Canadian contract manufacturer Patheon has teamed up with specialty pharmaceutical firm Depomed to offer its clients a controlled release formulation which can grant their drugs increased bioavailability and less frequent dosing.
By making Depomed's AcuForm drug delivery technology available to its clientele of 200 pharmaceutical and biotechnology companies, Patheon is signalling its determination to join the ranks of companies such as Cardinal Health, Baxter and 3M that offer proprietary solutions in dosage form development, ranging from controlled release formulation all the way to commercialisation.
Although Patheon has a long way to go before it can compete with the outsourcing industry's behemoths in patented drug delivery technology, the deal means that the Toronto-based company's five centres of excellence in Canada, USA, UK, Italy and Puerto Rico, with more than 550 scientists working on more than 150 projects, will be able to use the AcuForm platform for the purpose of formulating, developing or improving pharmaceutical products.
Depomed's technology embraces diffusional, erosional, bilayer, and multi-drug systems that can optimise oral drug delivery for both soluble and insoluble drugs.
One application of it enables standard-sized tablets to be retained in the stomach for six to eight hours after administration, thereby extending the time of drug delivery to the small intestine and allowing it to release substantially all of its drug payload to the upper gastrointestinal sites.
Since the polymer matrix acts as a buffer between harsh drug crystals and the stomach lining there is less irritation, while the fact that drugs which may be harmful to intestinal flora are kept out of the lower gastrointestinal tract means that there are also fewer side effects.
"The Depomed technology allows us to provide a patented option in those instances where gastric retention is important to controlled release of a drug," Patheon spokeswoman Shelley Jourard told In-PharmaTechnologist.com.
"Additionally, since Depomed's technology is patented and Patheon has exclusive rights, our clients can extend the patent life on their products."
According to Depomed, the technology incorporates standard inexpensive pharmaceutical excipients which, with standard tabletting, add less than one US cent to the direct cost of a tablet.
Patheon is already familiar with AcuForm because it is used in two of Depomed's products it manufactures; ProQuin XR, a once-daily, extended-release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections, and Glumetza, a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes, which is expected to be launched in the US in the coming weeks.
Therefore, to avoid conflicts with Depomed's internal programmes, the two companies will form joint committees to review compounds prior to initiating work with AcuForm for third parties.
Patheon will assume primary responsibility for initial feasibility work, with technical assistance from Depomed, and for projects that advance beyond that stage, Depomed, Patheon and the client will establish a licence agreement, with Depomed and Patheon sharing in any license fees, milestone payments and royalties.
"Depomed has done extensive work in developing this technology and has experience in rapidly evaluating feasibility," Jourard added.
"Development and manufacturing costs for this technology are not expected to be significantly higher than conventional tablets."
Patheon says its will continue to be on the lookout for new formulation technologies as it seeks to build up its drug delivery system portfolio.