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Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts

Cua, Michelle and Martin, Daniel and Meza, Patricia and Torraca, Gianni and Pearson, Thomas and Cao, Shawn and Yang, Changhuei (2020) Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts. Journal of Pharmaceutical Sciences . ISSN 0022-3549. (In Press) https://resolver.caltech.edu/CaltechAUTHORS:20200715-152735840

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Abstract

Pre-filled syringes (PFSs) are commonly used for parenteral delivery of protein therapeutics. In PFSs, the inner surface of the syringe barrel is typically coated with silicone oil for lubrication. The total amount of silicone oil as well as its distribution can impact syringe functionality and particle formation. However, methods to non-destructively characterize the silicone oil distribution are limited. In this paper, we developed a method to visualize and quantify the relative distribution of silicone oil in unfilled syringes using a custom-built multi-color interferometric imaging system. We then applied the system in a preliminary study to investigate the impact of the silicone oil distribution on the number of particles formed in solution after filling and extrusion for two different types of syringes. The syringe type with significantly lower particle counts also exhibited significantly more homogeneous silicone oil distributions. Within syringe types, no significant association was found between silicone oil distribution and particle formation. Our method can be used in further studies that investigate the impact of syringe siliconization on PFS functionality and particle formation.


Item Type:Article
Related URLs:
URLURL TypeDescription
https://doi.org/10.1016/j.xphs.2020.07.012DOIArticle
ORCID:
AuthorORCID
Yang, Changhuei0000-0001-8791-0354
Additional Information:© 2020 Published by Elsevier Inc. on behalf of the American Pharmacists Association. Received 25 February 2020, Revised 7 July 2020, Accepted 7 July 2020, Available online 15 July 2020.
Subject Keywords:particle size; drug delivery system(s); image analysis; imaging methods(s); injectables
Record Number:CaltechAUTHORS:20200715-152735840
Persistent URL:https://resolver.caltech.edu/CaltechAUTHORS:20200715-152735840
Official Citation:Michelle Cua, Daniel Martin, Patricia Meza, Gianni Torraca, Thomas Pearson, Shawn Cao, Changhuei Yang, Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts, Journal of Pharmaceutical Sciences, 2020, , ISSN 0022-3549, https://doi.org/10.1016/j.xphs.2020.07.012. (http://www.sciencedirect.com/science/article/pii/S0022354920303786)
Usage Policy:No commercial reproduction, distribution, display or performance rights in this work are provided.
ID Code:104391
Collection:CaltechAUTHORS
Deposited By: Tony Diaz
Deposited On:15 Jul 2020 22:35
Last Modified:15 Jul 2020 22:35

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