New Breakthrough in Oral Insulin Delivery in China, Promising to Solve a World-Class Challenge

On the 21st, reporters learned from Beihang University that a team led by Chen Junge from the School of Medical Science and Engineering, in collaboration with teams led by Liang Xingjie from the National Center for Nanoscience and Technology and Wang Jinqiang from Zhejiang University, has successfully developed an oral insulin formulation with "intelligent navigation" capabilities (MiNVs). This brings new hope for diabetic patients to break free from daily injection therapy. The research findings were recently published in the journal Science Advances.

Currently, over 800 million diabetic patients worldwide rely on insulin therapy. The mainstream treatment method is subcutaneous injection, which not only causes physical pain and psychological burden to patients but may also lead to side effects such as local infections and hypoglycemia. Chen Junge pointed out: "Oral insulin administration is a world-class challenge. It is necessary to overcome three major barriers in the gastrointestinal tract: the degradation of insulin by gastric acid and proteases, the barrier posed by intestinal epithelial cells to macromolecular drugs, and the rapid metabolism of insulin by the liver after it enters the bloodstream."

The research team drew inspiration from milk. By using membrane fusion technology to combine milk exosomes with smart-responsive liposomes, they constructed a novel intelligent milk exosome system. This system retains the natural stability of milk exosomes while possessing intelligent responsiveness, enabling it to break through the multiple barriers of oral drug delivery like a "multi-functional courier."

Experimental results show that MiNVs can increase the oral bioavailability of insulin to 20.4%, which is more than 20 times that of traditional oral formulations and has reached the standard for clinical application. In a porcine diabetes model, blood glucose levels dropped to normal within 2 to 4 hours after oral administration of MiNVs, with the glucose-lowering effect lasting over 8 hours and body weight remaining stable. Safety tests showed that after healthy pigs received high doses of MiNVs for 14 consecutive days, no abnormalities were observed in vital organs such as the heart, liver, spleen, lungs, kidneys, and stomach, and blood and immune indicators remained within normal levels, indicating good biocompatibility of the formulation.

Chen Junge stated that this intelligent milk exosome delivery system achieves precise insulin delivery through a "three-level navigation" mechanism, setting a new benchmark for the development of oral macromolecular drugs. This technology has significant potential for clinical translation. It not only holds promise for allowing diabetic patients to告别 the pain of daily injections, improving treatment compliance and quality of life, but also provides new ideas for the oral delivery of other biomacromolecular drugs. Currently, the research team is dedicated to further optimization and clinical translation research of this technology.