Department of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, United States.
Department of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, United States; Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, United States.
Adv Drug Deliv Rev. 2021 Jun;173:112-124. doi: 10.1016/j.addr.2021.03.011. Epub 2021 Mar 25.
The vast majority of drugs are not designed or developed for pediatric and infant populations. Peptide drugs, which have become increasingly relevant in the past several decades, are no exception. Unfortunately, nearly all of the 60+ approved peptide drugs are formulated for injection, a particularly unfriendly mode of administration for infants. Although three peptide drugs were recently approved for oral formulations, this major advance in peptide drug delivery is available only for adults. In this review, we consider the current challenges and opportunities for the oral formulation of peptide therapeutics, specifically for infant populations. We describe the strategies that enable oral protein delivery and the potential impact of infant physiology on those strategies. We also detail the limited but encouraging progress towards 1) adapting conventional drug development and delivery approaches to infants and 2) designing novel infant-centric formulations. Together, these efforts underscore the feasibility of oral peptide delivery in infants and provide motivation to increase attention paid to this underserved area of drug delivery and formulation.
绝大多数药物并非专门为儿科和婴儿人群设计或开发。在过去几十年中越来越重要的肽类药物也不例外。不幸的是，已批准的 60 多种肽类药物几乎全部都为注射剂型，而这种剂型对于婴儿来说尤其不友好。尽管最近有三种肽类药物被批准用于口服制剂，但这种肽类药物输送方面的重大进展仅适用于成人。在这篇综述中，我们考虑了肽类治疗药物口服制剂的当前挑战和机遇，特别是针对婴儿人群。我们描述了可实现口服蛋白递送的策略，以及婴儿生理学对这些策略的潜在影响。我们还详细介绍了在以下两个方面取得的有限但令人鼓舞的进展：1）将传统药物开发和输送方法应用于婴儿；2）设计新型针对婴儿的制剂。这些努力共同强调了在婴儿中进行口服肽类药物输送的可行性，并促使人们更加关注药物输送和制剂这一未得到充分关注的领域。
