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    CRYSTALS OF LAQUINIMOD SODIUM AND IMPROVED PROCESS FOR THE MANUFACTURE THEREOF
    1.
    发明申请
    CRYSTALS OF LAQUINIMOD SODIUM AND IMPROVED PROCESS FOR THE MANUFACTURE THEREOF 审中-公开
    LAQUINIMOD SODIUM水晶及其制造方法改进

    公开(公告)号：WO2014153145A3

    公开(公告)日：2015-04-23

    申请号：PCT/US2014029292

    申请日：2014-03-14

    申请人： TEVA PHARMA ,  TEVA PHARMA ,  FRENKEL ANTON ,  LAXER AVITAL ,  IOFFE VLADIMIR ,  JANSSON KARL-ERIK ,  FRISTEDT ULF TOMAS

    发明人： FRENKEL ANTON ,  LAXER AVITAL ,  IOFFE VLADIMIR ,  JANSSON KARL-ERIK ,  FRISTEDT ULF TOMAS

    IPC分类号： C07D215/56

    CPC分类号： C07D215/56 ,  A61K31/47 ,  C07B2200/13 ,  G01N30/06 ,  G01N33/15

    摘要： The present application provides subject-matter related to a mixture of crystalline laquinimod sodium particles, wherein (i) > 90% of the total amount by volume of the laquinimod sodium particles have a size of 50% of the total amount by volume of the laquinimod sodium particles have a size of

    摘要翻译： 本申请提供了与结晶laquinimod钠颗粒的混合物相关的主题，其中（i）拉喹莫德钠颗粒的总体积的90％具有<40微米的尺寸或（ii）> 50％的 拉喹莫德钠颗粒的总体积量具有<15μm的尺寸，并且其中关于堆积密度，抽头密度和某些杂质的量满足一个或多个进一步的要求。 本申请还提供了包含一定量的拉喹莫德和BH-3-HLAQ，MCQ，MCQCA，MCQME，NEA和MCQEE中的至少一种的药物组合物。 本发明还提供制备BH-3-HLAQ，MCQ，MCQCA，MCQME，MCQEE和由所述方法制备的化合物的方法。 还提供了一种用于测试拉喹莫德样品是否含有不期望的杂质的方法。 还提供了（a）制备包含拉喹莫德的经验证的药物组合物的方法，（b）分发经验证的药物组合物包含拉喹莫德，（c）验证一批含有拉喹莫德的药物产品，（d）制备包装的药物 组合物包含拉喹莫德，其各自包括测定样品或批次中BH-3-HLAQ，MCQ，MCQCA，MCQME，NEA和MCQEE中的至少一种的量。 本发明还提供使用BH-3-HLAQ，MCQ，MCQCA，MCQME，MCQEE作为参考标准，以检测包含拉喹莫德的药物组合物中痕量的杂质。 最后，本发明提供了在包含laquinimod的药物组合物中确定BH-3-HLAQ，MCQ，MCQCA，MCQME，MCQEE，5-HLAQ，SPIRO-LAQ或3-H-LAQ的浓度的方法。

    CRYSTALS OF LAQUINIMOD SODIUM AND IMPROVED PROCESS FOR THE MANUFACTURE THEREOF
    2.
    发明申请
    CRYSTALS OF LAQUINIMOD SODIUM AND IMPROVED PROCESS FOR THE MANUFACTURE THEREOF 审中-公开
    LAQUINIMOD SODIUM水晶及其制造方法改进

    公开(公告)号：WO2014153145A2

    公开(公告)日：2014-09-25

    申请号：PCT/US2014/029292

    申请日：2014-03-14

    申请人： TEVA PHARMACEUTICAL INDUSTRIES LTD. ,  TEVA PHARMACEUTICALS USA, INC. ,  FRENKEL, Anton ,  LAXER, Avital ,  IOFFE, Vladimir ,  JANSSON, Karl-Erik ,  FRISTEDT, Ulf, Tomas

    发明人： FRENKEL, Anton ,  LAXER, Avital ,  IOFFE, Vladimir ,  JANSSON, Karl-Erik ,  FRISTEDT, Ulf, Tomas

    CPC分类号： C07D215/56 ,  A61K31/47 ,  C07B2200/13 ,  G01N30/06 ,  G01N33/15

    摘要： The subject invention provides a mixture of crystalline laquinimod sodium particles, wherein (i) ≥ 90% of the total amount by volume of the laquinimod sodium particles have a size of ≤ 40 μm or (ii) ≥ 50% of the total amount by volume of the laquinimod sodium particles have a size of ≤ 15 μm, and wherein: a) the mixture has a bulk density of 0.2-0.4 g/mL; b) the mixture has a tapped density of 0.40-0.7 g/mL; c) an amount of heavy metal in the mixture is no more than 20ppm relative to the amount by weight of laquinimod sodium; d) an amount of MCQ in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; e) an amount of MCQCA in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; or f) an amount of MCQME in the mixture is no more than 0.12% relative to the amount of laquinimod sodium as measured by HPLC. The subject invention also provides a pharmaceutical composition comprising an amount of laquinimod and at least one of BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, and MCQEE. The subject invention also provides processes for preparing BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE, and compounds prepared by said processes. Further provided is a process for testing whether a sample of laquinimod contains an undesirable impurity. Further provided isp a process for preparing a validated pharmaceutical composition comprising laquinimod, for preparing a pharmaceutical composition comprising laquinimod, or for distributing a validated batch of a pharmaceutical composition comprising laquinimod, for validating a batch of a pharmaceutical product containing laquinimod and a pharmaceutically acceptable carrier for distribution, and for preparing a packaged pharmaceutical composition comprising laquinimod, each comprising determining the amount of at least one of BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, and MCQEE in a sample or batch. The subject invention further provides use of BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE as a reference standard to detect trace amounts of the impurity in a pharmaceutical composition comprising laquinimod. Finally, the subject invention provides methods of ddenrrining the concentration of BH-3- HLAQ, MCQ, MCQCA, MCQME, MCQEE, 5-HLAQ, SPIRO-LAQ or 3 H-LAQ in a pharmaceutical composition comprising laquinimod.

    摘要翻译： 本发明提供结晶laquinimod钠颗粒的混合物，其中（i）拉喹莫德钠颗粒的总体积的≥90％具有≤40μm的尺寸或（ii）≥体积总量的50％ 的拉喹莫德钠颗粒的尺寸为≤15μm，其中：a）混合物的堆积密度为0.2-0.4g / mL; b）混合物的敲击密度为0.40-0.7g / mL; c）相对于拉喹莫德钠的重量，混合物中的重金属量不超过20ppm; d）混合物中MCQ的量相对于通过HPLC测量的拉喹莫德钠的量不超过0.15％; e）混合物中MCQCA的量相对于通过HPLC测量的拉喹莫德钠的量不超过0.15％; 或f）混合物中MCQME的量相对于通过HPLC测量的拉喹莫德钠的量不超过0.12％。 本发明还提供了包含一定量的拉喹莫德和BH-3-HLAQ，MCQ，MCQCA，MCQME，NEA和MCQEE中的至少一种的药物组合物。 本发明还提供制备BH-3-HLAQ，MCQ，MCQCA，MCQME，MCQEE和由所述方法制备的化合物的方法。 还提供了一种用于测试拉喹莫德样品是否含有不期望的杂质的方法。 进一步提供的isp是制备包含laquinimod的经验证的药物组合物的方法，用于制备包含laquinimod的药物组合物或用于分配经验证的批次的包含laquinimod的药物组合物，用于验证一批含有laquinimod的药物产品和药学上可接受的载体 用于分配和用于制备包含拉喹莫德的包装药物组合物，每种包含确定样品或批次中BH-3-HLAQ，MCQ，MCQCA，MCQME，NEA和MCQEE中的至少一种的量。 本发明还提供使用BH-3-HLAQ，MCQ，MCQCA，MCQME，MCQEE作为参考标准，以检测包含拉喹莫德的药物组合物中痕量的杂质。 最后，本发明提供了包含laquinimod的药物组合物中BH-3-HLAQ，MCQ，MCQCA，MCQME，MCQEE，5-HLAQ，SPIRO-LAQ或3-H-LAQ的浓度的方法。

    L-DOPA ETHYL ESTER SALTS AND USES THEREOF
    9.
    发明申请
    L-DOPA ETHYL ESTER SALTS AND USES THEREOF 审中-公开
    L-多巴乙基酯盐及其用途

    公开(公告)号：WO03041646A2

    公开(公告)日：2003-05-22

    申请号：PCT/US0236257

    申请日：2002-11-12

    申请人： TEVA PHARMA ,  TEVA PHARMA ,  FRENKEL ANTON ,  LIDOR-HADAS RAMY

    发明人： FRENKEL ANTON ,  LIDOR-HADAS RAMY

    IPC分类号： A61K31/216 ,  C07C229/36 ,  A61K

    CPC分类号： A61K31/216 ,  C07C229/36

    摘要： The present invention provides non-hygroscopic, crystalline salts of levodopa ethyl ester (LDEE), wherein the salt is the octanoate salt, the myristate salt, the succinate dihydrate salt, the fumarate salt of the fumarate dihydrate salt of levodopa ethyl ester. The subject invention also encompasses compositions comprising a levodopa ethyl ester salt and a carrier and processes for making these compositions. In addition, the subject invention concerns pharmaceutical compositions comprising a levodopa ethyl ester salt and a pharmaceutically acceptable carrier, as well as processes for making these pharmaceutical compositions. Furthermore, the subject invention includes methods of treating a subject afflicted with Parkinson's disease, senile dementia, dementia of Alzheimer's type, a memory disorder, depression, hyperactive syndrome, an affective illness, a neurodegenerative disease, a neurotoxic injury, brain ischemia, a head trauma injury, a spinal injury, schizophrenia, an attention deficit disorder, multiple sclerosis and seizures by the administration of levodopa ethyl ester salts.

    摘要翻译： 本发明提供左旋多巴乙酯（LDEE）的非吸湿性结晶盐，其中所述盐为左旋多巴乙酯的富马酸盐二水合物盐的辛酸盐，肉豆蔻酸盐，琥珀酸盐二水合物盐，富马酸盐。 本发明还包括含有左旋多巴乙酯盐和载体的组合物以及制备这些组合物的方法。 此外，本发明涉及包含左旋多巴乙酯盐和药学上可接受的载体的药物组合物，以及制备这些药物组合物的方法。 此外，本发明包括治疗患有帕金森氏病，老年痴呆症，阿尔茨海默型痴呆，记忆障碍，抑郁症，多动综合征，情感性疾病，神经退行性疾病，神经毒性损伤，脑局部缺血，头部疾病 创伤，脊髓损伤，精神分裂症，注意力缺陷障碍，多发性硬化以及通过施用左旋多巴乙酯盐引起的癫痫发作。