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1. 发明授权

US09593083B2 Crystalline erlotinib hydrochloride process 有权
标题翻译：结晶埃洛替尼盐酸盐工艺
公开(公告)号：US09593083B2
公开(公告)日：2017-03-14
申请号：US14418449
申请日：2013-08-14
申请人： Shilpa Medicare Limited
发明人： Vimal Kumar Shrawat , Prashant Purohit , Rafiuddin Dr. , Vinod Kumar Singh , Akshay Kant Chaturvedi
IPC分类号： C07D239/94
CPC分类号： C07D239/94 , C07B2200/13
摘要： The present invention provides process for preparation of Crystalline Erlotinib HCl (I) Form-SE characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 2θ° peaks selected from the XRPD peak set of 5.60, 10.00, 11.40, 13.00, 13.50, 15.20, 18.40, 20.65, 21.86, 23.5, 31.80, 32.13, 32.80, 34.40±0.20 2θ°, DSC isotherm comprising the endothermic peaks ranging between 213 to 217° C. (Peak −1) and 225 to 235° C. (Peak −2) and IR absorption characteristic peaks at approximately 3278 cm−1, 1948 cm−1, 1871 cm−1, 1632 cm−1, 1164 cm−1, 1024 cm−1, 940 cm−1 and 742 cm−1 useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment cancer.
摘要翻译：本发明提供了制备结晶埃洛替尼（I）形式SE的方法，其特征在于X射线粉末衍射图，其包含至少5个特征2＆amp; tt;峰，其选自XRPD峰组5.60,10.00,11.40,13.00,13.50 ，15.20，18.40，20.65，21.86，23.5，31.80，32.13，32.80，34.40±0.20 2;该等温线包含213-217℃（峰-1）和225-235℃之间的吸热峰。（峰-2）和IR吸收特征峰在大约3278cm-1,1948cm -1，1871cm -1，1632cm -1，1164cm -1，1024cm -1，940cm -1和742cm -1， 1可用作用于治疗癌症的药物组合物中的活性药物成分。

2. 发明授权

US10226450B2 Pharmaceutical film composition 有权
公开(公告)号：US10226450B2
公开(公告)日：2019-03-12
申请号：US15512575
申请日：2014-11-07
申请人： SHILPA MEDICARE LIMITED , NU THERAPEUTICS PVT LTD
发明人： Navneet Mundada , Ritesh Vinod Birla , Badrinath Allampalli , Akshay Kant Chaturvedi
IPC分类号： A01N43/50 , A61K31/415 , A61K31/4178 , A61K9/00 , A61K47/32 , A61K9/70 , A61K47/10 , A61K47/26 , A61K47/38 , A61K47/36
摘要： The present invention relates to Film Compositions of Ondansetron or its pharmaceutically acceptable salt thereof, which dosage forms are useful for the treatment of various medical conditions.

3. 发明申请

US20150299141A1 Crystalline Erlotinib Hydrochloride Process 审中-公开
标题翻译：结晶埃罗替尼盐酸盐工艺
公开(公告)号：US20150299141A1
公开(公告)日：2015-10-22
申请号：US14418449
申请日：2013-08-14
申请人： Shilpa Medicare Limited
发明人： Vimal Kumar Shrawat , Prashant Purohit , Rafiuddin Dr. , Vinod Kumar Singh , Akshay Kant Chaturvedi
IPC分类号： C07D239/94
CPC分类号： C07D239/94 , C07B2200/13
摘要： The present invention provides process for preparation of Crystalline Erlotinib HCl (I) Form-SE characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 2θ° peaks selected from the XRPD peak set of 5.60, 10.00, 11.40, 13.00, 13.50, 15.20, 18.40, 20.65, 21.86, 23.5, 31.80, 32.13, 32.80, 34.40±0.20 2θ°, DSC isotherm comprising the endothermic peaks ranging between 213 to 217° C. (Peak -1) and 225 to 235° C. (Peak -2) and IR absorption characteristic peaks at approximately 3278 cm−1, 1948 cm−1, 1871 cm−1, 1632 cm−1, 1164 cm−1, 1024 cm−1, 940 cm−1 and 742 cm−1 useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment cancer.
摘要翻译：本发明提供了制备结晶埃洛替尼（I）形式SE的方法，其特征在于X射线粉末衍射图，其包含至少5个特征2＆amp; tt;峰，其选自XRPD峰组5.60,10.00,11.40,13.00,13.50 ，15.20，18.40，20.65，21.86，23.5，31.80，32.13，32.80，34.40±0.20 2;该等温线包含213-217℃（峰-1）和225-235℃之间的吸热峰。（峰-2）和IR吸收特征峰在大约3278cm-1,1948cm -1，1871cm -1，1632cm -1，1164cm -1，1024cm -1，940cm -1和742cm -1， 1可用作用于治疗癌症的药物组合物中的活性药物成分。

4. 发明申请

US20150259364A1 CRYSTALLINE BORTEZOMIB PROCESS 审中-公开
标题翻译：晶体BORTEZOMIB工艺
公开(公告)号：US20150259364A1
公开(公告)日：2015-09-17
申请号：US14434105
申请日：2013-11-12
申请人： SHILPA MEDICARE LIMITED
发明人： Vimal Kumar Shrawat , Rafiuddin N/A , Vinod Singh , Akshay Kant Chaturvedi
IPC分类号： C07F5/02
CPC分类号： C07F5/025 , C07B2200/13 , C07D241/12
摘要： The present invention provides process for preparation of crystalline Bortezomib (Ia) as its monohydrate which is designated as crystalline Form-SB and characterized by having water content ranging between 3.5-6.0% w/w; X-ray powder diffraction pattern comprising characteristic 20° peaks selected from the XRPD peak set of 5.6, 7.5, 9.8, 10.2, 11.3, 15.1, 18.0, 20.5, 21.5 and 23.6±0.20 2θ°, wherein peaks at 9.8 and 11.39±0.20 2θ° are un-split and 100% intensity peak is present at 5.6±0.20 2θ°, DSC isotherm comprising the endothermic peaks ranging between 45 to 60° C. (Peak-1) and 175 to 185° C. (Peak-2) and IR absorption characteristic peaks approximately at 3387 cm−1, 3304 cm−1, 2953 cm−1, 2927 cm−1, 2868 cm−1, 1627 cm−1, 1455 cm−1, 1400 cm−1, 1201 cm−1, 1150 cm−1, 1020 cm−1, 747 cm−1 and 702 cm−1 and Raman absorption spectra having characteristic peaks approximately at 3066 cm−1, 1583 cm−1, 1528 cm−1, 1281 cm−1, 1213 cm−1, 1035 cm−1, 1022 cm−1 and 1004 cm−1. The invention also provides the use of said crystalline Form-SB as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of cancer.
摘要翻译：本发明提供制备作为其一水合物的结晶硼替佐米（Ia）的方法，其被称为结晶形式-SB，其特征在于含水量在3.5-6.0％w / w之间; X射线粉末衍射图，其包括选自5.6,7.5,9.8,10.2,11.3,15.1,18.0,20.5,21.5和23.6±0.202的XRPD峰组的特征20°峰;其中在9.8和11.39± 0.20 2＆thetas;°是未分裂的，并且在5.6±0.20 2时存在100％强度峰值;°，DSC等温线包括在45至60℃（峰-1）和175至185℃之间的吸热峰峰-2）和IR吸收特征峰大约在3387cm -1，3304cm -1，2953cm -1，2927cm -1，2868cm -1，1627cm -1，1455cm -1，1400cm -1 ，具有约3066cm -1，1583cm -1，1528cm -1，1281的特征峰的1201cm -1，1150cm -1，1020cm -1，747cm -1和702cm -1以及拉曼吸收光谱 cm -1，1213cm -1，1035cm -1，1022cm -1和1004cm -1。本发明还提供所述结晶形式-SB作为药物组合物中的活性药物成分用于治疗癌症的用途。

5. 发明授权

US10435409B2 Process for the preparation of ibrutinib 有权
公开(公告)号：US10435409B2
公开(公告)日：2019-10-08
申请号：US16073809
申请日：2017-02-02
申请人： SHILPA MEDICARE LIMITED
发明人： Sriram Rampalli , Lav Kumar Upalla , Chanti Babu Patneedi , Gopala Krishna Dasari , Akshay Kant Chaturvedi
IPC分类号： C07D487/04 , C07D211/32
摘要： The present invention relates to a process for the preparation of 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one or Ibrutinib of Formula (I). The present invention further relates to a process for the preparation highly pure 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one or Ibrutinib(I).

6. 发明授权

US10072012B2 Process for crystalline pemetrexed dipotassium salt 有权
公开(公告)号：US10072012B2
公开(公告)日：2018-09-11
申请号：US15036819
申请日：2014-11-11
申请人： SHILPA MEDICARE LIMITED
发明人： Bhagat Raj Pipal , Venkata Reddy Gayam , Akshay Kant Chaturvedi
IPC分类号： C07D487/00 , C07D487/04 , A61K31/519
CPC分类号： C07D487/04 , A61K31/519
摘要： The present invention provides process for preparing crystalline Pemetrexed dipotassium (I) Form-SP9 characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 2θ° peaks selected from the XRPD peak set of 5.0, 12.5, 17.2, 20.8, 22.4, 25.7, 26.9 and 27.9±0.2 2θ°. The invention also provides process for preparing its pharmaceutical composition thereof, which may be useful for anti-cancer treatment.

7. 发明授权

US09789113B2 Pemetrexed dipotassium formulations 有权
公开(公告)号：US09789113B2
公开(公告)日：2017-10-17
申请号：US15310451
申请日：2015-06-23
申请人： SHILPA MEDICARE LIMITED
发明人： Pradeep Shivakumar , Akshay Kant Chaturvedi
IPC分类号： A01N43/90 , A61K31/519 , C07D487/00 , A61K47/26 , A61K9/00
CPC分类号： A61K31/519 , A61K9/0019 , A61K9/19 , A61K47/26 , C07D487/04
摘要： The present application provides pharmaceutical compositions derived from pemetrexed dipotassium Nonahydrate and its process thereof.The present application also provides a method of treating cancer by administering intravenously the reconstituted lyophilized compositions into a patient in need thereof.

8. 发明授权

US09403785B2 Process for preparing amorphous cabazitaxel 有权
标题翻译：制备无定形卡巴他赛的方法
公开(公告)号：US09403785B2
公开(公告)日：2016-08-02
申请号：US14349332
申请日：2012-12-26
申请人： SHILPA MEDICARE LIMITED
发明人： Vimal Kumar Shrawat , Prashant Purohit , Rafiuddin Dr , Vinod Kumar Singh , Akshay Kant Chaturvedi
IPC分类号： C07D305/14 , C07D413/12
CPC分类号： C07D305/14 , C07D413/12
摘要： The present invention provides a non-solvated amorphous form of (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I), and process for preparation thereof. The present application also provides a non-solvated amorphous form of (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I) having an XRPD pattern as per FIG. 1, and IR spectrum as per FIG. 3 and is useful as an active pharmaceutical in a pharmaceutical composition comprising thereof and has anti-cancer activity.
摘要翻译：本发明提供了非溶剂化的（2α，5β，7β，10β，13α）-4-乙酰氧基-13 - （{（2R，3S）-3 [（叔丁氧基羰基）氨基] -2- 羟基-3-苯基丙酰基}氧基）-1-羟基-7,10-二甲氧基-9-氧代-5,20-环氧塔纳-1-烯-2-基苯甲酸酯或卡巴他赛（I），及其制备方法。本申请还提供（2α，5β，7β，10β，13α）-4-乙酰氧基-13 - （{（2R，3S）-3 [（叔丁氧基羰基）氨基] -2 - 羟基-3-苯基丙酰基}氧基）-1-羟基-7,10-二甲氧基-9-氧代-5,20-环氧树脂-11-烯-2-基苯甲酸酯或具有XRPD图案的卡巴他赛（I）。 1和IR光谱如图1所示。并且可用作其包含其的药物组合物中的活性药物并具有抗癌活性。

9. 发明申请

US20150259348A1 PROCESS FOR PREPARING PEMETREXED DI POTASSIUM AND ITS HYDRATES 审中-公开
标题翻译：制备PEMETREXED DI POTASSIUM及其水合物的方法
公开(公告)号：US20150259348A1
公开(公告)日：2015-09-17
申请号：US14426765
申请日：2013-10-16
申请人： SHILPA MEDICARE LIMITED
发明人： Vimal Kumar Sharawat , Dr. Rafiuddin , Vinod Kumar Singh , Bhagat Raj Pipal , Akshay Kant Chaturvedi
IPC分类号： C07D487/04
CPC分类号： C07D487/04
摘要： The present invention provides Di potassium (S)-2-(4-(2-(2-amino-4-oxo-4,7-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioate (I) and its hydrates useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of cancer. The present invention also provides process for preparation thereof.
摘要翻译：本发明提供二（2-（4-（2-（2-氨基-4-氧代-4,7-二氢-3H-吡咯并[2,3-d]嘧啶-5-基））苯甲酰氨基）戊二酸盐（I）及其水合物可用作用于治疗癌症的药物组合物中的活性药物成分。本发明还提供其制备方法。

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