FIELD: chemical-pharmaceutical industry and technology, pharmacy.
SUBSTANCE: omeprazole is a strong anti-ulcer agent that is absorbed in intestine preferably but it unstable in acid medium. Some methods for preparing stable pharmaceutical compositions and solution of two main problems of effect on their stability, pH and moisture, have been studied. Invention describes a method for preparing pharmaceutical composition as tablet formulation comprising omeprazole, sodium alginate and basic amino acid and involving following steps: (a) preliminary modification of external morphology of basic amino acid by wetting and the following drying up to the water content in the total amount less 0.75 wt.-% of amino acid mass; (b) incorporation of basic amino acid to preliminary prepared granulate comprising omeprazole and sodium alginate with the low moisture content; (c) incorporation of other excipients up to preparing granulate; (d) grinding granulate from step (c) up to preparing uniform granulometric composite; (e) incorporation of lubricating agent, carrying out the tableting process and applying enterosoluble coating on tablets made. Such method is simpler as compared with known ones and provides preparing compositions with improved indices of extrusion. The content of sodium alginate can up to 15 wt.-% of tablet mass, preferably, from 8 to 12 wt.-%. Basic amino acid can represent L-arginine, L-lysine or L-histidine. Pharmaceutical compositions prepared by this method comprise omeprazole in concentrations 10-40 mg per a tablet.
EFFECT: improved preparing method.
6 cl, 4 ex
