KARABORNI SAMI,YODER GORM,KIM DERRICK K.,KIDNEY DAVID J.,EDGREN DAVID E.,PARGAONKAR NIKHIL
申请号:
NZ59464810
公开号:
NZ594648A
申请日:
2010.03.03
申请国别(地区):
NZ
年份:
2013
代理人:
摘要:
594648 Disclosed herein is an oral tablet dosage form comprising a tablet and a coating, the tablet comprising: 3 wt-% to 20 wt-% (3R)-4-{ [(1S)-2-methyl-1-(2-methylpropanoyloxy)propoxy) carbonylamino} -3-(4-chlorophenyl)butanoic acid or a pharmaceutically acceptable salt thereof 15 wt-% to 40 wt-% microcrystalline cellulose 15 wt-% to 40 wt-% hydroxypropylmethyl cellulose 3 wt-% to 30 wt-% of a release rate-controlling polymer and dibasic calcium phosphate dihydrate or dibasic calcium phosphate anhydrous in an amount selected from 19 wt-% to 22 wt-% and 23 wt-% to 33 wt-% based on the total weight of the dosage form wherein the release-rate controlling polymer is a poly( ethylacrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride) copolymer having 8.8% to 12.0% ammonio methacrylate units on a dry substance basis. Additionally disclosed is a method of preparing said oral table dosage form comprising compacting the dry blend formulation to provide an oral tablet dosage form.