Mayne Pharma Pelleting Technology and Processes
Pellet (or bead) technology allows a variety of different drug delivery profiles to be achieved by coating a ‘core’ of drug and excipient with various polymers. The drug cores are generally spheroidal in shape and have a diameter in the range of 300 to 1,700 µm. In order to generate the spheroidal particles, there are two main types of processes used:
- The first, extrusion granulation, granulates API with excipients, which is extruded to form a core then coated by polymers. This process allows drug potencies up to 90%.
- The second process is known as spheronization, where drug particles are fixed to the outside of a seed core, typically sugar, with the aid of a binder. The core is coated with a polymer. This process provides a very tight size distribution of pellets. Drug potencies up to 60% are possible.
The drug delivery system is then achieved by coating these particles with a polymer coat. Depending on the type of polymers used various release profiles can be achieved such as sustained-, targeted- or pulsed-release.
Pellet technology has successfully been applied to a number of proprietary pharmaceuticals with modified release profiles. These include:
- ERYC® (delayed-release erythromycin)
- DORYX® (delayed-release doxycycline)
- KADIAN® (extended-release morphine)
- ASTRIX® (delayed-release low-dose aspirin)