JASPART, Severine Francine Isabelle,PLATTEEUW, Johannes Jan,VAN DEN HEUVEL, Denny Johan Marijn
申请号:
PE2017002732
公开号:
PE20180522A1
申请日:
2016.06.17
申请国别(地区):
PE
年份:
2018
代理人:
摘要:
The invention provides a solid or dispersed effective dose unit with a weight between 30 and 1000 mg, wherein the dose unit is 0.1-25% of the weight of estetrol particles, which contains at least 80% of the weight of stellar components selected from estetrol, e. Estetrol mats and their combinations; and 75-99.9% (by weight) of one or more pharmaceutically acceptable ingredients; a solidified dose unit including at least 100 micrograms of estetrol components;The solid dose unit can be obtained by a program that includes providing estetrol particles containing at least 80% by weight of stellar components and with an average volume of diamonds from 2 microns to 50 microns; Mixing estetrol particles with one or more previous particles to produce a mixed particle; mixing the particles with a granular liquid to produce particles containing estetrol containing at least 60% of the granular liquid by weight of the liquid solvent;1. To remove the liquid solvent from the grains containing esttrol, so as to produce the dry grains containing esttrol; or mixing the dry grains with one or more pre absorbents to form a compression agent; And form dry or mixed dry granules and one or more rosin forming compressions, providing a solid dose unit. The solidifying dose unit is easy to manufacture and is completely suitable for the management of secondary inguinal or subinguinal.La invencion proporciona una unidad de dosificacion solida orodispersable farmaceutica que tiene un peso comprendido entre 30 y 1.000 mg, consistiendo dicha unidad de dosificacion en: 0.1-25% en peso de particulas de estetrol que contienen al menos 80 % en peso de un componente estetrol seleccionado entre estetrol, esteres de estetrol y combinaciones de los mismos; y 75-99,9 % en peso de uno o mas ingredientes farmaceuticamente aceptables; comprendiendo la unidad de dosificacion solida al menos 100 microgramos del componente estetrol; y en la que la unidad de dosificacion solida se puede obtener a traves de un pr