Einstein International Journal Organization(EIJO)

Abstract

Oral insulin delivery remains a long-standing goal in diabetes therapy because it offers a non-invasive alternative to injections and better mimics physiological insulin distribution through portal circulation. However, insulin is highly susceptible to gastrointestinal enzymatic degradation, variable pH conditions, mucus barriers, and limited epithelial permeability, resulting in extremely low oral bioavailability. Nanoparticle-based delivery systems have emerged as promising carriers capable of protecting insulin, enhancing intestinal absorption, and enabling controlled release. Incorporation of Quality-by-Design (QbD) principles in nanoparticle development allows systematic optimization of formulation variables such as particle size, surface charge, encapsulation efficiency, and stability to ensure consistent product quality and performance. Despite encouraging preclinical results, challenges including scalability, regulatory approval, reproducibility, long-term safety, and clinical translation persist. Future research integrating advanced materials, predictive modeling, regulatory harmonization, and patient-centric design is expected to accelerate the successful development of oral insulin nanomedicines.

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