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1. 发明申请

WO1996040074A2 DEVICE FOR RELEASING AGGREGATION-STABILIZED, BIOLOGICALLY ACTIVE AGENT 审中-公开
标题翻译：用于释放聚集稳定的生物活性剂的装置
公开(公告)号：WO1996040074A2
公开(公告)日：1996-12-19
申请号：PCT/US1996008526
申请日：1996-06-04
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC. , BURKE, Paul, A. , ZALE, Stephen, E. , TRACY, Mark, A. , JOHNSON, OluFunmi, Lily , BERNSTEIN, Howard , KHAN, M., Amin , BRICKNER, Avram , AUER, Henry
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC.
IPC分类号： A61K09/16
CPC分类号： B82Y5/00 , A61K9/0019 , A61K9/1611 , A61K9/1647 , A61K38/1816 , A61K38/27 , A61K47/02 , A61K47/26
摘要： A device for the sustained release in vivo of a water soluble, biologically active agent wherein the agent is susceptible to aggregation comprising a drug delivery device and aggregation-stabilized, biologically active agent wherein the aggregation-stabilized agent is disposed within the drug delivery device.
摘要翻译：用于在体内持续释放水溶性生物活性剂的装置，其中所述试剂易于凝集，其包含药物递送装置和聚集稳定的生物活性剂，其中所述聚集稳定的试剂置于所述药物递送装置内。

2. 发明申请

WO1996040072A2 COMPOSITION FOR SUSTAINED RELEASE OF HUMAN GROWTH HORMONE 审中-公开
标题翻译：用于持续释放人体生长激素的组合物
公开(公告)号：WO1996040072A2
公开(公告)日：1996-12-19
申请号：PCT/US1996008086
申请日：1996-06-03
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC. , JOHNSON, OluFunmi, Lily , GANMUKHI, Medha, M. , BERNSTEIN, Howard , AUER, Henry , KHAN, M., Amin
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC.
IPC分类号： A61K09/16
CPC分类号： B82Y5/00 , A61K9/1611 , A61K9/1647 , A61K38/27
摘要： A composition, and methods of forming and using said composition, for the sustained release of biologically active, stabilized human growth hormone (hGH). The sustained release composition of this invention comprises a polymeric matrix of a biocompatible polymer and particles of biologically active, stabilized hGH, wherein said particles are dispersed within the biocompatible polymer. The method of the invention for producing a composition for the sustained release of biologically active hGH, includes dissolving a biocompatible polymer in a polymer solvent to form a polymer solution, dispersing particles of biologically active, metal cation-stabilized hGH in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of said hGH particles. The method for using a composition of the invention is a method for providing a therapeutically effective blood level of biologically active, non-aggregated hGH in a subject for a sustained period. In this method, a subject is administered an effective dose of the sustained release composition of the present invention. The method of using the sustained release composition of the present invention comprises providing a therapeutically effective blood level of biologically active, non-aggregated human growth hormone in a subject for a sustained period by administering to the subject a dose of said sustained release composition.
摘要翻译：用于持续释放生物活性稳定的人生长激素（hGH）的组合物和形成和使用所述组合物的方法。本发明的缓释组合物包含生物相容性聚合物的聚合物基质和生物活性稳定的hGH颗粒，其中所述颗粒分散在生物相容性聚合物内。用于生产用于持续释放生物活性的hGH的组合物的本发明的方法包括将生物相容性聚合物溶解在聚合物溶剂中以形成聚合物溶液，将生物活性的金属阳离子稳定的hGH的颗粒分散在聚合物溶液中，以及然后固化聚合物以形成含有所述hGH颗粒的分散体的聚合物基质。使用本发明组合物的方法是在持续时间内在受试者中提供治疗有效的血液水平的生物活性，非聚集的hGH的方法。在该方法中，给予受试者有效剂量的本发明的持续释放组合物。使用本发明的持续释放组合物的方法包括通过向受试者施用一定剂量的所述持续释放组合物，在持续的时间内提供治疗有效的血液中的生物活性的，非聚集的人生长激素。

3. 发明申请

WO1995029664A1 MODULATED RELEASE FROM BIOCOMPATIBLE POLYMERS 审中-公开
标题翻译：生物降解聚合物的调节释放
公开(公告)号：WO1995029664A1
公开(公告)日：1995-11-09
申请号：PCT/US1995005511
申请日：1995-05-03
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC. , BERNSTEIN, Howard , ZHANG, Yan , KHAN, M., Amin , TRACY, Mark, A.
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC.
IPC分类号： A61K09/16
CPC分类号： A61K9/1694 , A61K9/1611 , A61K9/1647 , A61K9/7007 , A61K33/10 , A61K33/30 , A61K38/212 , A61K38/27 , A61K38/35 , A61K38/465 , C12Y301/27005 , Y10S514/805 , Y10S514/935
摘要： The present invention relates to a composition for the modulated release of a biologically active agent. The composition comprises a biocompatible polymeric matrix, a biologically active agent which is dispersed within the polymeric matrix, and a metal cation component which is separately dispersed within the polymeric matrix, whereby the metal cation component modulates the release of the biologically active agent from the polymeric matrix. The present invention also relates to a method for modulating the release of a biologically active agent from a biocompatible polymeric matrix, comprising the steps of dissolving a biocompatible polymer in a solvent to form a polymer solution and also separately dispersing a metal cation component and a biologically active agent within the polymer solution. The polymer solution is then solidified to form a polymeric matrix, wherein at least a significant portion of the metal cation component is dispersed in the polymeric matrix separately from the biologically active protein, and whereby the metal cation component modulates the release of the biologically active agent from the polymeric matrix.
摘要翻译：本发明涉及用于调节释放生物活性剂的组合物。组合物包含生物相容性聚合物基质，分散在聚合物基质内的生物活性剂和分散分散在聚合物基质内的金属阳离子组分，由此金属阳离子组分调节生物活性剂从聚合物中的释放矩阵。本发明还涉及一种用于调节生物相容性聚合物基质释放生物活性剂的方法，包括以下步骤：将生物相容性聚合物溶解在溶剂中以形成聚合物溶液，并且还分别分散金属阳离子组分和生物相容性聚合物聚合物溶液中的活性剂。然后将聚合物溶液固化以形成聚合物基质，其中至少大部分金属阳离子组分与生物活性蛋白质分开分散在聚合物基质中，由此金属阳离子组分调节生物活性剂的释放从聚合物基质。

4. 发明申请

WO1996003116A1 CONTROLLED RELEASE OF METAL CATION-STABILIZED INTERFERON 审中-公开
标题翻译：控制释放金属稳定干扰物
公开(公告)号：WO1996003116A1
公开(公告)日：1996-02-08
申请号：PCT/US1995007348
申请日：1995-06-07
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC. , TRACY, Mark, A. , BERNSTEIN, Howard , KHAN, M., Amin
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC.
IPC分类号： A61K09/16
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的干扰素颗粒，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。

5. 发明申请

WO1997007788A2 COMPOSITION FOR SUSTAINED RELEASE OF AN AGENT 审中-公开
标题翻译：用于持续发行代理的组合物
公开(公告)号：WO1997007788A2
公开(公告)日：1997-03-06
申请号：PCT/US1996013787
申请日：1996-08-29
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC. , LEE, Hye-Jung , JOHNSON, OluFunmi, L. , ZALE, Stephen, E. , TRACY, Mark, A.
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC.
IPC分类号： A61K09/54
CPC分类号： A61K9/5084 , A61K9/1647
摘要： Composition for the sustained release of a biologically active agent in vivo. The composition comprises microcarriers containing a first solid-phase biocompatible material and a biologically active agent, wherein said microcarriers sustain in vivo release of the biologically active agent. The composition also contains particles of a second biocompatible solid-phase material wherein the second solid-phase material further sustains the in vivo release of the biologically active agent. The invention also relates to a method for sustaining effective serum levels of a biologically active agent in a subject, including forming an injectable dose containing an effective amount of a biologically active agent, wherein the agent is contained in a microcarrier, with a release-period sustaining amount of a solid-phase material. The method further includes administering the injectable dose to the subject.
摘要翻译：用于体内持续释放生物活性剂的组合物。该组合物包含含有第一固相生物相容性材料和生物活性剂的微载体，其中所述微载体维持生物活性剂的体内释放。该组合物还含有第二生物相容性固相材料的颗粒，其中第二固相材料进一步维持生物活性剂的体内释放。本发明还涉及一种用于维持受试者中生物活性剂有效血清水平的方法，包括形成含有有效量的生物活性剂的可注射剂量，其中所述试剂包含在微载体中，释放期维持量的固相材料。该方法还包括向受试者施用可注射剂量。

6. 发明申请

WO1995018602A1 ORAL DOSAGE FORM OF DESMOPRESSIN (dDAVP) 审中-公开
标题翻译： DESMOPRESSIN的口服剂型（dDAVP）
公开(公告)号：WO1995018602A1
公开(公告)日：1995-07-13
申请号：PCT/US1995000275
申请日：1995-01-09
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC. , DIBIASE, Mary , BERNSTEIN, Howard
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC.
IPC分类号： A61K09/51
CPC分类号： A61K9/5169 , A61K9/1658
摘要： dDAVP oral delivery systems are described wherein dDAVP retains good biological activity. In the preferred embodiment, dDAVP protein microspheres are made by emulsifying a solution of a protein such as zein and dDAVP with an immiscible solvent. Pellets containing the microspheres are prepared by an extrusion and spheronisation process, and are placed in a hard gelatin capsule. Release of biologically active dDAVP is achieved when the capsules are administered in vivo to cynomolgus monkeys.
摘要翻译：描述了dDAVP口服递送系统，其中dDAVP保持良好的生物活性。在优选的实施方案中，dDAVP蛋白质微球体是通过将蛋白质如玉米醇溶蛋白和dDAVP的溶液与不混溶的溶剂乳化而制成的。通过挤出和滚圆法制备含有微球的颗粒，并置于硬明胶胶囊中。当将胶囊在体内施用于食蟹猴时，实现生物活性dDAVP的释放。

7. 发明申请

WO1996036317A1 PRODUCTION SCALE METHOD OF FORMING MICROPARTICLES 审中-公开
标题翻译：形成微生物的生产规模方法
公开(公告)号：WO1996036317A1
公开(公告)日：1996-11-21
申请号：PCT/US1996006889
申请日：1996-05-15
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC. , HERBERT, Paul, F. , HEALY, Michael, S.
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC.
IPC分类号： A61K09/16
CPC分类号： A61K9/1694 , A61K9/1647
摘要： The present invention relates to a method for forming microparticles of a material from microdroplets of a solution, wherein the solution comprises the material dissolved in a solvent. The method includes the steps of directing the microdroplets into a freezing zone, wherein the freezing zone is surrounded by a liquified gas, and wherein the microdroplets freeze. The frozen microdroplets are then mixed with a liquid non-solvent, whereby the solvent is extracted into the non-solvent, thereby forming the microparticles.
摘要翻译：本发明涉及从溶液的微滴形成材料的微粒的方法，其中溶液包含溶解在溶剂中的材料。该方法包括将微滴导入冷冻区域的步骤，其中冷冻区被液化气体包围，并且其中微滴冻结。然后将冷冻微滴与液体非溶剂混合，由此将溶剂萃取到非溶剂中，从而形成微粒。

8. 发明申请

WO1996040073A2 COMPOSITION FOR SUSTAINED RELEASE OF NON-AGGREGATED ERYTHROPOIETIN 审中-公开
标题翻译：用于持续释放非聚集ERYTHROPOIETIN的组合物
公开(公告)号：WO1996040073A2
公开(公告)日：1996-12-19
申请号：PCT/US1996008474
申请日：1996-06-03
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC.
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC. , ZALE, Stephen, E. , BURKE, Paul, A. , BERNSTEIN, Howard , BRICKNER, Avram
IPC分类号： A61K09/16
CPC分类号： B82Y5/00 , A61K9/0019 , A61K9/1611 , A61K9/1647 , A61K9/1658 , A61K9/1694 , A61K9/5031 , A61K9/5052 , A61K9/5153 , A61K9/5169 , A61K38/1816 , A61K47/02 , A61K47/26 , Y10S514/963 , Y10S514/965
摘要： A composition, and methods of forming and using said composition, for the sustained release of non-aggregated, biologically active, erythropoietin (EPO). The sustained release composition of this invention comprises a polymeric matrix of a biocompatible polymer and particles of biologically active, aggregation-stabilized EPO, wherein said particles are dispersed within the biocompatible polymer. The method of the invention for producing a composition for the sustained release of biologically active EPO, includes dissolving a biocompatible polymer in a polymer solvent to form a polymer solution, dispersing particles of biologically active, aggregation-stabilized EPO in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of said EPO particles. The method for using a composition of the invention is a method for providing a therapeutically effective blood level of biologically active, non-aggregated erythropoietin in a subject for a sustained period. In this method, a subject is administered an effective dose of the sustained release composition of the present invention.
摘要翻译：用于持续释放非聚集的，生物活性的促红细胞生成素（EPO）的组合物和形成和使用所述组合物的方法。本发明的持续释放组合物包含生物相容性聚合物的聚合物基质和生物活性聚集稳定的EPO的颗粒，其中所述颗粒分散在生物相容性聚合物内。用于制备用于持续释放生物活性EPO的组合物的本发明的方法包括将生物相容性聚合物溶解在聚合物溶剂中以形成聚合物溶液，将生物活性聚集稳定的EPO的颗粒分散在聚合物溶液中，然后固化聚合物以形成含有所述EPO颗粒的分散体的聚合物基质。使用本发明的组合物的方法是在持续时间内在受试者中提供治疗有效的血液中生物活性的非聚集的促红细胞生成素的方法。在该方法中，给予受试者有效剂量的本发明的缓释组合物。

9. 发明申请

WO1994012158A1 CONTROLLED RELEASE GROWTH HORMONE CONTAINING MICROSPHERES 审中-公开
标题翻译：受控释放含有微生物的生长激素
公开(公告)号：WO1994012158A1
公开(公告)日：1994-06-09
申请号：PCT/US1993011621
申请日：1993-12-02
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC.
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC. , AUER, Henry , KHAN, M., Amin , BERNSTEIN, Howard
IPC分类号： A61K09/16
CPC分类号： B82Y5/00 , A61K9/1611 , A61K9/1647 , A61K9/1694 , A61K38/27 , Y10S514/839 , Y10S530/839 , Y10T428/2985
摘要： Growth hormone polymeric controlled release systems are described wherein the growth hormone retains good biological activity and is released over an extended period of time following administration by injection. In the preferred embodiment, human growth hormone polymeric microspheres are made using very cold temperatures to freeze the polymer-growth hormone mixtures into polymeric microspheres with very high retention of biological activity and material. Sustained release of biologically active growth hormone is achieved when the microspheres are tested in vitro, extending over a period of greater than one day to several months. Altered release can be achieved by inclusion of degradation modifiers, pore forming agents, and stabilizers of the growth hormone.
摘要翻译：描述了生长激素聚合物控制释放系统，其中生长激素保持良好的生物活性并且通过注射施用后在延长的时间段内释放。在优选的实施方案中，使用非常低的温度制备人生长激素聚合物微球，以将聚合物 - 生长激素混合物冷冻成具有非常高的生物活性和材料保留度的聚合物微球体。当体外测试微球体时，持续释放生物活性生长激素，延长时间大于1天至数月。改变的释放可以通过包含降解改性剂，成孔剂和生长激素的稳定剂来实现。

10. 发明申请

WO1993025221A1 ERYTHROPOIETIN DRUG DELIVERY SYSTEM 审中-公开
标题翻译：艾滋病毒药物递送系统
公开(公告)号：WO1993025221A1
公开(公告)日：1993-12-23
申请号：PCT/US1993005497
申请日：1993-06-09
申请人： ALKERMES CONTROLLED THERAPEUTICS, INC.
发明人： ALKERMES CONTROLLED THERAPEUTICS, INC. , BERNSTEIN, Howard , MATHIOWITZ, Edith , MORREL, Eric , BRICKNER, Avram
IPC分类号： A61K37/02
CPC分类号： A61K9/5153 , A61K9/0019 , A61K9/1611 , A61K9/1647 , A61K9/1658 , A61K9/1694 , A61K9/5031 , A61K9/5052 , A61K9/5169 , A61K38/1816 , A61K47/02 , A61K47/26
摘要： Biodegradable polymer microspheres, preferably formed of zein, are used for in vivo release of erythropoietin (EPO). Examples demonstrate administration of the EPO in zein and polylactides and polymer microspheres to dogs and monkeys, with appropriate increases in blood levels and an increase in reticulocyte counts.
摘要翻译：优选由玉米醇溶蛋白形成的生物可降解聚合物微球用于促红细胞生成素（EPO）的体内释放。实施例证明，将玉米醇溶蛋白和聚丙交酯和聚合物微球体中的EPO施用于狗和猴，适当增加血液水平和增加网织红细胞计数。

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