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41. 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。

42. 发明申请

US20070178165A1 PROCESSES FOR MAKING PARTICLE-BASED PHARMACEUTICAL FORMULATIONS FOR PARENTERAL ADMINISTRATION 审中-公开
标题翻译：制备基于颗粒的药物制剂用于住院管理的方法
公开(公告)号：US20070178165A1
公开(公告)日：2007-08-02
申请号：US11610791
申请日：2006-12-14
申请人： David Altreuter , Howard Bernstein , Luis Brito , Shaina Brito , Olinda Carneiro , Donald Chickering , Eric Huang , Rajeev Jain , Sridhar Narasimhan , Namrata Pandit , Julie Straub
发明人： David Altreuter , Howard Bernstein , Luis Brito , Shaina Brito , Olinda Carneiro , Donald Chickering , Eric Huang , Rajeev Jain , Sridhar Narasimhan , Namrata Pandit , Julie Straub
IPC分类号： A61K9/14
CPC分类号： A61K9/0019 , A61K9/145 , A61K9/146 , A61K9/19
摘要： A method is provided for making a parenteral dosage form of a pharmaceutical agent which includes (a) providing particles of a pharmaceutical agent; (b) blending the particles with particles of at least one bulking agent to form a first powder blend, which does not include a surfactant; (c) milling the first powder blend to form a milled blend which comprises microparticles or nanoparticles of the pharmaceutical agent; and (d) reconstituting the milled blend with a liquid vehicle, which includes at least one surfactant, for parenteral administration. A method also is provided which includes (a) providing particles of a pharmaceutical agent; (b) blending these particles with particles of an excipient to form a first blend; and (c) milling the first blend to form a milled blend that includes microparticles or nanoparticles, which exhibits a greater dispersibility, wettability, and suspendability as compared to the particles of step (a) or the first blend.
摘要翻译：提供了制备药物的胃肠外剂型的方法，其包括（a）提供药剂的颗粒; （b）将颗粒与至少一种填充剂的颗粒混合以形成不包括表面活性剂的第一粉末混合物; （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）将研磨的共混物与包含至少一种表面活性剂的液体载体重组，用于肠胃外给药。还提供了一种方法，其包括（a）提供药剂的颗粒; （b）将这些颗粒与赋形剂的颗粒混合以形成第一共混物; 和（c）研磨第一共混物以形成包含微粒或纳米颗粒的研磨的共混物，其与步骤（a）或第一共混物的颗粒相比表现出更大的分散性，润湿性和悬浮性。

43. 发明授权

US07160557B2 Matrices formed of polymer and hydrophobic compounds for use in drug delivery 有权
标题翻译：由聚合物和疏水化合物形成的矩阵用于药物递送
公开(公告)号：US07160557B2
公开(公告)日：2007-01-09
申请号：US09730694
申请日：2000-12-06
申请人： Howard Bernstein , Donald Chickering , Sarwat Khattak , Julie Straub
发明人： Howard Bernstein , Donald Chickering , Sarwat Khattak , Julie Straub
IPC分类号： A61K9/10 , A61K9/16 , A61K47/30 , A61K47/24
CPC分类号： A61K9/1617 , A61K9/1647 , Y10S514/951 , Y10S514/952
摘要： A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.
摘要翻译：将脂质或其它疏水性或两亲性化合物（本文统称为“疏水性化合物”）整合到用于药物递送的聚合物基质中以改变药物释放动力学。在药物是水溶性的实施方案中，与不将疏水化合物掺入聚合物材料的聚合物基质的释放相比，药物在更长的时间内释放。与其中加入表面活性剂或脂质作为赋形剂的方法相反，疏水化合物实际上整合到聚合物基质中，从而改变水进入微粒的扩散并将溶解的药物扩散出基质。整合的疏水化合物还延长了形成基质的水解不稳定聚合物的降解，进一步延缓了包封药物的释放。

44. 发明授权

US06932983B1 Porous drug matrices and methods of manufacture thereof 失效
标题翻译：多孔药物基质及其制造方法
公开(公告)号：US06932983B1
公开(公告)日：2005-08-23
申请号：US09706045
申请日：2000-11-03
申请人： Julie Straub , Howard Bernstein , Donald E. Chichering, III , Sarwat Khattak , Greg Randall
发明人： Julie Straub , Howard Bernstein , Donald E. Chichering, III , Sarwat Khattak , Greg Randall
IPC分类号： A61K9/16
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。

45. 发明授权

US06730322B1 Matrices formed of polymer and hydrophobic compounds for use in drug delivery 失效
标题翻译：由聚合物和疏水化合物形成的矩阵用于药物递送
公开(公告)号：US06730322B1
公开(公告)日：2004-05-04
申请号：US10384902
申请日：2003-03-06
申请人： Howard Bernstein , Donald Chickering , Sarwat Khattak , Julie Straub
发明人： Howard Bernstein , Donald Chickering , Sarwat Khattak , Julie Straub
IPC分类号： A61K910
CPC分类号： A61K9/1647 , A61K9/1617
摘要： A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.
摘要翻译：将脂质或其它疏水性或两亲性化合物（本文统称为“疏水化合物”）整合到用于药物递送的聚合物基质中以改变药物释放动力学。在药物是水溶性的实施方案中，与不将疏水化合物掺入聚合物材料的聚合物基质的释放相比，药物在更长的时间内释放。与其中加入表面活性剂或脂质作为赋形剂的方法相反，疏水化合物实际上整合到聚合物基质中，从而改变水进入微粒的扩散并将溶解的药物扩散出基质。整合的疏水化合物还延长了形成基质的水解不稳定聚合物的降解，进一步延缓了包封药物的释放。

46. 发明授权

US06589557B2 Porous celecoxib matrices and methods of manufacture thereof 有权
公开(公告)号：US06589557B2
公开(公告)日：2003-07-08
申请号：US09881289
申请日：2001-06-14
申请人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Greg Randall
发明人： Julie Straub , Howard Bernstein , Donald E. Chickering, III , Greg Randall
IPC分类号： A61K914
CPC分类号： A61K47/02 , A61K9/0019 , A61K9/2095
摘要： Celecoxib is 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 celecoxib 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 celecoxib matrices preferably are made using a process that includes (i) dissolving celecoxib 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 celecoxib. 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.

47. 发明授权

US06423345B1 Matrices formed of polymer and hydrophobic compounds for use in drug delivery 有权
公开(公告)号：US06423345B1
公开(公告)日：2002-07-23
申请号：US09255179
申请日：1999-02-22
申请人： Howard Bernstein , Donald Chickering , Sarwat Khattak , Julie Straub
发明人： Howard Bernstein , Donald Chickering , Sarwat Khattak , Julie Straub
IPC分类号： A61K910
摘要： A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.

48. 发明授权

US06308434B1 Spray drying method 有权
标题翻译：喷雾干燥法
公开(公告)号：US06308434B1
公开(公告)日：2001-10-30
申请号：US09756950
申请日：2001-01-09
申请人： Donald E. Chickering, III , Mark J. Keegan , Greg Randall , Howard Bernstein , Julie Straub
发明人： Donald E. Chickering, III , Mark J. Keegan , Greg Randall , Howard Bernstein , Julie Straub
IPC分类号： F26B308
CPC分类号： B01J2/04 , B01D1/18
摘要： Improved spray drying methods of have been developed. The spray drying method includes use of 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 microparticles, between about 1 and 200 &mgr;m in diameter, which can be used to deliver therapeutic and diagnostic agents.
摘要翻译：已经开发出改进的喷雾干燥方法。喷雾干燥方法包括使用初级干燥室和二次干燥设备，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，以将颗粒干燥至所需的程度，干燥速率温度太低，无法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的微粒，其可用于递送治疗和诊断剂。

49. 发明授权

US6165508A Controlled release of metal cation-stabilized interferon 失效
标题翻译：金属阳离子稳定的干扰素的控制释放
公开(公告)号：US6165508A
公开(公告)日：2000-12-26
申请号：US765558
申请日：1997-03-07
申请人： Mark A. Tracy , Howard Bernstein , M. Amin Khan
发明人： Mark A. Tracy , Howard Bernstein , M. Amin Khan
IPC分类号： A61K9/16 , A61K38/21 , A61K47/30 , C07K14/56 , A61K9/10
CPC分类号： B82Y5/00 , A61K9/1611 , A61K9/1647 , A61K38/212 , C07K14/56
摘要： This invention relates to a composition, and method of forming said composition, for the controlled release of interferon. The controlled release composition of this invention comprises a biocompatible polymer and particles of metal cation-stabilized interferon, wherein the particles are dispersed within the biocompatible polymer. The method of the invention, for producing a composition for the controlled release of interferon, includes dissolving a polymer in a polymer solvent to form a polymer solution, dispersing particles of metal cation-stabilized interferon particles in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of the interferon particles.
摘要翻译：本发明涉及用于控制释放干扰素的组合物和形成所述组合物的方法。本发明的控释组合物包含生物相容性聚合物和金属阳离子稳定化干扰素颗粒，其中颗粒分散在生物相容性聚合物内。本发明的制备用于控制干扰素释放的组合物的方法包括将聚合物溶解在聚合物溶剂中以形成聚合物溶液，将金属阳离子稳定的干扰素颗粒的颗粒分散在聚合物溶液中，然后固化聚合物以形成含有干扰素颗粒的分散体的聚合物基质。

50. 发明授权

US5611344A Microencapsulated fluorinated gases for use as imaging agents 失效
标题翻译：微胶囊化氟化气体用作成像剂
公开(公告)号：US5611344A
公开(公告)日：1997-03-18
申请号：US611248
申请日：1996-03-05
申请人： Howard Bernstein , Julie A. Straub , Henry T. Brush , Richard E. Wing
发明人： Howard Bernstein , Julie A. Straub , Henry T. Brush , Richard E. Wing
IPC分类号： A61B8/00 , A61K49/22
CPC分类号： A61B8/481 , A61K49/223
摘要： It has been discovered that the incorporation of fluorinated gases, especially a perfluorocarbon such as octafluoropropane, into synthetic polymeric microparticles, significantly enhances echogenicity as compared with microparticles having air incorporated therein. The microencapsulated perfluorocarbon is manufactured with a diameter suitable for the targeted tissue to be imaged, for example, for intravenous or oral administration. In one embodiment, bioadhesive microparticles are formed for enhanced imaging of mucosal surfaces.
摘要翻译：已经发现，与合并有空气的微粒相比，将氟化气体，特别是全氟化碳如八氟丙烷掺入到合成的聚合物微粒中显着增强回波反应性。制造微胶囊化全氟化碳，其直径适用于待成像的目标组织，例如用于静脉内或口服给药。在一个实施方案中，形成生物粘附微粒用于增强粘膜表面的成像。

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