Comparative Study of Chemical Composition, Molecular and Rheological Properties of Silicone Oil Medical Devices.

PURPOSE: We evaluated chemical composition, and molecular and rheological properties in 10 commercially available silicone oils (SilOils), focusing on siloxane chains of low molecular weight (LMW components, LMWC) that are known to be "impurities" produced during the SilOil synthesis process. METHODS: We assessed the type of SilOil polymer and molecular weight distribution (MWD) by spectroscopy and conventional size exclusion chromatography, respectively. From the Cumulative MWD, we calculated the fractions of LMWC with molecular weight (M): ≤2000, ≤5000, and ≤10,000 g/mol. Due to the low MW, the content of LMWC with M ≤1000 g/mol was determined by gas chromatography-mass spectrometry. The dynamic viscosity (η) was assessed by rotational rheometry. RESULTS: For all SilOils, the polymer was polydimethylsiloxane. The samples differed significantly in terms of MWD and relative LMWC fractions. Specifically, the relative fraction of all LMWC (M ≤10,000 g/mol) ranged from 2.31% to 9.40% and the content of LMWC with M ≤1000 g/mol also varied significantly (range, 51-1151 ppm). The η values were different between the SilOils, and, for many of them, from the declared viscosity. CONCLUSIONS: Commercially available SilOils differ significantly in molecular and rheologic features. These compounds contain a significant amount of LMWC, "impurities" generated during the synthesis process, acting as emulsifier, potentially inducing ocular inflammation and toxicity. TRANSLATIONAL RELEVANCE: The amount of impurities in different SilOils may influence significantly their biocompatibility.