Design and Optimization of Novel Vaginal Microsphere Gel of Clotrimazole

Abstract

The objective of the study was to develop and evaluate sustained release microsphere gel for the drug clotrimazole to be administered through the vaginal route. The effect of polymer ethylcellulose and carbopol 934 on entrapment efficiency and diffusion behavior were investigated respectively. A 32 full-factorial design was used to optimize the formulation of Microsphere gel. Microspheres were characterized by SEM, FTIR, Entrapment efficiency, and particle size. Gels were evaluated for in-vitro drug release in simulated vaginal fluid. The microsphere loaded with clotrimazole in bioadhesive carbopol gel formulation was evaluated for various physicochemical studies and was found to be satisfactory. The rheological profile shows the gel formation at desired condition. It is evaluated for spreadability, drug content, In-vitro drug diffusion, stability study, and bioadhesive study. It may be concluded that spray drying is a suitable method for microsphere preparation and microsphere gel can be used as a novel drug delivery system to prolonge release of clotrimazole for vaginal candidiasis.