HEIKE DR. NEUMANN,KLAUS DR. BENKE,MICHAEL FORMELL,GABRIELE DR. WINTER
申请号:
ARP140103868
公开号:
AR098064A1
申请日:
2014.10.17
申请国别(地区):
AR
年份:
2016
代理人:
摘要:
Claim 1: Solid pharmaceutical dosage form for oral administration comprising 1 - [6 - (4 - (ii) pyrimidin-4-yl] - 4 - (1H - 1,2,3 - triazol 1 - il) - 1H pyrazole - 5 - olato Sodium (Active Principle (L)), characterized (a) that the concentration of adjuvants with cations. Alentes and / or Trivalent) is 0.1% based on the total mass of the formulation,(b) the concentration of Lactose is GBP 10% based on the total mass of the formulation (c) concentration of active Principle (i) is - 10% based on the total mass of the formulation, and (d) if the dosage form has a Coating Film, Coating Film Comp Rende polyethylene glycol.Claim 13: procedure for preparing a Solid pharmaceutical dosage form for oral administration comprising 1 - [6 - (morpholin-4-yl) pyrimidin-4-yl] - 4 - (1H - 1,2,3 - triazol 1 - il) - 1H pyrazole - 5 - olato Sodium (Active Principle (i), a concentration of adjuvants with CATI Divalent and Trivalent ones and / or 0.1% based on the total mass of the formulation,A concentration of Lactose and 10% based on the total mass of the formulation and concentration of active Principle (i) - 10% based on the total mass of the formulation, characterized in that (a) initially prepares a Granulate comprising the active Principle (i), (b) and granulated, or Pcionalmente containing pharmaceutically acceptable adjuvants.Then becomes the pharmaceutical dosage form.Reivindicación 1: Forma farmacéutica de dosificación sólida para administración oral que comprende 1-[6-(morfolin-4-iI)pirimidin-4-il]-4-(1H-1,2,3-triazol-1-il)-1H-pirazol-5-olato de sodio (principio activo (l)), caracterizada por que (a) la concentración de adyuvantes que tienen cationes divalentes y/o trivalentes es £ 0,1% basado en la masa total de la formulación, (b) la concentración de lactosa es £ 10% basado en la masa total de la formulación, (c) la concentración de principio activo (I) es ³ 10% basado en la masa total de la formulación, y (d) si la forma de dosificación tiene un recubrimiento de películ