Hetero Drugs (India)

The global pharmaceutical landscape is undergoing a profound shift with the rise of biosimilars-biologic medical products that are highly similar to original biologics but manufactured by different companies. Biological therapies encompass a range of therapies, including hormones such as insulin and growth hormone, vaccines, erythropoietin (EPO), monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and bispecific antibodies (BsAbs), etc. As patents for many blockbuster biologic drugs expire, biosimilars provide an opportunity to improve patient access to life-saving treatments while potentially lowering healthcare costs, especially in regions with high unmet medical needs. However, the development and integration of biosimilars into mainstream healthcare comes with various challenges, including regulatory approval processes, ensuring quality, potency, efficacy, immunogenicity, safety, and overcoming market resistance. In this article, we will explore the development of biosimilars in-depth, their approval pathways, benefits, and the hurdles in achieving widespread adoption.

Gymnema sylvestre is an Ayurvedic medicinal plant commonly known as gurmar used for the treatment of diabetes. The current study evaluated the phytochemical composition and antidiabetic potential of G. sylvestre leaf extracts and commercially available formulations. The extracts were prepared using ethanol and water through soxhelation. Phytochemical analysis revealed the presence of alkaloids, flavonoids, saponins and triterpenoids in the extracts. Chromatographic and spectroscopic techniques were employed for qualitative and quantitative comparison of the extracts and formulations. The ethanolic extract showed higher total phenolic and flavonoid content compared to the aqueous extract. In vitro antidiabetic assays demonstrated dose-dependent inhibition of alpha amylase and alpha glucosidase enzymes by the extracts. The ethanolic extract exhibited higher antioxidant and antidiabetic activity compared to the aqueous extract and formulations. Overall, the results indicate that G. sylvestre extracts possess phytochemicals and antidiabetic potential that can be further explored.

The purpose of the study was to evaluate the prevalence, co-morbidities, pharmacological therapy, and effectiveness of common lifestyle changes for metabolic dysfunction in women with the polycystic ovarian syndrome (PCOS) and related comorbidities in the gynaecology division. This 6-month prospective observational study of 120 PCOS patients who were gynaecology patients at a tertiary care hospital was conducted from September 2021 to February 2022. An interview with the patient was done using an assessment form. This study highlighted the supportive evidence among PCOS patients for the advantages of changing one's lifestyle. This study involved 90 PCOS individuals out of a total of 120 participants, many of them were in the 20–30 age group. This research analyses the high prevalence of cardiovascular disease co-morbidities and demonstrates that a high BMI is the most common risk factor for PCOS. The findings of our study indicate the necessity of evaluating the complications seen in individuals who are at risk, such as infertility. This line of research demonstrates the critical impact that medication and lifestyle modifications play in managing PCOS. Patients with the polycystic ovarian syndrome should get advice regarding lifestyle modifications from a clinical pharmacist.

Proliferative retinopathy is described as a progressive neovascularization in the inner surface of the retina or vitreous, which subsequently threatens vision by causing retinal detachment or vitreous hemorrhage. Reactive oxygen species generation and its related vasoproliferative factor up regulation play a major role in progression of the disease. The present study focuses on Carr induced reactive species generation with its related vasoproliferative factor up regulation and ameliorative activity of AML. Biochemical estimation of catalase, lipid peroxidation, hypoxia inducing factor (HIF-1α) and guanyl-s-transferase (GST) were done. AML treated group showed significant increase in catalase enzyme, guanyl-s-transferase and significantly reduced the lipid peroxidation. Western blotting assay showed a significant decrease in HIF-1α in AML treated group. The progression of PR alters the endogenous cell signalling thus causing havoc in retinal cells. Therefore, it could be hypothesized that use of AML can be a new detection method for therapeutic strategies to prevent blindness in PR.

Obeticholic acid (OBE) is being used to treat primary biliary cirrhosis and cholangitis. An HPLC with refractive index detection method for eight process related substances of OBE was developed and verified for use in quality assurance laboratories for regular analysis. The separation and analysis were performed on YMC Triart C18 (3.0 µm particle size, 250 mm × 4.6 mm) column. Mobile phase employed consisted of 0.01N potassium phosphate buffer (3.0 ± 0.05 pH, set with 0.1% orthophosphoric acid) and acetonitrile at 45:55 (v/v) ratio. The method established for determination of eight impurities in OBE was validated and verified in keeping with International Council for Harmonisation guidelines. This method can be used for routine analysis of eight impurities in OBE bulk samples.

Oz: Michel Foucault; 19. yuzyilin tarih, 20. yuzyilin ise mekân cagi oldugunu belirtir. Bundan dolayi Foucault, toplumu cozumlerken mekâna ozel bir onem vermis; getirmis oldugu “heterotopya” kavrami ile sosyal bilimler alaninda mekâna dair soylemleri genisletmistir. Heterotopya, kulturden kulture farklilik gosterebilir ve tek bir mekânin icinde bircok zaman ve mekâni barindirabilir. Heterotopyanin bu iki ozelligi, Ahmet Hamdi Tanpinar’in Ankara, Konya, Erzurum, Bursa ve Istanbul’u anlattigi Bes Şehir adli eserini cozumlemek icin de onemli veriler sunar. Tanpinar’in sectigi bes sehir, bircok farkli medeniyete ev sahipligi yaptigi icin farkli medeniyetlerin kendilerine ozgu dokusu mekâna islemistir. Dolayisiyla bahsedilen her mekânda farkli zamanlarin izlerine rastlanir. Bu makalede Michel Foucault’nun calismalari ekseninde Tanpinar’in Bes Şehir’inde yer alan heterotopik mekânlar incelenecektir. Anahtar kelimeler: Ahmet Hamdi Tanpinar, Bes Şehir, sehir, heterotopya, mekân.