Injection moulding is a method that has been used for decades for medical devices and is now adapted by Egalet to produce pharmaceutical tablets of more accurate weight and content compared with conventional compressed tablets.
Whereas most tablets are made with an accuracy of 4 to 5 per cent, Egalet's technology can produce tablets with 0.1 per cent accuracy, resulting in little or no variation between one tablet and the next, thereby reducing waste.
Moreover, since the manufacturing process follows standard procedures for injection moulding of thermoplastic materials, it allows manufacturers to easily vary the rate of production at times of greater demand and produce very high volumes to precise standards of accuracy in a virtually automatic environment.
The Danish company's tablets consist of a biodegradable coat and a matrix, comprising of the active drug, which is surface-erodible, hydrophobic and composed of polyethylene glycol (PEG)-stearate.
By changing the properties of the matrix, Egalet has developed a constant release system and a burst release system with a predetermined delay.
The formulation can be used for virtually any type of medicine and, unlike water soluble diffusion technology, it is not affected by the pH of the body fluid it comes in contact with.
"Our technology may be more expensive than conventional tabletting methods but, when it comes to other drug delivery systems, we can compete with any controlled release formulation," Egalet CEO Jan Quistgaard told In-PharmaTechnologist.com.
"Scale-up can often be a major step, particularly for small companies, so a particularly attractive aspect of our technology is that there is no scale-up involved, just the addition of more machines."
SP Medical, a subsidiary of SP Group, will manufacture tablets of Egalet products that are about to enter Phase III testing for hypertension and pain management using injection moulding.
If the products gain regulatory approval, SP Medical will also beresponsible for commercial scale-up and manufacture of both products.
All manufacturing will take place in a good manufacturing practice (GMP)-certified facility of SP Medical located just south of Copenhagen and is subject to approval by the Danish authorities and the US Food and Drug Administration (FDA).
Egalet's products have already been successfully tested in vitro and in vivo with a variety of active ingredients including peptides and unstable molecules.
The company is now making its technologies available to pharmaceutical companies wanting to optimise the formulation and delivery of their drugs.