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An international team of researchers from the United States, Denmark and Sweden has come up with a new approach offering an oral formulation of insulin that can be swallowed rather than injecting it a little closer to the clinic. Scientists have developed an unmanageable micro needle that can inject insulin into the lining of the stomach in a large animal model. They have also shown that their little pill – the size of a blueberry – can be adapted to administer other protein drugs.
Abramson et al developed a capsule that can be used to administer oral doses of insulin. Image credit: Felice Frankel.
For nearly a century, diabetic patients have been using injectable insulin to manage their disease. And for almost as long, the researchers looked for a way to administer insulin orally.
Although insulin injections can save lives, they are uncomfortable, cumbersome and increasingly expensive for patients. As a result, health care providers are often slow to prescribe insulin injections in favor of less effective oral medications.
"We really hope that our capsule will one day help diabetic patients and perhaps anyone who needs treatment that can now only be given by injection or infusion," said Professor Robert Langer of MIT, co-author of l & # 39; study.
Several years ago, Professor Langer and his colleagues devised a pill covered with many small needles that can be used to inject drugs into the lining of the stomach or small intestine.
For the new capsule, the researchers changed the design to no longer use only one needle, which allowed them to avoid injecting drugs inside the body. stomach, where they would be broken down by stomach acids before they have an effect.
The tip of the needle is composed of lyophilized insulin, compressed to almost 100%, according to the same process used to form drug tablets. The needle shaft, which does not penetrate the wall of the stomach, is made of another biodegradable material.
In the capsule, the needle is attached to a compressed spring held in place by a sugar disc. When the capsule is swallowed, the water in the stomach dissolves the disc of sugar, releases the spring and injects the needle into the wall of the stomach.
The wall of the stomach does not have any pain receptor, so scientists believe that patients could not feel the injection.
To make sure that the drug is injected into the stomach wall, they have designed their system so that, no matter how the capsule arises in the stomach, it can s & rsquo; Orientate so that the needle is in contact with the lining of the stomach.
"As soon as you take it, you want the system to correct itself in order to be in contact with the tissue," said lead co-author Dr. Giovanni Traverso, a researcher at Brigham Hospital. and Women's, at Harvard Medical School and at MIT. .
In tests on pigs, scientists have shown that they can successfully deliver up to 300 micrograms of insulin.
More recently, they were able to increase the dose to 5 milligrams, which is comparable to the amount that a patient with type 2 diabetes should inject.
Once the capsule has released its contents, it can pbad harmlessly into the digestive system.
The researchers found that the capsule, made of biodegradable polymers and stainless steels, had no adverse effects.
"Our self-orienting millimeter-scale applicator (SOMA) only worked in fasted animals," they noted.
"Further research will be needed to determine the chronic effects of daily gastric injections."
"Although additional studies are needed, SOMA is a platform that can deliver a multitude of medications. Our results are encouraging and warrant further evaluation of this technique for the oral administration of insulin and other drugs, "said Dr. Traverso.
The work of the team appears in the newspaper Science.
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Alex Abramson et al. 2019. Ingestible self-orienting system for the oral administration of macromolecules. Science 363 (6427): 611-615; doi: 10.1126 / science.aau2277
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