EP0960620B1 — A stable oral pharmaceutical composition containing a substituted pyridylsulfinyl benzimidazole

USPTO Abstract

A pharmaceutical composition which is stable and suitable for oral administration to a patient comprises a mixture of a substituted pyridyl sulfinyl benzimidazole having gastric acid secretion inhibitory activity (such as omeprazole, lansoprazole, or pantoprazole), and a pharmaceutically acceptable carrier. The carrier comprises a polymer having vinyl pyrrolidone monomeric units, such as polyvinylpyrrolidone or a vinyl pyrrolidone-vinyl acetate copolymer. Surprisingly, it has been found that the vinylpyrrolidone polymer acts as a stabilizing excipient on the substituted pyridyl sulfinyl benzimidazole so that the composition need not include any alkaline components to prevent degradation of the active ingredient. In a preferred embodiment, the composition is in the form of a capsule, whereby the mixture of the substituted pyridyl sulfinyl benzimidazole and the vinyl pyrrolidone polymer in the form of a powder blend or granules, is contained within a capsule shell, which capsule shell is made from an enteric material or is coated with an enteric material. A process for preparing the stable pharmaceutical composition is also disclosed.