Preparation and Quality Evaluation of Bepotastine Besilate Film-coated Tablets / 中国药师

ABSTRACT

Objective: To prepare bepotastine besilate film-coated tablets, determine the dissolution rate by HPLC, and evaluate the similarity of dissolution curves for self-made tablets and the original tablets. Methods: Bepotastine besilate tablets were prepared by using microcrystalline cellulose, hydroxypropyl cellulose, mannitol, aspartame and magnesium stearate as the accessories. Bepotas-tine besilate film-coated tablets were prepared by using OpadryⅡpremixed spray-coating liquid. The formulation was screened with the angle of repose, disintegration time, content uniformity and dissolution rate as the indices. The coating material amount was screened with the dissolution rate as the index. Results: The optimal formulation of bepotastine besilate film-coated tablet contained bepotastine besilate 5 mg,mannitol 43 mg,microcrystalline cellulose 21. 5mg,aspartame 0. 5 mg,magnesium stearate 0. 5 mg and hydroxypropyl cellulose 15 mg. The optimal weight of coating material was 5% . The self-made tablets and the original tablets had similar dissolution behavior in 4 media including water, hydrochloric acid(pH 1. 2), acetate buffer solution(pH 4. 5) and phosphate buffer solution(pH 6. 8). Conclusion:The self-made tablets have similar dissolution behavior in vitro with the original tablets, and their quality is similar.