Do you handle pharmaceutical preformulation and formulation as a single program?
Pharmaceutical preformulation and formulation are closely connected, but they are generally handled as separate yet integrated stages of pharmaceutical development. Pharmaceutical preformulation focuses on understanding the drug substance, including its physicochemical properties, solubility, stability, particle characteristics, and compatibility with potential excipients. The findings from these studies help guide the next stage of formulation development.
During formulation development, the preformulation data is used to select suitable excipients, develop formulation prototypes, optimize the composition and manufacturing process, and evaluate the final product for quality, stability, and performance. At Molkem, preformulation development can therefore serve as the scientific foundation for formulation development, allowing both stages to work together as part of a coordinated pharmaceutical development programme.