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1. 发明授权

US06573238B2 Method for producing sustained-release formulations 失效
标题翻译：缓释制剂的制备方法
公开(公告)号：US06573238B2
公开(公告)日：2003-06-03
申请号：US09187780
申请日：1998-11-06
申请人： Bret Shirley , Maninder Hora , Derek O'Hagan , Manmohan Singh
发明人： Bret Shirley , Maninder Hora , Derek O'Hagan , Manmohan Singh
IPC分类号： A61K3800
CPC分类号： A61K9/0019 , A61K9/0024 , A61K9/1647 , A61K9/1694 , A61K38/30 , A61K47/183
摘要： Methods for preparing biodegradable microparticles are provided. Also provided are microparticles prepared by the method which include IGF-1 entrapped therein. The microparticles allow for controlled release of IGF-1 and other polypeptides over prolonged periods of time.
摘要翻译：提供了制备可生物降解的微粒的方法。还提供了通过包含IGF-1的方法制备的微粒。微粒允许在长时间内控制释放IGF-1和其他多肽。

2. 发明申请

US20050266046A1 Novel IGF-1 composition and its use 失效
标题翻译：新型IGF-1组合物及其用途
公开(公告)号：US20050266046A1
公开(公告)日：2005-12-01
申请号：US11195008
申请日：2005-08-02
申请人： Bret Shirley , Maninder Hora
发明人： Bret Shirley , Maninder Hora
IPC分类号： A61K9/00 , A61K9/16 , A61K38/30 , A61K9/22
CPC分类号： A61K38/30 , A61K9/0024 , A61K9/1647 , A61K9/1694
摘要： A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.
摘要翻译：提供了高浓度，低含盐，生物活性糖浆形式的IGF-I或其变体及其制备方法。 IGF-I的这种新型糖浆形式具有至少约250mg / ml的IGF-I浓度，约1.0g / ml至约1.2g / ml的密度，约13,000厘泊（cps）至约在环境温度（23℃）下测量的19,000cps。 IGF-I糖浆通过从溶液中沉淀或分配IGF-I来制备，优选通过调节溶液pH或通过使用溶解度增强剂将IGF-I浓缩在溶液中，然后除去溶解度增强剂。沉淀的糖浆可用作以稳定形式存储IGF-I的手段，并且作为制备包含生物活性IGF-I的组合物的手段。提供了包含该浓缩的IGF-1糖浆的药物组合物和试剂盒。从IGF-I糖浆重建的沉淀的IGF-1糖浆，IGF-I，药物组合物和试剂盒可用于针对IGF-1反应性条件的IGF-1治疗。

3. 发明申请

US20050142110A1 HSA-free formulations of interferon-beta 有权
标题翻译：不含HSA的干扰素-β配方
公开(公告)号：US20050142110A1
公开(公告)日：2005-06-30
申请号：US11062146
申请日：2005-02-18
申请人： Bret Shirley , Susan Babuka , Bao-Lu Chen , Maninder Hora , Minna Choe , Melanie Tellers
发明人： Bret Shirley , Susan Babuka , Bao-Lu Chen , Maninder Hora , Minna Choe , Melanie Tellers
IPC分类号： A61K9/10 , A61K9/14 , A61K9/19 , A61K38/18 , A61K38/21 , A61K47/12 , A61K47/18 , A61K47/26 , A61P1/04 , A61P9/00 , A61P17/06 , A61P21/04 , A61P25/00 , A61P25/02 , A61P25/08 , A61P25/14 , A61P25/16 , A61P25/18 , A61P25/22 , A61P25/28 , A61P29/00 , A61P31/12 , A61P35/00 , A61P37/00 , A61P37/02
CPC分类号： A61K9/0019 , A61K38/1816 , A61K38/215 , A61K47/12 , A61K47/183
摘要： Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.
摘要翻译：提供包含基本上单体的干扰素-β（IFN-β）的稳定的药物组合物和其制备中有用的方法。组合物包含溶解在低离子强度制剂中的IFN-β，其将组合物保持在约3.0至约5.0的pH。提供了制备这些组合物并提高IFN-β在药物组合物中的溶解度的方法。

4. 发明申请

US20070249522A1 INJECTABLE FORMULATIONS CONTAINING SUCCINATE 审中-公开
标题翻译：含有成分的注射剂
公开(公告)号：US20070249522A1
公开(公告)日：2007-10-25
申请号：US11773184
申请日：2007-07-03
申请人： Bret Shirley , Maninder Hora
发明人： Bret Shirley , Maninder Hora
IPC分类号： A61K38/30 , A61K31/21
CPC分类号： A61K9/0019 , A61K38/30 , A61K47/12
摘要： The invention is directed to formulations of a pharmaceutically active agent for in vivo use. The formulations to which the invention is directed are designed to minimize the pain associated with components in injectable formulations, other than the pharmaceutically active agent. The invention is particularly directed to buffers that provide for minimum pain upon injection. Insulin-like growth factor I (IGF-I) is a preferred pharmaceutically active agent.
摘要翻译：本发明涉及用于体内使用的药物活性剂的制剂。本发明所针对的制剂被设计成尽可能减少与可注射制剂中除药学活性剂之外的组分相关的疼痛。本发明特别涉及提供注射时最小疼痛的缓冲液。胰岛素样生长因子I（IGF-I）是优选的药物活性剂。

5. 发明授权

US06306432B1 High and low load formulations of IGF-I in multivesicular liposomes 失效
标题翻译： IGF-I在多泡脂质体中的高负荷和低负荷配方
公开(公告)号：US06306432B1
公开(公告)日：2001-10-23
申请号：US08925531
申请日：1997-09-08
申请人： Bret Shirley , Maninder Hora , Qiang Ye , Nandini Katre , John Asherman
发明人： Bret Shirley , Maninder Hora , Qiang Ye , Nandini Katre , John Asherman
IPC分类号： A61K9127
CPC分类号： A61K9/1277 , A61K38/30
摘要： Disclosed are multivesicular liposomes (MVLs) containing IGF-I with substantially full bioavailability, wherein the loading of the IGF-I into the liposomes is modulated by adjusting the osmolarity of the aqueous component into which the agents are dissolved prior to encapsulation. In the making of MVLs, the process involves dissolving the IGF-I, an osmolarity excipient, and a pH modifying agent sufficient to solubilize the IGF-I in a first aqueous component used during manufacture of the MVLs. To increase the loading of the IGF-I, the osmolarity of the aqueous component used during manufacture of the MVLs is reduced, whereas the osmolarity of the aqueous component is increased to obtain the low load formulations. The rate of release of the active agent into the surrounding environment in which the liposomes are introduced can be simultaneously controlled by incorporating into the lipid component used in the formulation at least one long chain amphipathic lipid. Use of the long chain amphipathic lipid in the lipid component is particularly helpful in controlling the release rate from high drug load formulations.
摘要翻译：公开了含有基本上具有完全生物利用度的IGF-I的多泡脂质体（MVL），其中通过在包封之前调节其中溶解有药剂的水性组分的渗透压，调节IGF-1进入脂质体的载体。在制备MVL时，该方法包括将制备所述MVL的第一水性成分中的IGF-I，渗透性赋形剂和pH调节剂溶解在足以溶解IGF-I的第一水溶性成分中。为了增加IGF-I的负载量，在制造MVL期间使用的水性组分的渗透压降低，而水性组分的渗透压增加以获得低负荷制剂。引入脂质体的周围环境中活性剂的释放速率可以通过将至少一种长链两亲性脂质掺入用于制剂中的脂质组分中来同时控制。在脂质组分中使用长链两亲脂质特别有助于控制高药物负荷制剂的释放速率。

6. 发明申请

US20060074011A1 Compositions providing for increased IGF-I solubility 失效
标题翻译：提供增加IGF-I溶解度的组合物
公开(公告)号：US20060074011A1
公开(公告)日：2006-04-06
申请号：US11230105
申请日：2005-09-19
申请人： Bret Shirley , Kamaljit Bajwa
发明人： Bret Shirley , Kamaljit Bajwa
IPC分类号： A61K38/30 , A61K31/195
CPC分类号： A61K31/195 , A61K9/0019 , A61K9/0024 , A61K9/1647 , A61K9/1694 , A61K38/30 , A61K47/02 , A61K47/12 , A61K47/183
摘要： Novel IGF-I compositions are described. The compositions include a solubilizing compound comprising a guanidinium group that provides for IGF-I compositions in which IGF-I is highly soluble at pHs of about 5.5 or greater and at refrigerated temperatures.
摘要翻译：描述了新颖的IGF-I组合物。组合物包括提供IGF-I组合物的胍基的增溶化合物，其中IGF-I在约5.5或更高的pH值以及在冷藏温度下高度可溶。

7. 发明申请

US20110224138A1 METHODS FOR TREATING PAIN INDUCED BY INJURIES AND DISEASES OF AN ARTICULAR JOINT 审中-公开
标题翻译：用于治疗由伤口引起的疼痛和关节联合疾病的方法
公开(公告)号：US20110224138A1
公开(公告)日：2011-09-15
申请号：US12878716
申请日：2010-09-09
申请人： Julie Krop , Marilyn Pike , Dean Falb , Bret Shirley , Denis Schrier , Mary Elizabeth Goad
发明人： Julie Krop , Marilyn Pike , Dean Falb , Bret Shirley , Denis Schrier , Mary Elizabeth Goad
IPC分类号： A61K38/18 , A61P29/00 , A61P19/08
CPC分类号： A61K38/1875
摘要： Described herein are methods for using bone morphogenetic proteins (BMPs), such as OP-1 (also known as BMP-7), to treat pain caused by osteoarthritis. The methods involve administering to a patient suffering from pain caused by osteoarthritis a BMP, for example, intraarticularly by injection directly into the joint afflicted with osteoarthritis. The methods of the invention provide long-term pain relief to sufferers of osteoarthritis and can improve the functionality of the joint to which the BMP is administered.
摘要翻译：本文描述了使用骨形态发生蛋白（BMP）如OP-1（也称为BMP-7）来治疗由骨关节炎引起的疼痛的方法。所述方法包括向患有由骨关节炎引起的疼痛的患者施用BMP，例如通过注射直接注射到患有骨关节炎的关节中。本发明的方法为骨关节炎患者提供长期的疼痛缓解，并且可以改善施用BMP的关节的功能。

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