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    BIOADHESIVE POLYMERS
    3.
    发明申请
    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

    Applicant: SPHERICS, INC. ,  JACOB, Jules ,  NANGIA, Avinash ,  YEH, James ,  RAMANAN, Vijayalakshmi

    Inventor： JACOB, Jules ,  NANGIA, Avinash ,  YEH, James ,  RAMANAN, Vijayalakshmi

    IPC: C09J201/06 ,  C08F8/32 ,  C08F222/06 ,  C08G67/04 ,  A61K9/00

    Abstract: 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.

    MULTI-LAYER TABLETS AND BIOADHESIVE DOSAGE FORMS
    4.
    发明申请
    MULTI-LAYER TABLETS AND BIOADHESIVE DOSAGE FORMS 审中-公开
    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

    Applicant: SPHERICS INC ,  NANGIA AVINASH ,  JACOB JULES ,  MATHIOWITZ EDITH ,  RICKETTS THOMAS L ,  KREITZ MARK R

    Inventor： NANGIA AVINASH ,  JACOB JULES ,  MATHIOWITZ EDITH ,  RICKETTS THOMAS L ,  KREITZ MARK R

    IPC: A61K9/28

    CPC classification number: A61K9/209 ,  A61K9/2027 ,  A61K9/2031 ,  A61K9/2054 ,  A61K9/2086

    Abstract: 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.

    Abstract translation: 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。

    BIOADHESIVE POLYMERS WITH CATECHOL FUNCTIONALITY
    6.
    发明申请
    BIOADHESIVE POLYMERS WITH CATECHOL FUNCTIONALITY 审中-公开
    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

    Applicant: SPHERICS, INC. ,  SCHESTOPOL, Marcus, A. ,  JACOB, Jules, S. ,  DONNELY, Ryan ,  RICKETTS, Thomas, L. ,  NANGIA, Avinash ,  MATHIOWITZ, Edith ,  SHAKED, Ze'ev

    Inventor： SCHESTOPOL, Marcus, A. ,  JACOB, Jules, S. ,  DONNELY, Ryan ,  RICKETTS, Thomas, L. ,  NANGIA, Avinash ,  MATHIOWITZ, Edith ,  SHAKED, Ze'ev

    IPC: C09J129/00

    CPC classification number: 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

    Abstract: 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.

    Abstract translation: 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。

    BIOADHESIVE POLYMERS
    8.
    发明申请
    BIOADHESIVE POLYMERS 审中-公开
    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

    Applicant: SPHERICS INC ,  JACOB JULES ,  NANGIA AVINASH ,  YEH JAMES ,  RAMANAN VIJAYALAKSHMI

    Inventor： JACOB JULES ,  NANGIA AVINASH ,  YEH JAMES ,  RAMANAN VIJAYALAKSHMI

    IPC: C09J201/06 ,  A61K9/00 ,  C08F8/32 ,  C08F222/06 ,  C08G67/04

    CPC classification number: C08F8/00 ,  C08F222/00

    Abstract: 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.

    Abstract translation: 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。

    CONTROLLED REGIONAL ORAL DELIVERY
    10.
    发明申请
    CONTROLLED REGIONAL ORAL DELIVERY 审中-公开
    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

    Applicant: SPHERICS INC ,  MATHIOWITZ EDITH ,  NANGIA AVINASH ,  JACOB JULES S ,  SHAKED ZE EV ,  MOSLEMY PEYMAN

    Inventor： MATHIOWITZ EDITH ,  NANGIA AVINASH ,  JACOB JULES S ,  SHAKED ZE EV ,  MOSLEMY PEYMAN

    IPC: A61K9/28

    CPC classification number: 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

    Abstract: 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.

    Abstract translation: 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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