Contribution of Intravenous Administration Components to Subvisible and Submicron Particles Present in Administered Drug Product
| Autor: | Mark J. Pollo, Daniel Zimmermann, Anjali P. Mehta, Daniel Thorne, Parag Kolhe, Kate Torres |
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| Rok vydání: | 2019 |
| Předmět: |
Drug
Intravenous dose business.industry Drug Compounding media_common.quotation_subject Pharmaceutical Science 02 engineering and technology Particulates 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Flow imaging 03 medical and health sciences 0302 clinical medicine Pharmaceutical Preparations Medicine Drug product Administration Intravenous Particulate Matter 0210 nano-technology business Light obscuration media_common Biomedical engineering |
| Zdroj: | Journal of Pharmaceutical Sciences. 108:2406-2414 |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2019.02.020 |
| Popis: | 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 (light obscuration, flow imaging) and submicron particles (resistive 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. |
| Databáze: | OpenAIRE |
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