Understanding and predicting how chemicals in packaging and medical device materials are distributed and migrated in the pharmaceutical and medical device industries is critical to ensuring product safety and effectiveness. Chemical Characterization Solutions, a new study by Dr. Jianwei Li of LLC, published in the journal Journal of Peer Review, Chromatography, explores Abraham’s solvation parameter model as a model for predicting how different chemical compounds are in various mathematical methods of dissolution and distribution in such environments can be used for extraction and filling research. These studies examine chemicals that may migrate from packaging or medical devices to drugs or the body. The model provides a structured method to predict how chemicals are distributed across different materials, thereby improving the accuracy and reliability of safety assessments.
Dr. Li’s research focuses on applying the model to key aspects of extract and infiltration research, including selecting the right solvent, determining the interaction of materials with different chemicals, developing test solvents that simulate real drugs, and predicting chemicals in experiments role in chamber analysis. “By systematically using Abraham’s model, we can determine equivalent solvents, predict material-chemical interactions and enhance risk assessments,” he explained. The study is a practical guide to improving testing procedures to make regulatory compliance Smoother and ensure more consistent product safety assessment.
The study emphasized that the selection of the appropriate solvent is a key factor in extractable and fillable studies. The type of solvent used can affect how much chemicals are extracted and how to perform the analysis. By using the model, scientists can select equivalent solvents based on their properties, thus preventing excessive or unnecessary extraction. The study also highlights the measure of how solvent polarity dissolves different substances based on its molecular properties, which can help mimic real-world biological conditions, thereby more accurately assessing potential risks.
One particularly useful application discussed in the study is the creation of pharmaceutical products that simulate solvents. Rather than randomly selecting test solvents, the model provides a scientific method to identify test methods that closely match the behavior of actual drug formulations. “This approach reduces inconsistencies and improves reliability of extractable and fill tests,” Dr. Lee noted, highlighting the role of the model in making the study more reliable and repeatable.
The study also explains how the solvation parameter model can help scientists understand the powerful functions of different solvents in extracting chemicals from medical device materials. By considering factors that affect chemical interactions and how substances move through the material, the model helps to select the best test conditions to generate reliable data for a safety review. Furthermore, it extends to predict the performance of chemicals in laboratory tests, making it easier to identify and measure extractable substances in complex mixtures.
Dr. Li’s research provides valuable insights to scientists and professionals involved in safety testing of pharmaceutical and medical equipment. By applying Abraham’s solvation parameter model, extract and infiltration research can be carried out more accurately, ultimately providing consumers with safer and more reliable medical products.
Journal Reference
Li, J. “Abraham’s solvation parameter model for extractability and fillability in the pharmaceutical and medical device industry: a tutorial.” Journal of Chromatography Open, 2024. DOI: https://doi.org/10.1016/j.jcoa.2024.100158
About the Author
Dr. Jianwei Li Currently the principal E&L (or extracts and infiltrates) and chemical analysis consultants for medical devices, as well as technical writers Chemical Characterization Solutions LLC. He worked at Medtronic for 17 years and 17 years in the chemical characterization of medical devices, including implantable medical devices and drug device combination products. During his 30-year academic and industry career, he has published more than 50 publications in analytical chemistry, including 11 dedicated to the chemical characteristics of medical devices over the past four years. He is often invited to perform chemical analysis of medical equipment at international conferences. He has also served as a regular scientific reviewer for more than a dozen international journals.
He received his PhD in analytical chemistry from Purdue University and a postdoctoral research from the University of Minnesota.
