STABLE ORAL BENZIMIDAZOLE COMPOSITIONS AND PROCESSES FOR THEIR PREPARATION

摘要

The present invention relates to stable oral benzimidazole compositions and processes for their preparation. The stable oral benzimidazole pharmaceutical composition includes a core, a separating layer, and an enteric coating. The core includes a benzimidazole compound, a substantially water-soluble material and, optionally, one or more pharmaceutically acceptable excipients, wherein the core is not alkaline. The separating layer surrounds the core and includes a substantially water-soluble material and, optionally, one or more pharmaceutically acceptable excipients. The enteric coating surrounds the separating layer. At least one of the core and the separating layer includes the substantially water-soluble material without any pharmaceutically acceptable excipients.