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1. 发明授权

US08613949B2 Galenical formulations of organic compounds 有权
标题翻译：有机化合物的Galenical制剂
公开(公告)号：US08613949B2
公开(公告)日：2013-12-24
申请号：US13063955
申请日：2009-09-22
申请人： Stephen Valazza , Robert F Wagner , Sudha Vippagunta
发明人： Stephen Valazza , Robert F Wagner , Sudha Vippagunta
IPC分类号： A61K9/28 , A61K9/20
CPC分类号： A61K9/28 , A61K9/2027 , A61K9/2054 , A61K9/2077 , A61K9/209
摘要： The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.
摘要翻译：本发明涉及药物口服固定剂量组合，其包含a）治疗有效量的阿利吉仑或其药学上可接受的盐，b）治疗有效量的氨氯地平或其药学上可接受的盐，其中药物口服固定剂量 10分钟后组分（a）的体外溶出度为60％以下，20分钟后为98％以下，20分钟后成分（b）的溶出曲线为50％以上，70％以上在pH 2下30分钟后更多地，所述药物口服固定剂量组合与阿利吉仑和氨氯地平的游离剂量组合是生物等效的或接近达到生物等效性。

2. 发明申请

US20120190667A1 METHOD OF MAKING SOLID DISPERSIONS OF HIGHLY CRYSTALLINE THERAPEUTIC COMPOUNDS 有权
标题翻译：制备高结晶治疗化合物固体分散体的方法
公开(公告)号：US20120190667A1
公开(公告)日：2012-07-26
申请号：US13423329
申请日：2012-03-19
申请人： Indrajit Ghogh , Jennifer Snyder , Wei-Qin Tong , Sudha Vippagunta
发明人： Indrajit Ghogh , Jennifer Snyder , Wei-Qin Tong , Sudha Vippagunta
IPC分类号： A61K31/553 , B29C47/00 , B29C67/24
CPC分类号： A61K9/1641
摘要： A process for preparing solid dispersions of highly crystalline compounds. The highly crystalline or thermally labile therapeutic compounds are processed in an extruder in combination with a solubilizing agent and optionally a plasticizer. The resulting extrudate features the therapeutic compound in an amorphous state. Particularly useful as the solubilizing agents are surfactants such as poloxamers.
摘要翻译：制备高度结晶化合物的固体分散体的方法。高度结晶或热不稳定的治疗化合物在挤出机中与增溶剂和任选的增塑剂组合加工。所得挤出物的特征在于处于非晶状态的治疗化合物。增溶剂特别有用的是表面活性剂如泊洛沙姆。

3. 发明授权

US08641948B2 Method of making solid dispersions of highly crystalline therapeutic compounds 有权
标题翻译：制备高度结晶治疗化合物的固体分散体的方法
公开(公告)号：US08641948B2
公开(公告)日：2014-02-04
申请号：US13423329
申请日：2012-03-19
申请人： Indrajit Ghogh , Jennifer Snyder , Wei Quin Tong , Sudha Vippagunta
发明人： Indrajit Ghogh , Jennifer Snyder , Wei Quin Tong , Sudha Vippagunta
IPC分类号： B29C47/00 , B29C67/24
CPC分类号： A61K9/1641
摘要： A process for preparing solid dispersions of highly crystalline compounds. The highly crystalline or thermally labile therapeutic compounds are processed in an extruder in combination with a solubilizing agent and optionally a plasticizer. The resulting extrudate features the therapeutic compound in an amorphous state. Particularly useful as the solubilizing agents are surfactants such as poloxamers.
摘要翻译：制备高度结晶化合物的固体分散体的方法。高度结晶或热不稳定的治疗化合物在挤出机中与增溶剂和任选的增塑剂组合加工。所得挤出物的特征在于处于非晶状态的治疗化合物。增溶剂特别有用的是表面活性剂如泊洛沙姆。

4. 发明申请

US20110177166A1 Galenical Formulation Comprising Aliskiren and Process for its Preparation by Melt Extrusion Granulation 审中-公开
标题翻译：包含阿利吉仑的Galenical制剂及其通过熔体挤出造粒制备的方法
公开(公告)号：US20110177166A1
公开(公告)日：2011-07-21
申请号：US13120182
申请日：2009-09-23
申请人： Indrajit Ghosh , James Kowalski , Jennifer Snyder , Wei-Qin Tong , Sudha Vippagunta
发明人： Indrajit Ghosh , James Kowalski , Jennifer Snyder , Wei-Qin Tong , Sudha Vippagunta
IPC分类号： A61K31/41 , A61K31/165 , A61K9/20 , A61P9/12 , A61P9/00 , A61P3/10 , B29B9/02
CPC分类号： A61K9/209 , A61K9/2027 , A61K9/2054 , A61K9/2095 , A61K31/165 , A61K31/41 , A61K2300/00
摘要： The present invention relates to galenic formulations wherein the active ingredient aliskiren, preferably, a hemi-fumarate salt thereof, alone or in combination with another active ingredient, is melt-granulated and is present in an amount of more than 20% by weight based on the total weight of the oral dosage form, as well as a process of preparing said solid oral dosage form.
摘要翻译：本发明涉及盖仑制剂，其中活性成分阿利吉仑，优选其半富马酸盐单独或与另一种活性成分组合，被熔融制粒，并且以基于口服剂型的总重量，以及制备所述固体口服剂型的方法。

5. 发明申请

US20100038816A1 METHOD OF MAKING SOLID DISPERSIONS OF HIGHLY CRYSTALLINE THERAPEUTIC COMPOUNDS 审中-公开
标题翻译：制备高结晶治疗化合物固体分散体的方法
公开(公告)号：US20100038816A1
公开(公告)日：2010-02-18
申请号：US12376692
申请日：2007-08-14
申请人： Indrajit Ghogh , Jennifer Snyder , Wei-Quin Tong , Sudha Vippagunta
发明人： Indrajit Ghogh , Jennifer Snyder , Wei-Quin Tong , Sudha Vippagunta
IPC分类号： B29C47/00
CPC分类号： A61K9/1641
摘要： A process for preparing solid dispersions of highly crystalline compounds. The highly crystalline or thermally labile therapeutic compounds are processed in an extruder in combination with a solubilizing agent and optionally a plasticizer. The resulting extrudate features the therapeutic compound in an amorphous state. Particularly useful as the solubilizing agents are surfactants such as poloxamers.
摘要翻译：制备高度结晶化合物的固体分散体的方法。高度结晶或热不稳定的治疗化合物在挤出机中与增溶剂和任选的增塑剂组合加工。所得挤出物的特征在于处于非晶状态的治疗化合物。增溶剂特别有用的是表面活性剂如泊洛沙姆。

6. 发明申请

US20120009257A1 Galenical Formulations of a Fixed Dose Combination of Valsartan and Aliskiren 审中-公开
标题翻译：缬沙坦和阿利吉仑的固定剂量组合的Galenical制剂
公开(公告)号：US20120009257A1
公开(公告)日：2012-01-12
申请号：US13256454
申请日：2010-03-18
申请人： Indrajit Ghosh , Shoufeng Li , Wei-Qin Tong , Sudha Vippagunta , Hong Wen
发明人： Indrajit Ghosh , Shoufeng Li , Wei-Qin Tong , Sudha Vippagunta , Hong Wen
IPC分类号： A61K9/20 , A61P13/12 , A61P9/12 , A61K31/41
CPC分类号： A61K9/2086 , A61K9/209 , A61K31/165 , A61K31/41 , A61K2300/00
摘要： The invention provides a pharmaceutical oral fixed dose combination of aliskiren and valsartan. Aliskiren is shown to slow the dissolution rate of valsartan and the resultant undesirable gelling of valsartan in the presence of aliskiren is overcome by the use of disintegrants.
摘要翻译：本发明提供阿利吉仑和缬沙坦的药物口服固定剂量组合。阿利吉仑被证明可以减缓缬沙坦的溶解速度，并且在使用崩解剂的情况下克服了阿利吉仑存在下不希望的缬沙坦凝胶化。

7. 发明申请

US20110165240A1 GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS 有权
标题翻译：有机化合物的制剂配方
公开(公告)号：US20110165240A1
公开(公告)日：2011-07-07
申请号：US13063955
申请日：2009-09-22
申请人： Stephen Valazza , Robert F. Wagner , Sudha Vippagunta
发明人： Stephen Valazza , Robert F. Wagner , Sudha Vippagunta
IPC分类号： A61K9/28 , A61K31/4422 , A61K9/00 , A61K9/20 , A61P9/10 , A61P9/12 , B29C43/02 , B05D3/00
CPC分类号： A61K9/28 , A61K9/2027 , A61K9/2054 , A61K9/2077 , A61K9/209
摘要： The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.
摘要翻译：本发明涉及药物口服固定剂量组合，其包含a）治疗有效量的阿利吉仑或其药学上可接受的盐，b）治疗有效量的氨氯地平或其药学上可接受的盐，其中药物口服固定剂量 10分钟后组分（a）的体外溶出度为60％以下，20分钟后为98％以下，20分钟后成分（b）的溶出曲线为50％以上，70％以上在pH 2下30分钟后更多地，所述药物口服固定剂量组合与阿利吉仑和氨氯地平的游离剂量组合是生物等效的或接近达到生物等效性。

8. 发明申请

US20100209480A1 GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS 审中-公开
标题翻译：有机化合物的制剂配方
公开(公告)号：US20100209480A1
公开(公告)日：2010-08-19
申请号：US12678877
申请日：2008-09-24
申请人： Ralf Altenburger , Maggy B. Saunier , Nicole Bargenda , Michael A. Bock , Sabine Adler , Bruno Buss , Catherine Curdy , Indrajit Ghosh , Stefan Hirsch , Patrice F. Keller , Charu Kochhar , Shoufeng Li , Nicoletta Loggia , Amol S. Matharu , Julien Taillemite , Wei-Qin Tong , Sudha Vippagunta , Hong Wen , Marie-Christine Wolf , Jay P. Lakshman , James Kowalski
发明人： Ralf Altenburger , Maggy B. Saunier , Nicole Bargenda , Michael A. Bock , Sabine Adler , Bruno Buss , Catherine Curdy , Indrajit Ghosh , Stefan Hirsch , Patrice F. Keller , Charu Kochhar , Shoufeng Li , Nicoletta Loggia , Amol S. Matharu , Julien Taillemite , Wei-Qin Tong , Sudha Vippagunta , Hong Wen , Marie-Christine Wolf , Jay P. Lakshman , James Kowalski
IPC分类号： A61K31/41 , A61K9/70 , A61K9/48 , A61K9/24 , A61K9/14 , A61P13/12 , A61P9/10 , A61P9/04 , A61P9/12 , B29B9/06
CPC分类号： A61K9/209 , A61K9/4808 , A61K9/5084 , A61K31/165 , A61K31/41 , A61K45/06 , A61K2300/00
摘要： The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Valsartan, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component a) of 80% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component b) of 25% or more after 30 minutes, and 40% or more after 60 minutes at pH 4.5.
摘要翻译：本发明涉及药物口服固定剂量组合，其包含a）治疗有效量的阿利吉仑或其药学上可接受的盐，b）治疗有效量的缬沙坦或其药学上可接受的盐，其中药物口服固定剂量 10分钟后组分a）的体外溶出度为80％以下，20分钟后为98％以下，30分钟后组分b）的溶出曲线为25％以上，40％以上 pH 4.5时60分钟。

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