The new research comes from the Harvard John A. Paulson School of Engineering and Applied Sciences and it takes the form of an oral delivery method that could have a major lifestyle impact, by transforming the way by which diabetics keep their blood sugar levels in check: negating the need for injections.
Insulin is a peptide hormone produced by beta cells of the pancreas. The hormone regulates the metabolism of carbohydrates, fats and protein by promoting the absorption of glucose from the blood into liver, fat and skeletal muscle cells. Currently everyone with Type 1 diabetes and some people with Type 2 diabetes needs to take insulin – either by injection or a pump – to control their blood glucose levels.
According to lead researcher Samir Mitragotri on concern that has led to research into the insulin pill is the fact that some people “fail to adhere to that regimen due to pain, phobia of needles, and the interference with normal activities.”
However, developing a pill was not straightforward. The insulin protein does not last long when it reaches the stomach’s acidic environment and it is poorly absorbed out of the intestine. This meant an alternative approach was required. The answer was to transport insulin in an ionic liquid made of choline and geranic acid. This mixture is then place inside a capsule with an acid-resistant enteric coating.
In trials the new formulation has been found to be biocompatible, straightforward to manufacture, and it can be stored for up to two months at room temperature without showing signs of degrading. Research is currently on-going, and clinical trials and regulatory approval will need to be obtained before a licensed medicine is produced.
The research has been published in the Proceedings of the National Academy of Sciences. The research paper is titled “Ionic liquids for oral insulin delivery.”
