Putney S D
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
Curr Opin Chem Biol. 1998 Aug;2(4):548-52. doi: 10.1016/s1367-5931(98)80133-6.
Two recent advances have enabled the development of clinically useful, injectable, sustained-release protein formulations. The first is a nonaqueous, cryogenic atomization process that encapsulates the protein into microspheres composed of a biodegradable polymer from which the protein is released slowly. The second consists of numerous ways of maintaining protein stability within the microspheres for extended periods after injection. In addition to allowing less frequent administration of protein drugs, at possibly lower overall doses, it is possible that sustained-release formulations will justify commercial development of proteins that could not be marketed as solution formulations.
最近的两项进展推动了临床上可用的注射用缓释蛋白质制剂的开发。第一项是一种非水低温雾化工艺，该工艺将蛋白质封装到由可生物降解聚合物组成的微球中，蛋白质从微球中缓慢释放。第二项进展包括多种方法，可在注射后长时间维持微球内蛋白质的稳定性。除了可以减少蛋白质药物的给药频率，且总体剂量可能更低之外，缓释制剂还可能使那些无法以溶液制剂形式上市的蛋白质具备商业开发价值。
