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1. 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.

2. 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.

3. 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.

4. 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.

5. 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。

6. 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。

7. 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。

8. 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。

9. 发明授权

US06223455B1 Spray drying apparatus and methods of use 有权
标题翻译：喷雾干燥装置及使用方法
公开(公告)号：US06223455B1
公开(公告)日：2001-05-01
申请号：US09304257
申请日：1999-05-03
申请人： Donald E. Chickering, III , Howard Bernstein , Mark Keegan , Greg Randall , Julie Straub
发明人： Donald E. Chickering, III , Howard Bernstein , Mark Keegan , Greg Randall , Julie Straub
IPC分类号： F26B1700
CPC分类号： B01J2/04 , B01D1/18
摘要： Improved spray drying apparati, and methods of use thereof, have been developed. The spray drying equipment includes a primary drying chamber and a secondary drying apparatus which includes tubing having a length sufficient to increase the contact time between the drying gas and the droplets/particles to dry the particles to the extent desired, at a drying rate and temperature which would be too low to provide adequate drying without the secondary drying apparatus. The secondary drying apparatus increases the drying efficiency of the spray dryer system without increasing the drying rate, while minimizing loss in yield The ratio of the length of tubing to the length of the primary drying chamber is at least 2:1. The tubing diameter is substantially smaller than the diameter of the primary drying chamber, such that the particles move at higher velocity through the tubing to minimize product losses. The ratio of the cross-sectional area of the primary drying chamber to the cross-sectional area of the tubing most preferably is about 16:1. The tubing preferably is in a compact coil design, which can more easily be transported and which has minimum space requirements, and may optionally include a jacket to control the temperature of the secondary drying process. A preferred application for the spray drying process and equipment is in the production of polymeric microparticles, between about 1 and 200 &mgr;m in diameter, which can be used to deliver therapeutic and diagnostic agents.
摘要翻译：已经开发了改进的喷雾干燥装置及其使用方法。喷雾干燥设备包括初级干燥室和次级干燥设备，其包括具有足以增加干燥气体和液滴/颗粒之间的接触时间的长度的管道，以将干燥颗粒以期望的程度以干燥速率和温度这不足以在没有二次干燥装置的情况下提供足够的干燥。二次干燥装置提高喷雾干燥器系统的干燥效率，而不增加干燥速率，同时最小化产率损失。管道长度与初级干燥室长度之比至少为2:1。管道直径基本上小于初级干燥室的直径，使得颗粒以更高的速度移动通过管道以最小化产品损失。初级干燥室的横截面积与管道的横截面面积的比率最优选为约16:1。管道优选地处于紧凑的线圈设计中，其可以更容易地被输送并且具有最小的空间要求，并且可以可选地包括用于控制二次干燥过程的温度的护套。用于喷雾干燥方法和设备的优选应用是生产直径约1-200μm的聚合物微粒，其可用于递送治疗剂和诊断剂。

10. 发明申请

US20110181410A1 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：US20110181410A1
公开(公告)日：2011-07-28
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： G08B21/00
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。

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