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    • 2. 发明申请
    • SUSTAINED-RELEASING INJECTABLE FORMULATION FOR THE TREATMENT OR PREVENTION OF BONE-RELATED DISEASES COMPRISING BISPHORENATE-CONTAINING POLYMERIC MICROPARTICLES
    • 持续发布包含含双硫含量聚合物微生物治疗或预防骨相关疾病的指导性配方
    • WO2005105058A1
    • 2005-11-10
    • PCT/KR2005/001306
    • 2005-05-04
    • AMOREPACIFIC CORPORATIONCHOI, Woo JeongLEE, HyeokYANG, Jeong HwaKIM, Jung Ju
    • CHOI, Woo JeongLEE, HyeokYANG, Jeong HwaKIM, Jung Ju
    • A61K9/58
    • A61K9/0019A61K9/1641A61K47/26
    • Disclosed is a sustained-release injectable formulation for treating or preventing bone-related diseases, comprising bisphosphonate-containing polymeric microparticles prepared by dissolving and dispersing a bisphosphonate in an aqueous solution containing a water-soluble polymer and a hydrophilic surfactant to provide a polymer solution; adding the polymer solution to another polymer solution, prepared by adding a secondary organic solvent to a primary organic solvent containing a biodegradable polymer and a hydrophobic surfactant, to provide a primary emulsion (water-in oil (W/O) type); and dispersing the primary emulsion in an external continuous phase. The injectable formulation has an effect of sustaining drug release in vivo for a period of 4 weeks or more using only a single administration, thereby reducing administration frequency and total dosage compared to conventional oral formulations administered every day, as well as remarkably reducing local irritation compared to a directly injected non-encapsulated bisphosphonate. Therefore, this sustained-release injectable formulation is more useful in the treatment or prevention of diseases against which bisphosphonate drugs have therapeutic or preventive effects than conventional oral formulations and direct injections of bisphosphonates.
    • 公开了一种用于治疗或预防骨相关疾病的缓释可注射制剂,其包含通过将二膦酸盐溶解并分散在含有水溶性聚合物和亲水性表面活性剂的水溶液中制备的含二膦酸盐的聚合物微粒,以提供聚合物溶液; 将聚合物溶液加入到通过将二级有机溶剂加入到含有可生物降解的聚合物和疏水性表面活性剂的初级有机溶剂中以提供初级乳液(油包水(W / O)型)制备的另一种聚合物溶液中; 并将初级乳液分散在外部连续相中。 可注射制剂具有仅使用单一给药在体内维持药物释放持续4周或更长时间的效果,从而与每天施用的常规口服制剂相比降低施用频率和总剂量,并且显着降低局部刺激 直接注射未包封的双膦酸盐。 因此,这种持续释放的可注射制剂在治疗或预防双膦酸盐药物具有比常规口服制剂和直接注射双膦酸盐治疗或预防效果的疾病更有用。