APR APPLIED PHARMA RESEARCH SA;LABTEC GESELLSCHAFT FUR TECHNOLOGISCHE FORSCHUNG UND ENTWICKLUNG MBH
发明人:
BREITENBACH, ARMIN,LEHRKE, INGO,LEICHS, CHRISTIAN,GALFETTI, PAOLO
申请号：
NZ57590007
公开号：
NZ575900A
申请日:
2007.10.02
申请国别(地区):
NZ
年份:
2012
代理人:
摘要：
Disclosed herein is a non-mucoadhesive orally disintegrating film, able to disintegrate upon contact with saliva in the buccal cavity within about sixty seconds, said film comprises ondansetron or a pharmaceutically acceptable salt thereof in combination with a hydrophilic binder and a water-soluble diluent selected from the group consisting of polyvinyl alcohol, polyethylene glycol, propylene glycol, polyethylene oxide, starches, celluloses or gelatines and means for retarding absorption of said ondansetron through the oral mucosa said retarding means are selected from the group of: · an ion exchange resin, that bind the ondansetron and prevent its ionization and dissolution upon integration of the film, wherein said ion exchange resin is selected from the group consisting of polymers and copolymers of acrylic acid, methacrylic acid, sulfonated styrene, sulfonated divinylbezene, modified cellulose and dextrans, silica gel modified by the addition of ionic groups； · pH adjusting agents ionizing the ondansetron to a less permeable state, selected from the group consisting of cyclodextrin or acrylate polymers； · ondansetron in base form； wherein said retarding means result in a gastrointestinal absorption of at least 60% of said ondansetron when the film is placed on the tongue, allowed to disintegrate, and subsequently swallowed.
