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    EROSION-STABILIZED BIOADHESIVE POLYMERS FUNCTIONALIZED OR BLENDED WITH CATECHOL AND DERIVATIVES THEREOF
    3.
    发明申请
    EROSION-STABILIZED BIOADHESIVE POLYMERS FUNCTIONALIZED OR BLENDED WITH CATECHOL AND DERIVATIVES THEREOF 审中-公开
    功能化或与儿茶酚及其衍生物共混的抗蚀剂稳定的含水聚合物

    公开(公告)号：WO2008002471A3

    公开(公告)日：2008-02-21

    申请号：PCT/US2007014551

    申请日：2007-06-22

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

    Inventor： NANGIA AVINASH ,  JACOB JULES ,  YEH JAMES ,  RAMANAN VIJAYALAKSHMI ,  SHAKED ZE EV

    IPC: A61K31/74

    CPC classification number: A61L27/36 ,  A61K9/006 ,  A61K47/34 ,  A61L27/54 ,  A61L2300/214 ,  C08K5/13 ,  C08K5/1545 ,  C08K5/175 ,  C09J133/02 ,  C09J135/00

    Abstract: Polymers with improved bioadhesive properties and methods for improving bioadhesion of polymers have been developed. Such bioadhesive polymers can be stabilized against erosion, particularly in the gastrointestinal tract, by incorporating one or more additives selected from (1) polyanhydrides, such as those having a molecular weight average in excess of 20,000, (2) acidic components, (3) metal compounds, (4) stabilizing polymers, and (5) hydrophobic components. By stabilizing bioadhesive polymers against erosion, residence time at tissue surfaces can be further increased. The stabilized polymers are also useful to maintain the drug release rate-controlling properties for a prolonged period of time.

    Abstract translation: 已经开发出具有改善的生物粘附性质的聚合物和用于改善聚合物的生物粘附性的方法。 通过引入一种或多种选自如下的添加剂来稳定这种生物粘附聚合物以防止侵蚀，特别是在胃肠道中：（1）聚酐，如分子量平均超过20,000的聚酐，（2）酸性组分，（3） 金属化合物，（4）稳定聚合物，和（5）疏水组分。 通过稳定生物粘附聚合物抵抗侵蚀，组织表面处的停留时间可以进一步增加。 稳定化的聚合物也可用于长时间维持药物释放速度控制性能。

    POLYMERIC DRUG DELIVERY SYSTEM FOR HYDROPHOBIC DRUGS
    5.
    发明申请
    POLYMERIC DRUG DELIVERY SYSTEM FOR HYDROPHOBIC DRUGS 审中-公开
    用于疏水性药物的聚合物药物递送系统

    公开(公告)号：WO2005084639A2

    公开(公告)日：2005-09-15

    申请号：PCT/US2005/007525

    申请日：2005-03-03

    Applicant: SPHERICS, INC. ,  JACOB, Jules, S. ,  BASSETT, Michael ,  SCHESTOPOL, Marcus, A. ,  MATHIOWITZ, Edith ,  NANGIA, Avinash ,  CARTER, Bennett ,  MOSLEMY, Peyman ,  SHAKED, Ze'ev ,  ENSCORE, David ,  SIKES, Courtney

    Inventor： JACOB, Jules, S. ,  BASSETT, Michael ,  SCHESTOPOL, Marcus, A. ,  MATHIOWITZ, Edith ,  NANGIA, Avinash ,  CARTER, Bennett ,  MOSLEMY, Peyman ,  SHAKED, Ze'ev ,  ENSCORE, David ,  SIKES, Courtney

    IPC: A61K9/00

    CPC classification number: A61K9/209 ,  A61K9/0065 ,  A61K9/1635 ,  A61K9/1641 ,  A61K9/1647 ,  A61K9/1652 ,  A61K9/1676 ,  A61K9/2054 ,  A61K9/2077 ,  A61K9/2086 ,  A61K9/2853

    Abstract: An oral delivery system for Class II drugs that have low oral bioavailability due to their insolubility in water and slow dissolution kinetics and method for making such a drug delivery system are disclosed herein. The formulation may be a controlled release or immediate release formulation. The immediate release formulation contains a Class II drug, together with a hydrophobic polymer, preferably a bioadhesive polymer. In one embodiment, the drug and polymer are co-dissolved in a common solvent. The solution is formed into small solid particles by any convenient method, particularly by spray drying. The resulting particles contain drug dispersed as small particles in a polymeric matrix. The particles are stable against aggregation, and can be put into capsules or tableted for administration. The controlled release formulations contain a BCS Class II drug and a bioadhesive polymer. The controlled release formulations may be in the form of a tablet, capsules, mini-tab, microparticulate, or osmotic pump. Enhancement of oral uptake of the drug from use of bioadhesive polymers occurs through (1) increased dissolution kinetics due to stable micronization of the drug, (2) rapid release of the drug from the polymer in the GI tract; and (3) prolonged GI transit due to bioadhesive properties of the polymers. The combination of these effects allows the preparation of a compact, stable dosage form suitable for oral administration of many class II drugs.

    Abstract translation: 本文公开了由于其不溶于水且缓慢溶出动力学而具有低口服生物利用度的II类药物的口服递送系统以及制备此类药物递送系统的方法。 该制剂可以是控释或速释制剂。 速释制剂含有II类药物以及疏水聚合物，优选生物粘附聚合物。 在一个实施方案中，药物和聚合物共溶于普通溶剂中。 通过任何方便的方法，特别是通过喷雾干燥，溶液形成小的固体颗粒。 所得颗粒含有作为小颗粒分散在聚合物基质中的药物。 颗粒对于聚集是稳定的，并且可以放入胶囊或制成片剂给药。 控释制剂含有BCS II类药物和生物粘附聚合物。 控释制剂可以是片剂，胶囊剂，小片，微粒或渗透泵的形式。 （1）由于药物的稳定微粉化，溶解动力学增加，（2）药物从胃肠道中的聚合物中快速释放，因此通过使用生物粘附聚合物增强药物的口服摄取。 和（3）由于聚合物的生物粘附性而延长的GI运输。 这些效果的结合使得可以制备适用于许多II类药物的口服给药的致密稳定的剂型。

    BIOADHESIVE POLYMERS WITH CATECHOL FUNCTIONALITY
    6.
    发明申请
    BIOADHESIVE POLYMERS WITH CATECHOL FUNCTIONALITY 审中-公开
    具有儿茶酚官能度的亲水聚合物

    公开(公告)号：WO2005056708A3

    公开(公告)日：2005-07-28

    申请号：PCT/US2004041783

    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: A61K9/00 ,  A61K9/20 ,  A61K31/74 ,  C08F8/32 ,  C08G63/91 ,  C09J135/00 ,  C09J167/00 ,  C09J167/04 ,  C09J201/06 ,  C08F222/06 ,  C08G67/04

    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: 已经开发出具有改善的生物粘附性质的聚合物和用于改善聚合物的生物粘附性的方法。 含有含一个或多个羟基的芳族基团的化合物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。 在一些实施例中，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，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。 这些材料的生物粘附性能优于用于治疗和诊断应用的常规生物粘附剂。 这些生物粘附材料可用于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。 在一个优选的实施方案中，生物粘附材料是控释口服剂型中的包衣和/或在口服剂型中形成基质。

    PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF PARKINSON'S DISEASE AND RELATED DISORDERS
    7.
    发明申请
    PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF PARKINSON'S DISEASE AND RELATED DISORDERS 审中-公开
    用于治疗帕金森病和相关疾病的药物组合物

    公开(公告)号：WO2008079404A2

    公开(公告)日：2008-07-03

    申请号：PCT/US2007/026336

    申请日：2007-12-21

    Applicant: SPHERICS, INC. ,  NANGIA, Avinash ,  JACOB, Jules ,  YEH, James ,  MOSLEMY, Peyman ,  VERMA, Daya, D. ,  HASWANI, Dinesh, K. ,  SHAKED, Ze've

    Inventor： NANGIA, Avinash ,  JACOB, Jules ,  YEH, James ,  MOSLEMY, Peyman ,  VERMA, Daya, D. ,  HASWANI, Dinesh, K. ,  SHAKED, Ze've

    CPC classification number: A61K9/2031 ,  A61K9/0065 ,  A61K9/204 ,  A61K9/209 ,  A61K9/2853 ,  A61K9/5026 ,  A61K9/5031 ,  A61K9/5073 ,  A61K31/195 ,  A61K31/198 ,  A61K2300/00

    Abstract: The invention relates to the improvement in the treatment of certain neural disorders / diseases, such as Parkinson's disease and other motor disorders. The invention relates to drug compositions and dosage forms comprising said drug composition; methods of manufacturing the drug compositions and dosage forms; and methods of treatment, comprising administering the drug composition and dosage form to an individual. In certain embodiments, a decarboxylase enzyme inhibitor (e.g., carbidopa) extended release formulation is formulated with one or more bioadhesive polymers which may be useful for preferentially targeting the release of the decarboxylase enzyme inhibitor at the target absorption site. Upon administration to the patient, the inhibitor is delivered to a desired tissue location (e.g., proximal small intestine), and is released over an extended period (preferably from after dinner to the morning after).

    Abstract translation: 本发明涉及某些神经障碍/疾病如帕金森病和其他运动障碍的治疗的改善。 本发明涉及包含所述药物组合物的药物组合物和剂型; 制备药物组合物和剂型的方法; 和治疗方法，包括将药物组合物和剂型给予个体。 在某些实施方案中，脱羧酶抑制剂（例如卡比多巴）延长释放制剂配制有一种或多种生物粘附聚合物，其可用于优先靶向靶标吸收位点处的脱羧酶抑制剂的释放。 在给予患者时，将抑制剂递送至期望的组织位置（例如，近端小肠），并在延长的时期（优选从晚餐至早晨之后）释放。

    BIOADHESIVE RATE-CONTROLLED ORAL DOSAGE FORMULATIONS
    9.
    发明申请
    BIOADHESIVE RATE-CONTROLLED ORAL DOSAGE FORMULATIONS 审中-公开
    生物速率控制口服剂型

    公开(公告)号：WO2006026556A3

    公开(公告)日：2006-08-10

    申请号：PCT/US2005030681

    申请日：2005-08-29

    Applicant: SPHERICS INC ,  NANGIA AVINASH ,  JACOB JULES S ,  MOSLEMY PEYMAN

    Inventor： NANGIA AVINASH ,  JACOB JULES S ,  MOSLEMY PEYMAN

    IPC: A61K9/28

    CPC classification number: A61K9/2853 ,  A61K9/2018 ,  A61K9/2054 ,  A61K9/209 ,  A61K9/284 ,  A61K9/2846 ,  A61K9/2886

    Abstract: The present invention relates to a bioadhesive drug delivery system (BIOadhesive Rate controlled Oral Dosage (BIOROD) formulation) in which a drug containing core either alone or coated with a rate controlling membrane system is enveloped on its circumference by a bioadhesive coating, thereby yielding a monolithic system that allows for drug release in a regulated manner. Also described herein are polymers with improved bioadhesive properties and methods for improving bioadhesion of polymers.

    Abstract translation: 本发明涉及一种生物粘附药物递送系统（BIOadhesive Rate controlled Oral Dosage（BIOROD）制剂），其中单独或用速率控制膜系统涂覆的药物的核心通过生物粘附剂包被在其圆周上，从而产生 整体式系统允许以规定的方式释放药物。 本文还描述了具有改进的生物粘附性质的聚合物和用于改善聚合物生物粘附的方法。

    POLYMERIC DRUG DELIVERY SYSTEM FOR HYDROPHOBIC DRUGS
    10.
    发明申请
    POLYMERIC DRUG DELIVERY SYSTEM FOR HYDROPHOBIC DRUGS 审中-公开
    用于疏水性药物的聚合物药物递送系统

    公开(公告)号：WO2005084639A9

    公开(公告)日：2005-11-17

    申请号：PCT/US2005007525

    申请日：2005-03-03

    Applicant: SPHERICS INC ,  JACOB JULES S ,  BASSETT MICHAEL ,  SCHESTOPOL MARCUS A ,  MATHIOWITZ EDITH ,  NANGIA AVINASH ,  CARTER BENNETT ,  MOSLEMY PEYMAN ,  SHAKED ZE EV ,  ENSCORE DAVID ,  SIKES COURTNEY

    Inventor： JACOB JULES S ,  BASSETT MICHAEL ,  SCHESTOPOL MARCUS A ,  MATHIOWITZ EDITH ,  NANGIA AVINASH ,  CARTER BENNETT ,  MOSLEMY PEYMAN ,  SHAKED ZE EV ,  ENSCORE DAVID ,  SIKES COURTNEY

    IPC: A61K9/00 ,  A61K9/14 ,  A61K9/16 ,  A61K9/20 ,  A61K9/24 ,  A61K9/28 ,  A61K9/48

    CPC classification number: A61K9/209 ,  A61K9/0065 ,  A61K9/1635 ,  A61K9/1641 ,  A61K9/1647 ,  A61K9/1652 ,  A61K9/1676 ,  A61K9/2054 ,  A61K9/2077 ,  A61K9/2086 ,  A61K9/2853

    Abstract: An oral delivery system for Class II drugs that have low oral bioavailability due to their insolubility in water and slow dissolution kinetics and method for making such a drug delivery system are disclosed herein. The formulation may be a controlled release or immediate release formulation. The immediate release formulation contains a Class II drug, together with a hydrophobic polymer, preferably a bioadhesive polymer. In one embodiment, the drug and polymer are co-dissolved in a common solvent. The solution is formed into small solid particles by any convenient method, particularly by spray drying. The resulting particles contain drug dispersed as small particles in a polymeric matrix. The particles are stable against aggregation, and can be put into capsules or tableted for administration. The controlled release formulations contain a BCS Class II drug and a bioadhesive polymer. The controlled release formulations may be in the form of a tablet, capsules, mini-tab, microparticulate, or osmotic pump. Enhancement of oral uptake of the drug from use of bioadhesive polymers occurs through (1) increased dissolution kinetics due to stable micronization of the drug, (2) rapid release of the drug from the polymer in the GI tract; and (3) prolonged GI transit due to bioadhesive properties of the polymers. The combination of these effects allows the preparation of a compact, stable dosage form suitable for oral administration of many class II drugs.

    Abstract translation: 本文公开了由于不溶于水而具有低口服生物利用度和缓慢溶出动力学的II类药物的口服递送系统以及制备这种药物递送系统的方法。 该制剂可以是控释或速释制剂。 速释制剂含有II类药物以及疏水聚合物，优选生物粘附聚合物。 在一个实施方案中，药物和聚合物共溶于普通溶剂中。 通过任何方便的方法，特别是通过喷雾干燥，溶液形成小的固体颗粒。 所得颗粒含有作为小颗粒分散在聚合物基质中的药物。 颗粒对于聚集是稳定的，并且可以放入胶囊或制成片剂给药。 控释制剂含有BCS II类药物和生物粘附聚合物。 控释制剂可以是片剂，胶囊剂，小片，微粒或渗透泵的形式。 （1）由于药物的稳定微粉化，溶解动力学增加，（2）药物从胃肠道中的聚合物中快速释放，因此通过使用生物粘附聚合物增强药物的口服摄取。 和（3）由于聚合物的生物粘附性而延长的GI运输。 这些效果的组合允许制备适用于许多II类药物口服给药的紧凑稳定剂型。

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