Oral contraceptive (OC) pills contain estrogen and progestin that are synthetic analogs of natural hormones. These synthetic hormones affect the hypothalamus-pituitary-gonadal axis of the female reproductive system. There are many types of contraceptives; most of the OC pills prevent pregnancy by inhibiting ovulation. Estrogen and progestin are two female reproductive hormones that are critical. Typically, estradiol is produced by growing follicle (ovaries) which stimulates the hypothalamus to produce the gonadotropin-releasing hormone, which further stimulates the anterior pituitary to produce follicle-stimulating hormone (FSH) and luteinizing hormone (LH). LH production triggers the ovulation. Similarly, the progesterone is produced by corpus luteum (ovaries), which triggers the production of FSH and LH. There are many types of progesterone available. Long-term usage of synthetic estrogen and progesterone can disturb the balance between the level of these hormones in the body. This imbalance may lead to severe side effects such as breast cancer, cervical cancer, thrombosis, direct impact on the brain, and infertility.
Combined oral contraceptives (COCs) are prepared using synthetic progesterone, estrogen and serve as most convenient, safe, effective, and reversible method of contraception. Due to their side effects in most women, herbal medicines have been proposed as alternatives to these contraceptive methods. The present study was aimed at evaluating the antifertility effects of lepidine, isolated from Lepidium sativum, via in-silico and in vivo experimentation on female Rattus norvergicus (Wistar albino rats). Human homolog of Progesterone receptor (Pgr), which is 95.4% identical to the rat Pgr, was retrieved from the Protein Data Bank (PDB) for molecular docking evaluation. Schrödinger Suite was used for protein and ligand preparation. Schrödinger Glide with XP calculations were carried out to calculate the Glide Score, with human Pgr as receptor and Lepidine as a ligand. To further investigate the in vivo anti-fertility effects of lepidine on estrous cycle and its correlation with serum progesterone, adult Rattus norvergicus (Wistar albino rats) was administered with 10, 20 and30mg lepidine/kg body weight dissolved in DMSO: PBS (1:4) vehicle for 15 days. Vaginal smear samples were collected for cytological studies and progesterone hormone level in the serum was estimated through ELISA. In-silico observation has shown that lepidine has strong affinity with human progesterone receptors. Serum progesterone level was found to be maintained throughout the estrous cycle. This shows that the lepidine might be working as anti-ovulatory agent by acting as a phyto progesterone.
No abstract
A biosimilar is the new emerging drug product of the sector of Biologics that comes under speedily evolving area of pharmaceutical industry. It is the generic substitute for original research-based drugs. Since the Biologics are produced by a variety of products more commonly including cells extracted from humans, animals, microorganisms which varies phenotypically therefore they are “similar but not same” to the original product. Being a new product, it produces several challenges in the market including its regulation guidelines, production efficiency, quality management, and safety factors etc. The quality of these products along with its effectiveness and reduced costs are making them more and more popular. Different research is still being going on for enhancing the efficacy of biosimilars due to its more and more usage in the market. Several countries have developed their separate norms for the production and clinical usage of these biosimilars constituting Canada, Japan, Korea, and United States of America etc. The more biologics grab the attention of the eminent scientists for better innovations, the less marketing approval it gets. To enhance such a situation U S Congress passed the Biologics Price Competition and Innovation act 2009 and US FDA allowed “abbreviated pathway” for their approval and India being the most suited manufacturing area has also prepared certain guidelines stated as “Draft Guidelines on Similar Biologics” which were announced in June 2012, by Department of Biotechnology at Boston bio. The regulatory environment for biosimilars continues to evolve, both in recognition of advances in technology/ analytical methods and the availability of new targets for biosimilar development. With the advent of such efforts biosimilars are trying to surround the market. The demanding sector of biosimilars reveals the challenging gateway towards the nanomedicines also which shows that with the advancing biotechnology after these biosimilars, we are heading towards other newly biologically derived products.
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