Using QbD to Asses the Factors That Affect Stability and Packaging

Packaging is often the last step in drug product (DP) development; however packaging is extremely important in determining the marketability of a product. The ability to predict whether a product can be stored at room temperature early in development can affect how the drug is developed. In order to determine packaging requirements, and estimate shelf-life of the drug product it is important to understand the factors that impact DP degradation, which include storage temperature, water content, and starting materials.

Using quality by design (QbD) principles, an experimental plan and subsequent model were developed to systematically evaluate these factors. From the developed stability model, a strategy was determined to facilitate packaging selections, storage conditions and justification of specifications. The ability to use this model to determine the product packaging and justify the product specifications is crucial to patient safety and critical for a successful regulatory filing. Finally, discussed are the regulatory implications and how this information can be used in conjunction with ICH stability studies.