| abstract |
FIELD: medicine.SUBSTANCE: group of inventions relates to the treatment of diabetes mellitus. Osmotic pharmaceutical composition for treating diabetes mellitus contains a core containing: (I) a drug layer from 35 mg to 95 mg of vildagliptin or a salt thereof and one or more pharmaceutically acceptable excipients; (Ii) a layer of osmotic material containing polyethylene oxide with molecular weight from 5,000,000 to 8,000,000, wherein weight ratio of vildagliptin or its salt and polyethylene oxide ranges from 1:1 to 1:5; an insulating coating surrounding said core; a sustained release coating containing from 70 % to 95 % by weight cellulose acetate surrounding said insulating coating; and an immediate release medicinal agent layer containing 15 mg to 35 mg of vildagliptin or a salt thereof surrounding said sustained release coating; wherein said pharmaceutical composition in vitro shows a release profile in which 10 to 30 % of vildagliptin or its salt is released in 2 hours under conditions of USP measurement of Type 1, at 100 rpm using 900 ml, 0.1N HCl at 37 °C±0.5 °C. Other versions of the osmotic composition are also disclosed.EFFECT: group of inventions provides prolonged release of vildagliptin.15 cl, 4 dwg, 6 ex |