Application of QbD Principles for Lyophilized Formulation Development

A molecule that is not stable in solution is usually lyophilized to achieve pharmaceutically acceptable shelf life. However, just removing the solvent (generally water) does not assure stability. The formulation composition as well as the lyophilization process parameters is critical to achieve desired drug product quality attributes . This chapter describes how the elements of Quality by Design (QbD) can be applied to lyophilized formulation development. Lyophilization process design and development is discussed in the subsequent chapter; however, formulation development takes into consideration the impact of process parameters on product quality attributes.