Danish drug delivery company advances manufacturing of Phase III products

Egalet, a Copenhagen-based drug delivery company that is developing controlled release products using its eponymous technology, has signed a long-term agreement with fellow Danish company SP Medical, a manufacturer of moulded plastics and coatings, for the manufacture of clinical grade quantities of its Phase III hypertension and pain management products that use injection moulding.

The Egalet tablet builds upon a principle in which medicine is incorporated into a polymeric matrix that is eroded by bodily fluids at a constant rate. It is made using a similar injection moulding technique to that used in the plastics industry which involves only a few steps and ensures a higher uniformity of weight and content of drug compared with conventional compressed tablets.

"We have pioneered a unique technology that enables the controlled release of drugs through erosion of the delivery vehicle," said Jan Quistgaard, ceo of Egalet. "By introducing injection moulding, similar to that used in the plastics industry, to the pharmaceutical manufacturing process, precise and uniform tablets can be made time and time again.'

If the products gain regulatory approval, Juelsminde-based SP Medical, a subsidiary of SP Group, will also be responsible for commercial scale-up and manufacture.

"Egalet is very fortunate to have found a local manufacturer that has a premier reputation in the injection moulding field. We look forward to a long and productive collaboration," added Quistgaard.

Egalet's pipeline consists of four products in clinical development, two of which are entering late-stage pivotal studies for the cardiovascular and pain markets. The company is also making its technology available to pharmaceutical companies wanting to optimise the formulation and delivery of their drugs, as it claims that it can be used for virtually any type of medicine.