| 摘要 |
<p>Pharmaceutical composition of imatinib methanesulfonate has the form of a solid blend and consists of: a) from 99,7 to 96% by weight of granulate of imatinib methanesulfonate, wherein the granulate contains, based on total weight of the granulate, a1) from 81 to 100% by weight of imatinib methanesulfonate in the crystalline form alpha and a2) from 0 to 19% by weight of one or more pharmaceutical excipients; b) from 0,3 to 3% by weight of an external lubricant; and c) from 0 to 1% by weight of an extragranular glidant. The composition is manufactured by dry granulation of imatinib methanesulfonate, optionally with excipients, without using any solvents, followed by blending the resulting granulate with the lubricant, and optionally the glidant. The blend thus prepared is used for filling unit dosage forms.</p> |
