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1. 发明申请

US20090022793A1 MESALAMINE SUPPOSITORY 有权
标题翻译：木脂素支架
公开(公告)号：US20090022793A1
公开(公告)日：2009-01-22
申请号：US12245648
申请日：2008-10-03
申请人： Carl Gauthier , Yves Dumoulin , David Powell
发明人： Carl Gauthier , Yves Dumoulin , David Powell
IPC分类号： A61K9/20 , A61K31/137
CPC分类号： A61K9/02 , A61K31/137 , A61K47/44 , Y10S514/953
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%. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 850 to about 1150 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 2250 to about 2700 mg. 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. 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.
摘要翻译：本发明涉及美沙拉坦直肠栓剂，其旨在提供改善的使用舒适性。本发明的一个实施方案是美沙拉坦直肠栓剂，其包含美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的药物负载范围为35％至50％。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含约850至约1150mg美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的总重量为约2250至约2700mg。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含振荡密度范围为约600至约800g / L的美沙拉嗪（通过USP <616>测量）和具有上升熔点为32至35.5°的硬脂肪 C.还提供了制备方法和美沙拉嗪栓剂的治疗方法。本发明还提供了一种通过用USP装置＃2在40℃下测量溶解参数（例如溶解度）来测定美沙拉嗪直肠栓剂如1g美沙胺栓剂的溶出参数（如溶出速率），并且桨叶转速在pH 7.5的0.2M磷酸盐缓冲液中的125rpm。

2. 发明授权

US08436051B2 Mesalamine suppository 有权
标题翻译：美沙胺栓剂
公开(公告)号：US08436051B2
公开(公告)日：2013-05-07
申请号：US12639645
申请日：2009-12-16
申请人： Carl Gauthier , Yves Dumoulin , David Powell , Hugues Moreau
发明人： Carl Gauthier , Yves Dumoulin , David Powell , Hugues Moreau
IPC分类号： A01N33/02 , A01N37/36 , A01N37/12 , A01N37/44 , A61K31/135 , A61K31/60 , A61K31/195 , A61F13/00
CPC分类号： A61K9/14 , A61K9/0031 , A61K9/02 , A61K31/136 , A61K31/195 , A61K31/606 , A61K47/44
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 m2/g to about 2.8 m2/g (e.g., from about 0.1 m2/g to about 1.3 m2/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.
摘要翻译：本发明涉及美沙拉坦直肠栓剂，其旨在提供改善的使用舒适性。本发明的一个实施方案是美沙拉坦直肠栓剂，其包含美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的药物负载范围为35％至50％。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含振荡密度范围为约600至约800g / L的美沙拉嗪（通过USP <616>测量）和具有上升熔点为32至35.5°的硬脂肪 C.另一个实施方案是美沙拉坦直肠栓剂，其包含美沙拉嗪颗粒和一种或多种药学上可接受的赋形剂，其中美沙拉嗪颗粒的表面积为约0.1m 2 / g至约2.8m 2 / g（例如，约0.1m 2 / g至约1.3m 2 / g）。还提供了制备方法和美沙拉坦栓剂的治疗方法。本发明还提供了一种通过用USP装置＃2在40℃下测量溶解参数（例如溶解度）来测定美沙拉嗪直肠栓剂如1g美沙胺栓剂的溶出参数（如溶出速率），并且桨叶转速在pH 7.5的0.2M磷酸盐缓冲液中的125rpm。

3. 发明授权

US07541384B2 Mesalamine suppository 有权
标题翻译：美沙胺栓剂
公开(公告)号：US07541384B2
公开(公告)日：2009-06-02
申请号：US12245648
申请日：2008-10-03
申请人： Carl Gauthier , Yves Dumoulin , David Powell
发明人： Carl Gauthier , Yves Dumoulin , David Powell
IPC分类号： A01N33/02 , A01N37/36 , A01N37/12 , A01N37/44 , A61K31/135 , A61K31/60 , A61K31/195 , A61F13/00
CPC分类号： A61K9/02 , A61K31/137 , A61K47/44 , Y10S514/953
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 containing mesalamine and one or more pharmaceutically acceptable excipients, wherein the drug load of the suppository ranges from 35% to 50%. Another embodiment of the invention is a mesalamine rectal suppository containing from about 850 to about 1150 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 2250 to about 2700 mg. 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. 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.
摘要翻译：本发明涉及美沙拉坦直肠栓剂，其旨在提供改善的使用舒适性。本发明的一个实施方案是美沙拉坦直肠栓剂，其含有美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的药物负载范围为35％至50％。本发明的另一个实施方案是含有约850至约1150mg美沙拉嗪和一种或多种药学上可接受的赋形剂的美沙拉嗪直肠栓剂，其中栓剂的总重量为约2250至约2700mg。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含振荡密度范围为约600至约800g / L的美沙拉嗪（通过USP <616>测量）和具有上升熔点为32至35.5°的硬脂肪 C.还提供了制备方法和美沙拉嗪栓剂的治疗方法。本发明还提供了一种通过用USP装置＃2在40℃下测量溶解参数（例如溶解度）来测定美沙拉嗪直肠栓剂如1g美沙胺栓剂的溶出参数（如溶出速率），并且桨叶转速在pH 7.5的0.2M磷酸盐缓冲液中的125rpm。

4. 发明授权

US08217083B2 Mesalamine suppository 有权
标题翻译：美沙胺栓剂
公开(公告)号：US08217083B2
公开(公告)日：2012-07-10
申请号：US12476185
申请日：2009-06-01
申请人： Carl Gauthier , Yves Dumoulin , David Powell
发明人： Carl Gauthier , Yves Dumoulin , David Powell
IPC分类号： A01N33/02 , A01N37/36 , A01N37/12 , A01N37/44 , A61K31/135 , A61K31/60 , A61K31/195 , A61F13/00
CPC分类号： A61K9/02 , A61K31/137 , A61K47/44 , Y10S514/953
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%. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 850 to about 1150 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 2250 to about 2700 mg. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 400 to about 600 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 870 to about 1715 mg. 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. 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.
摘要翻译：本发明涉及美沙拉坦直肠栓剂，其旨在提供改善的使用舒适性。本发明的一个实施方案是美沙拉坦直肠栓剂，其包含美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的药物负载范围为35％至50％。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含约850至约1150mg美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的总重量为约2250至约2700mg。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含约400至约600mg的美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的总重量为约870至约1715mg。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含振荡密度范围为约600至约800g / L的美沙拉嗪（通过USP <616>测量）和具有上升熔点为32至35.5°的硬脂肪 C.还提供了制备方法和美沙拉嗪栓剂的治疗方法。本发明还提供了一种通过用USP装置＃2在40℃下测量溶解参数（例如溶解度）来测定美沙拉嗪直肠栓剂如1g美沙胺栓剂的溶出参数（如溶出速率），并且桨叶转速在pH 7.5的0.2M磷酸盐缓冲液中的125rpm。

5. 发明申请

US20100105639A1 MESALAMINE SUPPOSITORY 有权
标题翻译：木脂素支架
公开(公告)号：US20100105639A1
公开(公告)日：2010-04-29
申请号：US12639645
申请日：2009-12-16
申请人： Yves Dumoulin , Carl Gauthier , David Powell , Hugues Moreau
发明人： Yves Dumoulin , Carl Gauthier , David Powell , Hugues Moreau
IPC分类号： A61K31/606 , A61P1/00
CPC分类号： A61K9/14 , A61K9/0031 , A61K9/02 , A61K31/136 , A61K31/195 , A61K31/606 , A61K47/44
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 m2/g to about 2.8 m2/g (e.g., from about 0.1 m2/g to about 1.3 m2/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.
摘要翻译：本发明涉及美沙拉坦直肠栓剂，其旨在提供改善的使用舒适性。本发明的一个实施方案是美沙拉坦直肠栓剂，其包含美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的药物负载范围为35％至50％。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含振荡密度范围为约600至约800g / L的美沙拉嗪（通过USP <616>测量）和具有上升熔点为32至35.5°的硬脂肪 C.另一个实施方案是美沙拉坦直肠栓剂，其包含美沙拉嗪颗粒和一种或多种药学上可接受的赋形剂，其中美沙拉嗪颗粒的表面积为约0.1m 2 / g至约2.8m 2 / g（例如，约0.1m 2 / g至约1.3m 2 / g）。还提供了制备方法和美沙拉坦栓剂的治疗方法。本发明还提供了一种通过用USP装置＃2在40℃下测量溶解参数（例如溶解度）来测定美沙拉嗪直肠栓剂如1g美沙胺栓剂的溶出参数（如溶出速率），并且桨叶转速在pH 7.5的0.2M磷酸盐缓冲液中的125rpm。

6. 发明申请

US20090264386A1 MESALAMINE SUPPOSITORY 有权
标题翻译：木脂素支架
公开(公告)号：US20090264386A1
公开(公告)日：2009-10-22
申请号：US12476185
申请日：2009-06-01
申请人： Carl Gauthier , Yves Dumoulin , David Powell
发明人： Carl Gauthier , Yves Dumoulin , David Powell
IPC分类号： A61K31/606 , A61P1/00
CPC分类号： A61K9/02 , A61K31/137 , A61K47/44 , Y10S514/953
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%. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 850 to about 1150 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 2250 to about 2700 mg. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 400 to about 600 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 870 to about 1715 mg. 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. 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.
摘要翻译：本发明涉及美沙拉坦直肠栓剂，其旨在提供改善的使用舒适性。本发明的一个实施方案是美沙拉坦直肠栓剂，其包含美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的药物负载范围为35％至50％。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含约850至约1150mg美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的总重量为约2250至约2700mg。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含约400至约600mg的美沙拉嗪和一种或多种药学上可接受的赋形剂，其中栓剂的总重量为约870至约1715mg。本发明的另一个实施方案是美沙拉坦直肠栓剂，其包含振荡密度范围为约600至约800g / L的美沙拉嗪（通过USP <616>测量）和具有上升熔点为32至35.5°的硬脂肪 C.还提供了制备方法和美沙拉嗪栓剂的治疗方法。本发明还提供了一种通过用USP装置＃2在40℃下测量溶解参数（例如溶解度）来测定美沙拉嗪直肠栓剂如1g美沙胺栓剂的溶出参数（如溶出速率），并且桨叶转速在pH 7.5的0.2M磷酸盐缓冲液中的125rpm。

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