Early Enabling Pre-Clinical Formulation Development

Through the synergy between solid state chemistry and formulation, we can add value to your pre-clinical project, while decreasing timelines. During preformulation, the physicochemical properties of the drug substance are investigated. Understanding the relevant physiochemical and biopharmaceutical properties determines the appropriate formulation and delivery method for pre-clinical and Phase 1 studies. Performed using small-scale analysis techniques, we can determine key characteristics of drug molecules even when solubility is low and drug material is limited.

Our experience and technical knowledge can rapidly identify molecule challenges with protocols which emphasize efficient use of resources. Applying our understanding of drug physicochemical properties, we can offer tailored and rational preclinical formulation development.

Using the Developability Classification System (DCS) as our framework, we examine how the physicochemical characteristic of a compound may affect oral absorption and bioavailability, determining risk and suggesting formulation strategies. Using a rapid excipient screening approach, we can provide preclinical formulations which enhance drug solubility and overcome in vivo sources of pharmacokinetic variability. In vitro testing using biorelevant models can demonstrate formulation abilities to promote supersaturation and resist unfavorable situations such as pH-mediated precipitation and food effects.