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DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation

DC
  • US 10,022,379 B2
  • Filed: 01/11/2017
  • Issued: 07/17/2018
  • Est. Priority Date: 04/03/2008
  • Status: Active Grant
First Claim
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1. A method of treating type 2 diabetes mellitus comprising orally administering to a patient in need thereof a pharmaceutical composition comprising:

  • (a) 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in a dosage of 2.5 mg or 5 mg,(b) metformin hydrochloride,(c) one or more pharmaceutical excipients, and(d) a basic amino acid having an intramolecular amino group and alkaline characteristics, which basic amino acid is present in an amount sufficient to suppress degradation of said 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine,wherein the pharmaceutical composition is a tablet comprising a film-coat; and

    wherein the pharmaceutical composition comprises the following amounts;

    0.1-0.5% of 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, 47-85% of metformin hydrochloride, and 0.07-2.2% of the basic amino acid, wherein each of the foregoing percentage amounts are based on the weight of total coated tablet mass.

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