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1. 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。

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。

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

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。

6. 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。

7. 发明授权

US5456921A Use of cross-linked amylose as a matrix for the slow release of biologically active compounds 失效
标题翻译：使用交联的直链淀粉作为缓慢释放生物活性化合物的基质
公开(公告)号：US5456921A
公开(公告)日：1995-10-10
申请号：US194126
申请日：1994-02-09
申请人： Mircea A. Mateescu , Vincent Lenaerts , Yves Dumoulin
发明人： Mircea A. Mateescu , Vincent Lenaerts , Yves Dumoulin
IPC分类号： A61K9/20 , A61K9/26 , A61K9/36
CPC分类号： A61K9/2059
摘要： The present invention is concerned with a solid slow release oral pharmaceutical dosage unit which comprises a solid dosage unit made up of an admixture of a therapeutic dosage of an orally effective pharmaceutical product and a cross-linked polymer of amylose with a cross-linking agent selected from 2,3 dibromopropanol and epichlorohydrin, wherein the cross-linking of the polymer has been carried out with from about 0.1 to about 10 g of cross-linking agent per 100 g of amylose.
摘要翻译：本发明涉及一种固体缓释口服药物单位，其包含由口服有效药物的治疗剂量与直链淀粉的交联聚合物与选择的交联剂的混合物组成的固体剂量单位 2,3-二溴丙醇和表氯醇，其中聚合物的交联已经用每100g直链淀粉约0.1至约10g交联剂进行。

8. 发明授权

US5807575A Manufacture of cross-linked amylose useful as a excipient for control release of active compounds 失效
标题翻译：用于控制活性化合物释放的赋形剂的交联直链淀粉的制备
公开(公告)号：US5807575A
公开(公告)日：1998-09-15
申请号：US800518
申请日：1997-02-14
申请人： Yves Dumoulin , Fran.cedilla.ois Carriere , Andre Ingenito
发明人： Yves Dumoulin , Fran.cedilla.ois Carriere , Andre Ingenito
IPC分类号： A61K9/16 , A61K9/20 , A61K9/22 , C08B31/00 , C08B33/00 , A61K9/14
CPC分类号： A61K9/2059 , A61K9/1652 , C08B31/003 , C08B33/00
摘要： A process for the manufacture of a slow-release excipient consisting mainly of cross-linked amylose in the form of solid particles, for use in the preparation of tablets or pellets. A starch containing a high amount of amylose (high amylose starch) is first subjected to a gelatinization. The gelatinized high amylose starch is then cross-linked with 1 to 5 g of a cross-linking agent per 100 g of dry-based gelatinized high amylose starch in an alkali medium, thereby forming a reaction medium containing a reaction product consisting of a cross-linked high amylose starch slurry. The obtained reaction medium is neutralized, thereby forming by-products mainly consisting of salts, which are removed from the reaction medium. The recovered cross-linked high amylose starch slurry is then subjected to a thermal treatment at a temperature of at least 60.degree. C. and the thermally treated product is dried to obtain the requested slow release excipient. This process is economical and industrially advantageous since it is carried out in an aqueous medium.
摘要翻译：用于制备主要由固体颗粒形式的交联直链淀粉组成的缓释赋形剂的方法，用于制备片剂或丸剂。首先将含有大量直链淀粉（高直链淀粉）的淀粉进行糊化。然后将凝胶化的高直链淀粉淀粉与碱基培养基中每100g干基糊化高直链淀粉的交联剂与1-5g交联，从而形成含有由十字架构成的反应产物的反应介质连接的高直链淀粉浆。将所得反应介质中和，从而形成主要由盐组成的副产物，其从反应介质中除去。然后将回收的交联的高直链淀粉浆料在至少60℃的温度下进行热处理，并将热处理产物干燥以获得所需的缓释赋形剂。该方法是经济且工业上有利的，因为它在水性介质中进行。

9. 发明授权

US5616343A Cross-linked amylose as a binder/disintegrant in tablets 失效
标题翻译：交联直链淀粉作为片剂中的粘合剂/崩解剂
公开(公告)号：US5616343A
公开(公告)日：1997-04-01
申请号：US037119
申请日：1993-03-25
申请人： Louis Cartilier , Mircea A. Mateescu , Yves Dumoulin , Vincent Lenaerts
发明人： Louis Cartilier , Mircea A. Mateescu , Yves Dumoulin , Vincent Lenaerts
IPC分类号： A61K9/20 , A61K47/36
CPC分类号： A61K9/2059
摘要： The present invention is concerned with the manufacture of solid dosage units (pharmaceutical and others). More specifically, the invention is related to powders of cross-linked amylose, having a specific cross-linking degree for use as tablet binders and disintegrants.
摘要翻译：本发明涉及固体剂量单位（药物等）的制造。更具体地，本发明涉及交联直链淀粉的粉末，其具有用作片剂粘合剂和崩解剂的特定交联度。

10. 发明授权

US5603956A Cross-linked enzymatically controlled drug release 失效
标题翻译：交联酶抑制药物释放
公开(公告)号：US5603956A
公开(公告)日：1997-02-18
申请号：US261228
申请日：1994-06-16
申请人： Mircea A. Mateescu , Yves Dumoulin , Louis Cartilier , Vincent Lenaerts
发明人： Mircea A. Mateescu , Yves Dumoulin , Louis Cartilier , Vincent Lenaerts
IPC分类号： A61K9/20 , A61K9/22 , A61K47/36
CPC分类号： A61K9/2059 , A61K9/2068
摘要： The present application is concerned with a solid slow release pharmaceutical dosage unit. More specifically, the invention is directed to a tablet form prepared by direct compression of cross-linked amylose (CLA) having a definite cross-linking degree, .alpha.-amylase and a pharmaceutical agent. The presence of the cross-linked amylose allows a sustained release of the drug, while the .alpha.-amylase permits the modulation of the release time. In other words, the release time of the drug is function of the amount of .alpha.-amylase in the tablet. The amount of .alpha.-amylase is defined in terms of Enzyme Units.
摘要翻译：本申请涉及固体缓释药物剂量单位。更具体地，本发明涉及通过直接压缩具有确定的交联度的α-淀粉酶和药剂的交联直链淀粉（CLA）制备的片剂形式。交联的直链淀粉的存在允许药物的持续释放，而α-淀粉酶允许调节释放时间。换句话说，药物的释放时间是片剂中α-淀粉酶的量的函数。 α-淀粉酶的量以酶单位来定义。

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