Researchers at Harvard have developed an “insulin pill” that could change the way people manage their diabetes. This could affect millions of people living with diabetes that inject insulin daily.
The new drug delivery method may also solve the problem of so many patients reluctant to take their insulin due to their dislike of injections — saving potentially millions of people living with untreated diabetes.
“Many people fail to adhere to that regimen due to pain, phobia of needles, and the interference with normal activities,” said Dr. Samir Mitragotri, senior author of the study and professor at Harvard’s School of Engineering and Applied Sciences in a press release. “The consequences of the resulting poor glycemic control can lead to serious health complications.”
The hurdle all these years has been how to develop a suitable drug delivery mechanism for insulin: A pill has not been developed because it would have to sustain the powerful gastric acids in the stomach.
The team found that if they encapsulating the liquid insulin in a special coating, they would overcome a major obstacle: which is the pill resisting breakdown by gastric acids. The special polymer coating dissolves when it reaches a more alkaline environment in the small intestine, where the insulin is released.
The study, which was published in the Proceedings of the National Academy of Sciences, describes how the formulation of insulin inside the coated capsule was capable of lowering blood glucose levels in rats.
Mitragotri plans to carry out more testing of the formulation as well as long-term toxicological studies. Researchers hope gaining approval for eventual clinical trials in humans will be made easier by the fact that the key ingredients in their formulation – choline and geranic acid – are already considered safe.
The Food and Drug Administration has established a daily recommended dose of choline, a vitamin-like essential nutrient; and geranic acid, a chemical that naturally occurs in cardamom and lemongrass, is widely used as a food additive.