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21. 发明申请

WO2007112286A2 STABILIZED COMPOSITIONS CONTAINING ALKALINE LABILE DRUGS 审中-公开
标题翻译：包含碱性可溶性药物的稳定组合物
公开(公告)号：WO2007112286A2
公开(公告)日：2007-10-04
申请号：PCT/US2007/064714
申请日：2007-03-22
申请人： AUXILIUM PHARMACEUTICALS, INC. , CROWLEY, Michael, W. , KEEN, Justin, M. , KOLENG, John, J. , ZHANG, Feng
发明人： CROWLEY, Michael, W. , KEEN, Justin, M. , KOLENG, John, J. , ZHANG, Feng
IPC分类号： A61K9/20
CPC分类号： A61K9/70 , A61K9/0024 , A61K9/006 , A61K9/7023 , A61K9/703 , A61K9/7069 , A61K9/7084 , A61K9/7092 , A61K31/4468 , A61K31/568 , A61K45/06 , A61K47/10 , A61L15/44 , A61L27/54 , A61L31/16 , A61L2300/602
摘要： A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion. Various functional excipients can be included in the carrier system to improve process performance and/or improve the chemical or physical properties of the HME composition.
摘要翻译：提供了含有碱性不稳定药物的稳定的生物粘合剂组合物及其制备方法。在一个方面，组合物是热熔挤出（HME）组合物，其包含预先形成的赋形剂混合物，其包含酸性组分和碱性热塑性基质形成材料，例如，聚合物。赋形剂混合物在与碱性不稳定药物混合之前形成。然后将共混物热熔融挤出以形成HME组合物。通过这样做，酸性成分能够中和或赋予赋形剂混合物中度酸性。已经显示了该特定方法，以显着降低热熔融挤出期间碱性不稳定药物的降解。赋形剂混合物在热熔挤出过程中软化或熔化。在挤出过程中可溶解或不溶解含药颗粒。可以在载体体系中包括各种功能赋形剂以改善工艺性能和/或改善HME组合物的化学或物理性能。

22. 发明申请

WO2007112285A2 PROCESS FOR THE PREPARATION OF A HOT-MELT EXTRUDED LAMINATE 审中-公开
标题翻译：制备高熔点挤出层压板的方法
公开(公告)号：WO2007112285A2
公开(公告)日：2007-10-04
申请号：PCT/US2007064713
申请日：2007-03-22
申请人： AUXILIUM PHARMACEUTICALS INC , CROWLEY MICHAEL M , KEEN JUSTIN M , KOLENG JOHN J , ZHANG FENG
发明人： CROWLEY MICHAEL M , KEEN JUSTIN M , KOLENG JOHN J , ZHANG FENG
IPC分类号： B32B37/06
CPC分类号： A61K9/7007 , A61K9/006 , A61K9/7069 , B29C47/0019 , B29C47/0021 , B29C47/065 , B29C47/0816 , B29C47/145 , B29C47/16 , B29K2105/0097 , B29K2995/0092 , B29K2995/0093
摘要： A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.
摘要翻译：提供了一种用于制备包含热熔挤压储存层和热熔挤出背衬层的生物粘合层压材料的方法。储层包含含有活性剂的热塑性生物粘合剂组合物。将含活性剂的热塑性生物粘附性亲水性组合物与疏水组合物热熔共挤出以形成至少双层层压体。亲水组合物和疏水组合物具有至少一种共聚物。此外，疏水性组合物的熔体流动指数在亲水性组合物的熔体流动指数的50％以内。结果，层压体在层压体的整个长度上具有均匀的横截面和/或均匀的纵向横截面。此外，当将层压体分成大致相同尺寸的单位剂量时，它们相对于其中存在的活性剂具有高度的均匀度。

23. 发明申请

WO2007016176A2 SCF EXTRACT CONTAINING CARDIAC GLYCOSIDE 审中-公开
标题翻译： SCF提取物含有甘油三酯
公开(公告)号：WO2007016176A2
公开(公告)日：2007-02-08
申请号：PCT/US2006029061
申请日：2006-07-26
申请人： PHOENIX BIOTECHNOLOGY INC , ADDINGTON CRANDELL , ZHANG FENG , KOLENG JOHN J
发明人： ADDINGTON CRANDELL , ZHANG FENG , KOLENG JOHN J
IPC分类号： A61K36/185
CPC分类号： A61K36/24
摘要： A supercritical fluid (SCF) extract of a cardiac glycoside-containing plant mass is provided. The extract can be included in a pharmaceutical composition containing an extract-solubilizing amount of solubilizer. Oleandrin is included within the extract when a cardiac glycoside-containing plant, such as Nerium oleander, is extracted by SCF extraction. The extract can also contain one or more other SCF extractable pharmacologically active agents. The composition can be used to treat a wide range of disorders that are therapeutically responsive to a cardiac glycoside.
摘要翻译：提供了含有强心苷的植物体的超临界流体（SCF）提取物。提取物可以包含在含有提取物增溶量的增溶剂的药物组合物中。当通过SCF提取提取含有含有强心苷的植物，例如夹心夹心素时，包含在提取物中。提取物还可以含有一种或多种其它SCF可提取的药理学活性剂。该组合物可用于治疗对心脏糖苷治疗响应的各种各样的疾病。

24. 发明申请

WO2005097078A1 COMPRESSED COMPOSITION COMPRISING MAGNESIUM SALT 审中-公开
标题翻译：包含镁盐的压缩组合物
公开(公告)号：WO2005097078A1
公开(公告)日：2005-10-20
申请号：PCT/US2005/010979
申请日：2005-03-31
申请人： BLAINE PHARMACEUTICALS , KOLENG, John, J. , CROWLEY, Michael, M.
发明人： KOLENG, John, J. , CROWLEY, Michael, M.
IPC分类号： A61K9/20
CPC分类号： A61K9/2095 , A61K9/2054 , A61K9/2077 , A61K33/06 , A61K33/08 , A61K33/10
摘要： An oral solid compress composition comprising a magnesium salt is provided. The composition provides a rapid dissolution of the magnesium salt, wherein not less than 75% of the magnesium salt dissolves within 45 minutes after placement in hydrochloric acid (0.1 N, 900 mL) as per USP Method . In a particular embodiment, the magnesium salt is an inorganic salt such as MgO, Mg(OH) 2 , MgCl 2 , and others. The composition can be prepared by dry granulation, direct compression or another suitable process. The composition provides a substantially stable dissolution profile for the magnesium salt so that the dissolution profile changes only minimally even after an extended period of storage under pharmaceutically acceptable conditions when packaged in a sealed container-enclosure system. The solid composition may also exclude a cellulose-based composition. The compressed composition can be prepared and stored under anhydrous conditions.
摘要翻译：提供包含镁盐的口服固体压片组合物。该组合物提供镁盐的快速溶解，其中不少于75％的镁盐在按照USP Method <711>放入盐酸（0.1N，900mL）后45分钟内溶解。在一个具体实施方案中，镁盐是无机盐，例如MgO，Mg（OH）2，MgCl 2等。组合物可以通过干法制粒，直接压片或其它合适的方法制备。组合物为镁盐提供了基本上稳定的溶出曲线，使得即使在包装在密封的容器 - 封闭系统中的药学上可接受的条件下长时间的储存后，溶出曲线仅最小化。固体组合物还可以排除基于纤维素的组合物。压缩的组合物可以在无水条件下制备并储存。

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