複合錠剤の調製と評価―配合禁忌を防止するための造粒とレイヤリングについて―

抄録

Combination preparations play an important role in clinical treatment because of their better and wider curative effects or weaker side effects. However, the existence of incompatibility between active ingredients or between active ingredients and excipients presents a serious obstacle in the preparation of such combination solid dosage forms. In this study, aspirin and ranitidine hydrochloride were used as the model drugs, between which there existed an interaction. Aspirin was granulated by a Wurster fluidized bed and the operation condition was optimized using the ANN (Artificial Neutral Network) analysis. On the other hand, ranitidine hydrochloride was layered to the core particle with PEG4000 as a carrier using a high-speed agitation mixer, and the factors affecting the ranitidine chloride content and layering particle yield such as the amount of PEG4000 used, core particles and agitating rate, agitating time and melting temperature were investigated in detail. Optimized aspirin granules and ranitidine layering particles were mixed and compressed into tablets. The hardness, content uniformity, dissolution and stability of the tablet were evaluated.