PACKHAEUSER, CLAUDIA,STEIGER, NORBERT,LIEPOLD, BERND,KOSTELAC, DRAZEN,KNOBLOCH, MARTIN
申请号：
PE0020582011
公开号：
PE10842012A1
申请日:
2010.06.08
申请国别(地区):
PE
年份:
2012
代理人:
摘要：
Referring to a pharmaceutical dosage form comprising: (a) an active principle of N - (4 - (4 - ((2 - (4-chlorophenyl) - 5,5 - dimethyl - ciclohex - 1 - 1 - 1 - yl) methyl) piperazin-1-yl) benzoyl) - 4 - (((1R) - 3 - (morpholin-4-yl) - 1 - ((phenylsulfanyl) phenyl) propyl) amino) - 3 - ((trifluoromethyl) sulfonyl) in a bencenosulfamida Amount of 0,5 - 40% (b) a pharmaceutically acceptable Polymer selected from N - Vinyl pyrrolidone Copolymer and vinyl acetate in a quantity of 40 - 97.5% by weight (c) a Solvent selected from non-ionic solubilizer such as Alpha tocopheryl polyethylene glycol succinate, and poliox sorbitan monolaurate Ietilen sorbitan monolaurate, among others, present as Sodium lauryl sulfate,And combinations thereof in an amount of 2 - 20% (d) a non-volatile Solvent at room temperature to the liquid active substance such as propylene glycol (e) at least one Additive selected Flow regulators, disintegrating, Thickening agents and Lubricants in an amount of 15% and 0 - N weight.It also includes less than 1,5% by weight relative to the weight of active ingredient of sulfoxide decomposition products with the active ingredient. Solid dispersion composition that is useful in the treatment of proliferative DisordersREFERIDA A UNA FORMA DE DOSIFICACION FARMACEUTICA QUE COMPRENDE: A) UN PRINCIPIO ACTIVO DE N-(4-(4-((2-(4-CLOROFENIL)-5,5-DIMETIL-1-CICLOHEX-1-EN-1-IL)-METIL)PIPERAZIN-1-IL)BENZOIL)-4-(((1R)-3-(MORFOLIN-4-IL)-1-((FENILSULFANIL)FENIL)PROPIL)AMINO)-3-((TRIFLUOROMETIL)SULFONIL)BENCENOSULFAMIDA EN UNA CANTIDAD DE 0,5-40% B) UN POLIMERO FARMACEUTICAMENTE ACEPTABLE SELECCIONADO DE COPOLIMERO N-VINIL PIRROLIDONA Y ACETATO DE VINILO EN UNA CANTIDAD DE 40-97,5% EN PESO C) UN SOLUBILIZANTE SELECCIONADO DE SOLUBILIZANTE NO IONICO TAL COMO ALFA TOCOFERILO POLIETILENGLICOL SUCCINATO, MONOLAURATO DE SORBITAN Y POLIOXIETILEN MONOLAURATO DE SORBITAN, ENTRE OTROS SOLUBILIZANTES TAL COMO LAURILSULFATO DE SODIO, Y COMBINACIONES DE LOS MISMOS EN UNA CANTIDAD DE 2-20%
