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31. 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.

32. 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.

33. 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.

34. 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.

35. 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。

36. 发明申请

US20110009847A1 SYSTEMS AND METHODS FOR CREATING AND USING SUCTION BLISTERS OR OTHER POOLED REGIONS OF FLUID WITHIN THE SKIN 审中-公开
标题翻译：用于在皮肤中创建和使用吸液泡沫或其他液体区域的系统和方法
公开(公告)号：US20110009847A1
公开(公告)日：2011-01-13
申请号：US12716233
申请日：2010-03-02
申请人： Douglas A. Levinson , Howard Bernstein , Richard Rox Anderson
发明人： Douglas A. Levinson , Howard Bernstein , Richard Rox Anderson
IPC分类号： A61M31/00
CPC分类号： A61B5/150099 , A61B5/0013 , A61B5/0022 , A61B5/0077 , A61B5/1438 , A61B5/14532 , A61B5/14539 , A61B5/14546 , A61B5/1459 , A61B5/14865 , A61B5/150022 , A61B5/150221 , A61B5/150358 , A61B5/150389 , A61B5/150412 , A61B5/150442 , A61B5/150503 , A61B5/150969 , A61B5/150984 , A61B5/151 , A61B5/15125 , A61B5/157 , A61B5/411 , A61B5/4839 , A61B5/4845 , A61B5/486 , A61B5/685 , A61B5/6898 , A61B5/743
摘要： The present invention generally relates to devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications, for example, devices for delivering and/or withdrawing fluid from subjects, e.g., through the skin. In some embodiments, the device includes a system for accessing an extractable medium from and/or through the skin of the subject at an access site, and a pressure regulator supported by a support structure, able to create a pressure differential across the skin at least a portion of the access site. The device may also include, in some cases, a sensor supported by the support structure for determining at least one condition of the extractable medium from the subject, and optionally a signal generator supported by the support structure for generating a signal relating to the condition of the medium determined by the sensor.
摘要翻译：本发明一般涉及与诊断，治疗和其它应用相关联的装置和技术，包括皮肤相关应用，例如用于递送和/或从主体（例如通过皮肤）排出流体的装置。在一些实施例中，所述装置包括用于在进入位置从所述受试者的皮肤和/或穿过所述受试者的皮肤接入可提取介质的系统，以及由支撑结构支撑的压力调节器，所述压力调节器能够至少在所述皮肤上形成压差访问站点的一部分。在一些情况下，该装置还可以包括由支撑结构支持的传感器，用于确定来自主体的可提取介质的至少一个状况，以及可选地由支撑结构支撑的信号发生器，用于产生与介质由传感器确定。

37. 发明申请

US20100249560A1 OXYGEN SENSOR 审中-公开
标题翻译：氧传感器
公开(公告)号：US20100249560A1
公开(公告)日：2010-09-30
申请号：US12716222
申请日：2010-03-02
申请人： Douglas A. Levinson , Howard Bernstein
发明人： Douglas A. Levinson , Howard Bernstein
IPC分类号： A61B5/145
CPC分类号： G01N33/84 , A61B5/021 , A61B5/14532 , A61B5/14542 , A61B5/411 , A61B2560/0412 , A61M5/14244 , G01N33/54366 , G01N33/72
摘要： The present invention generally relates to systems and methods for determining oxygen in a sample, or in a subject. In one aspect, the present invention is generally directed to an article exhibiting a determinable feature responsive to oxygen, such as oxygen-sensitive particles. The particles may exhibit a determinable change with a change in oxygen concentration, and such particles can accordingly be used to determine oxygen. For example, in one set of embodiments, the particles may be at least partially coated with a protein, such as hemoglobin, that is able to interact with oxygen. In some cases, the protein may aggregate under certain conditions (e.g., under relatively low oxygen concentrations), and such protein aggregation may be used, for example, to cause the particles to become aggregated, which can be determined in some way. In some cases, such aggregation may be irreversible; i.e., the degree of aggregation corresponds to the most extreme oxygen concentrations that the proteins were exposed to. Such articles may be used, for example, to determine oxygen within a sample, or within a subject, such as a human subject. For instance, the article may be formed as a skin patch, or administered to the skin of a subject, e.g., on the surface of the skin, within the dermis or epidermis, etc., to determine oxygen within the subject.
摘要翻译：本发明一般涉及用于测定样品或受试者中的氧的系统和方法。一方面，本发明一般涉及一种表现出对氧敏感的颗粒有氧的可确定特征的物品。颗粒可以随着氧浓度的变化而呈现可确定的变化，因此可以使用这样的颗粒来确定氧气。例如，在一组实施方案中，颗粒可以至少部分地涂覆有能够与氧相互作用的蛋白质，例如血红蛋白。在一些情况下，蛋白质可以在某些条件下（例如，在相对低的氧浓度下）聚集，并且可以使用这种蛋白质聚集，例如使颗粒变得聚集，这可以以某种方式确定。在某些情况下，这种聚合可能是不可逆的; 即聚集度对应于蛋白质暴露于最极端的氧浓度。例如，这样的制品可用于测定样品内或受试者（例如人类受试者）内的氧。例如，制品可以形成为皮肤贴片，或者施用于受试者的皮肤，例如皮肤表面，真皮或表皮等内，以确定受试者内的氧。

38. 发明申请

US20110288389A9 OXYGEN SENSOR 审中-公开
标题翻译：氧传感器
公开(公告)号：US20110288389A9
公开(公告)日：2011-11-24
申请号：US12716222
申请日：2010-03-02
申请人： Douglas A. Levinson , Howard Bernstein
发明人： Douglas A. Levinson , Howard Bernstein
IPC分类号： A61B5/145
CPC分类号： G01N33/84 , A61B5/021 , A61B5/14532 , A61B5/14542 , A61B5/411 , A61B2560/0412 , A61M5/14244 , G01N33/54366 , G01N33/72
摘要： The present invention generally relates to systems and methods for determining oxygen in a sample, or in a subject. In one aspect, the present invention is generally directed to an article exhibiting a determinable feature responsive to oxygen, such as oxygen-sensitive particles. The particles may exhibit a determinable change with a change in oxygen concentration, and such particles can accordingly be used to determine oxygen. For example, in one set of embodiments, the particles may be at least partially coated with a protein, such as hemoglobin, that is able to interact with oxygen. In some cases, the protein may aggregate under certain conditions (e.g., under relatively low oxygen concentrations), and such protein aggregation may be used, for example, to cause the particles to become aggregated, which can be determined in some way. In some cases, such aggregation may be irreversible; i.e., the degree of aggregation corresponds to the most extreme oxygen concentrations that the proteins were exposed to. Such articles may be used, for example, to determine oxygen within a sample, or within a subject, such as a human subject. For instance, the article may be formed as a skin patch, or administered to the skin of a subject, e.g., on the surface of the skin, within the dermis or epidermis, etc., to determine oxygen within the subject.
摘要翻译：本发明一般涉及用于测定样品或受试者中的氧的系统和方法。一方面，本发明一般涉及一种表现出对氧敏感的颗粒有氧的可确定特征的物品。颗粒可以随着氧浓度的变化而呈现可确定的变化，因此可以使用这样的颗粒来确定氧气。例如，在一组实施方案中，颗粒可以至少部分地涂覆有能够与氧相互作用的蛋白质，例如血红蛋白。在一些情况下，蛋白质可以在某些条件下（例如，在相对低的氧浓度下）聚集，并且可以使用这种蛋白质聚集，例如使颗粒变得聚集，这可以以某种方式确定。在某些情况下，这种聚合可能是不可逆的; 即聚集度对应于蛋白质暴露于最极端的氧浓度。例如，这样的制品可用于测定样品内或受试者（例如人类受试者）内的氧。例如，制品可以形成为皮肤贴片，或者施用于受试者的皮肤，例如皮肤表面，真皮或表皮等内，以确定受试者内的氧。

39. 发明申请

US20120039809A1 SYSTEMS AND TECHNIQUES FOR MONITORING SUBJECTS 审中-公开
标题翻译：监控项目的系统和技术
公开(公告)号：US20120039809A1
公开(公告)日：2012-02-16
申请号：US13208808
申请日：2011-08-12
申请人： Douglas A. Levinson , Howard Bernstein
发明人： Douglas A. Levinson , Howard Bernstein
IPC分类号： A61K49/00 , G06F19/00 , G06Q30/00 , A61M5/168 , G06Q40/00
CPC分类号： A61B5/4833 , A61B5/1112 , A61B5/145 , A61B5/14503 , A61B5/14514 , A61B5/14546 , A61B5/150022 , A61B5/150099 , A61B5/150175 , A61B5/150389 , A61B5/150412 , A61B5/150503 , A61B5/150755 , A61B5/150809 , A61B5/150824 , A61B5/150854 , A61B5/150862 , A61B5/150969 , A61B5/150984 , A61B5/15113 , A61B5/15125 , A61B5/15142 , A61B5/154 , A61B5/157 , A61B5/4839 , A61B5/4848 , A61B5/6824 , A61B10/0045 , A61B2010/0009 , A61B2010/008 , A61M5/1723 , A61M37/0015 , A61M2037/0023 , G06F19/3418 , G06F19/3456 , G06F19/3468 , G06Q20/10 , G06Q30/02 , G06Q30/0207 , G06Q50/22 , G16H40/63 , Y02A90/22 , 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（有或没有待监测的药物）的试剂盒，促进这种系统的方法等。

40. 发明申请

US20070178166A1 PROCESSES FOR MAKING PARTICLE-BASED PHARMACEUTICAL FORMULATIONS FOR PULMONARY OR NASAL ADMINISTRATION 审中-公开
标题翻译：制备基于粒子的药物制剂用于肺癌或鼻咽管理的方法
公开(公告)号：US20070178166A1
公开(公告)日：2007-08-02
申请号：US11610814
申请日：2006-12-14
申请人： Howard Bernstein , Shaina Brito , Donald Chickering , Eric Huang , Rajeev Jain , Julie Straub
发明人： Howard Bernstein , Shaina Brito , Donald Chickering , Eric Huang , Rajeev Jain , Julie Straub
IPC分类号： A61K9/14
CPC分类号： A61K9/0075 , A61K9/0043 , A61K9/0073 , A61K9/143 , A61K9/145
摘要： Dry powder pharmaceutical formulations for pulmonary or nasal administration are made to provide an improved respired dose. These formulations may be blends of milled blends and may include a phospholipid, alone or in combination with other excipient materials. In one case, the process includes the steps of (a) providing particles which comprise a pharmaceutical agent, (b) blending the particles with particles of at least one first excipient to form a first powder blend; (c) milling the first powder blend to form a milled blend which comprises microparticles or nanoparticles of the pharmaceutical agent; and (d) blending the milled blend with particles of a second excipient to form a blended dry powder blend pharmaceutical formulation suitable for pulmonary or nasal administration.
摘要翻译：制备用于肺或鼻给药的干粉药物制剂以提供改善的呼吸剂量。这些制剂可以是研磨的共混物的混合物，并且可以包括单独或与其它赋形剂材料组合的磷脂。在一种情况下，该方法包括以下步骤：（a）提供包含药剂的颗粒，（b）将颗粒与至少一种第一赋形剂的颗粒混合以形成第一粉末混合物; （c）研磨第一粉末混合物以形成包含药剂的微粒或纳米颗粒的研磨混合物; 和（d）将研磨的共混物与第二赋形剂的颗粒混合以形成适于肺或鼻施用的混合的干粉混合药物制剂。

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