12.15.22 -- Diving Into Drug Product Formulation, Development, And Scale-Up

Understanding both the significant competitive advantages that fixed-dose combination (FDC) products can offer and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Explore considerations for design, formulation, manufacturing, and analysis.

Any changes to the equipment and processes used to produce a semi-solid dosage form may affect the physicochemical characteristics, bioavailability, and sensory qualities of the final product. The right CDMO should provide expertise and technology from development through scale-up and manufacturing needed to perform the formulation, engineering, analytical testing, and validation work critical for successful site transfer.

The challenges for developing PDFs are numerous and varied and relate to the scale of manufacturing, the complexity of development and reformulation work required to support reduced dosing, a range of doses targeted to different age/weight levels, and often more than one formulation type required to meet the needs of toddlers through adolescents. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing.