Novel salt 628
AssigneeAstraZeneca AB
InventorsLars-Erik BRIGGNER, Per Thomas KLINGSTEDT, Hans Roland LÖNN, Robert ZUBAN, Marie-Lyne ALCARAZ, Robert Anthony NIXON, Andrew James WATTS
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Abstract
6-M ethyl-5-(1-methyl-1H-pyrazol-5-yl)-N-{[5-(methylsulfonyl)pyridin-2-yl]methyl}-2-oxo-1-[3-(trifluoromethyl)phenyl]-1,2-dihydropyridine-3-carboxamide 4-methylbenzenesulfonate and a novel crystalline form thereof are disclosed together with processes for preparing such salt and form, pharmaceutical compositions comprising such a salt and form, and the methods of treatment using such a salt and form.
Claims10
A pharmaceutical composition comprising 6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-N-{[5-(methylsulfonyl)pyridin-2-yl]methyl}-2-oxo-1-[3-(trifluoromethyl)phenyl]-1,2-dihydropyridine-3-carboxamide 4-methylbenzenesulfonate Form A in admixture with a pharmaceutically acceptable diluent or carrier.
A pharmaceutical composition comprising 6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-N-{[5-(methylsulfonyl)pyridin-2-yl]methyl}-2-oxo-1-[3-(trifluoromethyl)phenyl]-1,2-dihydropyridine-3-carboxamide 4-methylbenzenesulfonate Form A and dibasic calcium phosphate.
A pharmaceutical composition comprising:
- 20 a) 0.1 to 40 parts of 6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-N- {[5-(methylsulfonyl)pyridin-2-yl]methyl}-2-oxo-1-[3-(trifluoromethyl)phenyl]-1,2-dihydropyridine-3-carboxamide 4-methylbenzenesulfonate Form A;
- b) 2 to 10 parts dibasic calcium phosphate;
- c) 60 to 90 parts microcrystalline cellulose;
- d) 2 to 10 parts of a disintegrant;
- e) 0.1 to 2 parts of a surfactant;
- and
- f) 0.1 to 3 parts of a lubricant;
- wherein all parts are parts by weight of the total composition and the sum of the parts a) to f)=100.
Dependencies are inferred from the claim text.