The delivery method, currently under preclinical development, has the potential to offer a convenient alternative to insulin injections for diabetic patients, according to professor of David H. Koch Institute at MIT, Robert Langer.
Giovanni Traverso, an assistant professor at the Institute and member of the research team, commented that this work is motivated by the recognition that “both patients and healthcare providers prefer the oral route of administration over the injectable one.”
The design of the capsule enables the delivery of a comparable amount of insulin to that of an injection, as well as to protect the drug substance from breaking down due to the harsh environment of the gastrointestinal tract.
More specifically, the capsule is coated by a polymer capable of surviving the acidic environment of the stomach, which has a pH of 1.5 to 3.5, but is able to dissolve in the small intestine, which has a pH of approximately 6.
Once dissolved, the coating allows the microneedles containing the drug to detach and penetrate the topmost layer of the small intestine tissue, to release drug for uptake into the bloodstream.
Although the capsule has so far been tested with insulin, researchers state that it could also be used to deliver other protein drugs, such as hormones, enzymes, or antibodies, as well as RNA-based drugs.
“We’re working very closely with our collaborators to identify the next steps and applications where we can have the greatest impact,” Traverso commented.
The research is funded by Novo Nordisk and the US National Institute of Health (NIH).
Commenting on the approach, Rose Joachim, an immunology analyst at GlobalData, said that “oral delivery of biologics has been long complicated by the poor absorption of the larger macromolecules through the intestinal wall.”
“It is possible the technology will soon be seen in Novo Nordisk’s pipeline or perhaps as the flagship product of a spin-out or start-up venture,” Joachim noted, adding that if the capsule is proven safe and effective in clinical trials, it could expand the range of treatment options available to patients receiving biologic therapies.
The scientists behind the approach have previously worked on similar delivery methods, including a star-shaped extended release capsule developed by Lyndra Therapeutics, a spin-out company from the MIT.