Researchers from Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have devised an oral insulin delivery approach that can potentially eliminate the need for daily injections for type 1 diabetics.
The oral delivery is expected to improve quality of life as well as reduce various life-threatening side effects of the condition that occur due to failure of self-injection by patients.
In the new approach, insulin is carried in an ionic liquid containing choline and geranic acid. The liquid is formulated as a capsule with an acid-resistant enteric coating.
This formulation, which is intended to protect the insulin protein from stomach’s acidic environment, dissolves upon reaching the more alkaline environment of the small intestine.
Furthermore, the researchers noted that the choline-geranic acid mixture can penetrate the intestine’s mucus lining and the tight cell junctions of its wall, which does not allow passage of large-molecule drugs.
SEAS Biologically Inspired Engineering professor Samir Mitragotri said: “Once ingested, insulin must navigate a challenging obstacle course before it can be effectively absorbed into the bloodstream.
“Our approach is like a Swiss Army knife, where one pill has tools for addressing each of the obstacles that are encountered.”
The insulin pills are said to be biocompatible, easy to manufacture and can be stored for longer duration than certain existing injectable insulin products.
Mitragotri is planning to perform additional animal tests of the oral formulation, along with long-term toxicological and bioavailability studies required to obtain necessary approvals for human clinical trials.