The University of Iowa Pharmaceuticals (UIP) has the capability to systematically build quality into products from inception by performing various pharmaceutical preformulation studies. All studies are performed according to FDA and ICH guidelines, client approved protocols, and standard operating procedures.
Once preformulation studies have been completed on an active pharmaceutical ingredient (API) or drug substance, UIP has the capability to develop product formulations and manufacture clinical supplies to meet clinical trial needs.
Typical preformulation studies of pharmaceuticals include:
- Excipient Compatibility Studies – These studies typically assess the stability of an API with individual and groups of commonly used pharmaceutical excipients in various accelerated stability conditions. The exact choice of excipients depends on the known stability and solubility characteristics of the active pharmaceutical ingredient (API) and the type of dosage form planned.
- Physical/Chemical Characterization – These studies focus on the crystal structure of the API. The tests which are typically performed include powder x-ray diffraction (XRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Fourier transform infrared spectroscopy (FTIR), microscopy, Raman spectroscopy, and Karl Fischer moisture analysis. Additional tests can be performed if requested.
- Solubility – Solubility of the API is determined as a function of pH in water, buffers and/or various solvents. The choice of solvents depends on the anticipated dosage form and the known solubility characteristics of the API or similar compounds.