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1. 发明授权

US08431539B2 Formulations of daptomycin 有权
标题翻译：达托霉素的制剂
公开(公告)号：US08431539B2
公开(公告)日：2013-04-30
申请号：US12884653
申请日：2010-09-17
申请人： Nagesh R. Palepu , Bulusu Bhanu Teja
发明人： Nagesh R. Palepu , Bulusu Bhanu Teja
IPC分类号： A61K38/12
CPC分类号： A61K47/12 , A61K38/00 , A61K47/20
摘要： Long term storage stable daptomycin-containing compositions are disclosed. The compositions include daptomycin or a pharmaceutically acceptable salt thereof at a concentration of less than or equal to about 25 mg/mL, a buffer having an acidic functional group and have a pH of from about 6.0 to about 7. The formulations are surprisingly free of degradation products such as the hydrolysis product of daptomycin and the β-isomer of daptomycin after storage periods of at least about 18 months.
摘要翻译：公开了长期储存稳定的含有达托泊霉素的组合物。组合物包含浓度小于或等于约25mg / mL的达托霉素或其药学上可接受的盐，具有酸性官能团并具有约6.0至约7的pH的缓冲液。该制剂令人惊奇地没有降解产物如达托霉素的水解产物和达托霉素的β-异构体在保存期至少约18个月后。

2. 发明授权

US07429390B2 Stable pharmaceutical compositions, processes for making the same and methods of their use 失效
标题翻译：稳定的药物组合物，制备方法及其使用方法
公开(公告)号：US07429390B2
公开(公告)日：2008-09-30
申请号：US11743262
申请日：2007-05-02
申请人： Nagesh R. Palepu
发明人： Nagesh R. Palepu
IPC分类号： A61K9/00 , A61K47/00 , A01N43/04
CPC分类号： A61K9/0095 , A61K9/08 , A61K31/34 , A61K47/36 , A61K47/38
摘要： The present invention is generally related to alcohol free, liquid ranitidine formulations for oral administration. In particular, the present invention is related to stable, syrup formulations having ranitidine as an active ingredient for oral administration, processes for making the same, and methods of their use. The ranitidine of the present invention is stable in non-polar media or media having a relatively low polarity such that the dielectric constant is less than about 60, and is achieved by using certain saccharides, certain relatively high molecular weight starches, and/or certain celluloses instead of alcohol.
摘要翻译：本发明通常涉及无酒精的用于口服给药的液体雷尼替丁制剂。特别地，本发明涉及具有雷尼替丁作为口服给药的活性成分的稳定的糖浆制剂，其制备方法及其使用方法。本发明的雷尼替丁在具有相对低极性的非极性介质或介质中是稳定的，使得介电常数小于约60，并且通过使用某些糖，某些相对高分子量的淀粉和/或某些纤维素代替酒精。

3. 发明授权

US09655898B2 Pharmaceutical compositions containing pemetrexed having extended storage stability 有权
公开(公告)号：US09655898B2
公开(公告)日：2017-05-23
申请号：US13806624
申请日：2011-07-26
申请人： Nagesh R. Palepu , Philip Christopher Buxton
发明人： Nagesh R. Palepu , Philip Christopher Buxton
IPC分类号： A61K31/519 , A61K9/08 , A61K47/10 , A61K47/12 , A61K47/18
CPC分类号： A61K31/519 , A61K9/08 , A61K47/10 , A61K47/12 , A61K47/183
摘要： Long term storage stable pemetrexed-containing liquid pharmaceutical compositions are disclosed. The compositions can include pemetrexed or pharmaceutically acceptable salts thereof; an antioxidant selected from lipoic acid, dihydrolipoic acid, methionine and mixtures thereof; a chelating agent selected from lactobionic acid, sodium citrate, tribasic and mixtures thereof; and a pharmaceutically acceptable fluid. The pH of the compositions is in a range of about 8 to about 9.5. The pemetrexed-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 227 nm, after at least about 18 months of storage at a temperature of from about 5° C. to about 25° C. Methods of preparing the formulation as well as methods of treatment of pemetrexed-susceptible diseases using the same are also disclosed.

4. 发明授权

US08609707B2 Formulations of bendamustine 有权
标题翻译：苯达莫司汀的配方
公开(公告)号：US08609707B2
公开(公告)日：2013-12-17
申请号：US13016473
申请日：2011-01-28
申请人： Nagesh R. Palepu , Philip Christopher Buxton
发明人： Nagesh R. Palepu , Philip Christopher Buxton
IPC分类号： A61K31/4184 , A61K31/095
CPC分类号： A61K31/4184 , A61K9/0019 , A61K9/08 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/186 , A61K47/20 , A61K47/22
摘要： Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
摘要翻译：公开了长期储存稳定的苯达莫司汀组合物。组合物可以包括苯达莫司汀或其药学上可接受的盐，以及药学上可接受的流体，其可在一些实施方案中包括PEG，PG或其混合物以及抗氧化剂或氯离子源。含苯达莫司汀的组合物具有小于约5％的总杂质，基于通过高效液相色谱（“HPLC”）在223nm波长下测定的标准化峰面积响应（“PAR”），至少约15 在约5℃至约25℃的温度下储存几个月

5. 发明申请

US20100119607A1 BIOENHANCED COMPOSITIONS 审中-公开
标题翻译：生物化合物
公开(公告)号：US20100119607A1
公开(公告)日：2010-05-13
申请号：US12557181
申请日：2009-09-10
申请人： Nagesh R. PALEPU , Pratibha S. PILGAONKAR , Maharukh T. RUSTOMJEE , Anilkumar S. GANDHI , Paras R. JAIN
发明人： Nagesh R. PALEPU , Pratibha S. PILGAONKAR , Maharukh T. RUSTOMJEE , Anilkumar S. GANDHI , Paras R. JAIN
IPC分类号： A61K31/41 , A61K9/10 , A61K31/4184 , A61K31/4178 , A61P3/10 , A61P25/22 , A61P13/12 , A61P25/28 , A61P25/24 , A61P3/04
CPC分类号： A61K31/41 , A61K9/1652 , A61K9/2054 , A61K31/4178 , A61K31/4184
摘要： The present invention relates to the method of increasing the bioavailability of Angiotensin II Receptor Blockers (ARBs) by preparing a composition of an ARB with at least one solubility enhancing agent. The invention is particularly focused to provide a novel or modified dissolution profile where the release of ARB in the GI tract is independent of physiological pH conditions.
摘要翻译：本发明涉及通过用至少一种溶解度增强剂制备具有ARB的组合物来增加血管紧张素II受体阻断剂（ARB）的生物利用度的方法。本发明特别集中于提供新颖或改良的溶出曲线，其中胃肠道中ARB的释放与生理pH条件无关。

6. 发明申请

US20090088468A1 NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF 有权
标题翻译：新型EPOPROSTENOL配方及其制备方法
公开(公告)号：US20090088468A1
公开(公告)日：2009-04-02
申请号：US12278061
申请日：2007-02-02
申请人： Nagesh R. Palepu
发明人： Nagesh R. Palepu
IPC分类号： A61K31/343 , C07D307/937 , A61P9/00
CPC分类号： A61K9/19 , A61K9/0019 , A61K31/557 , A61K31/5585 , A61K47/183 , A61K47/26
摘要： This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30° C. for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH>11. Methods for making the lyophilized composition are also disclosed.
摘要翻译：本发明涉及一种稳定的前荚MP素组合物，其可与市售IV液体组合，并且可以在约15-30℃的环境条件下以其重构和/或稀释形式施用大于24小时。组合物优选含有（a）依前列醇或其盐; （b）碱化剂; 和（c）碱，使得当重构或溶解时，溶液的pH> 11。还公开了制备冻干组合物的方法。

7. 发明授权

US08598227B2 Epoprostenol formulation and method of making thereof 有权
标题翻译： Eroprostenol制剂及其制备方法
公开(公告)号：US08598227B2
公开(公告)日：2013-12-03
申请号：US13621489
申请日：2012-09-17
申请人： Nagesh R. Palepu
发明人： Nagesh R. Palepu
IPC分类号： A01N43/00 , A01N43/06 , A61K31/33 , A61K31/38
CPC分类号： A61K9/19 , A61K9/0019 , A61K31/557 , A61K31/5585 , A61K47/183 , A61K47/26
摘要： This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30° C. for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH>11. Methods for making the lyophilized composition are also disclosed.
摘要翻译：本发明涉及一种稳定的前荚MP素组合物，其可与市售IV液体组合，并且可以在约15-30℃的环境条件下以其重构和/或稀释形式施用大于24小时。组合物优选含有（a）依前列醇或其盐; （b）碱化剂; 和（c）碱，使得当重构或溶解时，溶液的pH> 11。还公开了制备冻干组合物的方法。

8. 发明申请

US20130231357A1 PHARMACEUTICAL COMPOSITIONS CONTAINING PEMETREXED HAVING EXTENDED STORAGE STABILITY 有权
标题翻译：包含扩展存储稳定性的药物组合物
公开(公告)号：US20130231357A1
公开(公告)日：2013-09-05
申请号：US13806624
申请日：2011-07-26
申请人： Nagesh R. Palepu , Philip Christopher Buxton
发明人： Nagesh R. Palepu , Philip Christopher Buxton
IPC分类号： A61K31/519
CPC分类号： A61K31/519 , A61K9/08 , A61K47/10 , A61K47/12 , A61K47/183
摘要： Long term storage stable pemetrexed-containing liquid pharmaceutical compositions are disclosed. The compositions can include pemetrexed or pharmaceutically acceptable salts thereof; an antioxidant selected from lipoic acid, dihydrolipoic acid, methionine and mixtures thereof; a chelating agent selected from lactobionic acid, sodium citrate, tribasic and mixtures thereof; and a pharmaceutically acceptable fluid. The pH of the compositions is in a range of about 8 to about 9.5. The pemetrexed-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 227 nm, after at least about 18 months of storage at a temperature of from about 5° C. to about 25° C. Methods of preparing the formulation as well as methods of treatment of pemetrexed-susceptible diseases using the same are also disclosed.
摘要翻译：公开了长期储存稳定的含有培美曲塞的液体药物组合物。组合物可以包括培美曲塞或其药学上可接受的盐; 选自硫辛酸，二氢硫辛酸，甲硫氨酸及其混合物的抗氧化剂; 选自乳糖酸，柠檬酸钠，三元碱及其混合物的螯合剂; 和药学上可接受的流体。组合物的pH在约8至约9.5的范围内。在含有培美曲塞的组合物中，通过高效液相色谱法（“HPLC”）在227nm波长下测定的标准化峰面积响应（“PAR”），小于约5％的总杂质，至少约18 在约5℃至约25℃的温度下储存几个月。还公开了制备该制剂的方法以及使用该制剂治疗培美曲塞敏感性疾病的方法。

9. 发明申请

US20110184036A1 FORMULATIONS OF BENDAMUSTINE 有权
标题翻译： BENDAMUSTINE的配方
公开(公告)号：US20110184036A1
公开(公告)日：2011-07-28
申请号：US13016473
申请日：2011-01-28
申请人： Nagesh R. Palepu , Philip Christopher Buxton
发明人： Nagesh R. Palepu , Philip Christopher Buxton
IPC分类号： A61K31/4184 , A61P35/00
CPC分类号： A61K31/4184 , A61K9/0019 , A61K9/08 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/186 , A61K47/20 , A61K47/22
摘要： Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
摘要翻译：公开了长期储存稳定的苯达莫司汀组合物。组合物可以包括苯达莫司汀或其药学上可接受的盐，以及药学上可接受的流体，其可在一些实施方案中包括PEG，PG或其混合物以及抗氧化剂或氯离子源。含苯达莫司汀的组合物具有小于约5％的总杂质，基于通过高效液相色谱（“HPLC”）在223nm波长下测定的标准化峰面积响应（“PAR”），至少约15 在约5℃至约25℃的温度下储存几个月

10. 发明授权

US4963551A Stable lyophilized form of (S)-(+)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione and solutions thereof 失效
标题翻译：（S） - （+） - 双-2,4' - （1-甲基-1,2-乙二基）2,6-哌嗪二酮及其溶液的稳定冻干形式
公开(公告)号：US4963551A
公开(公告)日：1990-10-16
申请号：US463844
申请日：1990-01-12
申请人： Nagesh R. Palepu , Joyce W. Martin
发明人： Nagesh R. Palepu , Joyce W. Martin
IPC分类号： A61K9/00 , A61K9/19 , A61K31/495 , A61K47/02
CPC分类号： A61K31/495 , A61K47/02 , A61K9/0019 , A61K9/19 , Y10S514/97
摘要： The present invention is directed to a stable, rapidly soluble lyophilized injectable composition containing up to about 6% moisture and capable of being stored at room temperature comprising the hydrochloric or sulfate salt of a compound selected from the group consisting of (S)-(+)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione and (R)-(-)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione; wherein said lyophilized composition is prepared from a bulk solution comprising from about 25 mg/mL to about 40 mg/mL of said compound dissolved in a hydrochloric acid or sulfuric acid; wherein the pH of said bulk solution is from about 1.0 to about 2.0. The invention is further directed to an isotonic solution which is formed upon reconstitution of the lyophilizate of the invention with a pharmaceutically acceptable diluent.
摘要翻译：本发明涉及一种稳定，快速溶解的冻干可注射组合物，其含有高达约6％的水分并且能够在室温下储存，其包含选自（S） - （+）的化合物的盐酸盐或硫酸盐，） - 双 - 4,4' - （1-甲基-1,2-乙二基）2,6-哌嗪二酮和（R） - （ - ） - 双-4,4' - （1-甲基-1,2- 乙二基）2,6-哌嗪二酮; 其中所述冻干组合物由包含溶解在盐酸或硫酸中的约25mg / mL至约40mg / mL所述化合物的本体溶液制备; 其中所述本体溶液的pH为约1.0至约2.0。本发明进一步涉及在用药学上可接受的稀释剂重构本发明的冻干物时形成的等渗溶液。

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