Production of Y-90 Microspheres for Radiation Therapy

说明(由申请人提供)：继续和 节能型生物可吸收玻璃微球的经济制备 在治疗浓度下含有Y-90(Y-90) 在一期研究中成功示范了Y-89代用品的使用。这个 微球在大小和化学成分上都是一致的，并且定时生物吸收 可以根据同位素的半衰期和 剂量学要求。Y-90玻璃的可靠商业供应 微球将对局部放射治疗产生积极影响 全世界。这项第二阶段研究的目标是使这种供应成为 商业现实。建议的微细加工工艺可以简化 从Y-90同位素提取到包装Y-90微球的全自动化 准备交付和治疗注射。微球生产工艺 将在最大限度地减少人员辐射暴露方面进行优化， 最大限度地利用源放射性同位素，大大缩短了整个过程时间，以 保护放射性，最重要的是，大大降低了成本。微球 含有治疗浓度的放射性同位素将在 体外放射性保留、生物相容性和完整性 生物吸收；并在体内证明Y-90微球的有效性 治疗携带肿瘤的啮齿动物。 建议的商业应用： 含有Y-90的定时生物可吸收玻璃微球是直接在肿瘤内注射治疗肝癌、胰腺癌或类风湿性关节炎滑膜切除术的理想选择。含有其他放射性同位素的微球，如P-32，也可以通过上述方法很容易地生产出来。

DESCRIPTION (Provided by Applicant): The feasibility of continuous and economical microfabrication of timed-bioresorbable glass microspheres containing yttrium-90 (Y-90) at therapeutic concentrations has been successfully demonstrated using Y-89 surrogate in the Phase I research. The microspheres are uniform in size and chemistry, and the timed-bioresorption characteristics can be predetermined according to the isotope half-life and the dosimetry requirements. A dependable commercial supply of Y-90 glass microspheres will have a positive impact on localized radiation therapy worldwide. This Phase II research has the objective of making such a supply a commercial reality. The proposed microfabrication process can be streamlined and fully automated from Y-90 isotope extraction to packaged Y-90 microspheres ready for delivery and treatment injection. The microsphere production process will be optimized with regard to minimized personnel radiation exposure, maximized use of source radioisotopes, much shortened overall process time to preserve radioactivity, and above all, much reduced cost. Microspheres containing therapeutic concentrations of radioisotopes will be evaluated in vitro for radioactivity retention, biocompatibility, and completeness of bioresorption; and in vivo to demonstrate the efficacy of the Y-90 microspheres in treating tumor-bearing rodents. PROPOSED COMMERCIAL APPLICATIONS: Timed-bioresorbable glass microspheres containing Y-90 are ideal for direct intratumoral injection in the treatment of cancers such as the liver, pancreas, or the synovectomy of rheumatoid arthritis. Microspheres containing other radioactive isotopes such as P-32 can also be readily produced by the methods described.