BEIJING KEXIN BICHENG BIOMEDICAL TECHNOLOGY DEVELOPMENT CO.; LTD.
发明人:
JIANG, HAISONG,WANG, JINGANG
申请号:
EP09832823
公开号:
EP2380562A4
申请日:
2009.12.16
申请国别(地区):
EP
年份:
2013
代理人:
摘要:
The invention relates to the field of pharmaceutical preparation, in particular to a bilayer osmotic pump controlled-release tablet preparation and a preparation method thereof. Said bilayer osmotic pump controlled-release tablet comprises a conventional tablet core, release control layer(s) and drug release hole(s), wherein one or more lubricating layer structure(s) is/are disposed between the tablet core and the release control layer(s). The lubricating layer(s) is/are present in an amount of from 0.5% to 6% based on the weight of the bilayer tablet core. The lubricating layer(s) rapidly hydrates once in contact with water to form the favorable lubricating liquor between the tablet core and the release control layer(s), hence reducing the shear force between the drug-containing layer(s) and the release control layer(s), whereby the drug-containing layer(s) is/are pushed out completely by the propellant layer(s) to reach a drug release percent of nearly 100%. This solves the problem of the incomplete drug release due to the dead angle generated by the drug-containing layer of a conventional bilayer osmotic pump controlled-release tablet during the release procedure. This technique ensures the superior bioavailability of the bilayer osmotic pump controlled-release tablet as prepared.