Skalko-Basnet Nataša
Drug Transport and Delivery Research Group, Department of Pharmacy, University of Tromsø, Tromsø, Norway.
Biologics. 2014 Mar 19;8:107-14. doi: 10.2147/BTT.S38387. eCollection 2014.
The beginning of the 21st century saw numerous protein and peptide therapeuticals both on the market and entering the final stages of clinical studies. They represent a new category of biologically originated drugs termed biologics or biologicals. Their main advantages over conventional drugs can be summarized by their high selectivity and potent therapeutic efficacy coupled with limited side effects. In addition, they exhibit more predictable behavior under in vivo conditions. However, up to now most of the formulations of biologics are designed and destined for the parenteral route of administration. As a consequence, many suffer from short plasma half-lives, resulting in their frequent administration and ultimately poor patient compliance. This review represents an attempt to address some of the challenges and promises in the product development of biologics both for parenteral and noninvasive administration. Some of the products currently in the pipeline of pharmaceutical development and corresponding perspectives are discussed in more detail.
21世纪初，市场上出现了众多蛋白质和肽类治疗药物，并且有一些正进入临床研究的最后阶段。它们代表了一类新型的生物源药物，称为生物制品或生物制剂。与传统药物相比，它们的主要优势可以概括为高选择性、强效治疗效果以及有限的副作用。此外，它们在体内条件下表现出更可预测的行为。然而，到目前为止，大多数生物制品的制剂都是设计用于并注定采用非肠道给药途径。因此，许多生物制品的血浆半衰期较短，导致需要频繁给药，最终患者的依从性较差。本综述旨在尝试应对生物制品非肠道和非侵入性给药产品开发中的一些挑战并展望前景。文中更详细地讨论了目前处于药物开发阶段的一些产品及相应的观点。
