克服生物制药给药方面的挑战：制剂与递送策略。
Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies.
作者信息
Mitragotri Samir, Burke Paul A, Langer Robert
机构信息
Department of Chemical Engineering, Center for Bioengineering, University of California, Santa Barbara, California 92106, USA.
Burke Bioventures LLC, 277 Broadway, Cambridge, Massachusetts 02139, USA.
出版信息
Nat Rev Drug Discov. 2014 Sep;13(9):655-72. doi: 10.1038/nrd4363. Epub 2014 Aug 8.
Abstract
The formulation and delivery of biopharmaceutical drugs, such as monoclonal antibodies and recombinant proteins, poses substantial challenges owing to their large size and susceptibility to degradation. In this Review we highlight recent advances in formulation and delivery strategies--such as the use of microsphere-based controlled-release technologies, protein modification methods that make use of polyethylene glycol and other polymers, and genetic manipulation of biopharmaceutical drugs--and discuss their advantages and limitations. We also highlight current and emerging delivery routes that provide an alternative to injection, including transdermal, oral and pulmonary delivery routes. In addition, the potential of targeted and intracellular protein delivery is discussed.
摘要
生物制药药物，如单克隆抗体和重组蛋白，由于其分子量大且易降解，在制剂和给药方面面临重大挑战。在本综述中，我们重点介绍了制剂和给药策略的最新进展，如基于微球的控释技术的应用、利用聚乙二醇和其他聚合物的蛋白质修饰方法以及生物制药药物的基因操作，并讨论了它们的优缺点。我们还重点介绍了当前和新兴的给药途径，这些途径可替代注射给药，包括透皮、口服和肺部给药途径。此外，还讨论了靶向和细胞内蛋白质递送的潜力。
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