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Optimization and Characterization of Controlled Release Pellets of Dextromethorphan HBr

Dextromethorphan HBr持續釋出顆粒最佳處方組成及特性之研究

摘要


本研究乃探討Dextromethorphan HBr最佳處方組成之控釋劑型。本研究利用離心式流動床造粒機,以乙基纖維素為包衣材料,Myvacet 9-40為包衣塑化劑,成功地將原料(Dextromethorphan HBr)製成微粒膠囊,經體外溶離試驗證實,含60mg之Dextromethorphan HBr,藥物可以12小時內釋放。Dextromethorphan HBr持續釋出顆粒之最佳處方組成及製備過程條件皆以體外溶離試驗,熱差分析儀及電子顯微鏡等來予以驗證。

並列摘要


The objective of this study was to determine the optimized formulation to obtain multiparticulate controlled drug delivery of dextromethorphan HBr. It was found that a combination of ethylcellulose, myvacet 9-40 and talc produced a stable film coating over drug containing beads which resulted in a controlled drug delivery. A laboratory size fluidized bed processor (Glatt, GPCG-1) was used to coat dextromethorphan HBr loaded beads with experimental latex which was designed to release an equivalent of 60mg of drug in 12 hour. The coated dextromethorphan HBr beads prepared by the optimized formulation and processing conditions was characterized by in-vitro dissolution, differential scanning calorimetry and scanning electron microscopy.

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