专利内容由知识产权出版社提供
专利名称：MESALAMINE SUPPOSITORY发明人：Yves Dumoulin,Carl Gauthier,David
Powell,Hugues Moreau
申请号：US126395申请日：20091216
公开号：US20100105639A1公开日：20100429
摘要：The present invention relates to a mesalamine rectal suppository designed toprovide improved comfort of use. One embodiment of the invention is a mesalaminerectal suppository comprising mesalamine and one or more pharmaceutically acceptableexcipients, wherein the drug load of the suppository ranges from 35% to 50%. Yetanother embodiment of the invention is a mesalamine rectal suppository comprisingmesalamine having a tap density ranging from about 600 to about 800 g/L (as measuredby USP <616>) and a hard fat having an ascending melting point of 32 to 35.5° C. Yetanother embodiment is a mesalamine rectal suppository comprising mesalamine particlesand one or more pharmaceutically acceptable excipients, where the mesalamine particleshave a surface area of from about 0.1 m/g to about 2.8 m/g (e.g., from about 0.1 m/g toabout 1.3 m/g). Methods of preparing and methods of treatment with mesalaminesuppositories are also provided. The invention further provides a method of determininga 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 #2at 40° C. and a paddle rotation speed of 125 rpm in 0.2 M phosphate buffer at a pH of 7.5.
申请人：Yves Dumoulin,Carl Gauthier,David Powell,Hugues Moreau
地址：Quebec CA,Quebec CA,Loudon TN US,Luce FR
国籍：CA,CA,US,FR
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