Silicone oil is mainly composed of polydimethylsiloxane […]
Silicone oil is mainly composed of polydimethylsiloxane (PDMS). In the 20th century, PDMS has been used in various medical fields and has been approved by the US Pharmacopoeia for pharmaceutical applications, including pre-filled syringes. Silicone oil is used as a lubricant in the syringe barrel and in the rubber stopper, enabling the syringe and stopper to move smoothly with a low and consistent injection force.
The drug is in direct contact with the prefilled syringe needle, piston and injection needle. The active ingredients and functional auxiliary materials in the drug solution may also be absorbed by the packaging material, and the components in the packaging material may also migrate into the drug solution, affecting the stability of the drug Sex and safety. The safety problem is mainly caused by the leaching of toxic antioxidants, adhesives and some degradation products in the material; the stability problem is that the protein will gather, settle and deactivate when it contacts silicone oil and metal tungsten.
During the shelf life, the medicine in the pre-filled syringe will always be exposed to the environment with silicone oil, and the generated insoluble particles will enter the tissue or circulatory system with the injection, with a high degree of risk. The US, Europe, Japan and Chinese Pharmacopoeia have strict restrictions on insoluble particles in injections. But silicone oil is essential to ensure piston performance. Therefore, it is necessary to conduct a more in-depth study on the particle problem caused by silicone oil.
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