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31. 发明授权

US09041541B2 Monitoring or feedback systems and methods 有权
标题翻译：监控或反馈系统和方法
公开(公告)号：US09041541B2
公开(公告)日：2015-05-26
申请号：US13016575
申请日：2011-01-28
申请人： Douglas A. Levinson , Howard Bernstein , Donald E. Chickering, III
发明人： Douglas A. Levinson , Howard Bernstein , Donald E. Chickering, III
IPC分类号： G08B23/00 , G06F19/00
CPC分类号： G06F19/3456 , G06F19/00 , Y02A90/26
摘要： The present invention generally relates to systems and methods for monitoring and/or providing feedback for drugs or other pharmaceuticals taken by a subject. In one aspect, the present invention is directed to devices and methods for determining a species within the skin of a subject; and producing feedback to a subject based on the determination of the species. The feedback may be, for example, visual, audible, tactile, a change in temperature, etc. In some cases, information regarding the determination of the species may be transmitted to another entity, e.g., a health care provider, a computer, a relative, etc., which may then provide feedback to the subject in some fashion. In some cases, the feedback may be directly indicative of the species, e.g., whether the species is present, the concentration of the species, whether a by-product of a reaction involving the species is present, whether a compound affected by the species is present, etc. However, the feedback may also be indirect in some embodiments. For example, the subject may be presented with an external reward, e.g., based on the determination of the species within the skin. For instance, a reward such as cash, coupons, songs, discounts, personal items, etc., may be offered based on the level of compliance of the subject. Still other aspects of the invention are generally directed to kits involving such devices (with or without the drug to be monitored), methods of promoting such systems, or the like.
摘要翻译：本发明一般涉及用于监测和/或提供受试者所采取的药物或其他药物的反馈的系统和方法。一方面，本发明涉及用于确定受试者皮肤内物种的装置和方法; 并根据物种的确定向对象产生反馈。反馈可以是例如视觉，听觉，触觉，温度变化等。在一些情况下，关于物种的确定的信息可以被传输到另一个实体，例如医疗保健提供者，计算机，相对等，其然后可以以某种方式向受试者提供反馈。在一些情况下，反馈可以直接指示物种，例如物种是否存在，物种的浓度，是否存在涉及物种的反应的副产物，受物种影响的化合物是否为存在等。然而，在一些实施例中，反馈也可以是间接的。例如，受试者可以例如基于皮肤内物种的确定来呈现外部奖励。例如，可以基于主体的合规级别来提供诸如现金，优惠券，歌曲，折扣，个人物品等的奖励。本发明的其它方面通常涉及涉及这种装置的试剂盒（有或没有待监测的药物），促进这种系统的方法等。

32. 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。

33. 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.

34. 发明授权

US06800297B2 Porous COX-2 inhibitor matrices and methods of manufacture thereof 失效
公开(公告)号：US06800297B2
公开(公告)日：2004-10-05
申请号：US10441440
申请日：2003-05-19
申请人： David Altreuter , Julie Straub , Howard Bernstein , Donald E. Chickering, III , Paul Kopesky , Greg Randall
发明人： David Altreuter , Julie Straub , Howard Bernstein , Donald E. Chickering, III , Paul Kopesky , Greg Randall
IPC分类号： A51K914
CPC分类号： A61K9/0019 , A61K9/2095 , A61K47/02
摘要： One or more COX-2 inhibitors are provided in a porous matrix form wherein the dissolution rate of the drug is enhanced when the matrix is contacted with an aqueous medium. The porous matrix yields upon contact with an aqueous medium nanoparticles and microparticles of COX-2 inhibitors having a mean diameter between about 0.01 and 5 &mgr;m and a total surface area greater than about 0.5 m2/mL. The dry porous matrix preferably is in a dry powder form having a TAP density less than or equal to 1.0 g/mL. The porous COX-2 inhibitor matrices preferably are made using a process that includes (i) dissolving one or more COX-2 inhibitors 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 dry porous matrix of COX-2 inhibitors. 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.

35. 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.

36. 发明授权

US06528035B1 Multiwall polymeric microcapsules from hydrophilic polymers 失效
标题翻译：来自亲水聚合物的多壁聚合物微胶囊
公开(公告)号：US06528035B1
公开(公告)日：2003-03-04
申请号：US09707440
申请日：2000-11-06
申请人： Edith Mathiowitz , Jules S. Jacob , Donald E. Chickering, III , Kathleen Jo Leach
发明人： Edith Mathiowitz , Jules S. Jacob , Donald E. Chickering, III , Kathleen Jo Leach
IPC分类号： B32B516
CPC分类号： B01J13/04 , A61K9/1641 , A61K9/1652 , A61K9/1694 , A61K9/5036 , A61K9/5052 , A61K9/5089 , B29K2003/00 , Y10S514/963 , Y10S514/965 , Y10T428/2984 , Y10T428/2985 , Y10T428/2989 , Y10T428/2991
摘要： Two or more hydrophilic polymers that are not soluble in each other at a particular concentration and temperature, but which have a positive spreading coefficient in solution, are used to form multi-layered polymeric microspheres. The multi-layer microspheres produced by the method are distinguished by extremely uniform dimensioned polymer layers and actual incorporation of a substance to be delivered into the polymer layers. In the preferred embodiment of the method, two polymers are dissolved in an aqueous solvent, the substance to be incorporated is dispersed or dissolved in the polymer solution, the mixture is suspended in an organic solvent or polymer/water mixture and stirred, and the solvent is slowly evaporated, creating microspheres with an inner core formed by one polymer and an outer layer formed by the second polymer.
摘要翻译：在特定浓度和温度下彼此不溶的但在溶液中具有正扩散系数的两种或更多种亲水性聚合物用于形成多层聚合物微球体。通过该方法制备的多层微球的特征在于非常均匀的尺寸聚合物层和实际掺入待输送到聚合物层中的物质。在该方法的优选实施方案中，将两种聚合物溶解在水性溶剂中，将待加入的物质分散或溶解在聚合物溶液中，将混合物悬浮在有机溶剂或聚合物/水混合物中并搅拌，并将溶剂缓慢蒸发，产生具有由一种聚合物形成的内芯和由第二聚合物形成的外层的微球。

37. 发明授权

US06511749B1 Preparation of multiwall polymeric microcapsules from hydrophilic polymers 失效
标题翻译：从亲水聚合物制备多壁聚合物微胶囊
公开(公告)号：US06511749B1
公开(公告)日：2003-01-28
申请号：US08990365
申请日：1997-12-15
申请人： Edith Mathiowitz , Jules S. Jacob , Donald E. Chickering, III , Kathleen Jo Pekarek
发明人： Edith Mathiowitz , Jules S. Jacob , Donald E. Chickering, III , Kathleen Jo Pekarek
IPC分类号： B32B1502
CPC分类号： B01J13/04 , A61K9/1641 , A61K9/1652 , A61K9/1694 , A61K9/5036 , A61K9/5052 , A61K9/5089 , B29K2003/00 , Y10S514/963 , Y10S514/965 , Y10T428/2984 , Y10T428/2985 , Y10T428/2989 , Y10T428/2991
摘要： Two or more hydrophilic polymers that are not soluble in each other at a particular concentration and temperature, but which have a positive spreading coefficient in solution, are used to form multi-layered polymeric microspheres. The multi-layer microspheres produced by the method are distinguished by extremely uniform dimensioned polymer layers and actual incorporation of a substance to be delivered into the polymer layers. In the preferred embodiment of the method, two polymers are dissolved in an aqueous solvent, the substance to be incorporated is dispersed or dissolved in the polymer solution, the mixture is suspended in an organic solvent or polymer/water mixture and stirred, and the solvent is slowly evaporated, creating microspheres with an inner core formed by one polymer and an outer layer formed by the second polymer.
摘要翻译：在特定浓度和温度下彼此不溶的但在溶液中具有正扩散系数的两种或更多种亲水性聚合物用于形成多层聚合物微球体。通过该方法制备的多层微球的特征在于非常均匀的尺寸聚合物层和实际掺入待输送到聚合物层中的物质。在该方法的优选实施方案中，将两种聚合物溶解在水性溶剂中，将待加入的物质分散或溶解在聚合物溶液中，将混合物悬浮在有机溶剂或聚合物/水混合物中并搅拌，并将溶剂缓慢蒸发，产生具有由一种聚合物形成的内芯和由第二聚合物形成的外层的微球。

38. 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。

39. 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.

40. 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.

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