New tech Cholestosome from Niagara University spares diabetics from daily insulin injections by taking capsule instead
The dream of millions of diabetics of being spared from painful daily insulin injections may soon be over. Researchers from Niagara University have developed a new technology that would deliver the insulin in capsule form.
It is the second successful trial of an oral insulin after Oramed Pharmaceutical, an Israeli company, successfully held a Phase II clinical trial of its ORMD-0801.
Mary McCourt, leader of the research team, says they have developed Cholestosome, a neutral, lipid-based particle which solves the biggest obstacle to delivering insulin orally. The stomach’s highly acidic environment degrades proteins such as insulin before it gets a chance to move into the intestines and bloodstreams.
With the encapsulated insulin made of naturally occurring lipid molecules – the normal building blocks of fats – makes it unnecessary to package it in a polymer coating for protection. The researchers used simple lipid esters to make vesicles with the drug molecules inside, explains Lawrence Melinki, a member of the Niagara team which developed the technology at the McCourt/Melinki lab, reports ACS.
The team used computer modeling to show that once the lipids are assembled into spheres, it formed neutral particles resistant to stomach acid attacks. Drugs are loaded inside and the small packages pass through the stomach without degrading.
Once the Cholestosome reaches the intestines, the body recognises it as something to be absorbed. The vesicles pass through the intestines into the bloodstream, and the cells take it and break it apart to release insulin. Testing on animals showed certain formulations of Cholestosomes loaded with insulin have high bioavailabilty.
The next step for the team if to further optimise formulations, do more animal testings and develop new partnerships for human trials. The researchers will present their findings at the national meeting of the American Chemical Society in Philadelphia, reports the New York Post.
A capsule insulin, while it would be fully embraced by diabetics, would surely dent the sales of pharmaceutical giants that manufacture injectable insulin such as Eli Lilly, Novo Nordisk and Sanofi-Aventis.
Separately, Oramed, an Israeli pharmaceutical company is also working on an experimental insulin drug at its laboratory in Jerusalem. In May, Oramed announced it succeeded in its experiment oral insulin trial by significantly reducing night-time blood glucose for type 2 diabetics, reports Reuters.
Oramed would conduct a larger Phase III trial before it submits the drug, ORMD-0801, for regulatory approval.
VIDEO: Oramed Oral Insulin
Source: Oramed Pharmaceuticals
