Preformulation at Pharmaterials
Pharmaterials can provide formulation solutions for all phases of clinical trials, starting with very simple proof of concept formulation and developing to any level of sophistication that is needed to get your product into the clinic in the shortest possible time.
All formulations developed by Pharmaterials can be optimised and scaled up in order to manufacture cGMP samples for clinical trials supplies.
Your Pharmaterials formulator will transfer your formulation into production either in our own cGMP facility or to the facility of your choice.
The first (pre-clinical) formulation effort for a new API will usually be to prepare a solution formulation for IV administration as part of a toxicity test. Poorly soluble compounds present significant challenges in this respect.
There are a number of pre-clinical formulation strategies available and Pharmaterials has helped many companies in this phase of work. We will assess:
- The effect of pH
- Cyclodextrin inclusion complex formation
- Lipid based formulations
We will provide formulations for:
- solutions / suspensions
- powder for reconstitution
- control of physical form (salt etc)
- micronisation / nanoparticles / microfluidisation
- hard gelatin (or alternative) capsules
- amorphous solid solutions
- lipid formulations