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肽和蛋白质的肠外给药研究进展。

A review on parenteral delivery of peptides and proteins.

机构信息

a Custom Pharma Services (CPS) , Dr. Reddy's Laboratories Ltd , Hyderabad , India.

出版信息

Drug Dev Ind Pharm. 2019 Sep;45(9):1403-1420. doi: 10.1080/03639045.2019.1628770. Epub 2019 Jun 28.

Abstract

The recent advances in pharmaceutical industry in the area of drug delivery and development have resulted into wide variety of biomolecules, particularly peptides and proteins, to palliate the treatment for severe diseases. The rampant development of peptides and proteins in industry mandate the understanding of their characteristic nature and developability. Despite their therapeutic potential, peptides and proteins pose complex challenges in drug delivery and require scientist to contemplate to achieve suitable delivery system. As most of the commercial products for proteins and peptides are available as a parenteral delivery and freeze drying process is one commonly used technique, it is imperative to understand the complex steps of development for better and faster product development. This review provides an overview of the stability and formulation development for peptides and proteins. The most common route for protein delivery, parenteral, has been focused on parenteral solution and lyophilization as formulation strategy. Additionally, new drug delivery and half-life extension approaches will further the reach of this unique class of molecules. Efforts are underway to explore the area with new technologies and development.

摘要

近年来,制药行业在药物输送和开发领域取得了重大进展,产生了多种生物分子,特别是肽和蛋白质,以缓解严重疾病的治疗。肽和蛋白质在工业中的迅速发展要求人们了解其特征性质和可开发性。尽管具有治疗潜力,但肽和蛋白质在药物输送方面带来了复杂的挑战,需要科学家们考虑以实现合适的输送系统。由于大多数蛋白质和肽的商业产品都是作为注射剂提供的,并且冷冻干燥是一种常用的技术,因此了解开发的复杂步骤对于更好、更快的产品开发至关重要。本文综述了肽和蛋白质的稳定性和制剂开发。蛋白质输送的最常见途径是注射剂,已将注射剂溶液和冷冻干燥作为制剂策略进行了重点关注。此外,新的药物输送和半衰期延长方法将进一步扩大这一独特类分子的应用范围。目前正在努力探索新技术和开发领域。

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