Formulation and Evaluation of Bioadhesive Anti-Infective Vaginal Preparatins

Abstract

Vaginitis and vulvovaginal candidiasis are among the most common problems causing millions of women to visit physicians• clinics every _ year. The currently available vaginal dosage forms have limitations as leakage, messiness and low residence time which contribute to poor patient compliance. Attempts are being made by many workers to develop novel vaginal delivery systems that can meet clinical _ as well as user's requirements. These include bioadhesive vaginal tablets. Bioadhesive drug delivery systems are now widely spread for application of drugs to sites in the body rich in mucus. The potential of bioadhesive drug delivery systems is to localize the drug at the site of absorption for an extended period of time and promote the intimate contact between the formulation and the underlying absorbing tissue which has great appeal for both local and systemic effects. There are no bioadhesive vaginal tablets in the Egyptian market. Hence, we are aimed at formulation of antifungal bioadhesive vaginal tablets to attain better clinical perfonnance and meet patient compliance. Miconazole nitrate is one of the azole antifungal series, used widely in treatment of vaginal candidiasis. It is found in the market in form of creams and pessaries. Therefore, the present study was carried out to design and evaluate a new miconazole nitrate bioadhesive vaginal delivery system in the form of tablets. The work in this thesis is divided into the following three chapters: Chapter 1: Application of factorial design for preparation of bioadhesive vaginal matrix discs as a platform for drug incorporation. Chapter 2: Formulation of miconazole nitrate bioadhesive vaginal tablets. Chapter 3: Stability, pharmaceutical and microbiological evaluation of

selected miconazole nitrate bioadhesive vaginal tablets.

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