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    Prolonged release of GM-CSF
    2.
    发明授权
    Prolonged release of GM-CSF 失效
    长时间释放GM-CSF

    公开(公告)号：US5942253A

    公开(公告)日：1999-08-24

    申请号：US542445

    申请日：1995-10-12

    申请人： Wayne Gombotz ,  Dean Pettit ,  Susan Pankey ,  James Ronald Lawter ,  W. James Huang

    发明人： Wayne Gombotz ,  Dean Pettit ,  Susan Pankey ,  James Ronald Lawter ,  W. James Huang

    IPC分类号： A61K9/14 ,  A61K9/16 ,  A61K31/00 ,  A61K38/19 ,  A61K38/22 ,  A61K47/34 ,  A61P37/00 ,  A61P37/04 ,  A61K9/50 ,  A61F2/02 ,  A61K9/48

    CPC分类号： A61K9/0019 ,  A61K38/193 ,  A61K9/0024 ,  A61K9/06 ,  A61K9/1635 ,  A61K9/1641 ,  A61K9/1647 ,  Y10T428/2989

    摘要： Formulations for controlled, prolonged release of GM-CSF have been developed. These are based on solid microparticles formed of the combination of biodegradable, synthetic polymers such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and copolymers thereof with excipients and drug loadings that yield zero order or first order release, or multiphasic release over a period of approximately three to twenty one days, preferably one week, when administered by injection. In the preferred embodiment, the microparticles are microspheres having diameters in the range of 10 to 60 microns, formed of a blend of PLGA having different molecular weights, most preferably 6,000, 30,000 and 41,000. Other embodiments have been developed to alter the release kinetics or the manner in which the drug is distributed in vivo. For example, in some cases a polymer is selected which elicits a mild inflammatory reaction, for example, PLGA and polyanhydrides can act as chemoattractant, either due to the polymer itself or minor contaminants in the polymer, or polymers which are bioadhesive are used for transmucosal or oral delivery. In another embodiment, the GM-CSF is administered in a hydrogel which can be injected subcutaneous or at a specific site for controlled release. The microparticles or hydrogel are administered to the patient in an amount effect to stimulate proliferation of hematopoietic cells, especially white cells.

    摘要翻译： 已经开发了控制，长期释放GM-CSF的制剂。 这些基于由生物可降解的合成聚合物如聚（乳酸）（PLA），聚（乙醇酸）（PGA））及其与赋形剂的共聚物和药物负载的组合形成的固体微粒，其产生零级或一级 当通过注射给药时，在约3至20天，优选1周的时间内释放或多相释放。 在优选的实施方案中，微粒是具有10至60微米范围内的直径的微球，由具有不同分子量，最优选6,000,300和41,000的PLGA的共混物形成。 已经开发了其它实施方案来改变药物在体内分布的释放动力学或方式。 例如，在一些情况下，选择引起轻度炎症反应的聚合物，例如PLGA和聚酐可以作为化学引诱剂，这是由于聚合物本身或聚合物中的微量污染物，或生物粘附剂的聚合物用于经粘膜 或口服。 在另一个实施方案中，GM-CSF以可以皮下注射或在特定部位注射用于控制释放的水凝胶施用。 将微粒或水凝胶以刺激造血细胞，特别是白细胞增殖的量施用于患者。