Pharmaceutical compound, salts thereof, formulations thereof, and methods of making and using same
AssigneeGenentech, Inc.
InventorsKarthik Nagapudi, Yuan Liu, Shuai Wang, Wei Zhang
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Abstract
Pharmaceuticas composition comprising novel salts of Compound I, and methods of making and using the same, and related dosage forms thereof, are disclosed.
Claims15
A pharmaceutical composition containing a salt of 1-methyl-7-(1-methyl-1H-pyrazol-4-yl)-5-(4-(trifluoromethoxy)phenyl)-1,5-dihydro-4H-imidazo[4,5-c]pyridin-4-one (Compound I):
- wherein the salt is selected from the group consisting of besylate, citrate, fumarate, hemi-edisylate, hemi-napadisylate, hydrobromide, maleate, nicotinate, nitrate, oxalate, phosphate, saccharinate, sulfate, L-tartrate, and tosylate salts and the composition further comprises one or more pharmaceutically acceptable excipients.
A pharmaceutical composition comprising particles of a tosylate salt of Compound I, wherein the particles have a size distribution characterized by a D50 in a range of about 10 μm to about 60 μm or a volume mean diameter D[4,3] in a range of about 25 μm to about 45 μm.
A granulate comprising a tosylate salt of Compound I, microcrystalline cellulose, lactose, sodium carboxymethyl cellulose, and magnesium stearate.
Dependencies are inferred from the claim text.