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    METHOD FOR PREPARING BENZISOXAZOLE METHANE SULFONYL CHLORIDE AND ITS AMIDATION TO FORM ZONISAMIDE
    1.
    发明公开
    METHOD FOR PREPARING BENZISOXAZOLE METHANE SULFONYL CHLORIDE AND ITS AMIDATION TO FORM ZONISAMIDE 审中-公开
    生产工艺BENZISOXAZOLMETHANSULFONYLCHLORID及其酰胺化的教育唑尼沙胺

    公开(公告)号：EP1472236A4

    公开(公告)日：2006-04-19

    申请号：EP03716172

    申请日：2003-02-24

    申请人： TEVA PHARMA ,  TEVA PHARMA

    发明人： MENDELOVICI MARIOARA ,  GERSHON NEOMI ,  NIDAM TAMAR ,  PILARSKI GIDEON ,  STERINBAUM GRETA

    IPC分类号： A61K31/423 ,  A61P25/08 ,  C07B61/00 ,  C07D261/20 ,  C07D405/12

    CPC分类号： C07D261/20 ,  C07D405/12

    摘要： The present invention relates to a process of preparing benzisoxazole methane sulfonic acid-chloride (BOS-CI) as an zonisamide intermediate via chlorination of benzisoxazole methane sulfonate. The present invention also disloses a process of preparing zonisamide via amidation of BOS-CI. More particularly, the present invention provides a process of preparing zonisamide, comprising the steps of : a) chlorinating BOS; salts or esters thereof, with SOCl2 in an organic solvent and/or in the presence of a catalyst to form BOS-Cl; and b) amidating BOS-Cl in the presence of ammonia selected from the group consisting of aqueous ammonia in a biphasic system, masked ammonia and dry ammonia to form zonisamide.

    摘要翻译： 本发明涉及苯并异恶唑甲磺酸氯化物（BOS-Cl）的制备如经由苯并异恶唑甲磺酸盐的氯化唑尼沙胺中间体的处理。 因此，本发明的盘较少经由BOS-CL的酰胺化制备的唑尼沙胺的方法。 更具体地，本发明提供了制备唑尼沙胺，其包括以下步骤的处理：和/或在一个存在下，在有机溶剂中的）氯化BOS，其盐或酯，具有的SOCl 2 催化剂以形成BOS-CL; 和b）在氨从该组中的两相体系wässrige氨由......组成选择的存在酰胺化BOS-CL，掩蔽的氨和干氨反应形成的唑尼沙胺。

    GENETIC MARKERS PREDICTIVE OF RESPONSE TO GLATIRAMER ACETATE
    7.
    发明公开
    GENETIC MARKERS PREDICTIVE OF RESPONSE TO GLATIRAMER ACETATE 审中-公开
    GENETISCHE MARKER ALSPRÄDIKTORENDER REAKTION AUF GLATIRAMERACETAT

    公开(公告)号：EP3060681A4

    公开(公告)日：2017-06-07

    申请号：EP14855499

    申请日：2014-10-21

    申请人： TEVA PHARMA

    发明人： TCHELET AMIR ,  HAYDEN MICHAEL ,  HAYARDENY LIAT ,  ROSS COLIN JAMES DOUGLAS ,  GROSSMAN IRIS ,  LADKANI DAVID

    IPC分类号： C12Q1/68

    CPC分类号： C12Q1/6883 ,  A61K38/02 ,  A61K38/16 ,  C12Q2600/106 ,  C12Q2600/156

    摘要： The present invention provides a method for treating a human subject afflicted with multiple sclerosis or a single clinical attack consistent with multiple sclerosis with a pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier, comprising the steps of: (i) determining a genotype of the subject at a location corresponding to the location of one or more single nucleotide polymorphisms (SNPs) selected from the group consisting of: Group 1, (ii) identifying the subject as a predicted responder to glatiramer acetate if the genotype of the subject contains one or more A alleles at the location of Group 2, one or more C alleles at the location of Group 3, one or more G alleles at the location of Group 4, or one or more T alleles at the location of kgp18432055, kgp279772, kgp3991733 or kgp7242489; and (iii) administering the pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier to the subject only if the subject is identified as a predicted responder to glatiramer acetate.

    摘要翻译： 本发明提供了用包含醋酸格拉替雷和药学上可接受的载体的药物组合物治疗患有多发性硬化症或与多发性硬化症一致的单次临床发作的人受试者的方法，包括以下步骤：（i）确定 在对应于选自下组的一个或多个单核苷酸多态性（SNP）的位置的位置处受试者：组1，（ii）如果受试者的基因型含有一个或 第2组位置处的等位基因数目多于第3组，位于第3组位置处的一个或多个C等位基因，第4组位置处的一个或多个G等位基因或位于kgp18432055，kgp279772，kgp3991733处的一个或多个T等位基因或 kgp7242489; 和（iii）仅当所述受试者被鉴定为对醋酸格拉默的预测响应者时，将包含醋酸格拉替雷和药学上可接受的载体的药物组合物给予所述受试者。

    PROCESS FOR MANUFACTURING GLATIRAMER ACETATE PRODUCT
    8.
    发明公开
    PROCESS FOR MANUFACTURING GLATIRAMER ACETATE PRODUCT 审中-公开
    VERFAHREN ZUR HERSTELLUNG VON GLATIRAMERACETATPRODUKT

    公开(公告)号：EP3113785A4

    公开(公告)日：2017-05-10

    申请号：EP15880609

    申请日：2015-09-21

    申请人： TEVA PHARMA

    发明人： COHEN RAKEFET ,  HABBAH SASSON ,  SAFADI MUHAMMAD

    IPC分类号： A61K9/00 ,  A61K9/08 ,  A61K38/02 ,  A61K38/16 ,  A61K47/26 ,  A61P25/00

    CPC分类号： A61K38/02 ,  A61K9/0019 ,  A61K9/08 ,  A61K38/03 ,  A61K38/16 ,  A61K47/26

    摘要： The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0°C up to 17.5°C to produce a filtrate; and (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container. This patent further provides an aqueous pharmaceutical solution comprising 40mg/ml glatiramer acetate and 40mg/ml mannitol, wherein the aqueous pharmaceutical solution a) has a viscosity in the range of 2.0-3.5 cPa; or b) has an osmolality in the range of 275-325 mosmol/Kg. This patent also provides a prefilled syringe, an automated injector and a method of treatment of a human patient.

    摘要翻译： 该专利提供了一种在合适的容器中制备醋酸格拉替雷和甘露醇的药物制剂的方法，其包括以下步骤：（i）获得醋酸格拉替雷和甘露醇的水性药物溶液; （ii）在0℃以上至17.5℃的温度下过滤水性药物溶液以产生滤液; （iii）将步骤（ii）后获得的滤液填充到合适的容器中，从而在合适的容器中制备醋酸格拉替雷和甘露醇的药物制剂。 该专利进一步提供了包含40mg / ml醋酸格拉替雷和40mg / ml甘露醇的水性药物溶液，其中所述水性药物溶液a）具有2.0-3.5cPa范围内的粘度; 或b）具有275-325mosmol / Kg范围内的渗透压。 该专利还提供了预充式注射器，自动注射器和治疗人类患者的方法。