We can prepare the dose form that is to be used in a pre-clinical trial. Samples are produced under cGMP conditions ready for transfer to the team who are to carry out the study. The formulation will be tested and released to the specifications agreed during the development process.
Often additional pre-formulation sample preparation/optimisation work is required, which could include crystallisation, spray or freeze drying, milling or micronisation services. Our proprietary formulation solubility screen can be used to provide a fast and efficient route to investigate and solve many pre-clinical formulation challenges.
We also offer API processing services such as micronising or blending to prepare samples for further development. We can carry out such work on site with characterisation analysis. Again, we can support with small volume spray and freeze drying and a range of milling/micronisation approaches.
We have invested in a range of equipment to support this process including:
- Freeze Drier (SCANVAC 110-U PRO)
- Homoginiser (IKA T25D)
- Multi inlet vortex mixer (4 port custom design)
- Combined impinging jets mixer (custom design)
- Turbula Blender T2F