SUSTAINED RELEASE NIFEDIPINE PHARMACEUTICAL FOR APPLICATION TO ORAL MUCOSA

摘要

PURPOSE:The titled pharmaceutical, consisting of a rapidly soluble layer consisting of nifedipine and polyvinylpyrrolidone (PVP) of specific composition and a delayed dissolution layer consisting of the nifedipine, PVP and polyacrylic acid, and having ready absorbability and prolonged action of the nifedipine useful as an antianginous agent. CONSTITUTION:A pharmaceutical consisting of two layers of a rapidly soluble layer consisting of a solid solution of nifedipine and polyvinylpyrrolidone (PVP) and an excipient and a delayed dissolution layer consisting of the solid solution of the nifedipine, PVP and polyacrylic acid and a salt thereof. The pharmaceutical is characterized in that the content of the PVP in the rapidly soluble layer is 20-80wt% and the weight ratio between the solid solution component and the polyacrylic acid in the delayed dissolution layer is 5:95-95:5. The solid solution of the nifedipine dissolved in the PVP in the solid state enhances the absorption of the slightly soluble nifedipine, and the polyacrylic acid contributes to the sustained release and adhesive properties. The dissolution of the nifedipine in saliva is kept constant for a long time, and the blood concentration is kept constant for a long time.