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| Apollo Pushes Towards Oral Insulin Clinical Trial |
With the patenting of its Oradel™ oral delivery technology strengthened, Apollo is continuing preparations for its first use in human clinical trials – with oral insulin.
Dr Michael Luke, Director of Drug Delivery, said that in studies already completed, Apollo’s oral insulin had performed exceedingly well. "It has taken insulin down to normal levels in diabetic animals and been able to hold it there for up to 12 hours," he said.
"In preparing for human trials, it is also important to do a wide range of validation and quality control studies."
The development now under way for oral insulin includes quality control and assurance work for each aspect of the technology. The studies are designed to establish characteristics such as uniformity of particle size and the joining of vitamin B12 molecules to nanoparticles, as well as efficiency in transporting the oral insulin nanoparticles.
The Oradel™ technology has been designed to allow the delivery of a diverse range of biopharmaceuticals such as insulin, interferon, growth hormones, TNF blockers or other disease-modifying anti-rheumatic drugs in oral or tablet form – opening up a whole new delivery option for treatments previously thought unsuitable for oral administration.
Oradel™ enables oral delivery of these drugs for the first time by:
Stabilizing the drug within a patented protective structure to withstand the harsh acid and enzymes of the gastrointestinal tract
Presenting the drugs in a form that is specifically designed to utilise the normal digestion processes of the small intestine for active drug transport into the bloodstream
"The patented manufacturing process for Oradel™ is low cost and able to be scaled up for commercial use", said Apollo’s CEO, John Priest.
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Insulin is entrapped in nanoparticles which protect it from breakdown in the stomach. Particles are coated with a targeting agent. |
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Agent binds to receptors on cells lining the small intestine. Particles then transported across cells using natural vitamin uptake mechanism. |
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The particles enter the bloodstream via the portal vein, which carries them directly to the liver, where insulin is released. |
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