Evaluation of Incremental Siliconization Levels on Soluble Aggregates, Submicron and Subvisible Particles in a Prefilled Syringe Product
| Autor: | Olivia Henderson, Pavel Landsman, Deniz B. Temel, Andrea Spencer, Mark L. Brader, Fabian Vega, Damian Houde, Shujun Bai, Daniel P. DeCollibus |
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| Rok vydání: | 2016 |
| Předmět: |
inorganic chemicals
Materials science Pharmaceutical Science 02 engineering and technology complex mixtures 030226 pharmacology & pharmacy Polyethylene Glycols Protein Aggregates 03 medical and health sciences chemistry.chemical_compound Colloid 0302 clinical medicine Drug Stability Silicone Oils Particle Size Prefilled Syringe Syringe Chromatography Syringes technology industry and agriculture Interferon-beta equipment and supplies 021001 nanoscience & nanotechnology Barrel (unit) Mass measurement Silicone oil stomatognathic diseases Solubility chemistry Chromatography Gel Particle Particle size 0210 nano-technology |
| Zdroj: | Journal of Pharmaceutical Sciences. 105:50-63 |
| ISSN: | 0022-3549 |
| Popis: | The evaluation of stability with respect to particles in prefilled syringes is complicated by the presence of silicone oil. The mobility, colloidal characteristics, and kinetic instability of silicone oil in contact with a protein formulation may be influenced in unpredictable ways by pharmaceutical variables, storage, and handling conditions. To provide insight into the impact of these variables on silicone oil originating specifically from the siliconized prefillable syringe (PFS), a series of studies were conducted at incremental syringe barrel siliconization levels. Size-exclusion chromatography and particle counting methods were used to quantitate soluble aggregates and submicron and subvisible particles in peginterferon beta-1a in a PFS siliconized with a fixed nozzle spray-on siliconization process. The effect of silicone oil on the peginterferon beta-1a molecule was examined under pharmaceutically relevant conditions, accelerated degradation, and under denaturing conditions. Resonant mass measurement was used to discriminate silicone oil from protein particles establishing that silicone oil does not mask adverse trends in non-silicone oil particles. The peginterferon beta-1a molecule was shown to be stable in the presence of silicone oil and robust with respect to the formation of soluble aggregates and submicron and subvisible particles in its PFS siliconized over the range of 0-1.2 mg silicone oil per syringe barrel. |
| Databáze: | OpenAIRE |
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