FIELD: medicine; pharmaceuticals.
SUBSTANCE: present invention provides a pharmaceutical composition for preventing or treating cardiovascular disorders. Pharmaceutical composition contains losartan or its pharmaceutically acceptable salt, amlodipine or its pharmaceutically acceptable salt, a disintegrating agent in amount of 3 - 10 wt. % of the total weight of the composition and a coating agent. Disintegrant is selected from a group consisting of sodium glycolate, croscarmellose sodium and crospovidone. Coating agent contains hypromellose, having viscosity of 10 to 30 mPa·s and contained in amount of 1 to 10 wt. % based on the total weight of the composition. Weight ratio of disintegrating agent and coating agent in composition ranges from 1.5:1 to 4.0:1. Composition can be prepared in the form of a coated tablet, which shows an increase in thickness by 3 % or less when subjected to accelerated test conditions for 5 hours 40 °C and 75 % relative humidity and demonstrates weight increase by 5 % or less when exposed to accelerated test conditions for 5 hours 40 °C and 75 % relative humidity.
EFFECT: tablet of losartan and amlodipine with hypromellose coating according to the invention is characterized by stability during storage and provides inhibition of accompanying admixtures.
9 cl, 4 dwg, 7 tbl, 3 ex
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Authors
Dates
2019-08-29—Published
2015-09-01—Filed