Principal Research Scientist AbbVie North Chicago, Illinois
Amorphous solid dispersions (ASDs) of a poorly water-soluble active pharmaceutical ingredient (API) in a polymer matrix can enhance the solubility and improve the bioavailability. Many ASD products are kinetically stabilized, and inhibition of crystallization of an API within and beyond shelf life is still a matter of debate, since the formation of crystals may impact bioavailability. We present the first literature examples of ASD long-term stability studies over 25 years under ambient storage conditions, where no crystallization was observed. Additionally, a risk assessment and mitigation strategy of API crystallization in packaged drug product (DP) is outlined. The physical stability of ASDs during shelf-life storage is modeled by quantification of crystal growth by transmission Raman (TRS), modeling water sorption, and the glass-transition temperature of the packaged ASD DP during storage. Application of this approach to ASDs of AbbVie internal compounds is discussed.
Learning Objectives:
Participants will learn about historical examples of ASD shelf-life stability
Participants will be able to better interpret open dish stability data to assess the storage stability of a packaged ASD drug product.
Participants will learn about a lean approach for ASD physical stability assessment.