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1.发明公开MICROMOLDED OR 3-D PRINTED PULSATILE RELEASE VACCINE FORMULATIONS 审中-公开MICRO或形状3D打印机疫苗制剂PULSATING RELEASE
公开(公告)号：EP3082852A1
公开(公告)日：2016-10-26
申请号：EP14830756.4
申请日：2014-12-16
发明人： JAKLENEC, Ana , GATES, William , ECKHOFF, Philip, A. , NIKOLIC, Boris , WOOD, Lowell, L. , LANGER, Robert, S. , NORMAN, James J , NGUYEN, Thanh Duc , TZENG, Stephany Yi
CPC分类号： A61K39/39 , A61K39/00 , A61K39/12 , A61K2039/545 , A61K2039/55555 , A61K2039/55566 , A61K2039/6093 , C12N2770/32634 , Y02A50/466
摘要： Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.
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公开(公告)号：EP3154553B1
公开(公告)日：2020-08-05
申请号：EP15806483.2
申请日：2015-06-11
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公开(公告)号：EP3154553A1
公开(公告)日：2017-04-19
申请号：EP15806483.2
申请日：2015-06-11
发明人： ZHANG, Shiyi , BELLINGER, Andrew , TRAVERSO, Carlo, Giovanni , LANGER, Robert, S. , GLETTIG, Dean, Liang , WOOD, Lowell, L., Jr. , ECKHOFF, Philip, A.
IPC分类号： A61K31/78 , A61K31/197 , C07C57/04
摘要： Described are gastric residence structures that include an active substance. The gastric residence structures may include one or more arms that include a loadable polymeric component, an elastic polymeric component, and a separate linker component. The linker may connect the one or more arms with the elastic polymeric component. The gastric residence structures may be configured to be folded and physically constrained during administration and may be configured to assume an open retention shape upon removal of a constraint. The change between the folded shape and the open retention shape may be mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape.
摘要翻译： 通常提供住宅结构，系统和相关方法。 某些实施方案包括将住院结构施用（例如，口服）给对象（例如，患者），使得住宿结构保持在受试者内部某一时间（例如，至少约24小时） 在被释放之前。 在一些情况下，住院结构可以是胃停留结构。 在一些实施方案中，本文所述的结构和系统包括一种或多种配置用于在酸性环境中高水平的活性物质（例如治疗剂）负载，高活性物质和/或结构稳定性，在内部的机械柔性和强度 孔（例如，胃腔），容易通过胃肠道直到输送到期望的内部孔口（例如胃腔），和/或在生理环境（例如，肠环境）中快速溶解/降解）和/或 对化学刺激剂的反应（例如，摄入引起快速溶解/降解的溶液）。 在某些实施方案中，该结构具有模块化设计，将配置用于控制释放治疗剂，诊断和/或增强剂的材料与胃停留所必需的结构材料组合，但被配置用于控制和/或可调节的降解/溶解以确定 保留形状完整性丧失并且结构从胃腔排出的时间。 例如，在某些实施方案中，宿主结构包括第一弹性组分，被配置成释放活性物质（例如治疗剂）的第二组分和任选的连接体。 在一些这样的实施方案中，接头可以被配置为降解，使得停留结构在预定量的时间之后分裂并且从受试者内部的位置释放。
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公开(公告)号：EP3154622B1
公开(公告)日：2020-04-01
申请号：EP15805932.9
申请日：2015-06-11
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公开(公告)号：EP3154622A1
公开(公告)日：2017-04-19
申请号：EP15805932.9
申请日：2015-06-11
发明人： BELLINGER, Andrew , ZHANG, Shiyi , TRAVERSO, Carlo, Giovanni , LANGER, Robert, S. , MO, Stacy , LIN, Jiaqi , DICICCIO, Angela , GLETTIG, Dean, Liang , WOOD, Lowell, L., Jr. , ECKHOFF, Philip, A.
摘要： Residence structures, systems, and related methods are generally provided. Certain embodiments comprise administering (e.g., orally) a residence structure to a subject (e.g., a patient) such that the residence structure is retained at a location internal to the subject for a particular amount of time (e.g., at least about 24 hours) before being released. The residence structure may be, in some cases, a gastric residence structure. In some embodiments, the structures and systems described herein comprise one or more materials configured for high levels of active substances (e.g., a therapeutic agent) loading, high active substance and/or structure stability in acidic environments, mechanical flexibility and strength in an internal orifice (e.g., gastric cavity), easy passage through the GI tract until delivery to at a desired internal orifice (e.g., gastric cavity), and/or rapid dissolution/degradation in a physiological environment (e.g., intestinal environment) and/or in response to a chemical stimulant (e.g., ingestion of a solution that induces rapid dissolution/degradation). In certain embodiments, the structure has a modular design, combining a material configured for controlled release of therapeutic, diagnostic, and/or enhancement agents with a structural material necessary for gastric residence but configured for controlled and/or tunable degradation/dissolution to determine the time at which retention shape integrity is lost and the structure passes out of the gastric cavity. For example, in certain embodiments, the residence structure comprises a first elastic component, a second component configured to release an active substance (e.g., a therapeutic agent), and, optionally, a linker. In some such embodiments, the linker may be configured to degrade such that the residence structure breaks apart and is released from the location internally of the subject after a predetermined amount of time.
摘要翻译： 通常提供住宅结构，系统和相关方法。 某些实施方案包括将住院结构施用（例如，口服）给对象（例如，患者），使得住宿结构保持在受试者内部某一时间（例如，至少约24小时） 在被释放之前。 在一些情况下，住院结构可以是胃停留结构。 在一些实施方案中，本文所述的结构和系统包括一种或多种配置用于在酸性环境中高水平的活性物质（例如治疗剂）负载，高活性物质和/或结构稳定性，在内部的机械柔性和强度 孔（例如，胃腔），容易通过胃肠道直到输送到期望的内部孔口（例如胃腔），和/或在生理环境（例如，肠环境）中快速溶解/降解）和/或 对化学刺激剂的反应（例如，摄入引起快速溶解/降解的溶液）。 在某些实施方案中，该结构具有模块化设计，将配置用于控制释放治疗剂，诊断和/或增强剂的材料与胃停留所必需的结构材料组合，但被配置用于控制和/或可调节的降解/溶解以确定 保留形状完整性丧失并且结构从胃腔排出的时间。 例如，在某些实施方案中，宿主结构包括第一弹性组分，被配置成释放活性物质（例如治疗剂）的第二组分和任选的连接体。 在一些这样的实施方案中，接头可以被配置为降解，使得停留结构在预定量的时间之后分裂并且从受试者内部的位置释放。
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公开(公告)号：EP2979044B1
公开(公告)日：2020-10-07
申请号：EP14775659.7
申请日：2014-03-27
申请人： Tokitae LLC
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公开(公告)号：EP3021812B1
公开(公告)日：2018-04-11
申请号：EP14827020.0
申请日：2014-07-16
申请人： Tokitae LLC
发明人： ECKHOFF, Philip, A. , ISHIKAWA, Muriel, Y. , LEVINE, Orin , PETERSON, Nels, R. , WOOD, Lowell, L., Jr. , WOOD, Victoria Y., H.
CPC分类号： A61J1/1425 , A61J1/05 , A61J1/1406
摘要： Multi-compartment pharmaceutical vials are described. In some embodiments, a multi-compartment pharmaceutical vial includes: a multi-compartment pharmaceutical storage region including a bottom wall, at least one outer wall and at least one interior wall, the bottom wall, the at least one outer wall and the at least one interior wall forming a plurality of pharmaceutical storage compartments, each pharmaceutical storage compartment including an aperture positioned opposite to the bottom wall of the pharmaceutical storage region; and an access region attached to the pharmaceutical storage region, the access region including a plurality of conduits, each with a first end and a second end, wherein the first end of each conduit is connected to one aperture in a pharmaceutical storage compartment, and the second end of each conduit circumscribes an aperture positioned opposite to the bottom wall.
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公开(公告)号：EP3021812A1
公开(公告)日：2016-05-25
申请号：EP14827020.0
申请日：2014-07-16
申请人： Tokitae LLC
发明人： ECKHOFF, Philip, A. , ISHIKAWA, Muriel, Y. , LEVINE, Orin , PETERSON, Nels, R. , WOOD, Lowell, L., Jr. , WOOD, Victoria Y., H.
CPC分类号： A61J1/1425 , A61J1/05 , A61J1/1406
摘要： Multi-compartment pharmaceutical vials are described. In some embodiments, a multi-compartment pharmaceutical vial includes: a multi-compartment pharmaceutical storage region including a bottom wall, at least one outer wall and at least one interior wall, the bottom wall, the at least one outer wall and the at least one interior wall forming a plurality of pharmaceutical storage compartments, each pharmaceutical storage compartment including an aperture positioned opposite to the bottom wall of the pharmaceutical storage region; and an access region attached to the pharmaceutical storage region, the access region including a plurality of conduits, each with a first end and a second end, wherein the first end of each conduit is connected to one aperture in a pharmaceutical storage compartment, and the second end of each conduit circumscribes an aperture positioned opposite to the bottom wall.
摘要翻译： 描述了多室药物小瓶。 在一些实施方案中，多隔室药物瓶包括：多隔室药物储存区，包括底壁，至少一个外壁和至少一个内壁，底壁，至少一个外壁和至少 一个内壁形成多个药物储存室，每个药物储存室包括与药物储存区域的底壁相对定位的孔口; 以及附接到所述药物储存区域的进入区域，所述进入区域包括多个管道，每个管道具有第一端和第二端，其中每个导管的第一端连接到药物储存室中的一个孔，并且 每个导管的第二端围绕与底壁相对定位的孔。
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公开(公告)号：EP2979044A1
公开(公告)日：2016-02-03
申请号：EP14775659.7
申请日：2014-03-27
申请人： Tokitae LLC
发明人： ECKHOFF, Philip, A. , GATES, William , HYDE, Roderick, A. , JUNG, Edward, K.Y. , MYHRVOLD, Nathan, P. , PETERSON, Nels, R. , TEGREENE, Clarence, T. , WHITMER, Charles , WOOD, Lowell, L.
摘要： In some embodiments, a substantially thermally sealed storage container includes an outer assembly and an evaporative cooling assembly integral to the container. In some embodiments, the outer assembly includes one or more sections of ultra efficient insulation material substantially defining at least one thermally-controlled storage region, and a single access conduit to the at least one thermally-controlled storage region. In some embodiments, the evaporative cooling assembly integral to the container includes: an evaporative cooling unit affixed to a surface of the at least one thermally-controlled storage region; a desiccant unit affixed to an external surface of the container; a vapor conduit, the vapor conduit including a first end and a second end, the first end attached to the evaporative cooling unit, the second end attached to the desiccant unit; and a vapor control unit attached to the vapor conduit.
摘要翻译： 在一些实施例中，基本上热密封的储存容器包括与容器成一体的外部组件和蒸发冷却组件。 在一些实施例中，外部组件包括基本上限定至少一个热控存储区域的一个或多个超高效绝缘材料部分和至少一个热控制存储区域的单个进入导管。 在一些实施例中，与容器成一体的蒸发冷却组件包括：固定在至少一个热控储存区域的表面上的蒸发冷却单元; 固定在容器的外表面上的干燥剂单元; 蒸气导管，蒸气导管包括第一端和第二端，第一端连接到蒸发冷却单元，第二端连接到干燥剂单元; 以及附接到蒸汽管道的蒸汽控制单元。
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