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1. 发明申请

WO2007103286A3 RATE-CONTROLLED BIOADHESIVE ORAL DOSAGE FORMULATIONS 审中-公开
标题翻译：速率控制的生物配方口服制剂
公开(公告)号：WO2007103286A3
公开(公告)日：2009-07-02
申请号：PCT/US2007005549
申请日：2007-03-02
申请人： SPHERICS INC , NANGIA AVINASH , JACOB JULES , MOSLEMY PEYMAN , HASWANI DINESH K
发明人： NANGIA AVINASH , JACOB JULES , MOSLEMY PEYMAN , HASWANI DINESH K
IPC分类号： A61K9/20 , A61K9/22 , A61K9/24 , A61K9/26 , A61K9/28 , A61K9/32 , A61K31/403 , A61K31/5415
CPC分类号： A61K9/006 , A61K9/0004 , A61K9/0065 , A61K9/2018 , A61K9/2054 , A61K9/2072 , A61K9/2077 , A61K9/209 , A61K9/2853 , A61K9/2866 , A61K31/00 , A61K31/403 , A61K31/5415
摘要： The present invention relates to a drug delivery system, in which a drug containing core, either alone or coated with a rate controlling membrane system, is enveloped on its circumference by an optionally bioadhesive coating, thereby yielding a monolithic system that allows for drug release in a regulated manner.
摘要翻译：本发明涉及一种药物递送系统，其中单独或涂覆有速率控制膜系统的药物包含的核心通过任选的生物粘附性包被在其周围包围，从而产生允许药物释放的整体系统受规管的方式。

2. 发明申请

WO2007002516A3 IMPROVED DOSAGE FORMS FOR MOVEMENT DISORDER TREATMENT 审中-公开
公开(公告)号：WO2007002516A3
公开(公告)日：2007-01-04
申请号：PCT/US2006/024663
申请日：2006-06-23
申请人： SPHERICS, INC. , NANGIA, Avinash , JACOB, Jules , YEH, James , MOSLEMY, Peyman , VERMA, Daya, D. , HASWANI, Dinesh, K. , SHAKED, Ze'ev
发明人： NANGIA, Avinash , JACOB, Jules , YEH, James , MOSLEMY, Peyman , VERMA, Daya, D. , HASWANI, Dinesh, K. , SHAKED, Ze'ev
IPC分类号： A61K9/28 , A61K9/48 , A61K31/198 , A61K31/195 , A61K31/428 , A61K9/16 , A61K9/50
摘要： The invention relates to the improvement in the treatment of certain neural disorders / diseases, such as Parkinson's disease and other motor disorders. One aspect of the invention relates to drug compositions and dosage forms comprising said drug composition. Another aspect of the invention relates to methods of manufacturing the drug compositions and dosage forms. Another aspect of the invention relates to methods of treatment, comprising administering the drug composition and dosage form to an individual.

3. 发明申请

WO2007002318A3 BIOADHESIVE POLYMERS 审中-公开
公开(公告)号：WO2007002318A3
公开(公告)日：2007-01-04
申请号：PCT/US2006/024352
申请日：2006-06-23
申请人： SPHERICS, INC. , JACOB, Jules , NANGIA, Avinash , YEH, James , RAMANAN, Vijayalakshmi
发明人： JACOB, Jules , NANGIA, Avinash , YEH, James , RAMANAN, Vijayalakshmi
IPC分类号： C09J201/06 , C08F8/32 , C08F222/06 , C08G67/04 , A61K9/00
摘要： Polymers and compositions, collectively "bioadhesive materials", with improved bioadhesive properties have been developed. One or more compounds comprising: a) an aromatic moiety comprising two or more hydroxyl substituents, methoxy substituents, substituents hydrolyzable to hydroxyl substituents, or a combination thereof, and b) a primary or secondary amino moiety are either covalently attached to a polymer or are physically mixed with a polymer to form a bioadhesive material. These bioadhesive materials can be used, for example, to fabricate new drug delivery or diagnostic systems with increased residence time at tissue surfaces, and consequently increase the bioavailability of a drug or a diagnostic agent.

4. 发明申请

WO2006031420A2 MULTI-LAYER TABLETS AND BIOADHESIVE DOSAGE FORMS 审中-公开
标题翻译：多层片剂和全身用药剂型
公开(公告)号：WO2006031420A2
公开(公告)日：2006-03-23
申请号：PCT/US2005030651
申请日：2005-08-29
申请人： SPHERICS INC , NANGIA AVINASH , JACOB JULES , MATHIOWITZ EDITH , RICKETTS THOMAS L , KREITZ MARK R
发明人： NANGIA AVINASH , JACOB JULES , MATHIOWITZ EDITH , RICKETTS THOMAS L , KREITZ MARK R
IPC分类号： A61K9/28
CPC分类号： A61K9/209 , A61K9/2027 , A61K9/2031 , A61K9/2054 , A61K9/2086
摘要： Bioadhesives coatings increase the gastrointestinal retention time of orally-ingested medicaments. Certain bioadhesive coatings producing a fracture strength of at least 100 N/m 2 , as measured on rat intestine, when applied to at least one surface of a pharmaceutical dosage form for oral delivery of a drug, result in a gastrointestinal retention time of at least 4 hours in a fed beagle dog model, during which the drug is released from the dosage form. Multi-layer tablets, particularly those including hydrophobic excipients, are useful in administering hygroscopic and/or deliquescent drugs. In addition, varying the amount of drug in multi-layer tablets allows the release rate of the drug to be controlled.
摘要翻译：生物粘附剂涂层增加口服药物的胃肠道停留时间。当在大鼠肠道上测量时，产生至少100N / m 2的断裂强度的某些生物粘附涂层在应用于用于口服递送药物的药物剂型的至少一个表面时导致在喂养比格犬模型中至少4小时的胃肠道停留时间，在此期间药物从剂型释放。多层片剂，特别是那些包括疏水性赋形剂的片剂可用于施用吸湿性和/或潮解性药物。另外，改变多层片剂中药物的量可以控制药物的释放速率。

5. 发明申请

WO2006026592A2 ORAL ADMINISTRATION OF POORLY ABSORBED DRUGS, METHODS AND COMPOSITIONS RELATED THERETO 审中-公开
标题翻译：口服吸收性药物的口服给药，方法和组合物
公开(公告)号：WO2006026592A2
公开(公告)日：2006-03-09
申请号：PCT/US2005/030774
申请日：2005-08-29
申请人： SPHERICS, INC. , MATHIOWITZ, Edith , NANGIA, Avinash , JACOB, Jules S. , KREITZ, Mark R. , DOANE, Rebecca , DONNELLY, Ryan
发明人： MATHIOWITZ, Edith , NANGIA, Avinash , JACOB, Jules S. , KREITZ, Mark R. , DOANE, Rebecca , DONNELLY, Ryan
IPC分类号： A61K9/51
CPC分类号： A61K9/0095 , A61K9/5138 , A61K9/5146 , A61K9/5161 , A61K9/5192
摘要： The invention provides methods and compositions for the delivery of poorly absorbed drugs. In some embodiments, the drug is administered in the form of microparticles or nanoparticles. In other embodiments, the drug is encapsulated with polymer. In certain embodiments, the drug is administered in combination with an absorption enhancer. The invention further relates to dosing schedules to maintain the oral bioavailability of poorly absorbed drugs, such as paclitaxel. In another embodiment, the method involves administering inhibitors of one or more inhibitors of a drug efflux pump in combination with a poorly absorbed drug.
摘要翻译：本发明提供了用于输送吸收不良的药物的方法和组合物。在一些实施方案中，药物以微粒或纳米颗粒的形式施用。在其他实施方案中，药物用聚合物包封。在某些实施方案中，药物与吸收促进剂组合施用。本发明进一步涉及维持不良吸收药物（例如紫杉醇）的口服生物利用度的给药方案。在另一个实施方案中，该方法包括给药一种或多种药物外排泵抑制剂与吸收不良的药物的组合。

6. 发明申请

WO2005056708A2 BIOADHESIVE POLYMERS WITH CATECHOL FUNCTIONALITY 审中-公开
标题翻译：具有CATECHOL功能的生物聚合物
公开(公告)号：WO2005056708A2
公开(公告)日：2005-06-23
申请号：PCT/US2004/041783
申请日：2004-12-09
申请人： SPHERICS, INC. , SCHESTOPOL, Marcus, A. , JACOB, Jules, S. , DONNELY, Ryan , RICKETTS, Thomas, L. , NANGIA, Avinash , MATHIOWITZ, Edith , SHAKED, Ze'ev
发明人： SCHESTOPOL, Marcus, A. , JACOB, Jules, S. , DONNELY, Ryan , RICKETTS, Thomas, L. , NANGIA, Avinash , MATHIOWITZ, Edith , SHAKED, Ze'ev
IPC分类号： C09J129/00
CPC分类号： C08F8/32 , A61K9/0004 , A61K9/006 , A61K9/0065 , A61K9/204 , A61K9/2077 , A61K9/2081 , A61K9/2086 , C08G63/91 , C08G63/912 , C09J167/00 , C09J167/04 , C08F222/06
摘要： Polymers with improved bioadhesive properties and methods for improving bioadhesion of polymers have been developed. A compound containing an aromatic group which contains one or more hydroxyl groups is grafted onto a polymer or coupled to individual monomers. In one embodiment, the polymer is a biodegradable polymer. In another embodiment, the monomers may be polymerized to form any type of polymer, including biodegradable and non-biodegradable polymers. In some embodiments, the polymer is a hydrophobic polymer. In the preferred embodiment, the polymer is a hydrophobic polymer. In the preferred embodiment, the aromatic compound is catechol or a derivative thereof and the polymer contains reactive functional groups. In the most preferred embodiment, the polymer is a polyanhydride and the aromatic compound is the catechol derivative, DOPA. These materials display bioadhesive properties superior to conventional bioadhesives used in therapeutic and diagnostic applications. These bioadhesive materials can be used to fabricate new drug delivery or diagnostic systems with increased residence time at tissue surfaces, and consequently increase the bioavailability of a drug or a diagnostic agent. In a preferred embodiment, the bioadhesive material is a coating on a controlled release oral dosage formulation and/or forms a matrix in an oral dosage formulation.
摘要翻译：已经开发了具有改进的生物粘附性质的聚合物和改善聚合物生物粘附的方法。含有含有一个或多个羟基的芳族基团的化合物被接枝到聚合物上或与单独的单体偶联。在一个实施方案中，聚合物是可生物降解的聚合物。在另一个实施方案中，单体可以聚合以形成任何类型的聚合物，包括可生物降解和不可生物降解的聚合物。在一些实施方案中，聚合物是疏水性聚合物。在优选的实施方案中，聚合物是疏水性聚合物。在优选的实施方案中，芳族化合物是儿茶酚或其衍生物，并且聚合物含有反应性官能团。在最优选的实施方案中，聚合物是聚酐，芳族化合物是邻苯二酚衍生物DOPA。这些材料显示出比用于治疗和诊断应用的常规生物粘合剂优越的生物粘附性。这些生物粘附材料可用于制造具有增加的组织表面停留时间的新药物递送或诊断系统，并因此提高药物或诊断剂的生物利用度。在优选的实施方案中，生物粘附材料是在控释口服剂量制剂上的涂层和/或在口服剂量制剂中形成基质。

7. 发明申请

WO2008027557A2 TOPIRAMATE COMPOSITIONS AND METHODS OF ENHANCING ITS BIOAVAILABILITY 审中-公开
标题翻译： TOPIRAMATE组合物和增强其生物利用度的方法
公开(公告)号：WO2008027557A2
公开(公告)日：2008-03-06
申请号：PCT/US2007/019208
申请日：2007-08-31
申请人： SPHERICS, INC. , NANGIA, Avinash , VERMA, Daya, D. , JACOB, Jules , GRANDOLFI, George, P. , CARDOSO, Nicholas
发明人： NANGIA, Avinash , VERMA, Daya, D. , JACOB, Jules , GRANDOLFI, George, P. , CARDOSO, Nicholas
IPC分类号： A61K31/357 , A61K9/54 , A61P25/00 , A61P3/04
CPC分类号： A61K9/2846 , A61K9/1635 , A61K9/2013 , A61K9/2054 , A61K9/2077 , A61K9/2086 , A61K9/4808 , A61K9/4891 , A61K9/5073 , A61K31/357
摘要： The present invention is directed to pharmaceutical compositions that allow for once- daily or alternate day dosage forms of topiramate. The proposed delayed/extended release single dosage form is equivalent to the immediate-release multiple dose daily regimen, and upon administration, provides steady state blood levels of topiramate. Formulations with increased bioavailability and improved pharmacokinetics are disclosed. A once-a-day administration of topiramate is advantageous over the multiple dose regimen both in terms of patient compliance and reduced adverse events, thus providing better treatment of the conditions for which the topiramate is indicated.
摘要翻译：本发明涉及药物组合物，其允许每日一次或间日剂型的托吡酯。所提出的延迟/延长释放单剂量形式相当于立即释放多剂量日剂量方案，并且在给药时，提供托吡酯的稳态血药浓度。公开了具有增加的生物利用度和改善的药代动力学的制剂。托吡酯的一天一次给药在患者依从性和减少的不良事件方面优于多剂量方案，从而提供对托吡酯指示的条件的更好的治疗。

8. 发明申请

WO2007002318A2 BIOADHESIVE POLYMERS 审中-公开
标题翻译： BIOADHESIVE聚合物
公开(公告)号：WO2007002318A2
公开(公告)日：2007-01-04
申请号：PCT/US2006024352
申请日：2006-06-23
申请人： SPHERICS INC , JACOB JULES , NANGIA AVINASH , YEH JAMES , RAMANAN VIJAYALAKSHMI
发明人： JACOB JULES , NANGIA AVINASH , YEH JAMES , RAMANAN VIJAYALAKSHMI
IPC分类号： C09J201/06 , A61K9/00 , C08F8/32 , C08F222/06 , C08G67/04
CPC分类号： C08F8/00 , C08F222/00
摘要： Polymers and compositions, collectively "bioadhesive materials", with improved bioadhesive properties have been developed. One or more compounds comprising: a) an aromatic moiety comprising two or more hydroxyl substituents, methoxy substituents, substituents hydrolyzable to hydroxyl substituents, or a combination thereof, and b) a primary or secondary amino moiety are either covalently attached to a polymer or are physically mixed with a polymer to form a bioadhesive material. These bioadhesive materials can be used, for example, to fabricate new drug delivery or diagnostic systems with increased residence time at tissue surfaces, and consequently increase the bioavailability of a drug or a diagnostic agent.
摘要翻译：已经开发了聚合物和组合物，统称“生物粘附材料”，具有改善的生物粘附性质。一种或多种化合物，其包含：a）包含两个或更多个羟基取代基，甲氧基取代基，可水解成羟基取代基的取代基或其组合的芳族部分，和b）伯或仲氨基部分共价连接至聚合物或与聚合物物理混合以形成生物粘附材料。这些生物粘附材料可用于例如制造在组织表面处具有增加的停留时间的新型药物递送或诊断系统，并因此增加药物或诊断剂的生物利用度。

9. 发明申请

WO2006026592A3 ORAL ADMINISTRATION OF POORLY ABSORBED DRUGS, METHODS AND COMPOSITIONS RELATED THERETO 审中-公开
标题翻译：不良吸收药物的口服药物，相关方法和组合物
公开(公告)号：WO2006026592A3
公开(公告)日：2006-09-14
申请号：PCT/US2005030774
申请日：2005-08-29
申请人： SPHERICS INC , MATHIOWITZ EDITH , NANGIA AVINASH , JACOB JULES S , KREITZ MARK R , DOANE REBECCA , DONNELLY RYAN
发明人： MATHIOWITZ EDITH , NANGIA AVINASH , JACOB JULES S , KREITZ MARK R , DOANE REBECCA , DONNELLY RYAN
IPC分类号： A61K9/51 , A61K9/16 , A61K9/28
CPC分类号： A61K9/0095 , A61K9/5138 , A61K9/5146 , A61K9/5161 , A61K9/5192
摘要： The invention provides methods and compositions for the delivery of poorly absorbed drugs. In some embodiments, the drug is administered in the form of microparticles or nanoparticles. In other embodiments, the drug is encapsulated with polymer. In certain embodiments, the drug is administered in combination with an absorption enhancer. The invention further relates to dosing schedules to maintain the oral bioavailability of poorly absorbed drugs, such as paclitaxel. In another embodiment, the method involves administering inhibitors of one or more inhibitors of a drug efflux pump in combination with a poorly absorbed drug.
摘要翻译：本发明提供了用于递送吸收不良的药物的方法和组合物。在一些实施方案中，药物以微粒或纳米颗粒的形式施用。在其它实施方案中，药物用聚合物包封。在某些实施方案中，药物与吸收增强剂组合施用。本发明还涉及用于维持吸收不良的药物如紫杉醇的口服生物利用度的给药方案。在另一个实施方案中，该方法涉及将药物外排泵的一种或多种抑制剂与不良吸收的药物组合施用抑制剂。

10. 发明申请

WO2006039022A2 CONTROLLED REGIONAL ORAL DELIVERY 审中-公开
标题翻译：控制区域口供
公开(公告)号：WO2006039022A2
公开(公告)日：2006-04-13
申请号：PCT/US2005030552
申请日：2005-08-29
申请人： SPHERICS INC , MATHIOWITZ EDITH , NANGIA AVINASH , JACOB JULES S , SHAKED ZE EV , MOSLEMY PEYMAN
发明人： MATHIOWITZ EDITH , NANGIA AVINASH , JACOB JULES S , SHAKED ZE EV , MOSLEMY PEYMAN
IPC分类号： A61K9/28
CPC分类号： A61K9/5031 , A61K9/006 , A61K9/0092 , A61K9/1641 , A61K9/1652 , A61K9/1676 , A61K9/2018 , A61K9/2031 , A61K9/204 , A61K9/2054 , A61K9/2077 , A61K9/2086 , A61K9/209 , A61K9/4808 , A61K9/4891 , A61K9/5026 , A61K9/5084 , A61K31/74
摘要： A composite formulation has been developed for selective, high efficacy delivery to specific regions of the mouth and gastrointestinal tract. The formulation is typically in the form of a tablet or capsule, which may include microparticles or beads. The formulation uses bioadhesive and controlled release elements to direct release to specific regions, where the drug is absorbed in enhanced amounts relative to the formulation in the absence of the bioadhesive and/or controlled release elements. This is demonstrated by an example showing delivery of gabapentin with a greater area under the curve ("AUC") relative to the FDA reference immediate release drug, i.e., the AUC of the composite bioadhesive formulation is greater than 100% of the AUC of the immediate release drug. In the preferred embodiments, the formulation includes drug to be delivered, controlled release elements, and one or more bioadhesive elements. The bioadhesive polymer may be either dispersed in the matrix of the tablet or applied as a direct compressed coating to the solid oral dosage form. The controlled release elements are selected to determine the site of release. The bioadhesive components are selected to provide retention of the formulation at the desired site of uptake and administration. By selecting for both release and retention at a specific site, typically based on time of transit through the gastrointestinal tract, one obtains enhanced efficacy of uptake of the drug. This is particularly useful for drugs with narrow windows of absorption, and drugs with poor solubility such as the BCE class III and class IV drugs.
摘要翻译：已经开发出复合制剂用于选择性地，高效地递送到口腔和胃肠道的特定区域。制剂通常为片剂或胶囊形式，其可包括微粒或珠粒。该制剂使用生物粘附和控制释放元件将释放引导到特定区域，其中药物在不存在生物粘附和/或控制释放元件的情况下相对于制剂以增强的量被吸收。这通过示例显示，相对于FDA参考即时释放药物，曲线下面积更大的加巴喷丁（“AUC”）的递送，即复合生物粘附制剂的AUC大于100μg的AUC 立即释放药物。在优选的实施方案中，制剂包括待递送的药物，控制释放元件和一种或多种生物粘附元件。生物粘附聚合物可以分散在片剂的基质中，或作为直接压片包被施用于固体口服剂型。控制释放元件被选择以确定释放部位。生物粘附组分被选择以提供制剂在所需的摄取和给药部位的保留。通过选择在特定部位的释放和保留，通常基于通过胃肠道的转运时间，获得药物摄取的增强的功效。这对于具有狭窄吸收窗口的药物和溶解性差的药物如BCE III类和IV类药物特别有用。

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