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PAZOPANIBA COMPOSITION

机译:帕索帕尼巴组合物

摘要

1. A composition suitable for reconstitution in an aqueous suspension containing 5 - [[4 - [(2,3-dimethyl-2H-indazol-6-yl) methylamino] -2-pyrimidinyl] amino] -2-methylbenzenesulfonamide hydrochloride and guar gum. 2. The composition of claim 1, further comprising polyvinylpyrrolidone. 3. A composition according to claim 1 or 2, wherein said guar gum is present in an amount of from 3% to 8% by weight of the composition. The composition according to any one of paragraphs. 1 and 2, where the specified polyvinylpyrrolidone is present in an amount of from 3% to 12% by weight of the composition. The composition according to any one of paragraphs. 1 and 2, wherein said 5 - [[4 - [(2,3-dimethyl-2H-indazol-6-yl) methylamino] -2-pyrimidinyl] amino] -2-methylbenzenesulfonamide hydrochloride is micronized. 6. The composition of claim 5, wherein said micronized hydrochloride 5 - [[4 - [(2,3-dimethyl-2H-indazol-6-yl) methylamino] -2-pyrimidinyl] amino] -2-methylbenzenesulfonamide has a particle size distribution such that more than 90% of the particles have a size of from 0.61 to 10.0 microns. 7. The composition according to any one of paragraphs. 1 and 2, where when recovering the specified composition into an aqueous suspension, it has a pH from 3.0 to 4.2.8. The composition according to any one of paragraphs. 1 and 2, where when recovering the specified composition into an aqueous suspension, it has a pH from 3.5 to 4.0.9. Direct mixing powder for use in a pharmaceutical composition containing 1) 5 - [[4 - [(2,3-dimethyl-2H-indazol-6-yl) methylamino] -2-pyrimidinyl] amino] -2-methylbenzenesulfonamide hydrochloride, 2) thickener, 3) suspending agent, 4) surfactant, 5) buffer, 6) preservative, 7) release agent or glidant, 8) sweetener and 9) flavoring. 10. The powder according to claim 9, containing1) 35.0-50.0 wt./mass. % micronized hydrochloride 5 - [[4 - [(2,3-dimethyl-2H-i�
机译:1.适合在含有5-[[[4-[(2,3-二甲基-2H-吲唑-6-基)甲基氨基] -2-嘧啶基]氨基] -2-甲基苯磺酰胺盐酸盐和瓜尔胶的水悬浮液中重构的组合物胶。 2.权利要求1的组合物,其进一步包含聚乙烯吡咯烷酮。 3.根据权利要求1或2的组合物,其中所述瓜耳胶的存在量为组合物重量的3%至8%。根据段落中任一项的组合物。参照图1和2,其中指定的聚乙烯吡咯烷酮的存在量为组合物重量的3%至12%。根据段落中任一项的组合物。参照图1和2,其中将所述5-[[[4-[(2,3-二甲基-2H-吲唑-6-基)甲基氨基] -2-嘧啶基]氨基] -2-甲基苯磺酰胺盐酸盐微粉化。 6.权利要求5的组合物,其中所述微粉化盐酸盐5-[[[4-[(2,3-二甲基-2H-吲唑-6-基)甲基氨基] -2-嘧啶基]氨基] -2-甲基苯磺酰胺具有颗粒尺寸分布,使得超过90%的颗粒的尺寸为0.61至10.0微米。 7.根据段落任一的组合物。参照图1和2,其中当将指定的组合物回收到水悬浮液中时,其pH为3.0至4.2.8。根据段落中任一项的组合物。参照图1和2,其中当将指定的组合物回收到水性悬浮液中时,其pH为3.5至4.0.9。用于含有1)5-[[4-[(2,3-二甲基-2H-吲唑-6-基)甲基氨基] -2-嘧啶基]氨基] -2-甲基苯磺酰胺盐酸盐的药物组合物的直接混合粉剂,2 )增稠剂,3)悬浮剂,4)表面活性剂,5)缓冲剂,6)防腐剂,7)脱模剂或助流剂,8)甜味剂和9)调味剂。 10.根据权利要求9的粉末,包含1)35.0-50.0重量/质量。 %的微粉化盐酸盐5-[[4--(((2,3-二甲基-2H-i。

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