FIELD: technological processes.
SUBSTANCE: present invention relates to a novel dry granulation method for theproducing tablet compositions of Metformin, as well as a combination thereof with DPP-4 inhibitors. Method for producing pharmaceutical compositions of Metformin comprises use of the active substance with a diluent which is a mixture Microcrystalline Cellulose (MCC) and Dibasic Calcium Phosphate Anhydrous (DCPA). Amount of Metformin in the composition is from 60 to 80 % by weight. Ratio of Metformin to the stated diluent is 2.5 to 25 by weight. Composition contains vildagliptin as the DPP-4 inhibitor.
EFFECT: method of the present invention provides good compressibility of the ingredients in highly concentrated drugs, satisfactory flow characteristics and friabiity of the compressed tablets.
17 cl, 7 tbl, 3 ex
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Authors
Dates
2018-03-15—Published
2013-12-17—Filed