专利名称:BENZONATATE MODIFIED RELEASE SOLID
TABLETS AND CAPSULES
发明人:NELSON, Andrea,CHEN, Quin-zene,METHTA,
Harsh,TU, Yu-Hsing
申请号:EP14713016.5申请日:20140311公开号:EP2968151A1公开日:20160120
摘要:A 12-hour anti-tussive modified release solid tablet or capsule is describedwhich comprises a benzonatate in a matrix with a sufficient amount of one or morepharmaceutically acceptable modified release pH-independent, substances to provide a12-hour modified release profile to the benzonatate, wherein there is substantially nobenzonatate release from the tablet or capsule in the buccal cavity and no more thanabout 25% release of the benzonatate within 1 hour as determined in an in vitro
dissolution assay. The modified release may be provided by (a) a high melt temperature,water-insoluble wax or waxy substance, (b) a low viscosity hydrophilic polymer such ahydroxypropyl methylcellulose, (c) a reverse enteric coating, or combinations thereof.The benzonatate may be in an adsorbate with a silico or silicate or in a complex with aweak acidic ion exchange resin complex.
申请人:Tris Pharma, Inc.
地址:2033 Route 130, Suite D Monmouth Junction, NJ 08852 US
国籍:US
代理机构:Pohlman, Sandra M.
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