'fabrication of biodegradable vaginal ring for combine contraceptive therapy of ethinyl estradiol and levonorgesterel'

摘要

"FABRICATION OF BIODEGRADABLE VAGINAL RING FOR COMBINED CONTRACEPTIVE THERAPY OF ETHINYL ESTRADIOL AND LEVONORGESTREL" The aim of the present investigation was to fabricate and evaluate biodegradable vaginal ring for contraceptive therapy of ethinyl estradiol (EE) and levonorgesrel (LNG). Biodegradable intravaginal rings for contraceptive drug delivery present the potential of an easily adhered to women controlled and environment friendly method for contraception and hormone replacement. Fourier transform infrared spectroscopy (FTIR) had employed to study drug-drug and drugs-excipients incompatibility. Analytical method was developed by UV spectrophotometer using Q-Absorbance method. Vaginal ring of EE and LNG was successfully prepared with EE, LNG, polyurethane and polyethylene glycol by injection molding method and evaluated for tensile strength, percent elongation, percent compression, drug content, in-vitro drug release study, sterility testing and stability study. Optimization of process parameter was done by 3 factorial design using Design Expert software. Drug and excipients were found to be compatible to each other which were confirmed by FTIR study. Differential Scanning Calorimetry (DSC) study indicated that both drugs were found to be stable at 120 °C. Tensile strength, percent elongation and percent compression were found to be show good mechanical property of vaginal ring. In-vitro drug release of EE and LNG were found to be good for optimized batch up to 21 days. Sterility test suggested that the developed vaginal ring shows no microbial growth. Stability study shows vaginal ring containing EE and LNG were stable at accelerated condition. The present study demonstrated that, a vaginal ring is suitable for contraception and hold great potential for hormone replacement therapy. Keywords: Ethinyl Estradiol; Levonorgestrel; Contraception; Vaginal Ring; Controlled Release; 3 Factorial Design; Injection Molding.