Addressing the toxicological risks associated with patient exposure to leachables requires a strategy tailored to the unique characteristics of each dosage form. This webinar explores the technical challenges and solutions for various dosage forms, focusing on Metered Dose Inhalers (MDIs), topical drugs, and Large Volume Parenteral (LVP) drug products.
Metered Dose Inhalers (MDIs): Widely regarded as the highest risk dosage form from an Extractables and Leachables (E&L) perspective, MDIs often contain leachables at levels that necessitate stringent control strategies post-approval. This segment will discuss how to develop and implement these strategies to ensure leachable levels remain within safe limits in commercial batches.
Topical Drugs: The complex formulations of topical drugs present unique analytical challenges. Analyzing these products or justifying the use of appropriate surrogate solvent systems to generate extracts from the container closure system requires sophisticated techniques. This part of the presentation will delve into the methods and considerations needed to overcome these challenges.
Large Volume Parenteral (LVP) Drug Products: Although similar to Small Volume Parenteral (SVP) products in being mostly aqueous-based, LVPs pose additional challenges due to their increased daily dosage volumes. These challenges push the boundaries of current scientific capabilities and analytical instruments. The talk will cover the complexities involved in deriving the Maximum Daily Dosage (MDDs) for LVPs and how this impacts the Analytical Evaluation Threshold (AET).
Furthermore, the presentation will discuss the evolving Safety Concern Thresholds (SCTs) and the difficulties in detecting and identifying extractables/leachables within these new parameters. Incorporating risk-based concepts into a leachable study to ensure the testing effort is proportional to the level of risk will also be examined. This approach ensures a balanced and efficient strategy for managing toxicological risks associated with leachables.
Join us to gain a comprehensive understanding of the technical challenges in E&L testing across different dosage forms and learn how to address these issues effectively to ensure patient safety and product compliance.