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| Apollo's oral insulin - key studies completed for trial |
Nanoparticles made 15,000 times
the actual size of Oradel™ particles | Apollo Life Sciences has completed a number of key studies as it prepares to move into the Phase I trial of its oral insulin product.
Apollo CEO John Priest said the company's Oradel™ drug delivery technology had passed a series of pre-trial tests showing the technology has the characteristics needed to protect insulin molecules from the harsh conditions of the gastrointestinal tract and deliver a therapeutic dose of insulin across the wall of the intestine into the bloodstream.
"This is part of the ongoing building of Apollo's capabilities in the field of oral insulin delivery," said Mr Priest.
The pre-trial studies demonstrated that Apollo's research has unlocked some of the key obstacles to the oral delivery of insulin; notably the (1) efficient incorporation of insulin molecules in protective nanoparticles, and (2) production of nanoparticles of consistent size.
The company has developed a unique production method whereby up to 100 per cent of insulin molecules are entrapped in the matrix of Apollo's Oradel™ nanoparticles. By maximising insulin entrapment during the production process, Apollo's Oradel™ nanoparticles can deliver up to 160 milligrams of insulin per microgram of attached vitamin B12 (a 36,000:1 payload ratio).
Apollo's production method has also overcome a key stumbling block for producing oral insulin through its ability to produce nanoparticles of consistent size.
"This is a critical factor considering that particle size is a key physical attribute that determines the ability of nanoparticles to cross the intestinal wall," said Dr Luke.
Dr Luke said recent studies indicate that particles between 100 to 200 nanometres in diameter are the optimal size at which nanoparticles are able to be carried through the wall of the human intestine.
"Nanoparticles need to be small enough to pass through the intestinal wall but large enough to carry enough insulin to have a therapeutic effect. To satisfy these tight parameters, we believe 100 to 200 nanometres to be the most appropriate diameter range for Apollo’s Oradel™ insulin nanoparticles," said Dr Luke.
Apollo has demonstrated, using several validation techniques that it can consistently manufacture insulin-loaded nanoparticles between 100 to 200 nanometres in diameter – an optimal size to carry enough insulin to have a therapeutic effect and still be able to easily pass through the wall of the human intestine.
According to Mr Priest, Apollo Life Sciences Oradel™ drug delivery technology has the potential to become a global market leader for the treatment of diabetes.
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| www.apollolifesciences.com |