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1. 发明专利

NZ562495A Sustained-release tablet comprising pramipexole 未知
公开(公告)号：NZ562495A
公开(公告)日：2009-03-31
申请号：NZ56249503
申请日：2003-07-25
申请人： PHARMACIA CORP
发明人： NOACK RAINER , REO JOSEPH P , AMIDON GREGORY E , GANORKAR LOKSIDH D , HEIMLICH JOHN M , LEE ERNEST J , SKOUG CONNIE J
IPC分类号： A61K31/513 , A61K31/428 , A61K9/20 , A61K9/28 , A61K31/4745 , A61K31/5375
摘要： A method for determining suitability of a starch for use in a sustained-release orally deliverable tablet comprising an active pharmaceutical agent, having solubility not less than about 10 mg/ml is disclosed, wherein the method comprises the steps of: (a) preparing compacts of a sample of the starch on an automated tablet press at a range of compression forces applied for a dwell time of at least about 4 seconds; (b) measuring hardness of each compact, expressed as the force required to cause crushing of the compact; (c) determining solid fraction of each compact; (d) calculating tensile strength of each compact from the equation given in the specification; (e) establishing relationship of tensile strength to solid fraction of the compacts; and (f) using said relationship to estimate tensile strength at a solid fraction representative of a desired sustained-release tablet; the starch being deemed suitable for said use if its tensile strength as so estimated is at least about 0.15 kN cm-2. Also disclosed is a process for preparing a sustained-release pharmaceutical composition in a form of an orally deliverable tablet comprising an active pharmaceutical agent which is pramipexole or a salt thereof, the process comprising selecting by a suitable test a starch having a tensile strength of at least about 0.15 kN cm-2 at a solid fraction representative of the tablet; admixing with the selected starch a hydrophilic polymer and pramipexole or a salt thereof to provide a mixture wherein the agent is dispersed in a matrix comprising the polymer and the starch; and compressing the mixture to form said tablet.

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