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Contribution of Intravenous Administration Components to Subvisible and Submicron Particles Present in Administered
Mark Pollo1, Anjali Mehta1, Kate Torres1
1Pfizer, Biotherapeutics/Pharmaceutical R&D - BioTherapeutics Pharmaceutical Sciences, Chesterfield, Missouri 63017.
Journal of Pharmaceutical Sciences
|March 9, 2019
Summary
Drug administration supplies, not just drug products, contribute significant particulate matter. Understanding these sources is crucial for predicting and controlling patient exposure to particulates.
Area of Science:
- Pharmaceutical Science
- Drug Delivery Systems
- Biomaterials
Background:
- Particulate matter in parenteral drugs poses risks to patients.
- Current controls focus on the finished drug product, not administration materials.
Purpose of the Study:
- To assess subvisible and submicron particulates from drug preparation and administration materials.
- To identify sources of extrinsic particulate matter in parenteral therapies.
Main Methods:
- Quantified particles from syringes, diluents, and IV supplies.
- Utilized light obscuration, flow imaging, and resistive pulse sensing.
Main Results:
- Disposable syringes, diluents, and IV supplies are significant sources of particulates.
- Each administration component contributes varying particulate loads.
- Particulate load delivered to patients is not solely from the drug product.
Conclusions:
- Administration method and supplies influence particulate levels in drug preparations.
- Controlling particulates requires considering both drug product and administration materials.
- Improved predictability of particulate levels is achievable with careful consideration of administration supplies.
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