One of the most onerous components of life with diabetes is dealing with all of the needles.
Needles for regular blood glucose testing as well as needles for insulin injection.
For those who have anxiety over being regularly pricked, it can mean avoidance or noncompliance, which can have dire results.
But a new study indicates that relief for the needle-averse may be on the horizon.
An oral form of insulin is in development. Researchers presented their studies on this topic at the American Chemical Society national meeting this week.
A solution in liquid form
Until now, needles have been the only way of effectively delivering insulin to a patient’s bloodstream.
A few prior approaches, including an inhalable form of insulin, had temporary successes, but nothing has proved to be as effective as injections.
Researchers have been attempting to develop an “insulin pill” for many years but have been thwarted by two main problems.
One was that harsh stomach acids easily destroy orally ingested insulin before it could be absorbed into the body.
The second has been that it has been difficult for insulin to cross the intestinal membrane in order to reach the bloodstream.
Now, a team of researchers led by Dr. Mary McCourt and Dr. Lawrence Mielnicki of Niagara University, have discovered a new vehicle for orally ingested insulin.
It’s not a pill, but neutral lipid vesicles called Cholestosomes, which are delivered in liquid form. These lipid vesicles can be made in any size and are made of materials that are naturally occurring in the body.
“We discovered that insulin could survive intact inside the GI tract, and then pass through into the bloodstream.” Mielnicki said at a press conference this week. “The interesting part is that anything can be packaged inside these vesicles, even beyond insulin, so there could be many applications for this therapy. So we are happy to see success in the initial animal studies.”
Unique delivery method
The researchers stress that the reason for the success of this method is the unique mechanism of delivery.
The insulin is packaged in a nanoscale vesicle that is in essence a cocoon of lipids that surrounds and protects the insulin, and yet allows it to easily release into the bloodstream.
The lipid vesicles are not recognized in the body as something foreign, so they are generally regarded as “safe.”
Once the lipids are assembled into spheres, they form neutral particles resistant to attack from stomach acids.
Drugs can be loaded inside, and the tiny packages can pass through the stomach without being destroyed. When Cholestosomesreach the intestines, the body recognizes them as something to be absorbed.
The vesicles pass through the intestines, into the bloodstream, and then cells take them in and break them apart, releasing the insulin.
Since they are packaged as neutral, they have no reaction to the environment, and the acid on the stomach has no effect on them. Additionally, the vesicles are structurally stable and amenable to storage without leaking or breaking down before ingestion.
When asked about the effectiveness of this delivery method versus that of an insulin injection, McCourt responded that it was found to be similar in the control studies, and that it had the potential to be even longer lasting than injected insulin.
More research needed
Since the process is still in the stage of animal studies, it is too early to predict how effective it will be in humans or what this new form of insulin treatment might cost.
However, the team indicated that all of the materials used are widely available, so it is not anticipated to be excessively expensive.
Based on the animal studies, the researchers stated that this method could be universally applicable for any patients who are insulin dependent.
Looking beyond diabetes treatment, they have also successfully encapsulated molecules of varying sizes. This bodes well for other pharmaceutical treatments.