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1. 发明申请

WO2013175483A1 PROCESS FOR PREPARING CRYSTALLINE SORAFENIB TOSYLATE 审中-公开
标题翻译：制备水溶性磺酰苯甲酸酯的方法
公开(公告)号：WO2013175483A1
公开(公告)日：2013-11-28
申请号：PCT/IN2012/000866
申请日：2012-12-31
申请人： SHILPA MEDICARE LIMITED , PUROHIT, Prashant , SRIRAM, Rampalli , MOHANRAO, Seshagiri Vijaya Murali , LAVKUMAR, Upalla
发明人： PUROHIT, Prashant , SRIRAM, Rampalli , MOHANRAO, Seshagiri Vijaya Murali , LAVKUMAR, Upalla
IPC分类号： C07D213/81 , A61K31/44 , A61P35/00
CPC分类号： C07D213/81 , A61K31/44
摘要： The present invention provides an industrially suitable process for the preparation of substantially pure 4-{4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide or Sorafenib and its tosylate salt, with a suitable impurity profile and without requirement of any additional purification steps. The present invention also provides Sorafenib base (II) as stable crystalline Form-SSB. The present invention further relates to a process for the preparation of crystalline Sorafenib tosylate Form-I which is free from contamination of any other polymorphic form of Sorafenib tosylate, for e.g. Form II or Form III, and does not involve any seeding requirement for crystallization step.
摘要翻译：本发明提供工业上合适的制备基本上纯的4- {4 - [（{[4-氯-3-（三氟甲基） - 苯基]氨基}羰基）氨基]苯氧基} -N-甲基吡啶-2-甲酸的方法，甲酰胺或索拉非尼及其甲苯磺酸盐，具有合适的杂质分布，并且不需要任何额外的纯化步骤。本发明还提供了索拉非尼碱（II）作为稳定的晶型SSB。本发明还涉及一种制备结晶索拉非尼甲苯磺酸盐形式I的方法，其不含任何其它多晶型索拉非尼甲苯磺酸盐的污染物，例如， II型或III型，不涉及结晶步骤的任何接种要求。

2. 发明申请

WO2014203177A1 AMORPHOUS (R) -3- [1- (2, 6-DICHLORO-3-FLUOROPHENYL) METHOXY] -5- [1- (PIPERIDIN-4- YL) -1H-PYRAZOL-4-YL] PYRIDIN-2-AMINE 审中-公开
标题翻译： -3- [1-（2,6-二氯-3-氟代甲基）甲氧基] -5- [1-（哌啶-4-基）-1H-吡唑-4-基]吡啶-2-胺
公开(公告)号：WO2014203177A1
公开(公告)日：2014-12-24
申请号：PCT/IB2014/062361
申请日：2014-06-18
申请人： SHILPA MEDICARE LIMITED
发明人： UPALLA, Lavkumar , SRIRAM, Rampalli , PATNEEDI, Chantibabu , DANGUDUBIYYAM, Chandrasekhar , CHATURVEDI, Akshaykant
IPC分类号： A61K31/4965 , C07D413/00
CPC分类号： C07D401/14
摘要： The present invention relates to a process for preparation of amorphous ( R )-3-[1-(2,6- Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1 H -pyrazol-4-yl]pyridin-2-amine (I) or its premix. (I) The present invention also relates to the amorphous ( R )-3-[1-(2,6-Dichloro-3- fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1 H -pyrazol-4-yl]pyridin-2-amine (I) having mass spectrum peak at about [M+] = 450.1, at least three IR peaks selected from 3470 cm -1 , 3388 cm -1 , 1117 cm -1 , 1252 cm -1 , or 740 cm -1 ± 2.0 cm -1 and less than 2% w/w of volatiles measured up to 170 °C by TGA. The invention further relates to pharmaceutical compositions comprising amorphous ( R )-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1 H -pyrazol-4-yl]pyridin- 2-amine or its premix, having anti-cancer activity.
摘要翻译：本发明涉及一种制备无定形（R）-3- [1-（2,6-二氯-3-氟苯基）乙氧基] -5- [1-（哌啶-4-基）-1H-吡唑 -4-基]吡啶-2-胺（I）或其预混物。（I）本发明还涉及无定形（R）-3- [1-（2,6-二氯-3-氟苯基）乙氧基] -5- [1-（哌啶-4-基）-1H-吡唑（I）在约[M +] = 450.1处具有质谱峰，至少三个选自3470cm -1，3388cm -1，1117cm -1，1252cm -1的IR峰， 1或740cm -1±2.0cm -1和小于2％w / w的挥发物，通过TGA测量至170℃。本发明还涉及包含无定形（R）-3- [1-（2,6-二氯-3-氟苯基）乙氧基] -5- [1-（哌啶-4-基）-1H-吡唑-4-基] - 基]吡啶-2-胺或其预混物，具有抗癌活性。

3. 发明申请

WO2015068055A1 CRYSTALLINE DASATINIB PROCESS 审中-公开
标题翻译：结晶DASATINIB工艺
公开(公告)号：WO2015068055A1
公开(公告)日：2015-05-14
申请号：PCT/IB2014/060968
申请日：2014-04-24
申请人： SHILPA MEDICARE LIMITED
发明人： SRIRAM, Rampalli , PRADEEP, Pothana , SURESH, Garbapu , PRASHANT, Purohit , AKSHAY KANT, Chaturvedi
IPC分类号： C07D417/12 , A61K31/506 , A61K35/00
CPC分类号： C07D417/12 , A61K31/506 , C07B2200/13 , C07H3/02
摘要： The present invention relates to a process for preparation of crystalline Form-SDI of Dasatinib (I). Said crystalline Form-SDI of Dasatinib is characterized by X-ray powder diffraction pattern comprising of at least seven 2θ° peaks selected from the XRPD peak set of 5.8, 11.5, 12.7, 13.2, 17.3, 17.5, 18.1, 20.1, 20.5, 22.1, 25.4, 26.6, 26.8 ± 0.20 2θ°; IR spectrum having at least five absorption peaks selected from about 3390 cm -1 , 2923 cm -1 , 1621 cm -1 , 1615 cm -1 , 1537 cm -1 , 1316 cm -1 , 1061 cm -1 , 815 cm -1 and 783 cm -1 ; and DSC isotherm comprising at least two endothermic peaks ranging between- 130 °C to 150 °C, 160 °C to 175 °C or 280 °C to 290 °C. The pharmaceutical compositions of the crystalline Form-SDI of Dasatinib or its hydrate thereof may be useful as an anti-cancer agent.
摘要翻译：本发明涉及制备达沙替尼（I）的晶型SDI的方法。达沙替尼的所述晶型SDI通过X射线粉末衍射图谱来表征，其包含至少7个选自5.8,11.5,12.7,13.2,17.3,17.5,18.1,20.1,20.5,22.1的XRPD峰组的2θ°峰，25.4,26.6,26.8±0.202θ°; 具有选自约3390cm -1,2923cm -1,1621cm -1，1615cm -1，1537cm -1，1316cm -1,106cm -1，815cm -1的至少5个吸收峰的IR光谱和783厘米-1; DSC等温线包括在130℃至150℃，160℃至175℃或280℃至290℃之间的至少两个吸热峰。达沙替尼或其水合物的晶型SDI的药物组合物可用作抗癌剂。

4. 发明申请

WO2014167436A2 SUNITINIB GLUCURONATE SALT & PROCESS FOR PREPARATION THEREOF 审中-公开
标题翻译： SUNITINIB葡萄糖酸盐及其制备方法
公开(公告)号：WO2014167436A2
公开(公告)日：2014-10-16
申请号：PCT/IB2014/060023
申请日：2014-03-21
申请人： SHILPA MEDICARE LIMITED
发明人： SRIRAM, Rampalli , LAVKUMAR, Upalla , VIJAYA MURALI MOHANRAO, Seshagiri , SHIVAKUMAR, Pradeep , CHATURVEDI, Akshaykant
CPC分类号： C07D403/06
摘要： The present invention relates to novel pharmaceutically acceptable glucuronic acid addition salt of Sunitinib Formula (I) or its solvate thereof. The present invention further relates to the processes for preparation of the glucuronic acid addition salt of Sunitinib. Glucuronic acid addition salt of Sunitinib (I) prepared according to the process of the present invention is obtained as a solid material. The pharmaceutical compositions comprising glucuronic acid addition salt of Sunitinib or its solvate thereof may be useful as anti-cancer agent.
摘要翻译：本发明涉及舒尼替尼配方（I）或其溶剂合物的新药学上可接受的葡萄糖醛酸加成盐。本发明还涉及舒尼替尼的葡糖醛酸加成盐的制备方法。得到根据本发明方法制备的舒尼替尼（I）的葡糖醛酸加成盐作为固体材料。包含舒尼替尼的葡糖醛酸加成盐或其溶剂合物的药物组合物可用作抗癌剂。

5. 发明申请

WO2014102670A2 PROCESS FOR PREPARING AMORPHOUS CABAZITAXEL 审中-公开
标题翻译：制备无定形卡宾的方法
公开(公告)号：WO2014102670A2
公开(公告)日：2014-07-03
申请号：PCT/IB2013/061089
申请日：2013-12-18
申请人： SHILPA MEDICARE LIMITED
发明人： SRIRAM, Rampalli , POTHANA, Pradeep , DUNGA, AnandKumar , PUROHIT, Prashant , CHATURVEDI, Akshaykant
CPC分类号： C07D305/14 , A61K31/337
摘要： The present invention provides a process for preparing amorphous Cabazitaxel from the solvate form of Cabazitaxel. The present invention also provides novel diisopropyl ether solvate form of Cabazitaxel (I) and process for preparation thereof. Said amorphous Cabazitaxel and crystalline diisopropyl ether solvate of Cabazitaxel of the present invention can be utilized in preparing the pharmaceutical composition/s useful in the treatment of cancer.
摘要翻译：本发明提供了从卡巴他赛的溶剂合物形式制备无定形卡巴他赛的方法。本发明还提供新的二异丙基醚溶剂合物形式的卡巴他赛（I）及其制备方法。本发明的卡马西他定的非卡拉司他和结晶二异丙基醚溶剂合物可用于制备可用于治疗癌症的药物组合物。

6. 发明申请

WO2013190569A2 NOVEL SALTS OF SUNITINIB AND THEIR PREPARATION 审中-公开
标题翻译： SUNITINIB和他们的准备的新的销售
公开(公告)号：WO2013190569A2
公开(公告)日：2013-12-27
申请号：PCT/IN2013/000374
申请日：2013-06-17
申请人： SHILPA MEDICARE LIMITED
发明人： SRIRAM, Rampalli , LAVKUMAR, Upalla , VIJAYA MURALI MOHANRAO, Seshagiri , CHATURVEDI, Akshaykant
CPC分类号： C07D403/06
摘要： The present invention relates to novel pharmaceutically acceptable substituted aryl acrylic acid addition salts of Sunitinib (I) or its hydrate or solvate thereof. [Formula should be inserted here] The present invention further relates to processes for preparation of the said substituted aryl acrylic acid addition salts of Sunitinib (I). The present application also provides pharmaceutically acceptable substituted aryl acrylic acid addition salts of Sunitinib (I) or its hydrate or solvate useful as active pharmaceutical ingredient in pharmaceutical composition comprising thereof, possessing anti-cancer activity.
摘要翻译：本发明涉及舒尼替尼（I）或其水合物或溶剂化物的新的药学上可接受的取代的芳基丙烯酸加成盐。 [这里应该插入配方]本发明还涉及制备所述的舒尼替尼（I）的取代的芳基丙烯酸加成盐的方法。本申请还提供了具有抗癌活性的舒尼替尼（I）或其水合物或溶剂合物的药学上可接受的取代的芳基丙烯酸加成盐，其作为活性药物成分在其包含的药物组合物中有用。

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