Convolution, Alcoholic Beverage Effect on Lansoprazole DR Capsules.

      Аннотация: The potential effect of alcoholic beverage to alter drug release from an oral dosage form is a general concern. Lansoprazole, a proton pump inhibitor, is used to treat ulcers in the stomach and duodenum. In order to protect this acid labile drug from being degraded in the gastric medium, the marketed oral dosage forms are formulated into capsule containing delayed release pellets and oral disintegrating delayed release tablet. The aims of this chapter were mainly four folds. First was to understand how the dosage form was formulated. Second, the data collected from an in vitro dissolution study were convoluted with the lansoprazole plasma concentration time profile of an intravenous bolus reported by Gerloff, et al. to investigate the principal site of drug release and absorption rate. Third, it was to propose laboratory preparations of alcoholic containing beverages to simulate the administration of this medicine with a cup of beer or wine. Fourth, the in vitro dissolution data form Aim No. 3 was further used to determine whether the FDA similarity factor of a delayed release capsules should be plotted from (a) Acid to Buffer stages, or (2) Buffer stage only.

Ключевые слова: Convolution, similarity factor, Oral Delayed-Release Capsules, Two-Stage In Vitro Dissolution Paradigm