作者: Donald E. Panoz , Edward J. Geoghegan , Seamus Mulligan
DOI:
关键词: Dissolution testing 、 Pellet 、 Diltiazem 、 Dissolution 、 Chemistry 、 Membrane 、 Chromatography 、 Oral administration 、 Absorption (skin) 、 Organic acid
摘要: A diltiazem pellet formulation for oral administration comprises a core of or pharmaceutically acceptable salt thereof in association with an organic acid, and multi-layer membrane surrounding the containing major proportion film-forming, water insoluble synthetic polymer minor soluble polymer. The number layers ratio to being effective permit release from at rate allowing controlled absorption over twelve hour period following administration. has dissolution vitro which when measured apparatus (Paddle) according U.S. Pharmacopoeia XXI 0.05 M KCl pH 7.0 results not more than 35% total released after 2 hours measurement. Not 80% is six measurement less 85% 13