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1. 再颁专利

USRE40493E1 Porous paclitaxel matrices and methods of manufacture thereof 有权
标题翻译：多孔紫杉醇基质及其制备方法
公开(公告)号：USRE40493E1
公开(公告)日：2008-09-09
申请号：US11213257
申请日：2005-08-26
申请人： Julie A. Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
发明人： Julie A. Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61K9/14 , A61K9/70 , A61F2/00
CPC分类号： A61K9/1623 , A61K9/1611 , A61K9/1635 , A61K9/1694 , Y10S977/906
摘要： Paclitaxel is provided in a porous matrix form, which allows the drug to be formulated without Cremophor and administered as a bolus. The paclitaxel matrices preferably are made using a process that includes (i) dissolving paclitaxel in a volatile solvent to form a paclitaxel solution, (ii) combining at least one pore forming agent with the paclitaxel solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of paclitaxel. The pore forming agent can be either a volatile liquid that is immiscible with the paclitaxel solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. In a preferred embodiment, microparticles of the porous paclitaxel matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.
摘要翻译：紫杉醇以多孔基质形式提供，其允许药物在没有Cremophor的情况下配制并作为大剂量给药。紫杉醇基质优选使用包括（i）将紫杉醇溶解在挥发性溶剂中以形成紫杉醇溶液的方法制备，（ii）将至少一种成孔剂与紫杉醇溶液组合以形成乳液，悬浮液或第二溶液，和（iii）从乳液，悬浮液或第二溶液中除去挥发性溶剂和成孔剂以产生紫杉醇的多孔基质。成孔剂可以是与紫杉醇溶剂或挥发性固体化合物，优选挥发性盐不混溶的挥发性液体。在优选的实施方案中，使用喷雾干燥来除去溶剂和成孔剂。在优选的实施方案中，多孔紫杉醇基质的微粒用水性介质重新配制，并肠胃外给药，或使用标准技术加工成用于口服给药的片剂或胶囊。

2. 发明授权

US08821938B2 Porous drug matrices and methods of manufacture thereof 有权
标题翻译：多孔药物基质及其制造方法
公开(公告)号：US08821938B2
公开(公告)日：2014-09-02
申请号：US13022776
申请日：2011-02-08
申请人： Julie Straub , David Altreuter , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
发明人： Julie Straub , David Altreuter , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61K9/14 , A61K9/00 , A61K31/335 , A01N43/02
CPC分类号： A61K9/1635 , A61K9/1611 , A61K9/1623 , A61K9/1688 , A61K9/1694
摘要： Drugs, especially low aqueous solubility drugs, are provided in a porous matrix form, preferably microparticles, which enhances dissolution of the drug in aqueous media. The drug matrices preferably are made using a process that includes (i) dissolving a drug, preferably a drug having low aqueous solubility, in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution and hydrophilic or hydrophobic excipients that stabilize the drug and inhibit crystallization, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. Hydrophobic or hydrophilic excipients may be selected to stabilize the drug in crystalline form by inhibiting crystal growth or to stabilize the drug in amorphous form by preventing crystallization. The pore forming agent can be either a volatile liquid that is immiscible with the drug solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. The resulting porous matrix has a faster rate of dissolution following administration to a patient, as compared to non-porous matrix forms of the drug. In a preferred embodiment, microparticles of the porous drug matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.
摘要翻译：药物，特别是低含水溶性药物以多孔基质形式提供，优选微粒，其增强药物在水性介质中的溶解。药物基质优选使用以下方法制备，所述方法包括（i）将挥发性溶剂中的药物（优选为低溶解度的药物）溶解以形成药物溶液，（ii）将至少一种成孔剂与药物溶液以形成稳定药物并抑制结晶的乳液，悬浮液或第二溶液和亲水或疏水赋形剂，和（iii）从乳液，悬浮液或第二溶液中除去挥发性溶剂和成孔剂以产生多孔基质药物。可以选择疏水性或亲水性赋形剂，以通过抑制晶体生长来稳定药物的结晶形式，或者通过防止结晶来稳定药物的无定形形式。成孔剂可以是与药物溶剂或挥发性固体化合物，优选挥发性盐不混溶的挥发性液体。在优选的实施方案中，使用喷雾干燥来除去溶剂和成孔剂。与药物的无孔基质形式相比，得到的多孔基质在给予患者后具有更快的溶解速率。在优选的实施方案中，多孔药物基质的微粒用水性介质重新配制，并肠胃外给药，或使用标准技术加工成用于口服给药的片剂或胶囊。

3. 发明授权

US06610317B2 Porous paclitaxel matrices and methods of manufacture thereof 有权
公开(公告)号：US06610317B2
公开(公告)日：2003-08-26
申请号：US09798824
申请日：2001-03-02
申请人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
发明人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61F200
CPC分类号： A61K9/1623 , A61K9/1611 , A61K9/1635 , A61K9/1694 , Y10S977/906
摘要： Paclitaxel is provided in a porous matrix form, which allows the drug to be formulated without Cremophor and administered as a bolus. The paclitaxel matrices preferably are made using a process that includes (i) dissolving paclitaxel in a volatile solvent to form a paclitaxel solution, (ii) combining at least one pore forming agent with the paclitaxel solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of paclitaxel. The pore forming agent can be either a volatile liquid that is immiscible with the paclitaxel solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. In a preferred embodiment, microparticles of the porous paclitaxel matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.

4. 发明授权

US06395300B1 Porous drug matrices and methods of manufacture thereof 有权
标题翻译：多孔药物基质及其制造方法
公开(公告)号：US06395300B1
公开(公告)日：2002-05-28
申请号：US09433486
申请日：1999-11-04
申请人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
发明人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61K914
CPC分类号： A61K9/1688 , A61K9/1611 , A61K9/1623 , A61K9/1635 , A61K9/1694 , Y10S514/951 , Y10S977/906 , Y10S977/923
摘要： Drugs, especially low aqueous solubility drugs, are provided in a porous matrix form, preferably microparticles, which enhances dissolution of the drug in aqueous media. The drug matrices preferably are made using a process that includes (i) dissolving a drug, preferably a drug having low aqueous solubility, in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. The pore forming agent can be either a volatile liquid that is immiscible with the drug solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. The resulting porous matrix has a faster rate of dissolution following administration to a patient, as compared to non-porous matrix forms of the drug. In a preferred embodiment, microparticles of the porous drug matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.
摘要翻译：药物，特别是低含水溶性药物以多孔基质形式提供，优选微粒，其增强药物在水性介质中的溶解。药物基质优选使用以下方法制备，所述方法包括（i）将挥发性溶剂中的药物（优选为低溶解度的药物）溶解以形成药物溶液，（ii）将至少一种成孔剂与药物溶液以形成乳液，悬浮液或第二溶液，和（iii）从乳液，悬浮液或第二溶液中除去挥发性溶剂和成孔剂以产生药物的多孔基质。成孔剂可以是与药物溶剂或挥发性固体化合物，优选挥发性盐不混溶的挥发性液体。在优选的实施方案中，使用喷雾干燥来除去溶剂和成孔剂。与药物的无孔基质形式相比，得到的多孔基质在给予患者后具有更快的溶解速率。在优选的实施方案中，多孔药物基质的微粒用水性介质重新配制，并肠胃外给药，或使用标准技术加工成用于口服给药的片剂或胶囊。

5. 发明申请

US20110129533A1 POROUS DRUG MATRICES AND METHODS OF MANUFACTURE THEREOF 有权
标题翻译：多糖药物及其制造方法
公开(公告)号：US20110129533A1
公开(公告)日：2011-06-02
申请号：US13022776
申请日：2011-02-08
申请人： Julie Straub , David Altreuter , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
发明人： Julie Straub , David Altreuter , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61K31/337 , A61K9/10 , A61P35/00
CPC分类号： A61K9/1635 , A61K9/1611 , A61K9/1623 , A61K9/1688 , A61K9/1694
摘要： Drugs, especially low aqueous solubility drugs, are provided in a porous matrix form, preferably microparticles, which enhances dissolution of the drug in aqueous media. The drug matrices preferably are made using a process that includes (i) dissolving a drug, preferably a drug having low aqueous solubility, in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution and hydrophilic or hydrophobic excipients that stabilize the drug and inhibit crystallization, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. Hydrophobic or hydrophilic excipients may be selected to stabilize the drug in crystalline form by inhibiting crystal growth or to stabilize the drug in amorphous form by preventing crystallization. The pore forming agent can be either a volatile liquid that is immiscible with the drug solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. The resulting porous matrix has a faster rate of dissolution following administration to a patient, as compared to non-porous matrix forms of the drug. In a preferred embodiment, microparticles of the porous drug matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.
摘要翻译：药物，特别是低含水溶性药物以多孔基质形式提供，优选微粒，其增强药物在水性介质中的溶解。药物基质优选使用以下方法制备，所述方法包括（i）将挥发性溶剂中的药物（优选为低溶解度的药物）溶解以形成药物溶液，（ii）将至少一种成孔剂与药物溶液以形成稳定药物并抑制结晶的乳液，悬浮液或第二溶液和亲水或疏水赋形剂，和（iii）从乳液，悬浮液或第二溶液中除去挥发性溶剂和成孔剂以产生多孔基质药物。可以选择疏水性或亲水性赋形剂，以通过抑制晶体生长来稳定药物的结晶形式，或者通过防止结晶来稳定药物的无定形形式。成孔剂可以是与药物溶剂或挥发性固体化合物，优选挥发性盐不混溶的挥发性液体。在优选的实施方案中，使用喷雾干燥来除去溶剂和成孔剂。与药物的无孔基质形式相比，得到的多孔基质在给予患者后具有更快的溶解速率。在优选的实施方案中，多孔药物基质的微粒用水性介质重新配制，并肠胃外给药，或使用标准技术加工成用于口服给药的片剂或胶囊。

6. 发明授权

US07919119B2 Porous drug matrices and methods of manufacture thereof 有权
标题翻译：多孔药物基质及其制造方法
公开(公告)号：US07919119B2
公开(公告)日：2011-04-05
申请号：US10053929
申请日：2002-01-22
申请人： Julie Straub , David Altreuter , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
发明人： Julie Straub , David Altreuter , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61K9/14 , A61K9/50 , B29B9/00
CPC分类号： A61K9/1635 , A61K9/1611 , A61K9/1623 , A61K9/1688 , A61K9/1694
摘要： Drugs, especially low aqueous solubility drugs, are provided in a porous matrix form, preferably microparticles, which enhances dissolution of the drug in aqueous media. The drug matrices preferably are made using a process that includes (i) dissolving a drug, preferably a drug having low aqueous solubility, in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution and hydrophilic or hydrophobic excipients that stabilize the drug and inhibit crystallization, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. Hydrophobic or hydrophilic excipients may be selected to stabilize the drug in crystalline form by inhibiting crystal growth or to stabilize the drug in amorphous form by preventing crystallization. The pore forming agent can be either a volatile liquid that is immiscible with the drug solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. The resulting porous matrix has a faster rate of dissolution following administration to a patient, as compared to non-porous matrix forms of the drug. In a preferred embodiment, microparticles of the porous drug matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.
摘要翻译：药物，特别是低含水溶性药物以多孔基质形式提供，优选微粒，其增强药物在水性介质中的溶解。药物基质优选使用以下方法制备，所述方法包括（i）将挥发性溶剂中的药物（优选为低溶解度的药物）溶解以形成药物溶液，（ii）将至少一种成孔剂与药物溶液以形成稳定药物并抑制结晶的乳液，悬浮液或第二溶液和亲水或疏水赋形剂，和（iii）从乳液，悬浮液或第二溶液中除去挥发性溶剂和成孔剂以产生多孔基质药物。可以选择疏水性或亲水性赋形剂，以通过抑制晶体生长来稳定药物的结晶形式，或者通过防止结晶来稳定药物的无定形形式。成孔剂可以是与药物溶剂或挥发性固体化合物，优选挥发性盐不混溶的挥发性液体。在优选的实施方案中，使用喷雾干燥来除去溶剂和成孔剂。与药物的无孔基质形式相比，得到的多孔基质在给予患者后具有更快的溶解速率。在优选的实施方案中，多孔药物基质的微粒用水性介质重新配制，并肠胃外给药，或使用标准技术加工成用于口服给药的片剂或胶囊。

7. 发明授权

US06645528B1 Porous drug matrices and methods of manufacture thereof 有权
公开(公告)号：US06645528B1
公开(公告)日：2003-11-11
申请号：US09694407
申请日：2000-10-23
申请人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
发明人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61K914
CPC分类号： A61K9/1688 , A61K9/1611 , A61K9/1623 , A61K9/1635 , A61K9/1694 , Y10S514/951 , Y10S977/906 , Y10S977/923
摘要： Drugs, especially low aqueous solubility drugs, are provided in a porous matrix form, preferably microparticles, which enhances dissolution of the drug in aqueous media. The drug matrices preferably are made using a process that includes (i) dissolving a drug, preferably a drug having low aqueous solubility, in a volatile solvent to form a drug solution, (ii) combining at least one pore forming agent with the drug solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of drug. The pore forming agent can be either a volatile liquid that is immiscible with the drug solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. The resulting porous matrix has a faster rate of dissolution following administration to a patient, as compared to non-porous matrix forms of the drug. In a preferred embodiment, microparticles of the porous drug matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.

8. 发明授权

US06918991B2 Methods and apparatus for making particles using spray dryer and in-line jet mill 失效
公开(公告)号：US06918991B2
公开(公告)日：2005-07-19
申请号：US10752910
申请日：2004-01-07
申请人： Donald E. Chickering, III , Sridhar Narasimhan , David Altreuter , Paul Kopesky , Mark Keegan , Julie A. Straub , Howard Bernstein
发明人： Donald E. Chickering, III , Sridhar Narasimhan , David Altreuter , Paul Kopesky , Mark Keegan , Julie A. Straub , Howard Bernstein
IPC分类号： A61K9/16 , B01D1/18 , B01J2/04 , F26B3/12 , F26B17/10 , B01D1/16
CPC分类号： F26B17/102 , A61K9/1647 , A61K9/1688 , B01D1/18 , B01J2/04 , F26B3/12
摘要： Methods and apparatus are provided for making particles comprising: (a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material (e.g., a pharmaceutical agent), through an atomizer and into a primary drying chamber, having a drying gas flowing therethrough, to form droplets comprising the solvent and bulk material dispersed in the drying gas; (b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in drying gas; and (c) flowing the particles and at least a portion of the drying gas through a jet mill to deagglomerate or grind the particles. By coupling spray drying with “in-line” jet milling, a single step process is created from two separate unit operations, and an additional collection step is advantageously eliminated. The one-step, in-line process has further advantages in time and cost of processing.

9. 发明授权

US06921458B2 Methods and apparatus for making particles using spray dryer and in-line jet mill 失效
公开(公告)号：US06921458B2
公开(公告)日：2005-07-26
申请号：US10752861
申请日：2004-01-07
申请人： Donald E. Chickering, III , Sridhar Narasimhan , David Altreuter , Paul Kopesky , Mark Keegan , Julie A. Straub , Howard Bernstein
发明人： Donald E. Chickering, III , Sridhar Narasimhan , David Altreuter , Paul Kopesky , Mark Keegan , Julie A. Straub , Howard Bernstein
IPC分类号： A61K9/16 , B01D1/18 , B01J2/04 , F26B3/12 , F26B17/10 , B01D1/16
CPC分类号： F26B17/102 , A61K9/1647 , A61K9/1688 , B01D1/18 , B01J2/04 , F26B3/12
摘要： Methods and apparatus are provided for making particles comprising: (a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material (e.g., a pharmaceutical agent), through an atomizer and into a primary drying chamber, having a drying gas flowing therethrough, to form droplets comprising the solvent and bulk material dispersed in the drying gas; (b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in drying gas; and (c) flowing the particles and at least a portion of the drying gas through a jet mill to deagglomerate or grind the particles. By coupling spray drying with “in-line” jet milling, a single step process is created from two separate unit operations, and an additional collection step is advantageously eliminated. The one-step, in-line process has further advantages in time and cost of processing.

10. 发明授权

US06962006B2 Methods and apparatus for making particles using spray dryer and in-line jet mill 失效
公开(公告)号：US06962006B2
公开(公告)日：2005-11-08
申请号：US10324943
申请日：2002-12-19
申请人： Donald E. Chickering, III , Sridhar Narasimhan , David Altreuter , Paul Kopesky , Mark Keegan , Julie A. Straub , Howard Bernstein
发明人： Donald E. Chickering, III , Sridhar Narasimhan , David Altreuter , Paul Kopesky , Mark Keegan , Julie A. Straub , Howard Bernstein
IPC分类号： A61K9/16 , B01D1/18 , B01J2/04 , F26B3/12 , F26B17/10 , F26B3/08
CPC分类号： F26B17/102 , A61K9/1647 , A61K9/1688 , B01D1/18 , B01J2/04 , F26B3/12
摘要： Methods and apparatus are provided for making particles comprising: (a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material (e.g., a pharmaceutical agent), through an atomizer and into a primary drying chamber, having a drying gas flowing therethrough, to form droplets comprising the solvent and bulk material dispersed in the drying gas; (b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in drying gas; and (c) flowing the particles and at least a portion of the drying gas through a jet mill to deagglomerate or grind the particles. By coupling spray drying with “in-line” jet milling, a single step process is created from two separate unit operations, and an additional collection step is advantageously eliminated. The one-step, in-line process has further advantages in time and cost of processing.

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