Extractable Silicone Oil

Development & Validation of a Generalized Method for Determination of Extractable or Leachable Silicone Oil Content

Authors: Sam M. Jones, Michelle E Cree, Catalent Pharma Solutions

Summary: Silicone oil is used as a lubricant or mold-releasing agent in drug packaging materials. Consistent lubrication with silicone oil ensures proper function of values over the lifetime of a product. Additionally, silicone oil may be introduced into products as mold-releasing agents during manufacturing. The silicone oil can leach or be extracted into the drug product over time or during valve actuation. The objective of this work is to develop and validate a generalized method for determination of extractable silicone oil on components and leachable silicone oil in formulated drug products.