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1. 发明申请

WO2011084638A3 MESALAMINE SUPPOSITORY 审中-公开
公开(公告)号：WO2011084638A3
公开(公告)日：2011-07-14
申请号：PCT/US2010/060849
申请日：2010-12-16
申请人： APTALIS PHARMA CANADA INC. , POWEL, David
发明人： POWEL, David , DUMOULIN, Yves , GAUTHIER, Carl , MOREAU, Hugues
IPC分类号： A61K9/00 , A61K9/02 , A61K47/44 , A61K31/606
摘要： The present invention relates to a mesalamine rectal suppository designed to provide improved comfort of use. One embodiment of the invention is a mesalamine rectal suppository comprising mesalamine and one or more pharmaceutically acceptable excipients, wherein the drug load of the suppository ranges from 35% to 50%. Yet another embodiment of the invention is a mesalamine rectal suppository comprising mesalamine having a tap density ranging from about 600 to about 800 g/L (as measured by USP ) and a hard fat having an ascending melting point of 32 to 35.5° C. Yet another embodiment is a mesalamine rectal suppository comprising mesalamine particles and one or more pharmaceutically acceptable excipients, where the mesalamine particles have a surface area of from about 0.1 m 2 /g to about 2.8 m 2 /g (e.g., from about 0.1 m 2 /g to about 1.3 m 2 /g). Methods of preparing and methods of treatment with mesalamine suppositories are also provided. The invention further provides a method of determining a dissolution parameter (such as dissolution rate) of a mesalamine rectal suppository, such as a 1 g mesalamine suppository, by measuring its dissolution with USP Apparatus #2 at 40° C and a paddle rotation speed of 125 rpm in 0.2 M phosphate buffer at a pH of 7.5.

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