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11. 发明授权

US08481078B2 Solid dosage form comprising a fibrate 有权
标题翻译：包含贝特类的固体剂型
公开(公告)号：US08481078B2
公开(公告)日：2013-07-09
申请号：US13315030
申请日：2011-12-08
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K9/20
CPC分类号： A61K9/20 , A61K9/2013 , A61K9/2018 , A61K31/192 , A61K31/195 , A61K31/216 , A61K31/22 , A61K31/40 , A61K45/06 , A61K2300/00
摘要： The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.
摘要翻译：本发明提供稳定的固体剂型和药物组合物，其包含溶解在非水载体中的贝特类，例如非诺贝特，以确保相对于已知的贝特类制剂口服给药时活性成分的生物利用度得到改善。

12. 发明申请

US20080249076A1 Pharmaceutical Compositions Comprising Danazol 审中-公开
标题翻译：药物组合物包含达那唑
公开(公告)号：US20080249076A1
公开(公告)日：2008-10-09
申请号：US10581170
申请日：2004-12-03
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K31/58
CPC分类号： A61K9/1611 , A61K9/146 , A61K9/1623 , A61K9/1635 , A61K9/2018 , A61K9/2027 , A61K9/2054 , A61K9/2846 , A61K9/5026 , A61K9/5042 , A61K31/00 , A61K31/58 , A61K47/02
摘要： A controlled release pharmaceutical comprising danazol has the property of slow release of danazol over an extended period of time and markedly increased bioavailability compared to commercially available danazol-containing products. The pharmaceutical composition comprises danazol dissolved in a solid vehicle or carrier and is especially suitable for oral solid dosage forms. The composition significantly reduces food effect and may reduce side effects.
摘要翻译：包含达那唑的控释药物具有延长的时间段缓慢释放达那唑的性质，与市售的达那唑产品相比显着提高了生物利用度。药物组合物包含溶于固体载体或载体中的达那唑，特别适用于口服固体剂型。该组合物显着降低食物的作用并可能减少副作用。

13. 发明申请

US20080131503A1 Stable Pharmaceutical Composition Comprising a Fixed Dose Combination of Fenofibrate and an Hmg-Coa Reductase Inhibitor 审中-公开
标题翻译：包含非诺贝特和Hmg-Coa还原酶抑制剂的固定剂量组合的稳定的药物组合物
公开(公告)号：US20080131503A1
公开(公告)日：2008-06-05
申请号：US10582410
申请日：2006-02-10
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K31/216 , A61K9/28 , A61K9/16 , A61K31/40 , A61P43/00 , A61K31/366 , A61K9/50
CPC分类号： A61K45/06 , A61K9/209 , A61K31/216 , A61K31/366 , A61K31/40 , A61K2300/00
摘要： A pharmaceutical composition for oral administration comprising a fixed dose combination of a first solid pharmaceutical composition containing fenofibrate as the active substance and second solid pharmaceutical composition containing an HMG-CoA reductase inhibitor such as a statin as the active substance, wherein the first and the second pharmaceutical compositions are present in separate entities in a single solid dosage form. For example a multilayer tablet, a two-layer tablet, or capsules or sachets containing the active ingredients in separate granulates or beads, either granulate or bead optionally being coated with a protective coating or an entero-coating.
摘要翻译：一种用于口服给药的药物组合物，其包含含有非诺贝特作为活性物质的第一固体药物组合物和含有作为活性物质的他汀类的HMG-CoA还原酶抑制剂的第二固体药物组合物的固定剂量组合，其中第一和第二药物组合物以单一固体剂型存在于分开的实体中。例如，在分离的颗粒或珠粒中含有活性成分的多层片剂，双层片剂或胶囊或小袋，任选地用保护性涂层或肠衣涂覆的颗粒或珠粒。

14. 发明申请

US20070009603A1 Compositions comprising fenofibrate and atorvastatin 审中-公开
标题翻译：包含非诺贝特和阿托伐他汀的组合物
公开(公告)号：US20070009603A1
公开(公告)日：2007-01-11
申请号：US10988917
申请日：2004-11-15
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K31/401 , A61K31/192 , A61K9/14
CPC分类号： A61K31/366 , A61K9/1611 , A61K9/1617 , A61K9/1623 , A61K9/1652 , A61K9/2013 , A61K9/2018 , A61K9/2077 , A61K31/192 , A61K31/195 , A61K31/216 , A61K31/22 , A61K31/40 , A61K31/505 , A61K45/06 , A61K2300/00
摘要： The present invention relates to pharmaceutical compositions in particulate form or in solid dosage forms comprising a combination of fenofibrate and the HMG CoA reductase inhibitor atorvastatin or a pharmaceutically active salt thereof, which upon oral administration provides a relative AUC0-24 value (AUCfibric acid/AUCatorvastatin) of between about 250 and about 10,000. The solid compositions are manufactured without any need of addition of water or aqueous medium and comprise at least 80% of the active substances fenofibrate and atorvastatin in dissolved form, or, optionally, atorvastatin in micronized form, in order to ensure suitable bioavailability.
摘要翻译：本发明涉及颗粒形式的药物组合物或固体剂型，其包含非诺贝特和HMG CoA还原酶抑制剂阿托伐他汀或其药物活性盐的组合，其在口服给药时提供相对AUC 0-24％大约250至大约10,000之间的值（AUC / /阿托伐他汀AUC）。制备固体组合物，而不需要加入水或水性介质，并且包含至少80％的活性物质非诺贝特和溶解形式的阿托伐他汀，或任选地以微粉化形式的阿托伐他汀，以确保合适的生物利用度。

15. 发明授权

US08124125B2 Solid dosage form comprising a fibrate 有权
标题翻译：包含贝特类的固体剂型
公开(公告)号：US08124125B2
公开(公告)日：2012-02-28
申请号：US12642563
申请日：2009-12-18
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K9/20
CPC分类号： A61K9/20 , A61K9/2013 , A61K9/2018 , A61K31/192 , A61K31/195 , A61K31/216 , A61K31/22 , A61K31/40 , A61K45/06 , A61K2300/00
摘要： The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.
摘要翻译：本发明提供稳定的固体剂型和药物组合物，其包含溶解在非水载体中的贝特类，例如非诺贝特，以确保相对于已知的贝特类制剂，口服给药后活性成分的生物利用度得到改善。

16. 发明申请

US20120029009A1 Tacrolimus For Improved Treatment Of Transplant Patients 有权
标题翻译：他克莫司用于改善移植患者的治疗
公开(公告)号：US20120029009A1
公开(公告)日：2012-02-02
申请号：US13167420
申请日：2011-06-23
申请人： Robert D. Gordon , Per Holm , Anne-Marie Lademann , Tomas Norling
发明人： Robert D. Gordon , Per Holm , Anne-Marie Lademann , Tomas Norling
IPC分类号： A61K31/436 , A61P37/06
CPC分类号： A61K31/436 , A61K9/0053 , A61K9/1617 , A61K9/1641 , A61K9/1652 , A61K9/2013 , A61K9/2027 , A61K9/2031 , A61K9/2054 , A61K9/2077 , A61K9/284 , A61K9/2846 , A61K9/4891 , A61K47/10 , Y10S514/885
摘要： An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
摘要翻译：包括作为活性物质他克莫司或其药学活性类似物的延长释放口服剂型，每天一次免疫抑制治疗有需要的患者，优选肾或肝移植患者。剂型长时间释放活性物质。它还提供改善的药物动力学参数，由于延长的和恒定的体内释放，包括显着降低的峰浓度，尽管与常规立即释放剂型和最近的改进释放他克莫司相比，尽管生物利用度增加，最大浓度的显着延长时间和更高的最小浓度剂型

17. 发明申请

US20110250277A1 Modified release compositions comprising tacrolimus 有权
公开(公告)号：US20110250277A1
公开(公告)日：2011-10-13
申请号：US13167160
申请日：2011-06-23
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K9/14 , A61P37/06 , A61K31/436
CPC分类号： A61K31/436 , A61K9/0053 , A61K9/10 , A61K9/1611 , A61K9/1617 , A61K9/1623 , A61K9/1641 , A61K9/1652 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2027 , A61K9/2031 , A61K9/2054 , A61K9/2077 , A61K9/2095 , A61K9/2846 , A61K9/2893 , A61K31/00 , A61K31/439 , A61K31/4745 , Y10S514/885
摘要： A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

18. 发明申请

US20100008984A1 Solid dispersions comprising tacrolimus 有权
标题翻译：包含他克莫司的固体分散体
公开(公告)号：US20100008984A1
公开(公告)日：2010-01-14
申请号：US10569863
申请日：2004-08-30
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K9/20 , A61K31/4745
CPC分类号： A61K31/436 , A61K9/0053 , A61K9/10 , A61K9/1611 , A61K9/1617 , A61K9/1623 , A61K9/1641 , A61K9/1652 , A61K9/2009 , A61K9/2013 , A61K9/2018 , A61K9/2027 , A61K9/2031 , A61K9/2054 , A61K9/2077 , A61K9/2095 , A61K9/2846 , A61K9/2893 , A61K31/00 , A61K31/439 , A61K31/4745 , Y10S514/885
摘要： A pharmaceutical composition comprising tacrolimus (FK-506) dissolved and/or dispersed in a hydrophilic or water-miscible vehicle to form a solid dispersion or solid solution at ambient temperature have improved bioavailability.
摘要翻译：溶解和/或分散在亲水或水混溶媒介物中的他克莫司（FK-506）在环境温度下形成固体分散体或固溶体的药物组合物具有改善的生物利用度。

19. 发明申请

US20080275076A1 Pharmaceutical Compositions Comprising Sirolimus and/or an Analogue Thereof 审中-公开
标题翻译：包含西罗莫司和/或其类似物的药物组合物
公开(公告)号：US20080275076A1
公开(公告)日：2008-11-06
申请号：US11885992
申请日：2006-03-08
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K31/4353 , A61P37/06
CPC分类号： A61K9/1617 , A61K9/1652 , A61K9/2013 , A61K9/2018 , A61K9/2031 , A61K9/2054 , A61K9/4858 , A61K9/4866 , A61K31/436
摘要： The present invention relates to pharmaceutical compositions in particulate form or in solid dosage forms comprising sirolimus (rapamycin) and/or derivatives and/or analogues thereof. Compositions of the invention exhibit an acceptable bioavailability of sirolimus and/or a derivative and/or an analogue thereof. The pharmaceutical compositions of the invention are designed to release sirolimus in a controlled manner so that the plasma levels stays within the narrow therapeutic window that exist for this class of substances. An extended release profile, where the peak concentration has been reduced without loosing significant bioavailability, together with less variable absorption, is expected to improve the safety/efficacy ratio of the drug. Furthermore, compositions according to the invention provide for a significant reduced food effect and a delayed release of sirolimus is expected to reduce the number of gastro-intestinal related side effects.
摘要翻译：本发明涉及颗粒形式或包含西罗莫司（雷帕霉素）和/或其衍生物和/或类似物的固体剂型的药物组合物。本发明的组合物表现出西罗莫司和/或其衍生物和/或其类似物的可接受的生物利用度。本发明的药物组合物被设计为以受控的方式释放西罗莫司，使得血浆水平停留在对于这类物质存在的狭窄的治疗窗口内。延长释放曲线，其中峰值浓度已经降低而不失去显着的生物利用度，以及更少的可变吸收，预期将提高药物的安全性/功效比。此外，根据本发明的组合物提供显着降低的食物效应，并且期望西罗莫司的延迟释放减少胃肠相关副作用的数量。

20. 发明申请

US20070026062A1 Tablet comprising a fibrate 有权
标题翻译：片剂包含贝特类
公开(公告)号：US20070026062A1
公开(公告)日：2007-02-01
申请号：US11449918
申请日：2006-06-09
申请人： Per Holm , Tomas Norling
发明人： Per Holm , Tomas Norling
IPC分类号： A61K9/48 , A61K9/20 , A61K9/14 , A61K31/192
CPC分类号： A61K9/2077 , A61K9/1623 , A61K31/192
摘要： Stable tablets and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved or dispersed in an non-aqueous vehicle with improved bioavailability, thereby eliminating the food effect so that the tablet or composition can be administered to a patient irrespective of being in fed or fasted state.
摘要翻译：稳定的片剂和药物组合物，其包含溶解或分散在具有改善的生物利用度的非水性载体中的贝特类贝特类，例如非诺贝特，从而消除食物效应，使得片剂或组合物可以施用于患者，而不管进食或禁食状态。

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