Aimed at the manufacturing of co-crystals for use in inhaled and oral medicines
Prosonix, a UK leader in the use of ultrasonic pharmaceutical particle engineering for the manufacture of pharmaceutical powders, has launched a co-crystal development and processing service, aimed at the manufacturing of pharmaceutical co-crystals for use in inhaled and oral medicines.
The Oxford-based company says its proprietary technologies can facilitate co-crystal manufacture at any scale alongside controlled particle size distribution and high purity.
Prosonix technologies such as UMAX, DISCUS, and USOBR have been successfully applied to the production of a significant number of co-crystals, including carbamazepine:saccharin (1:1), carbamazepine:nicotinamide (1:1) and indamethacin:saccharin (1:1).
The co-crystals produced are of higher purity and with a defined particle size distribution compared with those obtained from standard crystallisation techniques, the company says. In addition, the solubility and dissolution properties of the APIs are significantly improved by co-crystallisation. The techniques can also be used for identifying new co-crystals.
Protonix says its novel approach overcomes the need for critical matching of solubility during nucleation and growth of the co-crystal. In addition the risk of crystallising single components is significantly reduced. The stoichiometric composition of the components is maintained throughout the process, and the conditions for nucleation and growth of the co-crystal is generated within the process.
‘The methods we have developed allow us to control both the fundamental co-crystallisation and the desired particle size, whether micro-crystals for respiratory products or larger particles for oral delivery.
‘We are confident that our manufacturing techniques have the potential to be used as the first choice production method of pharmaceutical co-crystals in the future.’