Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 108, Issue 7, Pages 2406-2414Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2019.02.020
Keywords
biopharmaceutical characterization; injectable(s); microparticle(s); nanoparticle(s); particle size; physical characterization
Funding
- Pfizer, Inc.
Ask authors/readers for more resources
Particulate matter present in drug products intended for parenteral administration to patients is typically monitored and controlled in the finished drug product to minimize potential risks to patients. In contrast to particulates found in drug products, the current study evaluated particulates representative of materials and operations typically used in the dose preparation and administration of drug products. A comprehensive assessment of intrinsic and extrinsic sources of subvisible and submicron particulates arising from materials associated with subcutaneous and intravenous dose preparation and administration was conducted. In particular, particles arising from disposable syringes, commercial sterile diluents, and intravenous supplies were quantitated using established methods for subvisible (ilight obscuration, flow imaging) and submicron particles (iresistive pulse sensing). Each of these sources contributed varying amounts of particulates; therefore, owing to sources from materials required for administration, it is inadequate to assume that the total particulate load delivered to patients arises solely from the drug product. Careful consideration of the administration method and supplies used can improve the predictability of particulate levels present in dose preparations or administration volumes. (c) 2019 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available