Pharmaceutical compositions of amlodipine and valsartan
AssigneeLupin Limited
InventorsAnirudha Bhagirath Kute, Nikhil Prabhakar Malewar, Makarand Krishnakumar Avachat
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Abstract
A single layer pharmaceutical composition comprising active agent(s) amlodipine or a pharmaceutically acceptable salt thereof and valsartan or a pharmaceutically acceptable salt thereof wherein the composition exhibits bioequivalence to the commercially available bilayer tablet dosage form comprising amlodipine besylate and valsartan; when administered to human subject, under the bioequivalence parameters of a 90% Confidence Interval for AUC which is between 80% and 125%, and a 90% Confidence Interval for Cmax, which is between 80% and 125%.
Claims11
A single layer pharmaceutical composition comprising active agent(s)
- (a) amlodipine or a pharmaceutically acceptable salt thereof and
- (b) valsartan or a pharmaceutically acceptable salt thereof
- wherein:
- (i) the composition exhibits bioequivalence to the commercially available bilayer tablet dosage form comprising amlodipine besylate and valsartan;
- when administered to a human subject, under the bioequivalence parameters of:
- (a) a 90% Confidence Interval for AUC which is between 80% and 125%, and (b) a 90% Confidence Interval for Cmax, which is between 80% and 125%;
- and
- (ii) wherein valsartan is present in an amount less than 35% by weight, based on the total weight of the pharmaceutical composition.
Dependencies are inferred from the claim text.