies in ANDA from FDA submissions in 2014-2023 to address issues, facilitating more efficient approvals and minimizing delays.

Material And Methods: The research involved analysing regulatory documents available on official websites, including the FDA, EMA, CDSCO, PMDA, and NMPA to achieve first objective.

Unlocking the potential of THR-β agonist therapies: resmetirom's chemistry, biology, and patent insights.

Non-alcoholic steatohepatitis (NASH) is a severe manifestation of non-alcoholic fatty liver disease (NAFLD), which is characterized by hepatic steatosis, inflammation, and hepatocyte destruction. Newly adopted nomenclature, metabolic dysfunction-associated fatty liver disease (MAFLD), allows to signify the importance of metabolic dysfunction. For which the current treatment options are limited and often associated with adverse effects, creating a need for targeted therapies.

Emerging therapeutic application of clemastine: a review of recent patents updates.

Clemastine, a first-generation antihistamine traditionally used for treating allergic rhinitis and urticaria, has recently gathered interest due to its potential therapeutic applications beyond its antihistaminergic properties. This review examines recent patent filings (2015-2024) to elucidate the emerging therapeutic landscape for this compound. The analysis reveals various potential applications, including neurodegenerative disorders, cardiovascular diseases, and cancer treatment.

Improved pharmacokinetic parameters and reduced tissue distribution of prodrug of triamcinolone acetonide in lipid nanospheres - a preliminary investigation.

Objective: In the current research work, we synthesized triamcinolone acetonide palmitate (TAP), a lipophilic prodrug of triamcinolone acetonide (TA) and formulated it into lipid nanospheres (TAP-LN) to improve pharmacokinetics and tissue distribution on intravenous administration.

Significance: Triamcinolone acetonide is a parenteral glucocorticoid used to treat several inflammatory disorders. It has a short plasma half-life (2-3 h) and its parenteral administration causes severe side effects.

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Biosensors play a crucial role in the diagnosis and monitoring of diseases as therapeutic applications that come with ease through incorporation and collaboration with wearable medical devices. Various regulatory markets are implementing development and management strategies for this emerging medical device field. This paper provides regulatory navigation of biosensors in wearable diagnostic devices across the US, EU, and Indian markets.

Exploring the multifaceted side effects of isotretinoin: a deep dive into case reports and observational studies.

This review addresses gaps in understanding isotretinoin's side effects for acne vulgaris. While effective, the risks are often underestimated. It emphasizes careful patient selection and monitoring to optimize outcomes and minimize harm.

Pathogenesis, attenuation, and treatment strategies for keloid management.

Keloid is an outcome of abnormal cellular response in the wound healing process with excessive fibroblast and collagen deposition in the dermal layer of the skin. It is characterized by a scar showing fibrous outgrowth that grows beyond the original boundaries of the wound. Thus, it is cosmetically and functionally disturbing to the patient.

Ocular polymeric nanomicelles for the posterior eye segment in the management of retinoblastoma: formulation, optimization, and evaluations.

The existing study focuses on the development, optimization, and evaluation of sorafenib-loaded polymeric nanomicelles for posterior segment delivery in treating retinoblastoma. The formulation involved adjusting various process and product parameters to create effective drug-loaded polymeric nanomicelles. The particle size, PDI, and zeta potential of optimized formulation were found to be 65.

Acute and Subacute Oral Toxicity Study of a Herbal Formulation Containing , , and in Mice.

The synergistic activity of compounds in herbal drugs has been well established by multiple scientific studies. The compounds present in plants may have increased toxicity and increased efficacy. Owing to the notion that traditional medicines do not have any adverse effects, these are used heftily.

EFSA prohibits titanium dioxide in food- should pharmaceuticals be next?

Titanium dioxide (TiO) is a natural, inorganic compound widely used across various industries due to its multiple properties. Recently, the European Food Safety Authority (EFSA) raised safety concerns regarding the use of TiO in foods, specifically its potential for genotoxicity, accumulation in the body, and associated health risks when used as a food additive. As a result, its use in food has been banned in the food industry in the European Union (EU) since 2022.

Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights.

Objective: Achieving first-cycle approval in Abbreviated New Drug Applications (ANDAs) is a critical goal in the generic drug industry, as it enables faster market entry. This study covers common areas of deficiency within ANDA submissions that often lead to delays and multiple review cycles. This review also delves into FDA initiatives aimed at improving first-cycle approval rates and case study analysis that assess deficiencies impact on approval timelines.

Advanced Drug Delivery Systems Utilizing β-Lactoglobulin: An Efficient Protein-Based Drug Carrier.

Proteins have shown significant potential as carrier systems due to specific binding interactions with several drug molecules. Among several other animal proteins, whey protein (WP) is a by-product of the dairy industry, mainly composed of globular proteins. β-Lactoglobulin (BLG) is a major component of WP, which offers a unique functional property for drug delivery, such as thermal stability, binding interactions, favorable charge characteristics, and a spherical shape.

Thiazolidinedione derivatives: emerging role in cancer therapy.

Cancer remains the leading cause of death worldwide, with the Globocan 2022 study reporting an estimated 9.7 million cancer deaths. Without the selectivity built for tumour cells, chemotherapeutic agents could be toxic to non-cancerous cells.

Functional and structural polypharmacology of indazole-based privileged ligands to tackle the undruggability of membrane transporters.

Despite the significant roles of solute carrier (SLC) and ATP-binding cassette (ABC) transporters in human health and disease, most remain poorly characterized as intrinsic and/or xenobiotic ligands are unknown, rendering them as 'undruggable'. Polypharmacology, defined as the simultaneous engagement of multiple targets by a single ligand, offers a promising avenue for discovering novel lead compounds addressing these emerging pharmacological challenges - a major focus in contemporary medicinal chemistry. While common structural motifs among phylogenetically diverse proteins have been proposed to underlie polypharmacology through the concept of 'multitarget binding sites', a comprehensive analysis of these functional and structural aspects from a medicinal chemistry perspective has yet to be undertaken.

A herbal approach to diabetic cardiomyopathy: moringa, ginger, and garlic unveiled.

Objective: Chronic inflammation contributes to myocardial complications in diabetes, marked by tissue fibrosis, necrosis, and apoptosis. and have individually demonstrated efficacy in diabetes management. In this study, it is hypothesised that a combination of these herbs in a polyherbal formulation would protect against diabetic cardiomyopathy.

Mechanisms involved in the valproic acid-induced hepatotoxicity: a comprehensive review.

Adverse drug reactions (ADR) remain a challenge in modern healthcare, particularly given the increasing complexity of therapeutics. An anticonvulsant medicine which is frequently used in treatment of epilepsy and other neurological conditions is valproic acid (VPA), is frequently associated with hepatotoxicity, a severe ADR that complicates its clinical use, which can take two different forms: Type I, which is defined by dose-dependent and reversible liver damage, and Type II, an idiosyncratic reaction that can result in severe liver failure, frequently complicates its clinical application. Oxidative stress, the creation of reactive metabolites, mitochondrial dysfunction, carnitine shortage, immune-mediated reactions, glutathione depletion, and blockage of the bile salt export pump (BSEP) are some of the numerous underlying mechanisms of VA-induced hepatic damage.

Liposomal Formulations: A Recent Update.

Liposome-based drug delivery technologies have showed potential in enhancing medication safety and efficacy. Innovative drug loading and release mechanisms highlighted in this review of next-generation liposomal formulations. Due to poor drug release kinetics and loading capacity, conventional liposomes have limited clinical use.

Acetohydroxyacid Synthase (AHAS) Inhibitors as Antitubercular Agents: Insights From Molecular Docking and Dynamics Simulations.

Acetohydroxyacid synthase (AHAS) is a vital enzyme in Mycobacterium tuberculosis, the pathogen causing tuberculosis (TB), involved in branched-chain amino acid synthesis. Targeting AHAS for drug design against TB offers a promising strategy due to its essentiality in bacterial growth. In current investigation, we have designed 160 novel compounds by leveraging key scaffolds identified through structure-based drug design (SBDD) methodologies.

Molecularly imprinted polymer-based biosensor for detection of salivary glucose in diabetes.

Diabetes is a disorder attributed to impaired production or utilization of insulin and requires rapid precise monitoring of glucose levels. The fabrication of nanotechnology-based non-invasive biosensors for glucose detection holds significant promise for improved diabetes care and point-of-care diagnostics. The study demonstrates a novel molecularly imprinted polymers (ADMIPs) based sensitive biosensor for glucose estimation in saliva using three distinct sensing platforms -cotton swab, paper strip and polymeric film by colorimetric assay.

Tofacitinib in focus: Fascinating voyage from conventional formulations to novel delivery systems.

Tofacitinib, a Janus kinase (JAK) inhibitor, has emerged as a primary therapeutic agent for managing autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, dermatitis and ulcerative colitis. By inhibiting the phosphorylation of JAK enzymes, tofacitinib prevents their activation within the JAK-STAT signaling pathway, which is vital for inflammatory responses. However, the tofacitinib delivery presents significant challenges, including pH-dependent solubility, poor permeability and susceptibility to oral degradation.

Vasant Kusumakar Rasa Ameliorates Diabetic Encephalopathy by Reducing Oxidative Stress and Neuroinflammation and Improving Neurotransmitter Levels in Experimental Animals.

Purpose: Diabetic encephalopathy (DE) is one of the complications of diabetes that affects the brain. In the Ayurveda system of medicine, Vasant Kusumakar Rasa (VKR) is cited as a classical herbo-mineral formulation for diabetes. However, the role of VKR in DE is still unclear.

The role of biomaterials-based scaffolds in advancing skin tissue construct.

Despite extensive clinical studies and therapeutic interventions, addressing significant skin wounds remains challenging, necessitating novel approaches for effective regeneration therapy. In the current review, we analyzed and evaluated the application, advancements, and future directions of biomaterials-based scaffolds for skin tissue construct. In addition, we investigated the role of other biological substitutes in promoting wound healing and skin tissue regeneration.

Terminalia catappa aqueous extract reduces hyperglycaemia and oxidative stress in diabetic-hypercholesterolemic rats.

Background: Terminalia catappa is an important medicinal plant. Plants from the genus Terminalia have been reported for antidiabetic effects.

Objective: To study effect of Terminalia catappa leaves aqueous extract in type 2 diabetic rats.

Functionalization of polymeric nanomicelles and mixed nanomicelles for targeted retinal delivery in the management of retinoblastoma.

The current research discusses polymer conjugation, formulation development, and evaluation of sorafenib-loaded polymeric nanomicelles of conjugated soluplus (solu-tin) and polymeric mixed nanomicelles of conjugated soluplus (solu-tin) with conjugated poloxamer 188 (polo-tin) for site-specific posterior segment delivery to the retina in managing retinoblastoma. Firstly, the soluplus and poloxamer 188 were conjugated with biotin by Fischer esterification reaction and evaluated by FTIR and H NMR for confirmation of covalent bond formation involving the carboxyl group of biotin and hydroxyl group of polymers. Secondly, the sorafenib-loaded solu-tin nanomicelles and mixed nanomicelles of solu-tin with polo-tin were formulated by the thin film hydration method.