Sun Pharma

People with plaque psoriasis are more likely to live with obesity relative to individuals without psoriasis, which can affect response to biologic treatment. This pooled analysis of the phase III reSURFACE 1 and reSURFACE 2 trials explored efficacy and safety of tildrakizumab 100 mg and 200 mg in patients with plaque psoriasis who were living with obesity for up to 244 weeks of treatment. Both doses of tildrakizumab were effective long-term, with comparable safety profiles in patients who were living with obesity and those who were not. Patients who were not living with obesity experienced more improvement with treatment than those with obesity, and those living with obesity had more long-term improvement after treatment with tildrakizumab 200 mg vs. tildrakizumab 100 mg.

The growing demand for assisted reproductive technology (ART) has increased the need for effective luteal phase support. Progesterone, essential for maintaining early pregnancy, is a critical component of ART. This open-label, balanced, randomized, two-treatment, crossover, single-dose study compared the bioequivalence of aqueous progesterone 25 mg injection (AqSusten® [Test, Sun Pharma Laboratories Limited]), compared to the innovator's aqueous progesterone 25 mg injection (Lubion® [Reference, IBSA Farmaceutici Italia Srl]), in healthy postmenopausal women under fasting conditions. Forty-eight subjects received either treatment in Period 1, followed by alternate treatment in Period 2, with a 14-day washout period. Pharmacokinetics (Cmax, AUC0-t, AUC0-∞) and mean plasma concentration-time profiles were assessed. Forty-five subjects completed the study. Pharmacokinetic data for both products were comparable, with percentage ratios for AUC0-t, AUC0-∞, and Cmax of 99.16%, 98.78%, and 103.36%, respectively, within the acceptable bioequivalence range of 80%-125%. Plasma concentration-time profiles were similar, and no serious adverse events were reported. Mild adverse events with Lubion® included increased white blood cell count and blood glucose. AqSusten® demonstrated bioequivalence to Lubion® in healthy postmenopausal women under fasting conditions. Both formulations exhibited similar pharmacokinetic profiles, with favorable safety and tolerability, suggesting AqSusten® as a viable alternative in ART treatments.

PURPOSE:Dry eye disease (DED) is a multifactorial ocular surface disorder characterized by tear film instability, hyperosmolarity, and inflammation. Although the exact etiology may vary between patients, inflammation remains a central pathogenic mechanism. Key inflammatory pathways in DED include T-cell activation and the upregulation of cytokines such as interleukin-1 (IL-1), tumor necrosis factor-alpha (TNF-α), and matrix metalloproteinases (MMPs). Cyclosporine A (CsA) is an immunomodulatory agent that reduces ocular surface inflammation by inhibiting calcineurin, thereby suppressing T-cell activation. METHODS:This narrative review summarizes the available evidence on the role of topical CsA 0.09% in DED, including its formulation characteristics, mechanism of action, efficacy, safety, and tolerability. Relevant preclinical and clinical studies of the aqueous nanomicellar formulation of CsA 0.09% (OTX-101 0.09%) were reviewed. RESULTS:Conventional ophthalmic preparations of CsA are oil-based or oil-in-water emulsions, which have several limitations, including poor ocular tolerability and a slow onset of efficacy. An aqueous nanomicellar formulation of CsA 0.09% (OTX-101 0.09%) has been approved by the US Food and Drug Administration and the European Medicines Agency. It is widely used for treating DED, enhancing ocular bioavailability while improving ocular tolerability. Clinical studies have demonstrated that nanomicellar CsA 0.09% therapy significantly improves both signs and symptoms of DED, supporting its utility as an effective and well-tolerated treatment option. CONCLUSION:Nanomicellar CsA 0.09% therapy significantly improves both signs and symptoms of DED, supporting its utility as an effective and well-tolerated treatment option.

Abstract: Indole, a prominent bicyclic heteroaromatic scaffold, has attracted significant attention due to its wide-ranging biological, pharmaceutical, and industrial relevance. This review summarizes key advancements made between 2014 and 2025 in the green synthesis of indole derivatives, emphasizing the growing importance of sustainable strategies in modern organic chemistry. The review critically discusses various environmentally benign approaches, including solvent-free reactions, biobased and recyclable catalysts, microwave-assisted synthesis, and green solvents. These methodologies not only enhance reaction efficiency but also reduce environmental impact, thereby aligning synthetic practices with the principles of green chemistry. The review systematically evaluates the advantages, limitations, and scalability of these green approaches, providing a comparative understanding of their applicability in both laboratory and industrial settings. Furthermore, it highlights the significant role of indole derivatives in contemporary drug discovery, agrochemical development, and industrial applications, including their presence in several FDA-approved therapeutics. Special attention is given to the integration of sustainable methodologies in the synthesis of pharmacologically active compounds, demonstrating their potential to revolutionize medicinal chemistry. This review provides a comprehensive and up-to-date perspective on green synthetic strategies for indole derivatives. It serves as a valuable resource for researchers and industry professionals aiming to design efficient, eco-friendly synthetic routes while addressing global sustainability challenges in chemical sciences.

The principal of generic product development is to match the critical quality attributes. Most of the time during complex product development, life cycle management; biowaiver, pre- and post-change approvals the significant efforts are made by scientist to match the drug release profile. In order to get the vivo bioequivalence testing waived based on in vitro performance of drug product; the dissolution testing is mostly act as a surrogate or performance indicator. Hence, assessment of similarity or equivalence of release profile is most critical aspect with respect to regulatory decision making. Available guideline defines the methodologies and acceptance criteria for same based on data structure e.g., application of mathematical and statistical model like similarity factor (F2), bootstrapped F2, model independent and model dependent approach etc. However, during regulatory review lot of discrepancies usually raise by regulators with respect to similarity demonstration like selection of proper methodology, define suitable acceptance criteria in case of high variability. Current article emphases on the visions behind regulatory expectations, with respect to dissolution profile comparison and highlights the prerequisites and answer the common question like how to choose the correct methodology, what are the limitations, way forward and regulatory expectations and alternative methodologies in order to evaluate the dissolution data statistically to make wise decision on in vitro equivalence. Overall, various approaches are available for dissolution similarity analysis. However, the intension of statistical comparability should be like; neither force the dissimilar product to pass the criteria, nor fail the product which are similar. This comprehensive review will enhance the overall understanding and help the formulation and biopharmaceutics scientists; how to ensure regulatory compliance during similarity evaluation.