There are currently several schools of thought on formulation of early stage drug candidates, and each has strengths. At the lead optimization stage, there may be several candidates under consideration.We believe that in order to rank these candidates, it is vital that each is optimally formulated for pharmacokinetic or proof-of-concept studies. Further, evaluation of each compound’s aqueous solubility and physicochemical stability in the formulation must be performed to ensure consistent dosing over the treatment period. Thus, even with multi-candidate lead optimization, we believe there is enormous value in accruing some fundamental physico-chemical data for each drug candidate, a task that can be accomplished with as little as 10 mg of compound. Post-candidate selection, PDDC can define a formulation strategy, based on preformulation data, to enable toxicology studies as well as a robust formulation for clinical studies.
PDDC have extensive experience supporting preclinical pharmacokinetic, efficacy, and safety studies. Formulations approaches suitable for cell based, tissue, whole organ, and whole animal dosing can be envisionaged, depending on the screening model conditions. We have the experience to tailor formulations to avoid animal species sensitivities to certain excipients and, importantly, ensure compatibility of formulations with disease models. We can train your staff to properly and routinely perform these formulation tasks. In addition, preclinical testing will lay the foundation for developing the initial clinical formulation (Phase 0/1).