VAN DEN HEUVEL, DENNIE, JOHAN, MARIJN,WEIJERS, JOHANNES, WILHELMUS, MAURICE,PAMPERIN, DIRK
申请号：
NZ59323708
公开号：
NZ593237A
申请日:
2008.12.09
申请国别(地区):
NZ
年份:
2013
代理人:
摘要：
Abstract 593237 Disclosed is a combination dosage form comprising a dose of tamsulosin physically separated from a dose of a testosterone-5a-reductase inhibitor, wherein said combination dosage form comprises an inner capsule loaded with the testosterone-5a-reductase inhibitor and an outer capsule entirely covering the inner capsule, wherein the space between the inner capsule and outer capsule is filled with the tamsulosin dose in the form of a population of pellets comprising tamsulosin hydrochloride uniformly dispersed in a carrier matrix, wherein said pellets in the population have a size ofless than about 1.4 mm and at least 90% of the pellets have a size of larger than 0.30 mm and an average content of tamsulosin hydrochloride in the population of pellets is between about 0.15 - 3.00 weight per cent, calculated on a dry pellet basis, such that the dissolution release profile, when measured as a plurality of pellets, is less than 25% of tamsulosin is released during the first two hours in simulated gastric fluid using Ph.Eur. basket method at 100 rpm, and is 30-65% of the tamsulosin in one hour, and/or more than 80% of the tamsulosin in six hours in a phosphate buffer of pH 6.8, using Ph.Eur. basket method at 100 rpm., to a process of making such combination dosage forms, and to their use as medicaments for treatment of benign prostatic hyperplasia.
