Immediate release 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-n-[5-(4-methyl- 1h-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide formulation

摘要

Provided is a solid dosage form in the form of a film coated tablet that comprises: (i) a core comprising 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide (nilotinib) or a pharmaceutically acceptable salt thereof and excipients; and (ii) at least one polymeric coating over the core, wherein the polymeric coating comprises hydroxypropylmethyl cellulose, and the coating is 7-13% of the dosage form. Also provided is a method for preparing a solid dosage form comprising amorphous 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide or a pharmaceutically acceptable salt thereof comprising the steps of: (i) roller compacting a core comprising 4-Methyl-3-[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide or a pharmaceutically acceptable salt thereof and excipients; and (ii) coating said core with at least one polymer.