HYDROFORMED MICROSPHERES AS NEW INJECTABLE DRUG VEHICLE

Biotek已经开发出一种新的液压成形工艺，用于制造持续 适合注射用可生物降解微球和微囊的释放 用于运送多肽和蛋白质等水溶性药物。这个 方法将药物结合到由稀释物制成的氢化形成的微球中 可溶性钙矿物，如S的硫酸钙，然后可以 覆盖有聚合物、矿物或类脂外壳的。这项技术可以 由含有硫酸盐、磷酸盐的钙化合物制备微球 或硅酸盐阴离子。 硫酸钙水泥，更为人所知的是巴黎石膏，被用作 临时骨填充剂和磷酸钙粘固剂 骨矿物羟基磷灰石正在进行牙齿和无人机的研究 修理。与热成型陶瓷不同，热成型陶瓷可能会无限期存在 在人体内，已经发现水形成的钙矿物可以吸收生物。 无害的。尽管它们提供了许多优点，如可注射 微球，它们以前从未为此目的进行过研究。 使用阿片类拮抗剂美沙酮盐酸盐作为水溶性药物的原型 毒品。第一阶段将制备和表征水力形成的微胶囊和 检查它们的体外侵蚀和释放情况。然后，第二阶段将进行 活体动物试验，向FDA提交IND，并启动人类 该可注射微囊作为部分治疗药物的临床研究 鸦片滥用疗法。

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.