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    • 2. 发明申请
    • COMPOSITION FOR SUSTAINED RELEASE OF HUMAN GROWTH HORMONE
    • 用于持续释放人体生长激素的组合物
    • WO1996040072A2
    • 1996-12-19
    • PCT/US1996008086
    • 1996-06-03
    • ALKERMES CONTROLLED THERAPEUTICS, INC.JOHNSON, OluFunmi, LilyGANMUKHI, Medha, M.BERNSTEIN, HowardAUER, HenryKHAN, M., Amin
    • ALKERMES CONTROLLED THERAPEUTICS, INC.
    • A61K09/16
    • B82Y5/00A61K9/1611A61K9/1647A61K38/27
    • 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.
    • 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。