A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

May 15, 2019
Neal Andrist

,
Roxanne Aide

,
Nicholas Keyes

,
Jeffrey Nordin

,
Ashley Hellenbrand

,
Xiaochun Yu

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2019, Volume 2019 eBook, Issue 1
Page Number: 20–29

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Silicone oil has been widely used to coat the components of container/closure systems for biopharmaceutical products, including syringe barrels and plungers for prefilled syringes and stoppers for glass vials. Drug product formulations are therefore typically in direct contact with the silicone oil coating over long periods of time, causing concern that the silicone oil may leach into the formulations, which may affect the drug product’s purity and efficacy.

Read this article in Pharmaceutical TechnologyBiologics and Sterile Drug Manufacturing 2019 eBook.

Article Details

Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2019
May 2019
Pages: 20–29

Citation

When referring to this article, please cite it as X. Yu et al., "A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).