New microneedle pill for a painless insulin injection

Insulin is a hormone produced by your pancreas to allow cells to use glucose. When your body does not make insulin properly, you can take synthetic insulin to control your blood sugar.

For many years, diabetic patients need injectable insulin to manage their disease. And for a long time, researchers have been looking for a way to orally control insulin.

Insulin injections can save your life. However, they are uncomfortable, bulky and very expensive for patients. For example, most health centers are often slow to prescribe insulin injections for less effective oral medications.

A team of scientists from Harvard-affiliated Brigham and Women's hospitals and Novo Nordisk has discovered a new way to bring the clinic closer to the oral training of insulin, which can be ingested instead of injected.

With funding and in collaboration with scientists from Novo Nordisk, the team has developed an unmanageable micro-needle that can inject insulin into the lining of the stomach in a large model animal.

The correponding author, C. Giovanni Traverso, gastroenterologist at the Brigham Division of Gastroenterology, said: "The described work is being built and is motivated by some critical clinical observations, especially when a drug is injected into the wall of the stomach, this drug can become very quickly spread throughout the body. In addition, we recognize that the stomach is insensitive to sharp pains and very tolerant of small sharp objects.

Traverso and his colleagues had to take on several challenges, such as navigating under extreme conditions in terms of pH, thick layers of mucus, temperature and reliable orientation so that the microneedle could s & # 39; 39; inject into the lining of the stomach.

Their ingestible device, known as the SOMA (Self-Orienting Scale Applicator), is inspired by the leopard turtle with automatic orientation. These are the species that can turn around when they are on the back. The shape and density distribution of the SOMA were optimized so that the micro-needle landed in the stomach at the same place each time.

SOMA is a pea-sized pill that may contain a needle in insulin. Its injection is controlled by a spring held in place by a sugar disc.

The moisture in the stomach is fed through the sugar disc to trigger the microinjection, and the solid insulin needle helps to deliver a sufficient dose of the drug. Its size and material composition are similar to those of previously approved FDA unmanageable devices.

"The scientific principles underlying the SOMA system, and the system itself, have the potential to allow the oral delivery of large molecules such as peptides, proteins and nucleic acids," said the author. Robert Langer, professor at the Harvard-MIT Institute. Division of Health Sciences and Technology. "This discovery has the potential to transform not only drug delivery, but also drug delivery, as most current efforts in this area are aimed at creating small molecule drugs that patients can take orally. "

The team tested it on a pig first and administered microneedles containing 0.3 mg of human insulin and poly (ethylene) oxide (PEO). Then they measured the amount of insulin and PEO combined that entered the blood and measured the blood glucose level in five different animals.

When injecting insulin, they found a noticeable reduction in blood glucose levels, with similar active drug concentrations in the blood. They also note that this gastric insulin causes no abnormality or tissue damage, no signs of distress and no change in eating habits or bowel movements.

They also noted that SOMA only worked in fasted animals. In addition, additional 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 Traverso.

Other authors of this study include Alex Abramson, Ester Caffarel-Salvador, Minsoo Khang, David Dellal, David Silverstein, Yuan Gao, Morten Revsgaard Frederiksen, Andreas Vegge, František Hubálek, Jorrit J. Water, Anders V. Friderichsen, Johannes Fels , Rikke Kaae Kirk, Cody Cleveland, Joy Collins, Siddartha Tamang, Alison Hayward, Tomas Landh, Stephen T. Buckley, Niclas Roxhed and Ulrik Rahbek.

The results are published in Science.