Abstract
A significant number of therapeutic proteins are marketed as pre-filled syringes or other drug/device combination products and have been safely used in these formats for years. Silicone oil, which is used as lubricant, can migrate into the drug product and may interact with therapeutic proteins. In this study, particles in the size range of 0.2-5 mu m and >= 1 mm as determined by resonant mass measurement and micro-flow imaging/light obscuration, respectively, resulted from silicone sloughing off the container barrel after agitation. The degree of droplet formation correlated well with the applied baked-on silicone levels of 13 mu g and 94 mu g per cartridge. Silicone migration was comparable in placebo, 2 mg/mL and 33 mg/mL IgG1 formulations containing 0.04% (w/v) polysorbate 20. Headspace substantially increased the formation of silicone droplets during agitation. The highest particle concentrations reached, however, were still very low compared to numbers described for spray-on siliconized containers. When applying adequate baked-on silicone levels below 100 mu g, bake-on siliconization efficiently limits silicone migration into the drug product without compromising device functionality. (C) 2016 American Pharmacists Association (R). Published by ELSEVIER. All rights reserved.
Item Type: | Journal article |
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Faculties: | Chemistry and Pharmacy > Department of Pharmacy |
Subjects: | 500 Science > 540 Chemistry |
ISSN: | 0022-3549 |
Language: | English |
Item ID: | 48482 |
Date Deposited: | 27. Apr 2018, 08:15 |
Last Modified: | 04. Nov 2020, 13:26 |