STABLE OMEPRAZOLE COMPOSITIONS IN THE FORM OF MICROGRANULES AND PROCESS FOR THEIR PRODUCTION

摘要

The composition includes an active layer consisting of a dilution of omeprazole in mannitol in substantially equal quantities and an external gastroprotection layer consisting of a gastroresistant coating of hydroxypropyl methylcellulose phthalate and talc. The active omeprazole layer contains 10 percent by weight of carboxymethylstarch and 5 percent by weight of a sodium lauryl sulfate surface-active compound, and the surface thereof contains an additional protective layer consisting of mannitol. Said protective layer is applied by means of a high viscosity binder of hydroxypropyl methylcellulose. There is further disclosed a process for producing the compositions, wherein a dry dilution of mannitol and of omeprazole is applied to neutral grains consisting of sugar and of starch with the aid of a high-viscosity binding solution of hydroxypropyl methylcellulose in solution in a mixture of at least 80 percent ethanol and at most 20 percent water and subsequent application of the additional protective layer and/or gastroresistant coating. Each application of the dry dilution is followed by drying at a temperature between 35 and 40 degrees Celsius for a time which makes it possible to lower the water content of the active microgranules to 1 percent and their ethanol content to 2000 ppm.