|Title:||Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate|
|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 method for preparing a pharmaceutical composition comprising the steps of: (a) forming a powder blend of nilotinib hydrochloride monohydrate and at least one
pharmaceutically acceptable excipient; (b) wet massing and kneading the powder blend with a granulation liquid to form moist granules; and (c) drying the moist granules to form granules.
2. The method of claim 1, wherein the granulation liquid comprises water.
3. The method of claim 2 wherein the granulation liquid is present in a concentration from about 10% to about 25% by weight of the powder blend.
4. The method of claim 1, further comprising the step of sieving the granules.
5. The method of claim 1, wherein the moist granules are dried to a loss on drying value less than or equal to about two percent by weight of the moist granules prior to drying.
6. The method of claim 1, wherein said powder blend comprises a surfactant.
7. The method of claim 6, wherein said surfactant is a poloxamer.
8. The method of claim 7, wherein said poloxamer is poloxamer 188.
9. The method of claim 1, wherein the powder blend consists of nilotinib hydrochloride monohydrate, lactose monohydrate and polyvinyl pyrrolidone.
10. A pharmaceutical composition produced by the method according to claim 1.
11. A pharmaceutical composition produced by the method according to claim 8.
12. A pharmaceutical composition produced by the method according to claim 9.