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US 9,867,829 B2Granted
Stable pharmaceutical composition containing 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione or a pharmaceutically acceptable salt thereof
AssigneeSandoz Ltd.
InventorsFranz X. Schwarz, Georg Anker, Johann Bacher, Andreas Hotter
Life of this patent
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Abstract
The present invention relates to a stable pharmaceutical composition comprising amorphous or crystalline linagliptin or a pharmaceutically acceptable salt of linagliptin, mannitol, copovidone, and magnesium stearate, processes for preparing the stable pharmaceutical composition, and a container comprising the stable pharmaceutical composition.
Claims21
A coated pharmaceutical composition comprising:
- a composition comprising linagliptin or a pharmaceutically acceptable salt thereof as active ingredient;
- mannitol;
- copovidone;
- and
- magnesium stearate, wherein the mannitol is present in an amount greater than 90 to 95% by weight, based on the weight of the pharmaceutical composition;
- and
- a coating comprising hydroxypropylmethylcellulose on the composition.
4 more elements
A coated compressed tablet of a pharmaceutical composition comprising:
- a composition comprising linagliptin or a pharmaceutically acceptable salt thereof as active ingredient;
- mannitol;
- copovidone;
- and
- magnesium stearate, wherein the mannitol is present in an amount greater than 90 to 95% by weight, based on the weight of the pharmaceutical composition, wherein the composition is in the form of a directly compressed tablet;
- and
- a coating comprising hydroxypropylmethylcellulose on the directly compressed tablet.
4 more elements
Dependencies are inferred from the claim text.