Sr. Principal Scientist Eli Lilly and Company Indianapolis, Indiana
Spray dried dispersion (SDD) is a technique that is used in the pharmaceutical industry to formulate amorphous solid dispersions (ASD) which are typically comprised of drug substance and polymer. Pharmaceutical ASDs are often complex and present challenges, for example, increased risk for chemical or physical instability. The challenge that will be discussed is the investigation of the unexpected water increase for multiple ASDs while on stability in sealed packaging which should prevent water ingress. For one of the assessed ASDs, the water increase had a negative impact on a critical quality attribute (CQA) where crystallinity of drug substance increased from the initial timepoint to the one-month timepoint. This talk will provide an overview of these challenges, including results from investigations and packaging studies that have been completed to understand the root cause of the water ingress and best practices for mitigation to reduce the water uptake.
Learning Objectives:
Upon completion, participates will be able to recognize trends in stability data for drug product intermediates.
Upon completion, participants will be able to apply root cause analysis tools to identify unexpected causal factors.
Upon completion, participates will be able to implement mitigation steps to avoid water ingress for drug product intermediates.
Upon completion, participates will be able to understand the impact of water on physicochemical properties of drug product intermediates.
