The selection of a suitable solid form of the drug substance is a vital step in pharmaceutical development, with the potential to impact bioavailability, solubility, dissolution rate, stability and manufacturability.
The route of application and the intended daily dose play an important role within solid form selection. For example, the solid state property requirements depend on whether an oral, parenteral, transdermal or inhalation route is the desired method of administration.
We support our customers in their selection of the optimal crystal form with a series of preformulation studies, including:
- Solubility and dissolution rate in aqueous media and simulated body fluids at various pH values
- Solubility in organic (pharmaceutically relevant) solvents
- Hygroscopicity evaluation
- Thermal characterisation
- Determination of partition coefficients
- Determination of pKa
- Drug-excipient compatibility
- Particle size distribution
Using our preformulation expertise, our customers are able to make informed decisions on how to proceed in the development of their drug candidate.