Pharmaceutical dosage forms are primarily distinguished by their route of administration, with secondary differentiation based on other dosing parameters. Parenteral dosage forms are unique as they are administered through injection or implantation, allowing the direct delivery of active drug substances into blood vessels, organs, tissues, or lesions. Among these, large-volume parenteral drug products (LVPs) stand out due to their specific characteristics and challenges.
LVPs are liquid parenteral products packaged in unit doses exceeding 100 ml. They are typically contained in flexible plastic packaging, which raises concerns about leachables—substances that can migrate from the packaging into the drug product, potentially becoming impurities. The large volume and often complex composition of LVPs make it challenging to screen for unspecified leachables effectively.
This presentation will provide an in-depth introduction to LVPs as a pharmaceutical dosage form, highlighting their unique attributes and the specific issues they present. Participants will gain a comprehensive understanding of the packaging-related challenges associated with LVPs and the implications for drug product purity and safety.
A significant focus of the presentation will be on the Analytical Evaluation Threshold (AET) Challenge. The AET is a critical concept in the context of leachables, representing the threshold above which a leachable must be identified and quantified. Understanding and applying the AET is essential for accurately assessing the risk posed by leachables in LVPs.
Attendees will learn about the complexities involved in testing LVPs for unspecified leachables, including the methodologies used and the limitations of current approaches. The presentation will also explore strategies to overcome these challenges, ensuring the reliability and accuracy of leachables testing in large-volume parenteral products.
By the end of the presentation, participants will have a clear understanding of LVPs, the potential risks posed by leachables, and the importance of the AET in managing these risks. This knowledge is crucial for ensuring the safety and efficacy of large-volume parenteral drug products and maintaining compliance with regulatory standards.