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1. 发明申请

WO2007070851A2 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：WO2007070851A2
公开(公告)日：2007-06-21
申请号：PCT/US2006/062093
申请日：2006-12-14
申请人： ACUSPHERE, INC. , BERNSTEIN, Howard , BRITO, Shaina , CHICKERING, Donald, E. , HUANG, Eric, K. , JAIN, Rajeev , STRAUB, Julie, A.
发明人： BERNSTEIN, Howard , BRITO, Shaina , CHICKERING, Donald, E. , HUANG, Eric, K. , JAIN, Rajeev , STRAUB, Julie, A.
IPC分类号： A61K9/00 , 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 Ên 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) railling the first powder blend to form a milled blend which comprises microparticies 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，并且可以包括单独的磷脂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）冲击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。

2. 发明申请

WO2007070843A2 PROCESSES FOR MAKING PARTICLE-BASED PHARMACEUTICAL FORMULATIONS FOR ORAL ADMINISTRATION 审中-公开
标题翻译：口服给药的粒状药物制剂的制备方法
公开(公告)号：WO2007070843A2
公开(公告)日：2007-06-21
申请号：PCT/US2006/062073
申请日：2006-12-14
申请人： ACUSPHERE, INC. , ALTREUTER, David , BERNSTEIN, Howard , BRITO, Luis, A. , BRITO, Shaina , CHICKERING, Donald, E., III , HUANG, Eric, K. , JAIN, Rajeev , NARASIMHAN, Sridhar , STRAUB, Julie, A.
发明人： ALTREUTER, David , BERNSTEIN, Howard , BRITO, Luis, A. , BRITO, Shaina , CHICKERING, Donald, E., III , HUANG, Eric, K. , JAIN, Rajeev , NARASIMHAN, Sridhar , STRAUB, Julie, A.
IPC分类号： A61K9/14 , A61K9/16 , A61K9/20
CPC分类号： A61K9/145 , A61K9/0056 , A61K9/0095 , A61K9/2072 , A61K9/2077 , A61K9/2095
摘要： A method is provided for making an oral dosage form of a pharmaceutical agent which includes the steps of (a) providing particles which include a pharmaceutical agent; (b) blending the particles with particles of a pre-processed excipient to form a primary blend, wherein the pre-processed excipient is prepared by (i) dissolving a bulking agent (e.g., a sugar) and at least one non-friable excipient (e.g., a waxy or liquid surfactant) in a solvent to form an excipient solution, and (ii) removing the solvent from the excipient solution to form the pre-processed excipient in dry powder form; (c) milling the primary blend to form a milled pharmaceutical formulation blend that includes microparticles or nanoparticles of the pharmaceutical agent; and (d) processing the milled pharmaceutical formulation blend into a solid oral dosage form or liquid suspension for oral administration. The process yields formulations having improved wettability or dispersibility.
摘要翻译：提供了制备药剂口服剂型的方法，其包括以下步骤：（a）提供包含药剂的颗粒; （b）将所述颗粒与预加工的赋形剂的颗粒共混以形成主要共混物，其中所述预加工的赋形剂通过以下步骤制备：（i）将填充剂（例如糖）和至少一种不易碎的赋形剂（例如蜡质或液体表面活性剂）在溶剂中混合以形成赋形剂溶液，和（ii）从赋形剂溶液中除去溶剂以形成干粉形式的预处理赋形剂; （c）研磨所述主要共混物以形成包含所述药剂的微粒或纳米颗粒的研磨的药物制剂共混物; 和（d）将碾磨的药物制剂混合物加工成用于口服给药的固体口服剂型或液体悬浮液。该过程产生具有改进的润湿性或分散性的制剂。

3. 发明申请

WO2007070852A2 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：WO2007070852A2
公开(公告)日：2007-06-21
申请号：PCT/US2006/062094
申请日：2006-12-14
申请人： ACUSPHERE, INC. , ALTREUTER, David , BERNSTEIN, Howard , BRITO, Luis , BRITO, Shaina , CARNEIRO, Olinda, C. , CHICKERING, Donald, E. , HUANG, Eric, K. , JAIN, Rajeev , NARASIMHAN, Sridhar , PANDIT, Namrata , STRAUB, Julie, A.
发明人： ALTREUTER, David , BERNSTEIN, Howard , BRITO, Luis , BRITO, Shaina , CARNEIRO, Olinda, C. , CHICKERING, Donald, E. , HUANG, Eric, K. , JAIN, Rajeev , NARASIMHAN, Sridhar , PANDIT, Namrata , STRAUB, Julie, A.
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 nanopartides 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 tianopartÊcles, which exhibits a greater dispersibility, wettability, and suspcndability as compared to the particles of step (a) or the first blend.
摘要翻译：提供了制备药物的肠胃外剂型的方法，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，以形成与步骤（a）或第一共混物的颗粒相比显示出更大的分散性，润湿性和悬浮性的微粒或天然配料的研磨混合物。

4. 发明申请

WO2005032523A1 INJECTABLE, ORAL, OR TOPICAL SUSTAINED RELEASE PHARMACEUTICAL FORMULATIONS 审中-公开
标题翻译：可注射，口服或局部持续释放药物制剂
公开(公告)号：WO2005032523A1
公开(公告)日：2005-04-14
申请号：PCT/US2004/031570
申请日：2004-09-27
申请人： ACUSPHERE, INC. , BERNSTEIN, Howard , CHICKERING, Donald, E., III , HUANG, Eric, K. , NARASIMHAN, Sridhar , REESE, Shaina , STRAUB, Julie, A.
发明人： BERNSTEIN, Howard , CHICKERING, Donald, E., III , HUANG, Eric, K. , NARASIMHAN, Sridhar , REESE, Shaina , STRAUB, Julie, A.
IPC分类号： A61K9/16
CPC分类号： A61K9/1647 , A61K9/1617
摘要： Pharmaceutical formulations and methods are provided for the sustained delivery of a pharmaceutical agent to a patient by injection, by oral administration or by topical administration. The injectable formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein upon injection of the formulation a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles for at least 24 hours. The oral formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles for at least 2 hours following oral administration. The topical formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles for at least 2 hours following topical administration.
摘要翻译：提供药物制剂和方法用于通过注射，口服给药或通过局部给药将药剂持续递送至患者。可注射制剂包括包含药剂和基质材料的多孔微粒，其中在注射制剂时，治疗或预防有效量的药剂从微粒释放至少24小时。口服制剂包括包含药剂和基质材料的多孔微粒，其中在口服给药后至少2小时将治疗或预防有效量的药剂从微粒释放至少2小时。局部制剂包括包含药剂和基质材料的多孔微粒，其中治疗或预防有效量的药剂在局部给药后从微粒释放至少2小时。

5. 发明申请

WO2004060547A1 METHODS AND APPARATUS FOR MAKING PARTICLES USING SPRAY DRYER AND IN-LINE JET MILL 审中-公开
标题翻译：使用喷雾干燥机和在线喷射机制造颗粒的方法和装置
公开(公告)号：WO2004060547A1
公开(公告)日：2004-07-22
申请号：PCT/US2003/037108
申请日：2003-11-20
申请人： ACUSPHERE, INC.
发明人： CHICKERING, Donald, E., III , NARASIMHAN, Sridhar , ALTREUTER, David , KOPESKY, Paul , KEEGAN, Mark , STRAUB, Julie, A. , BERNSTEIN, Howard
IPC分类号： B01J2/04
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 (14) and into a primary drying chamber (12), 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 (12), 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 (24) 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.
摘要翻译：提供了用于制备颗粒的方法和装置，包括：（a）通过雾化器（14）将包含溶剂和散装材料（例如药剂）的乳液，溶液或悬浮液喷雾到初级干燥室（12），其具有流过其中的干燥气体，以形成包含分散在干燥气体中的溶剂和散装材料的液滴; （b）在主干燥室（12）中将至少一部分溶剂蒸发到干燥气体中以固化液滴并形成分散在干燥气体中的颗粒; 和（c）使颗粒和至少一部分干燥气体流过喷射磨机（24）以使颗粒解聚或研磨。通过将喷雾干燥与“直列式”喷射式研磨相结合，由两个单独的单元操作产生单步骤，有利地消除了另外的收集步骤。一步一步的在线过程在处理时间和成本方面具有进一步的优势。

6. 发明申请

WO2004060344A2 METHODS FOR MAKING PHARMACEUTICAL FORMULATIONS COMPRISING DEAGGLOMERATED MICROPARTICLES 审中-公开
标题翻译：制备包含去胶微粒的药物制剂的方法
公开(公告)号：WO2004060344A2
公开(公告)日：2004-07-22
申请号：PCT/US2003/037100
申请日：2003-11-20
申请人： ACUSPHERE, INC.
发明人： CHICKERING, Donald, E., III , REESE, Shaina , NARASIMHAN, Sridhar , STRAUB, Julie, A. , BERNSTEIN, Howard , ALTREUTER, David , HUANG, Eric, K.
IPC分类号： A61K9/00
CPC分类号： B01D1/18 , A61K9/0075 , A61K9/145 , A61K9/1647 , A61K9/1694 , B01J2/04
摘要： Methods are provided for making a dry powder blend pharmaceutical formulation comprising (i) forming microparticles which comprise a pharmaceutical agent; (ii) providing at least one excipient in the form of particles having a volume average diameter that is greater than the volume average diameter of the microparticles; (iii) blending the microparticles with the excipient to form a powder blend; and (iv) jet milling the powder blend to deagglomerate at least a portion of any of the microparticles which have agglomerated, while substantially maintaining the size and morphology of the individual microparticles. Jet milling advantageously can eliminate the need for more complicated wet deagglomeration processes, can lower residual moisture and solvent levels in the microparticles (which leads to better stability and handling properties for dry powder formulations), and can improve wettability, suspendability, and content uniformity of dry powder blend formulations.
摘要翻译：提供了制备干粉混合药物制剂的方法，所述药物制剂包含（i）形成包含药剂的微粒; （ii）以体积平均直径大于微粒体积平均直径的颗粒形式提供至少一种赋形剂; （iii）将微粒与赋形剂混合以形成粉末混合物; 和（iv）喷射研磨该粉末共混物以解聚附聚的任何微粒的至少一部分，同时基本保持单个微粒的尺寸和形态。喷射研磨有利地可以消除对更复杂的湿解聚集工艺的需要，可以降低微粒中的残留水分和溶剂水平（这导致对干粉制剂更好的稳定性和处理性能），并且可以改善润湿性，可悬浮性和含量均匀性干粉混合制剂。

7. 发明申请

WO2004030659A1 SUSTAINED RELEASE POROUS MICROPARTICLES FOR INHALATION 审中-公开
标题翻译：持续释放多孔微波炉用于吸入
公开(公告)号：WO2004030659A1
公开(公告)日：2004-04-15
申请号：PCT/US2003/030835
申请日：2003-09-30
申请人： ACUSPHERE, INC.
发明人： BERNSTEIN, Howard , CHICKERING, III, Donald, E. , HUANG, Eric, K. , NARASIMHAN, Sridhar , REESE, Shaina , STRAUB, Julie, A.
IPC分类号： A61K9/72
CPC分类号： A61K9/0075 , A61K9/008 , A61K9/1611 , A61K9/1617 , A61K9/1647 , A61K31/00 , A61K31/56 , A61K31/58
摘要： Pharmaceutical formulations and methods are provided for the sustained delivery of a pharmaceutical agent to the lungs of a patient by inhalation. The formulation includes porous microparticles which comprise a pharmaceutical agent and a matrix material, wherein upon inhalation of the formulation a therapeutically or prophylactically effective amount of the pharmaceutical agent is released from the microparticles in the lungs for at least 2 hours. Preferably, a majority of the pharmaceutical agent is released from the microparticles by 24 hours following inhalation, for example where a majority of the pharmaceutical agent is released no earlier than about 2 hours and no later than about 24 hours following inhalation. Methods for delivering a pharmaceutical agent, such as a corticosteroid, to the lungs of a patient are also provided. For example, the method includes having the patient inhale a dry powder blend comprising the present microparticles and a pharmaceutically acceptable bulking agent.
摘要翻译：提供药物制剂和方法用于通过吸入将药剂持续递送至患者的肺。制剂包括包含药剂和基质材料的多孔微粒，其中在吸入制剂时，治疗或预防有效量的药剂从肺中的微粒释放至少2小时。优选地，大多数药剂在吸入之后24小时从微粒释放，例如大多数药剂在吸入后不早于约2小时且不迟于约24小时释放。还提供了将药剂如皮质类固醇递送到患者的肺的方法。例如，该方法包括使患者吸入包含本发明的微粒和药学上可接受的填充剂的干粉混合物。

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