FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to a solid oral dosage form for the delivery of a therapeutically effective amount of valsartan in the form of a free acid or a pharmaceutically acceptable salt thereof. The dosage form contains a double-action compound in the amount of 4 to 90 % at composition weight, and pharmaceutically acceptable excipients. The double-action compound is trisodium salt [3-((1S3R)_1_biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3'-methyl-2'-(pentanoyl{2"-tetrazol-5-ylate)biphenyl-4'-ylmethyl}amino)butyric acid] hemipentahydrate. The above double-action compound is found in one standard dosage form in the amount of 40, 50, 100, 200 or 400 mg. Also, the invention refers to a method for preparing a solid oral dosage forms. The dosage form according to the invention is characterized by a solution profile in vitro such that 30 min later approximately 10 to approximately 100 wt % of valsartan in average is released in the form of a free acid or a pharmaceutically acceptable salt thereof.
EFFECT: specified valsartan solution profile and absorption rate provide a lower dosage of valsartan.
15 cl, 3 dwg, 6 tbl, 6 ex
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Authors
Dates
2013-09-27—Published
2008-11-04—Filed