CONTROLLED-RELEASE FORMULATION COMPRISING TAMSULOSIN HYDROCHLORIDE

摘要

A solid oral controlled-release formulation of tamsulosin hydrochloride in the form of an enteric coated tablet, wherein tamsulosin hydrochloride is ho-mogenously dispersed within a matrix consisting of a mixture of fatty component and hydrophilic component, together with at least one diluent and optionally other pharmaceutically acceptable excipients, exhibiting ex- hibiting a dissolution profile of tamsulosin hydrochloride, as measured in a Type II paddle apparatus in accordance with the dissolution testing method specified in the European Pharmacopoeia at 37±0.5°C and 100 rpm in a 0.1 N HC1 buffer for 2 hours, followed by pH 7.2 buffer for the rest of test: 10-40% during first 2 hours (in HC1), 35-70% after 3 h (in pH 7.2 buffer system), not less than 70% of the declared content after 5 h (in pH 7.2 buffer system).