HYDROFORMED MICROSPHERES AS NEW INJECTABLE DRUG VEHICLE

BIOTEK开发了一种新的液压成型工艺， 释放可注射的可生物降解的微球和微胶囊 用于递送水溶性药物如肽和蛋白质。 的 该方法将药物掺入到由少量 可溶性钙矿物质，如硫酸钙，然后可以 用聚合物、矿物质或脂质壳包覆。 该技术可以 从含硫酸盐、磷酸盐的钙化合物制备微球 或硅酸盐阴离子。 硫酸钙水泥，更好地称为巴黎石膏，被用作 临时性骨填充物和基于天然的磷酸钙骨水泥 骨矿物质，羟基磷灰石，正在研究中的牙齿， 维修. 与热成型陶瓷不同， 在体内，已经发现液压成形的钙矿物质可以被生物吸收， 无害的 虽然它们提供了许多优点， 微球，它们以前没有被研究用于该目的。 使用阿片拮抗剂，盐酸美沙酮，作为原型水溶性 药 第一阶段将制备和表征加氢成型微胶囊， 检查它们的侵蚀和体外输送。 第二阶段将进行 体内动物试验，向FDA提交IND，并启动人类 使用这种可注射微囊作为 阿片类药物滥用治疗

BIOTEK has developed a new hydroforming process for making sustained release injectable biodegradable microsphere and microcapsule well suited for delivery of water soluble drugs such as peptides and proteins. The process incorporates drug into hydroformed microspheres made of sparingly soluble calcium minerals, such s calcium sulfate, which can then be overcoated with a polymer, mineral or lipid shell. The technique can produce microsphere from calcium compounds involving sulfate, phosphate or silicate anions. Calcium sulfate cement, better known as plaster of Paris, is used as a temporary bone filler, and calcium phosphate cements based on a natural bone mineral, hydroxyapatite, are under investigation for tooth an drone repairs. Unlike thermoformed ceramics, which may persist indefinitely in the body, hydroformed calcium minerals have been found to bioresorb harmlessly. Although they offer many advantages as injectable microsphere, they have not previously been investigated for that purpose. Using an opiate antagonist, methadone HCL, as a prototype water-soluble drug. Phase I will prepare and characterize hydroformed microcapsule and examine their erosion and delivery in vitro. Phase II will then conduct in vivo animal tests, submit an IND to the FDA,and initiate human clinical studies on the use of such injectable microcapsule as part of opiate abuse therapy.