Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System
| Autor: | Keisuke Yoshino, Kazuhiro Iwasaki, Koji Nakamura, Tsuyoshi Yoshimoto, Arisa Yamashita, Yukie Kanazawa, Yoshihiko Abe, Kaori Funatsu, Shigeru Suzuki |
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| Rok vydání: | 2014 |
| Předmět: |
gliding force
prefilled syringe Chemistry Pharmaceutical silicone oil Pharmaceutical Science surface chemistry Nanotechnology engineering.material Pharmaceutics Drug Delivery and Pharmaceutical Technology protein aggregation physical stability chemistry.chemical_compound Silicone Drug Stability Coating Silicone Oils Composite material Syringe Plunger container closure integrity Chemistry Syringes Proteins Penetration (firestop) particle size stability imaging analysis Silicone oil Imaging analysis engineering Particle size |
| Zdroj: | Journal of Pharmaceutical Sciences |
| ISSN: | 0022-3549 |
| DOI: | 10.1002/jps.23945 |
| Popis: | The functionality of a newly developed silicone oil-free (SOF) syringe system, of which the plunger stopper is coated by a novel coating technology (i-coating™), was assessed. By scanning electron microscopy observations and other analysis, it was confirmed that the plunger stopper surface was uniformly covered with the designed chemical composition. A microflow imaging analysis showed that the SOF system drastically reduced both silicone oil (SO) doplets and oil-induced aggregations in a model protein formulation, whereas a large number of subvisible particles and protein aggregations were formed when a SO system was used. Satisfactory container closure integrity (CCI) was confirmed by means of dye and microorganism penetration studies. Furthermore, no significant difference between the break loose and gliding forces was observed in the former, and stability studies revealed that the SOF system could perfectly show the aging independence in break loose force observed in the SO system. The results suggest that the introduced novel SOF system has a great potential and represents an alternative that can achieve very low subvisible particles, secure CCI, and the absence of a break loose force. In particular, no risk of SO-induced aggregation can bring additional value in the highly sensitive biotech drug market. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:1520–1528, 2014 |
| Databáze: | OpenAIRE |
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