Pharmaceutical formulation comprising omeprazole, a substituted pyridylsulfinylbenzimidazole a gastric acid secretion inhibitor, where the storage period is extended

摘要

An enteric coated oral pharmaceutical formulation comprising as active ingredient a compound selected from the group of omeprazole, an alkaline salt of omeprazole, one of the single enantiomers of omeprazole and an alkaline salt of one of the single enantiomers of omeprazole, wherein the formulation comprises a core material that comprises the active ingredient and optionally an alkaline reacting compound. The active ingredient is in admixture with a pharmaceutically acceptable excipient, such as a binding agent, and on the core material is a separating layer and an enteric coating layer. A hydroxypropyl cellulose (HPC) with a specific cloud point is used in the manufacture of the claimed pharmaceutical formulations. Furthermore, described is the process for their preparation and the use of the claimed formulations in medicine The figure shows two graphs representing two different dosage forms based on two qualities of HPC named Type A and Type B. The graphs show released omeprazole from the dosage forms after 3 months and 6 months storage at accelerated conditions at 40oC and 75% relative humidity. With a separating layer comprising HPC Type A the release rate of omeprazole over time has decreased. With the HPC Type B the release rate of omeprazole over time is almost the same as for a freshly produced product.