Preformulation refers to the collective studies directed at defining the chemical and physical properties of a new drug candidate. These studies include chemical and physical stability in solid and solution states, solubility in various media, potential for oxidative degradation and photoinstability, compatibility of drug with potential excipients and so forth.
The purpose of the preformulation process is to guide and optimize the preclinical formulation development of a suitable dosage form for Phase 0, Phase I, and beyond, while at the same time identifying physico-chemical issues that may arise and complicate the development pathway. Preformulation study designs can be tailored to also support adaptive or combination therapy clinical trials.
Based on preformulation data, PDDC can also offer advice on the reformulation or repurposing of compounds. Studies are useful to identify suitable alternative routes of administration or new formulations that can be used to enhance the product profile, support a new indication, add line extensions, and improve patient compliance.
PDDC scientists are well versed in all of these aspects of preformulation study design. They are able to define the appropriate preformulation strategy necessary to adequately profile a new or repositioned candidate, assess any assets, opportunities, or risks, and provide concrete early formulation recommendations to quickly move projects into the clinic.