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1. 发明申请

WO2004064752A3 METHOD OF PREPARING SUSTAINED RELEASE MICROPARTICLES 审中-公开
标题翻译：制备持续释放微生物的方法
公开(公告)号：WO2004064752A3
公开(公告)日：2005-05-12
申请号：PCT/US2004001501
申请日：2004-01-21
申请人： ALKERMES INC , BROWN JOSIAH , JAWOROWICZ WARREN E , TROIANO GREGORY C
发明人： BROWN JOSIAH , JAWOROWICZ WARREN E , TROIANO GREGORY C
IPC分类号： A61K9/00 , A61K9/16 , A61K9/50
CPC分类号： A61K9/1694 , A61K9/0024 , A61K9/1647 , A61K9/5031 , Y10T428/2982 , Y10T428/2991 , Y10T428/2998
摘要： The present invention relates to a method for preparing an injectable composition of microparticles for the sustained release of a biologically active agent. The microparticles include a biocompatible polymer and a biologically active agent. The invention provides an improved process for the preparation of microparticles, wherein the physical characteristics of the microparticles, for example, the morphology, density and size, are independent of the process used to prepare the initially formed polymer/drug matrix. The method includes the steps of (a) providing a polymer/biologically active agent matrix; (b) compressing the polymer/biologically active agent matrix, thereby forming a compressed matrix; and (c) fragmenting the compressed matrix, thereby forming an injectable microparticle composition. The polymer/drug matrix can be provided by any suitable method.
摘要翻译：本发明涉及制备用于持续释放生物活性剂的微粒的可注射组合物的方法。微粒包括生物相容性聚合物和生物活性剂。本发明提供了一种制备微粒的改进方法，其中微粒的物理特性，例如形态，密度和尺寸，与用于制备初始形成的聚合物/药物基质的方法无关。该方法包括以下步骤：（a）提供聚合物/生物活性剂基质; （b）压缩聚合物/生物活性剂基质，从而形成压缩基质; 和（c）将压缩的基质分段，从而形成可注射的微粒组合物。聚合物/药物基质可以通过任何合适的方法提供。

2. 发明申请

WO2005025543A2 POLYMER-BASED SUSTAINED RELEASE DEVICE AND METHOD FOR PREPARATION 审中-公开
标题翻译：基于聚合物的持续释放装置及其制备方法
公开(公告)号：WO2005025543A2
公开(公告)日：2005-03-24
申请号：PCT/US2004029645
申请日：2004-09-08
申请人： ALKERMES INC , TROIANO GREGORY C , PASZYC TINA , JAWOROWICZ WARREN E , BROWN JOSIAH
发明人： TROIANO GREGORY C , PASZYC TINA , JAWOROWICZ WARREN E , BROWN JOSIAH
IPC分类号： A61K9/16 , A61K38/00
CPC分类号： A61K9/1694 , A61K9/1647
摘要： Methods for preparing a polymer-based sustained release device including a biocompatible polymer having incorporated therein a biologically active agent are described. In one embodiment, the method of preparing a polymer-based sustained release device comprises the steps of (a) exchanging a continuous medium component of a disperse system, the disperse system including a biologically active agent as a dispersed entity, with an organic liquid, thereby forming a first mixture that includes the biologically active agent and the organic liquid; (b) combining a biocompatible polymer with the first mixture, thereby forming a second mixture that includes the biologically active agent, the organic liquid, and the biocompatible polymer; and (c) separating the organic liquid from the second mixture, thereby forming the polymer-based sustained release device. In one embodiment, the continuous medium component of the disperse system is exchanged with the organic liquid using diafiltration, for example, diafiltration using tangential flow filtration.
摘要翻译：描述了制备包含其中并入生物活性剂的生物相容性聚合物的基于聚合物的持续释放装置的方法。在一个实施方案中，制备基于聚合物的持续释放装置的方法包括以下步骤：（a）将分散系统的连续介质组分（包括分散体的生物活性剂）与有机液体交换，从而形成包含生物活性剂和有机液体的第一混合物; （b）将生物相容性聚合物与第一混合物结合，从而形成包含生物活性剂，有机液体和生物相容性聚合物的第二混合物; 和（c）从第二混合物中分离有机液体，从而形成基于聚合物的持续释放装置。在一个实施方案中，使用渗滤将有机液体与分散系统的连续介质组分进行交换，例如使用切向流过滤进行渗滤。

3. 发明申请

WO0213783A8 PROCESS FOR PREPARING POLYMER-BASED SUSTAINED RELEASE COMPOSITIONS 审中-公开
标题翻译：制备基于聚合物的持续释放组合物的方法
公开(公告)号：WO0213783A8
公开(公告)日：2002-10-03
申请号：PCT/US0124166
申请日：2001-07-30
申请人： ALKERMES INC , JAWOROWICZ WARREN E , WRIGHT JAMES I
发明人： JAWOROWICZ WARREN E , WRIGHT JAMES I
IPC分类号： A61K9/16
CPC分类号： A61K9/1647 , A61K9/1694 , Y10S514/964 , Y10S514/965
摘要： The invention relates to a sustained release composition and methods of forming and using said composition for the sustained release of biologically active agent. The sustained release compositions of the invention comprise a biocompatible polymer and a biologically active agent characterized by a porous center and a less porous outer layer wherein the center and outer layer consist of essentially the same materials. The sustained release compositions can be prepared by annealing at least a substantial portion of the exterior surface of a polymer/active agent matrix. The compositions which have been annealed exhibit a decrease in the release of agent over the first 24 hours following administration (i.e., reduced burst) and as a result can show an increase in the duration of sustained release thereby providing increased therapeutic benefits.
摘要翻译：本发明涉及缓释组合物和形成和使用所述组合物以持续释放生物活性剂的方法。本发明的持续释放组合物包含生物相容性聚合物和生物活性剂，其特征在于多孔中心和较少多孔外层，其中中心层和外层由基本上相同的材料组成。持续释放组合物可以通过使至少大部分的聚合物/活性剂基质的外表面退火来制备。已经退火的组合物在给药后的前24小时表现出试剂释放的降低（即，减少的爆发），结果可以显示持续释放的持续时间的增加，从而提供增加的治疗益处。

4. 发明申请

WO0213783A3 PROCESS FOR PREPARING POLYMER-BASED SUSTAINED RELEASE COMPOSITIONS 审中-公开
标题翻译：制备基于聚合物的持续释放组合物的方法
公开(公告)号：WO0213783A3
公开(公告)日：2002-08-15
申请号：PCT/US0124166
申请日：2001-07-30
申请人： ALKERMES INC , WRIGHT JAMES I , JAWOROWICZ WARREN E
发明人： WRIGHT JAMES I , JAWOROWICZ WARREN E
IPC分类号： A61K9/16
CPC分类号： A61K9/1647 , A61K9/1694 , Y10S514/964 , Y10S514/965
摘要： The invention relates to a sustained release composition and methods of forming and using said composition for the sustained release of biologically active agent. The sustained release compositions of the invention comprise a biocompatible polymer and a biologically active agent characterized by a porous center and a less porous outer layer wherein the center and outer layer consist of essentially the same materials. The sustained release compositions can be prepared by annealing at least a substantial portion of the exterior surface of a polymer/active agent matrix. The compositions which have been annealed exhibit a decrease in the release of agent over the first 24 hours following administration (i.e., reduced burst) and as a result can show an increase in the duration of sustained release thereby providing increased therapeutic benefits.
摘要翻译：本发明涉及持续释放组合物以及形成和使用所述组合物用于持续释放生物活性剂的方法。本发明的持续释放组合物包含生物相容性聚合物和生物活性剂，其特征在于多孔中心和少孔多孔外层，其中中心层和外层基本上由相同的材料组成。持续释放组合物可以通过退火聚合物/活性剂基质的至少大部分外表面来制备。已经退火的组合物在给药后的最初24小时内表现出药剂释放减少（即减少的爆发），并且因此可以显示持续释放持续时间的增加，从而提供增加的治疗益处。

5. 发明申请

WO0052049A3 A METHOD FOR PURIFYING HUMAN GROWTH HORMONE 审中-公开
标题翻译：一种净化人类生长激素的方法
公开(公告)号：WO0052049A3
公开(公告)日：2000-12-21
申请号：PCT/US0005210
申请日：2000-02-29
申请人： ALKERMES INC
发明人： JAWOROWICZ WARREN E
IPC分类号： A61K9/58 , A61K38/00 , A61K38/27 , A61K47/02 , A61P5/06 , C07K1/32 , C07K14/61
CPC分类号： C07K14/61 , A61K38/00
摘要： A method of purifying human growth hormone (hGH) from deamidated hGH, oxidized hGH or both. The method comprises the steps of forming a metal cation complexed-hGH composition enriched in native hGH under conditions wherein none or less than all of the deamidated hGH, oxidized hGH or both complex with a metal cation and, isolating the metal cation-complexed hGH composition from the deamidated hGH, oxidized hGH or combination thereof. The method can further comprise the step of releasing purified hGH from the complex. Alternatively, the metal cation-complexed hGH can be encapsulated into a biocompatible polymer for sustained release of hGH. The purification method can be performed one or more times using the hGH released from the metal cation-complexed hGH composition, depending on the purity of hGH desired.
摘要翻译：从脱酰胺hGH，氧化hGH或两者纯化人生长激素（hGH）的方法。该方法包括以下步骤：在不存在或少于所有脱酰胺hGH，氧化的hGH或两者与金属阳离子络合物并分离金属阳离子络合的hGH组合物的条件下形成富含天然hGH的金属阳离子复合hGH组合物从脱酰胺hGH，氧化hGH或其组合。该方法还可以包括从复合物中释放纯化的hGH的步骤。或者，金属阳离子络合的hGH可以包封在生物相容性聚合物中以持续释放hGH。取决于所需的hGH的纯度，可以使用从金属阳离子络合的hGH组合物释放的hGH一次或多次进行纯化方法。

6. 发明专利

CA2373635A1 METHOD OF PRODUCING SUBMICRON PARTICLES OF A LABILE AGENT 未知
公开(公告)号：CA2373635A1
公开(公告)日：2000-12-07
申请号：CA2373635
申请日：2000-05-09
申请人： ALKERMES INC
发明人： JAWOROWICZ WARREN E , WARD KEVIN L , TRACY MARK A
IPC分类号： A61K9/50 , A61K9/10 , A61K9/26 , A61K9/51 , A61K38/27 , A61P5/02
摘要： The present invention relates to a sustained release composition comprising micron particles of labile agent and a method of preparing and using the sustained release composition. The invention further relates to micron particles of a labile agent and a method of preparing the micron particles. The method of the invention for preparing a composition for the sustained release of a labile agent, comprises forming a suspension comprising the labile agent dispersed in a polymer solution comprising at least one biocompatible polymer and at least one polymer solvent. The suspension is th en wet milled to achieve micron particles of the labile agent. The polymer solvent is then removed resulting in a solid polymer/labile agent matrix. Th e composition for sustained release of a labile agent is likewise prepared according to the method of the invention. The sustained release composition of the present invention can be used in a method for providing a therapeuticall y effective blood level of a labile agent, in a subject in need of treatment with said agent, for a sustained period comprising administering to the subject the sustained release composition described herein. The method for preparing micron particles of a labile agent comprises forming a suspension comprising the labile agent, dispersed ina polymer solution comprising at least one biocompatible polymer and at least one polymer solvent, and wet milling of the suspension. The submicron particles of labile agent, as described herein, are prepared according to this method.

7. 发明专利

AU761472B2 Method of producing sub-micron particles of biologically active agents 未知
公开(公告)号：AU761472B2
公开(公告)日：2003-06-05
申请号：AU2116501
申请日：2000-10-18
申请人： ALKERMES INC
发明人： COSTANTINO HENRY R , JAWOROWICZ WARREN E , TRACY MARK A , BEGANSKI CHRISTOPHER P
IPC分类号： A61K9/19 , A61K9/16 , A61K38/00 , A61K38/27 , A61K47/02 , A61K47/34 , A61K9/51

8. 发明专利

AU2116501A Method of producing sub-micron particles of biologically active agents 未知
公开(公告)号：AU2116501A
公开(公告)日：2001-04-30
申请号：AU2116501
申请日：2000-10-18
申请人： ALKERMES INC
发明人： COSTANTINO HENRY R , JAWOROWICZ WARREN E , TRACY MARK A , BEGANSKI CHRISTOPHER P
IPC分类号： A61K9/19 , A61K9/16 , A61K38/00 , A61K38/27 , A61K47/02 , A61K47/34 , A61K9/51

9. 发明申请

WO0128525A3 METHOD OF PRODUCING SUB-MICRON PARTICLES OF BIOLOGICALLY ACTIVE AGENTS 审中-公开
标题翻译：生产生物活性剂的亚微米颗粒的方法
公开(公告)号：WO0128525A3
公开(公告)日：2002-05-02
申请号：PCT/US0041308
申请日：2000-10-18
申请人： ALKERMES INC
发明人： COSTANTINO HENRY R , JAWOROWICZ WARREN E , TRACY MARK A , BEGANSKI CHRISTOPHER P
IPC分类号： A61K9/19 , A61K9/16 , A61K38/00 , A61K38/27 , A61K47/02 , A61K47/34 , A61K9/51
CPC分类号： A61K9/1688 , A61K9/1694 , Y10S977/906 , Y10T428/2985
摘要： Submicron particles of a biologically active agent are prepared by atomizing using multifluid atomization a dispersed system comprising at least one biologically active agent and at least one solvent to produce droplets, freezing the droplets to produce frozen droplets, lyophilizing the frozen droplets to obtain microstructures capable of being further fragmented into submicron particles by techniques such as probe sonication. The submicron particles can be incorporated into sustained release compositions having a reduced initial release of biologically active agent. The sustained release compositions can be administered to a human or animal.
摘要翻译：通过使用多流体雾化将包含至少一种生物活性剂和至少一种溶剂的分散系统进行雾化来制备生物活性剂的亚微米颗粒，以产生液滴，冷冻液滴以产生冷冻液滴，冻干冷冻液滴以获得能够通过诸如探针超声处理的技术进一步碎裂成亚微米颗粒。亚微米颗粒可以并入具有降低的生物活性剂的初始释放的缓释组合物中。持续释放组合物可以施用于人或动物。

10. 发明专利

CA2388653A1 METHOD OF PRODUCING SUB-MICRON PARTICLES OF BIOLOGICALLY ACTIVE AGENTS 未知
公开(公告)号：CA2388653A1
公开(公告)日：2001-04-26
申请号：CA2388653
申请日：2000-10-18
申请人： ALKERMES INC
发明人： TRACY MARK A , JAWOROWICZ WARREN E , COSTANTINO HENRY R , BEGANSKI CHRISTOPHER P
IPC分类号： A61K9/19 , A61K9/16 , A61K38/00 , A61K38/27 , A61K47/02 , A61K47/34 , A61K9/51
摘要： Submicron particles of a biologically active agent are prepared by atomizing using multifluid atomization a dispersed system comprising at least one biologically active agent and at least one solvent to produce droplets, freezing the droplets to produce frozen droplets, lyophilizing the frozen droplets to obtain microstructures capable of being further fragmented into submicron particles by techniques such as probe sonication. The submicron particles can be incorporated into sustained release compositions having a reduced initial release of biologically active agent. The sustained release compositions can be administered to a human or animal.

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