Microgranular Rapid dispersion composition comprising at least one sugar alcohol, a saccharide, or a mixture of these, at least a Super disintegrant and at least a multifunction Additive； ORALLY DISINTEGRATING Tablet composition comprising at least a First and microgranular acti Vo； and Manufacturing methods.
VENKATESH, GOPI M.,SWAMINATHAN, VIJAYA,LAI, JIN-WANG,CLEVENGER, JAMES M.
申请号：
CL2013001586
公开号：
CL2013001586A1
申请日:
2013.06.03
申请国别(地区):
CL
年份:
2013
代理人:
摘要：
This invention relates to rapidly dispersing microgranules comprising at least one sugar alcohol or saccharide, at least one super disintegrant, and a pharmaceutically acceptable additive with multi-functionality (e.g., starch acting as a binder, disintegrant, diluent/filler, glidant, etc) at a low level, which can be formed by not only eliminating a wet milling step but also avoiding an extensive dry milling step. Furthermore, such rapidly dispersing microgranules could also comprise a pharmaceutically active agent thereby providing for a pharmaceutical composition, or the rapidly dispersing microgranules thus produced are suitable for blending with a pharmaceutically active agent that is optionally taste-masked and/or controlled release coated microparticles to also provide for a pharmaceutical composition and the invention is also directed to a method for manufacturing such rapidly dispersing microgranules in a high useable yield, as well as orally disintegrating tablets comprising such rapidly dispersing microgranules. The rapidly dispersing microgranules are also free flowing.COMPOSICION MICROGRANULAR DE RAPIDA DISPERSION QUE COMPRENDE AL MENOS UN ALCOHOL DE AZUCAR, UN SACARIDO, O UNA MEZCLA DE ESTOS, AL MENOS UN SUPER DISGREGANTE Y AL MENOS UN ADITIVO MULTIFUNCION； COMPRIMIDO DE DESINTEGRACION ORAL QUE COMPRENDE LA COMPOSICION MICROGRANULAR Y AL MENOS UN PRINCIPIO ACTIVO； Y METODOS DE FABRICACION.
