CROWLEY, MICHAEL M,KEEN, JUSTIN M,KOLENG, JOHN J,ZHANG, FENG
申请号:
NZ57220607
公开号:
NZ572206A
申请日:
2007.03.22
申请国别(地区):
NZ
年份:
2012
代理人:
摘要:
Disclosed herein is a process for preparing a bioadhesive hot-melt coextruded laminate comprising a bioadhesive hydrophilic reservoir layer and a hydrophobic low permeability backing layer, the process comprising the step of: coextruding a thermoplastic hydrophilic first composition and a thermoplastic hydrophobic second composition to form the laminate, wherein the first composition comprises poly(ethylene oxide); an active agent; and optionally one or more antioxidants, one or more lubricants, one or more hydrophobic polymers, one or more excipients, or a combination thereof, wherein the second composition comprises poly(ethylene oxide), at least one hydrophobic polymer; a plasticizer; and optionally one or more hydrophilic polymers, one or more excipients, or a combination thereof, wherein the second composition is hydrophobic, wherein the first and second compositions comprise at least one polymer in common. Also disclosed is a bioadhesive bi-layered hot-melt extruded laminate comprising a hydrophilic bioadhesive reservoir layer and a hydrophobic backing layer, wherein a) the reservoir layer comprises an active agent; b) the backing layer is hydrophobic; c) the reservoir layer and the backing layer both comprise poly(ethylene oxide) d) the laminate has (i) a uniform transverse cross-section throughout a majority of its length along its linear axis, and (ii) a uniform longitudinal cross-section throughout a majority of its transverse width; and e) the melt flow index of the reservoir layer is within 50% of the melt flow index of the backing layer.