4.6 Review

Challenges and opportunities in delivering oral peptides and proteins

Journal

EXPERT OPINION ON DRUG DELIVERY
Volume -, Issue -, Pages -

Publisher

TAYLOR & FRANCIS LTD
DOI: 10.1080/17425247.2023.2237408

Keywords

Oral proteins; absorption barriers; advanced drug delivery; clinical trials; protein drugs market; >

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The rapid development of bioengineering has made it possible to use complex proteins as therapeutic agents for treating diseases. Oral delivery of proteins is a promising approach to improve patient compliance and reduce production costs. However, the gastrointestinal environment poses challenges to this delivery path, leading to reduced delivery efficiency and poor clinical outcomes.
IntroductionRapid advances in bioengineering enable the use of complex proteins as therapeutic agents to treat diseases. Compared with conventional small molecule drugs, proteins have multiple advantages, including high bioactivity and specificity with low toxicity. Developing oral dosage forms with active proteins is a route to improve patient compliance and significantly reduce production costs. However, the gastrointestinal environment remains a challenge to this delivery path due to enzymatic degradation, low permeability, and weak absorption, leading to reduced delivery efficiency and poor clinical outcomes.Areas coveredThis review describes the barriers to oral delivery of peptides and complex proteins, current oral delivery strategies utilized and the opportunities and challenges ahead to try and circumvent these barriers. Oral protein drugs on the market and clinical trials provide insights and approaches for advancing delivery strategies.Expert opinionAlthough most current studies on oral protein delivery rely on in vitro and in vivo animal data, the safety and limitations of the approach in humans remain uncertain. The shortage of clinical data limits the development of new or alternative strategies. Therefore, designing appropriate oral delivery strategies remains a significant challenge and requires new ideas, innovative design strategies and novel model systems.

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