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|Title:||Pharmaceutical compositions comprising nilotinib or its salt|
|Abstract:||A pharmaceutical composition, especially capsules, comprising granules containing nilotinib or a salt thereof with at least one pharmaceutically acceptable excipient. The granules may be produced by a wet granulation process.|
|Inventor(s):||Bruneau; Nathalie (Cran-Gevrier, FR)|
|Assignee:||Novartis AG (Basel, CH)|
1. A pharmaceutical composition, in the form of a capsule comprising: a granule comprising a therapeutic compound in an intimate mixture with at least one pharmaceutically
acceptable excipient, wherein said therapeutic compound is a monohydrochloride salt of 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imida- zol-1-yl)-3-(trifluoromethyl)phenyl]benzamide of formula: ##STR00003## as a monohydrate,
wherein said granule further comprises a surfactant and a lubricant, said surfactant is in a concentration from 0 to 1% by weight of said pharmaceutical composition and the concentration of said lubricant does not exceed 1% by weight of the
2. The pharmaceutical composition of claim 1, wherein said lubricant is magnesium stearate.
3. The pharmaceutical composition of claim 2, wherein said surfactant is a poloxamer.
4. The pharmaceutical composition of claim 3, wherein said poloxamer is poloxamer 188.
5. The pharmaceutical composition of claim 1, wherein said said therapeutic compound and excipients are combined to form granules, which are further dried to form a powder blend of granules.
6. A pharmaceutical composition, in the form of a capsule comprising: 55.2% by weight of monohydrochloride salt of 4-Methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imida- zol-1-yl)-3-(trifluoromethyl)phenyl]benzamide of formula: ##STR00004## as a monohydrate; 0.8% by weight of a surfactant; 19.6% by weight of a diluent; 4% by weight of a disintegrant; and an external phase further comprising: 19.4% by weight of a diluent; 0.5% by weight of a glidant; and 0.5% by weight of a lubricant and water, wherein water is used as a granulation liquid.
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