-
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
-
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。
-