The innovative technology, Oradel, has been developed by Australian biotech firm Apollo Life Sciences, and late last week the company announced that the World Intellectual Property Organisation (WIPO) has issued a positive search report following the company's Patent Cooperation Treaty (PCT) application.
The PCT is an international treaty that makes it possible for Apollo to secure patent protection for its " breakthrough " Oradel delivery technology in the 137 countries that are members of the PCT, including the US, UK, EU countries, Japan and Australia.
Oradel is being touted by the company as a product that could revolutionise the delivery of large molecules, overcoming the obstacles that have stood in the way of oral delivery and creating tablet forms of drugs that have previously been restricted to needle-based administration.
The company's most advanced product - and the one likely to have the biggest impact both for the company and for patients - is an insulin tablet formulated using the Oradel technology.
The successful development and launch of an oral insulin tablet could mean big bucks for the company, allowing patients to do away with numerous painful injections each day and offering a potentially more attractive option than alternative delivery options such the inhalable insulin products that are starting to come out on the market.
Apollo's Oradel technology has been designed to allow the delivery of biopharmaceuticals such as interferon, growth hormones or TNF blockers in oral or tablet form, opening up a whole new delivery option for treatments traditionally thought unsuitable for oral administration.
The problem with delivering these large, water soluble molecules orally lies in the fact that they tend to be digested in the stomach or passed down the intestine unabsorbed and end up in the bowel.
Apollo's Oradel platform makes it possible for these large molecules to actually enter the bloodstream from the stomach, with "exciting potential to revolutionise the biopharmaceutical industry," says the company.
The technology allows the drug to survive the harsh enzymatic environment in the stomach by stabilising it within a protective structure, with further degradation also reduced by formulating Oradel pharmaceuticals in solid dosage forms that dissolve in the small intestine rather then the stomach.
As many of the large molecules that Apollo is seeking to work with are poorly absorbed through biological membranes such as those lining the small intestine, the Oradel technology has been designed to overcome this hurdle as well.
Oradel consists of specific targeting agents which bind to naturally occurring transporters embedded in the intestinal wall.
Binding to these features promotes the uptake of the formulated drug so that it crosses the intestinal wall and enters the bloodstream.
Once there, the Oradel structure breaks down, releasing the biologic drug into the bloodstream.
The nanoparticles that make up the Oradel formulation can be loaded with a range of pharmaceutical agents, including large molecules up to 150kDa in weight in sub-micron structures of around 200nm in size, and can be coated with one of five distinct targeting moieties, according to Apollo.
The novel three-step manufacturing process for Oradel is also low-cost and readily scalable, says the company.
Back in February, Apollo announced successful results of toxicity studies for the company's oral insulin tablet formulated using the Oradel technology.
Studies in rats and rabbits showed that Oradel loaded with generic insulin was safe at both high and low doses, with the slow-release formulation also avoiding potentially toxic spikes in insulin levels and allowing sustained insulin release over at least eight hours.
According to the company "it is only a matter of time before we enter the marketplace with our insulin in a tablet," and with that market worth around $18bn a year and growing at an annual rate of around 40 per cent, the benefits that the Oradel technology is promising means the insulin tablet could cause serious waves in the diabetes treatment arena.
The insulin tablet will be entering clinical trials later this year, closely followed by another Oradel-formulated therapy for rheumatoid arthritis.