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    SALTS OF PRASUGREL AND A METHOD OF THEIR PRODUCTION
    3.
    发明申请
    SALTS OF PRASUGREL AND A METHOD OF THEIR PRODUCTION 审中-公开
    PRASUGREL的销售及其生产方法

    公开(公告)号：WO2011057593A3

    公开(公告)日：2011-07-07

    申请号：PCT/CZ2010000116

    申请日：2010-11-12

    Applicant: ZENTIVA K S ,  STEPANKOVA HANA ,  KAMINSKA KATERINA ,  HAJICEK JOSEF ,  BRUSOVA HANA

    Inventor： STEPANKOVA HANA ,  KAMINSKA KATERINA ,  HAJICEK JOSEF ,  BRUSOVA HANA

    IPC: C07D495/04

    CPC classification number: C07D495/04

    Abstract: The invention relates to new pharmaceutically acceptable salts of the well-known substance reducing coagulation of blood, prasugrel of formula (I), which are characterized by high chemical stability, and a method of their production. The prasugrel salts are prepared from prasugrel of formula (I) in the base form by reaction with an inorganic or organic acid in a suitable solvent or in mixtures of solvents. The inorganic acid means hydrobromic acid, hydrogen bromide, hydroiodic and sulphuric acid and the organic acid means cyclamic, ethane sulfonic, benzene sulfonic and 2-naphthalene sulfonic acid.

    Abstract translation: 本发明涉及众所周知的减少血液凝血的药学上可接受的盐，具有高化学稳定性的式（I）的普拉格雷及其制备方法。 普拉格雷盐通过与无机或有机酸在合适的溶剂或溶剂的混合物中反应而以碱形式由式（I）的普拉格雷制备。 无机酸是指氢溴酸，溴化氢，氢碘酸和硫酸，有机酸表示环己烷氨基磺酸，苯磺酸和2-萘磺酸。

    IMATINIB MESYLATE POLYMORPHS GENERATED BY CRYSTALLIZATION IN AQUEOUS INORGANIC SALT SOLUTIONS
    5.
    发明申请
    IMATINIB MESYLATE POLYMORPHS GENERATED BY CRYSTALLIZATION IN AQUEOUS INORGANIC SALT SOLUTIONS 审中-公开
    通过在无水无机盐溶液中结晶生成的IMATINIB MESYLATE POLYMORPHS

    公开(公告)号：WO2011023146A1

    公开(公告)日：2011-03-03

    申请号：PCT/CZ2010/000094

    申请日：2010-08-19

    Applicant: ZENTIVA, K.S. ,  KRAL, Vladimir ,  BRUSOVA, Hana ,  JAMPILEK, Josef ,  HAVLICEK, Jaroslav ,  PEKAREK, Tomas ,  TKADLECOVA, Marcela

    Inventor： KRAL, Vladimir ,  BRUSOVA, Hana ,  JAMPILEK, Josef ,  HAVLICEK, Jaroslav ,  PEKAREK, Tomas ,  TKADLECOVA, Marcela

    IPC: C07D401/04 ,  A61P35/00 ,  A61K31/506

    CPC classification number: C07D401/04

    Abstract: The solution relates to a method of preparation of an imatinib mesylate polymorph as an AP1 form suitable for dosage forms. Formation of new polymorphs of tyrosine kinase inhibitors proceeds depending on the conditions, said method consisting of the following steps: a) preparation of imatinib mesylate by reaction of the imalinib base and methanesulfonic acid in aqueous environment or in a water-organic solvent mixture, with optional addition of an organic solvent; b) addition of an inorganic salt in an aqueous solution, controlling the pH and ionic strength of the solution; c) crystallization process at controlled temperature. The solution also relates to the crystalline form of imatinib mesylate polymorph and use thereof. Two new polymorphous forms of Imatinib mesylate are accessible through this method, these forms are named polymorph "Z1" and "Z2". "Z1 " is characterized by peaks in the XRPD at 5,3; 7,5; 10,0; 10,6; 14,1; 15,0 and 16;6°. "Z2" is characterized by peaks in the XRPD at 5,5; 10,6; 10,9; 14.9; 17,0 and 21,9°.

    Abstract translation: 该解决方案涉及一种制备适合剂型的AP1形式的甲磺酸伊马替尼多晶型物的制备方法。 酪氨酸激酶抑制剂的新多晶型物的形成根据条件进行，所述方法由以下步骤组成：a）通过在水性环境或水 - 有机溶剂混合物中与imalinib碱和甲磺酸反应制备甲磺酸伊马替尼， 任选加入有机溶剂; b）在水溶液中加入无机盐，控制溶液的pH和离子强度; c）控制温度下的结晶过程。 该溶液还涉及甲磺酸伊马替尼多晶型物的结晶形式及其用途。 通过这种方法可以获得两种新的多晶型甲磺酸伊马替尼，这些形式被称为多晶型“Z1”和“Z2”。 “Z1”的特征在于XRPD中的峰为5,3; 7,5; 10,0; 10,6; 14,1; 15,0和16; 6°。 “Z2”的特征在于XRPD中的峰为5,5; 10,6; 10,9; 14.9; 17,0和21,9°。

    A PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN AND A METHOD OF ITS MANUFACTURE
    8.
    发明申请
    A PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN AND A METHOD OF ITS MANUFACTURE 审中-公开
    含有固体的药物组合物及其制造方法

    公开(公告)号：WO2011137877A3

    公开(公告)日：2012-05-18

    申请号：PCT/CZ2011000039

    申请日：2011-04-21

    Applicant: ZENTIVA K S ,  SVOBODA MARTIN ,  HERT JAKUB ,  BRUSOVA HANA ,  PILARCIK TOMAS

    Inventor： SVOBODA MARTIN ,  HERT JAKUB ,  BRUSOVA HANA ,  PILARCIK TOMAS

    IPC: A61K9/20 ,  A61K9/28 ,  A61K31/4725

    CPC classification number: A61K9/2054 ,  A61K9/2866 ,  A61K31/4725

    Abstract: The present solution relates to a coated tablet, comprising the active ingredient solifenacin succinate and the binder hydroxypropyl methyl cellulose, wherein the tablet comprises solifenacin I in the range of 3 to 10% wt. of the solifenacin base and methocel as the binder in the range of 0.5 to 5% wt., related to the core weight, wherein after 3-month stability tests at the 75% relative humidity and 40 °C an increase of the content of the N-oxide impurity of formula II is lower than 0.1% of the HPLC integrated area. Another solutions consist in a pharmaceutical preparation comprising the coated tablet packed in a blister package and a manufacturing method of the coated tablets, wherein a powder mixture containing the active ingredient and the binder is granulated by addition of water, whereafter the granulate is tabletted, the resulting tablets are coated and packed.

    Abstract translation: 本解决方案涉及包含活性成分琥珀酸solifenacin和粘合剂羟丙基甲基纤维素的包衣片剂，其中片剂包含3-10重量％范围内的solifenacin I。 的solifenacin碱和methocel作为粘合剂，与核心重量有关，其中在75％相对湿度和40℃下经过3个月的稳定性试验后，其含量的增加 式II的N-氧化物杂质低于HPLC整合面积的0.1％。 另一种解决方案包括药物制剂，其包含包装在泡罩包装中的包衣片剂和包衣片剂的制备方法，其中含有活性成分和粘合剂的粉末混合物通过加入水造粒，此后将颗粒压片， 得到的片剂被包衣和包装。

    NEW SALTS OF PRASUGREL AND A METHOD OF THEIR PRODUCTION
    10.
    发明申请
    NEW SALTS OF PRASUGREL AND A METHOD OF THEIR PRODUCTION 审中-公开
    PRASUGREL的新销售及其生产方法

    公开(公告)号：WO2011057593A2

    公开(公告)日：2011-05-19

    申请号：PCT/CZ2010/000116

    申请日：2010-11-12

    Applicant: ZENTIVA, K.S. ,  STEPANKOVA, Hana ,  KAMINSKA, Katerina ,  HAJICEK, Josef ,  BRUSOVA, Hana

    Inventor： STEPANKOVA, Hana ,  KAMINSKA, Katerina ,  HAJICEK, Josef ,  BRUSOVA, Hana

    IPC: C07D495/04

    CPC classification number: C07D495/04

    Abstract: The invention relates to new pharmaceutically acceptable salts of the well-known substance reducing coagulation of blood, prasugrel of formula (I), which are characterized by high chemical stability, and a method of their production. The prasugrel salts are prepared from prasugrel of formula (I) in the base form by reaction with an inorganic or organic acid in a suitable solvent or in mixtures of solvents. The inorganic acid means hydrobromic acid, hydrogen bromide, hydroiodic and sulphuric acid and the organic acid means cyclamic, ethane sulfonic, benzene sulfonic and 2-naphthalene sulfonic acid.

    Abstract translation: 本发明涉及众所周知的减少血液凝血的药学上可接受的盐，具有高化学稳定性的式（I）的普拉格雷及其制备方法。 普拉格雷盐通过与无机或有机酸在合适的溶剂或溶剂的混合物中反应而以碱形式由式（I）的普拉格雷制备。 无机酸是指氢溴酸，溴化氢，氢碘酸和硫酸，有机酸表示环己烷氨基磺酸，苯磺酸和2-萘磺酸。

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