Silicone Oil in Pharmaceutical Products: An Emerging Issue in Extractables and Leachables Studies

It takes approximately ten years after its discovery before a new drug product (DP) is on the market when all intermediate test phases are successful. Besides the clinical trials which focus on the efficacy of the drug itself, a number of studies are designed (and obligatory from the regulatory point of view) to study the interaction between the drug product and its container, the so-called extractables and leachables studies. The main objective is to identify the molecules which leach into the DP whereafter a toxicological assessment can be done.

Due to its chemical characteristics, silicone oil is used in a wide variety of applications, from medical equipment to contact lenses and in the manufacture of elastomers. Silicone oil itself is not considered to be a toxic molecule within extractables and leachables studies, but unfortunately the presence of PDMS may have detrimental effects on the drug products (DP) within the container when the DP contains proteins.

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