| 摘要 |
PROBLEM TO BE SOLVED: To provide a stabilized amorphous form of imatinib mesylate.SOLUTION: A pharmaceutical composition comprises a formulation principle that stabilizes an amorphous form of Imatinib mesylate and amorphous Imatinib mesylate, optionally together with a least one pharmaceutically acceptable carrier. The formulation principle is selected from solid dispersions, cyclodextrin complexes, co-milling with selected excipients. A capsule contains between an amount of stabilized amorphous Imatinib mesylate which corresponds to 50 mg and 200 mg of Imatinib mesylate, wherein the shell contains gelatine, titanium dioxide, or red iron oxide. The ratio of weight of capsule fill to capsule shell is between about 100:25 and 100:50. A tablet comprises an amount of stabilized amorphous Imatinib mesylate which corresponds to 100 mg, 400 mg or 800 mg of Imatinib mesylate. |
