JASPART, Severine Francine Isabelle,PLATTEEUW, Johannes Jan,VAN DEN HEUVEL, Denny Johan Marijn
申请号：
PE0027322017
公开号：
PE5222018A1
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 pharmaceutical dosage orodispersable unit which has a Weight of between 30 and 1000 mg, consisting in the Dosing Unit.1 - 25% by weight of estetrol particles containing at least 80% by weight of a component selected from estetrol estetrol, estetrol esters and combinations thereof and 75 - 999% by weight of one or more pharmaceutically acceptable ingredients Realizing the Unity of Solid dosage at least 100 micrograms of estetrol Component and the unit scheduleOn Solid can be obtained through a procedure that includes providing estetrol particles containing at least 80% by weight of the component and have an average diameter estetrol volumEtric 2 microns to 50 micrometers mixing the particles with one or more excipients estetrol granulation granulation to produce a mixture Mix granulation with a lIquido granulation to produce Granules containing estetrol,The granulating Liquid containing at least 60% by weight of liquid solvent removing the Solvent Liquid of the Granules that contain estetrol to produce Dry Granules containing eOptionally, stetrolMIX THE DRY Granules with one or more excipients to form and form Dry granules or tablets mixing the dry Granules and one or more excipients to form compressed to give aUnit of Solid dosage. The Dosing Unit Solid is easy to Fabricate and perfectly suitable for oral or sublingual Administration, sublabialLa 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 t
