Volume 9 ; Issue 2 ; in Month : July-Dec (2025) Article No : 191
Sharma P, Kumar R, Gulati P.

Abstract

Oral delivery of biologics offers unmatched advantages in patient compliance and therapeutic convenience but faces formidable challenges due to enzymatic degradation, poor epithelial permeability, and first-pass metabolism. Hydrogel-based delivery systems have emerged as a promising solution, leveraging their biocompatibility, tunable structures, and responsiveness to gastrointestinal stimuli to protect fragile biologic drugs and enhance their systemic bioavailability. This review explores the physiological barriers hindering oral biologic delivery and discusses advanced hydrogel design strategies, including mucoadhesion, pH-sensitive release, enzyme-responsive behavior, and nanoparticle embedding. Recent innovations such as microbiome-responsive hydrogels and artificial intelligence-assisted formulation design are reshaping the landscape, enabling smart, targeted, and patient-specific therapies. In vivo studies demonstrate significant improvements in pharmacokinetics, absorption, and therapeutic efficacy, while early clinical trials suggest a promising translational potential. However, regulatory, stability, and large-scale manufacturing challenges persist, necessitating further multidisciplinary collaboration. By overcoming these barriers, hydrogel-based oral delivery platforms are poised to revolutionize the administration of proteins, peptides, nucleic acids, and antibodies, offering a future where non-invasive, precision-targeted biologic therapies become the standard of care.

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