Efforts to deliver insulin into the body of a patient without painful injections now seem to come to fruition. Researchers have developed a new oral delivery technique that promises to dramatically change how diabetics keep their sugar levels in check.
The approach comes in to improve the quality of life of over 40 million patients subjected to either daily or weekly insulin injections, worldwide, as therapy for their type 1 diabetes.
Adherence to Insulin Injections
Depending on the dosage given, patients are required to inject themselves or have the doctor do so regularly, to ensure their glucose levels are stable. What medics call insulin therapy. When this is followed carefully, the concerned is guaranteed of living a normal life.
However, findings have it that most folks fail to stick to their prescribed dosage of injection because of the phobia of needles and pain. Others find it hard to go out of their daily busy timetable to administer the medicine, which increases their risk for farther complications.
Solving the Problem with Oral Delivery
Previous efforts to deliver insulin orally were marred by challenges that it was not possible. Reason being, the acidic environment in the digestive system doesn’t rate well the protein, which ideally interferes with its absorption.
However, with the new approach taken by Harvard John A. Paulson School of Engineering and Applied Science, the team of experts is considering ways to mitigate around the previous hurdles by hiding the insulin inside a special capsule.
This capsule will comprise of the insulin drug in an ionic liquid basically made from choline and geranic acid. The capsule carrying the two substances will have an acid-resistant enteric coating to protect it from digestive acids.
A plus to this discovery is that the formulation can easily be manufactured, it is biocompatible, and could be stored longer (up to two months) contrary to many injectable products.
How it Works
“Once ingested, the pill needs to be able to navigate the course and obstacles so that it reaches the point where it can be absorbed into the bloodstream effectively,” explained prof. Samir Mitragotri, senior author of the report. The work also appears in the recent issue of the Proceedings of National Academy of Science.
Encapsulating the pill in an enteric coating was the first game changer to ensure the content arrives safely. The second strategy was to keep the insulin in the ionic liquid to boost or enhance absorption after delivery.
On reaching a more alkaline than the acidic environment, the polymer coating would dissolve easily, which makes the target destination to be the small intestine. That’s where the ionic liquid comprising of the insulin would then be released.
After release, the protein is acted upon by enzymes which convert it into smaller particles of amino acids, (without degrading ionic liquid-born insulin,) ready for absorption, Explain the lead author Amrita Banerjee, a postdoctoral fellow at Mitragotri’s lab.
The choline-geranic acid formulation managed to as well overcome the final barriers, by penetrating across the layer of mucus lining in the small intestine and making through cell joints on the walls of the intestine. In previous attempts, the large molecules making insulin drugs didn’t make to come that far.
The Future with Insulin Pills
While Mitragotri and his fellow researchers made it clear that more animal tests, bioavailability, and long-term toxicological studies will follow, they are optimistic that the technique and the pill will get approval from FDA.
If all goes well and looking at the cost of manufacturing the drug, more patients would prefer the pill over injection. This might also pave way for oral delivery of other proteins to replace the needle.
Commercialization of this technology is already rolling, being driven by Harvard’s Office of Technology Development, so the pills might reach the users faster after FDA’s approval. But as at now, the insulin pill is not available for sale nor for human use.