PHARMACOKINETIC DRUG INTERACTION BETWEEN CLOPIDOGREL AND ESOMEPRAZOLE IN ADULT HEALTHY MALE VOLUNTEERS

Objective: Proton pump inhibitors (PPIs) are known to impair cytochrome P2C19 mediated activation of clopidogrel, the antiplatelet agent used for cardiovascular risk prevention. Esomeprazole is an optical isomer of omeprazole with better efficacy and tolerability than conventional PPIs. Esomeprazole is often co-administered with clopidogrel considering the risk of associated gastrointestinal bleeding. This study was designed to determine the effect of esomeprazole on the mean pharmacokinetic profile clopidogrel.Methods: A total of 14 adult healthy male participants who volunteered participation were enrolled, randomized equally into two cross-over sequences, dosed with clopidogrel and clopidogrel + esomeprazole in respective periods. Blood samples were collected through antecubital or forearm vein indwelling catheter. Concentration of clopidogrel parent prodrug in isolated plasma was determined using validated sensitive liquid chromatography – mass spectrometry. Pharmacokinetic modeling was carried out using PKSOLVER add-in for Microsoft Excel.Results: The pharmacokinetic profile of clopidogrel was non-significantly altered by esomeprazole. Statistically significant difference in peak plasma concentration, apparent volume of distribution, and clearance of clopidogrel was observed only during period II in participants co-dosed with esomeprazole (p=0.0483, 0.0011, and 0.0015, respectively). All other primary and secondary pharmacokinetic parameters displayed minor alterations during either period (p>0.05).Conclusion: The non-significant alteration of clopidogrel pharmacokinetics by esomeprazole can be potentiated by underlying predisposing factors such as the presence of CYP2C19 allelic variants and increasing the risk of cardiovascular events. Hence, co-administration of clopidogrel and esomeprazole should be under clinical monitoring and is not recommended in poor responders of antiplatelet therapy with clopidogrel

Formulation And Evaluation Of Dutasteride Coated Microneedles For The Treatment Of Hair Loss

Coated microneedles have been shown to deliver proteins and DNA into the skin in a minimum invasive manner. Still, detailed studies of preparing coated microneedles and their breadth of applicability are lacking. Male androgenetic alopecia is the most commonly known form of scalp hair loss in men and as a part of hormone therapy in transgender women.  Till now, in India dutasteride is marketed as a topical solution in an aqueous vehicle in the treatment of alopecia. A high percentage of alcohol present in marketed formulations as a permeation enhancer was known to damaged hair, hair follicle, and scalp epidermal cells due to dehydration. The goal of the study was to enhance the permeation of drugs with the aid of microneedles, thus reducing the concentration of alcohol and damage of scalp cells. A microsyringe was used to coat each needle present on the roller. Coated microneedles were studied for coating uniformity, in-vitro drug release. The drug release profile of coated microneedles was found to be comparable with the marketed solution of minoxidil of the same strength

Anti mullerian hormone and antral follicle count for prediction of ovarian reserve in female infertile patients: A cross sectional study

Ovarian reserve (OR)determines the quantity and quality of follicles present in the ovary. It is independent of menstrual cycle in women of reproductive age. The chances of conceiving in infertile women can be predicted by understanding and determining the OR. The aim of the study was to assess and determine whether Anti-Mullerian Hormone (AMH) with Antral Follicle Count (AFC) or AMH alone is a better predictor of ovarian reserve in female infertile patients. Methods: In this prospective, cross-sectional study, a total of 60 patients were measured for AMH levels of which 30 patients was assessed along with AFC. The demographic details were collected and 5ml of venous blood samples were taken on day 2 of menstrual cycle. Serum was separated and stored at -20oC. Serum AMH levels were analysed using enzyme-linked immune sorbent assay (ELISA) whereas Antral Follicle Count with ultrasonography. Finally, 54 patients completed the analysis with the mean age of 26.32±3.95 years and body mass index of 24.09±4.62. The average AMH levels and AFC were found to be 2.49±4.05 ng/ml and 14.92±8.69 follicles respectively. AMH showed negative correlation with both FSH and LH and no correlation with estradiol