Clinical studies for candidate selection or first-in-man studies for initial safety evaluation often require simple dosage forms that allow little time for development. API-in-bottle or API-in-capsule dosage forms that contain nothing but the drug in a container meet these requirements. Not only is little development needed, but analytical methods developed for the API alone can often be used for analyzing the drug product as well.
Formex can also provide development of what we term “Fast Formulations” for early clinical studies. These are powder-in-capsule or powder-in-bottle formulations that can be quickly developed using a minimal number of excipients selected for function and non-interference with existing analytical methods. This approach provides the advantages of the API-in-capsule or bottle, while also providing a more robust formulation, capable of manufacture at a variety of scales with different equipment.