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    • 2. 发明申请
    • ZERO-ORDER PROLONGED RELEASE COAXIAL IMPLANTS
    • 零轴释放同轴植入物
    • WO2003000156A1
    • 2003-01-03
    • PCT/US2002/019475
    • 2002-06-20
    • SOUTHERN BIOSYSTEMS, INC.
    • GIBSON, John, W.TIPTON, Arthur, J.HOLL, Richard, J.MEADOR, Stacey
    • A61F2/02
    • A61K9/0002A61F2/02A61F2250/0067A61K9/0024
    • A coaxial implant has been developed using entirely biodegradable polymeric materials. As referred to herein, a coaxial implant is a device having a core containing drug, surrounded by a semi-permeable membrane that controls the rate of release from the core. The device is formed by extrusion, using a pre-milling and extruding step to maximize uniformity of drug dispersion within the polymeric material. In one embodiment, the polymer is processed to yield a semi-crystalline polymer, rather than an amorphous polymer. The core containing the drug and the polymer membrane(s) can be the same or different polymer. The polymer can be the same or different composition (i.e., both polycaprolactone, or both poly(lactide-co-glycolide) of different monomer ratios, or polycaprolactone outside of a core of poly(lactide)), of the same or different molecular weights, and of the same or different chemical structure (i.e., crystalline, semi-crystalline or amorphous). The core acts as a reservoir of drug, which partitions from the core polymer to form a saturated solution of at least 10% drug at the polymer membrane.
    • 已经开发了使用完全可生物降解的聚合材料的同轴植入物。 如本文所提及的,同轴植入物是具有含核心的药物的装置,被半透膜隔开,半透膜控制从核心释放的速率。 该装置通过挤出形成,使用预研磨和挤出步骤以最大化聚合物材料内药物分散的均匀性。 在一个实施方案中,加工聚合物以产生半结晶聚合物,而不是无定形聚合物。 含有药物和聚合物膜的核心可以是相同或不同的聚合物。 聚合物可以具有相同或不同的组成(即,不同单体比的聚己内酯或聚(丙交酯 - 共 - 乙交酯)或聚(丙交酯)核心外的聚己内酯)具有相同或不同分子量 ,以及相同或不同的化学结构(即结晶,半结晶或无定形)。 核心作为药物储存器,其与芯聚合物分隔开,以在聚合物膜上形成至少10%药物的饱和溶液。