To compare the analytical quality characteristics of currently available CE-marked silicone oils used as ocular endotamponades in vitreoretinal surgery.
Thirty-four samples of 12 brands were analysed. To assess the quality characteristics of silicone oils, we measured the oligosiloxane content and polydispersity, widely accepted as purity parameters. UV-active substances (> 220 nm) were analysed to draw conclusions about the integrity of primary packaging components.
We identified significant differences in the impurity profiles of the products tested, which revealed oligosiloxane contents ranging from < 0.1 to 491 ppm, polydispersity ranging from 1.6 to 3.0 and UV-active substances (> 220 nm) ranging from 0.2 to 3.8 AU.
The quality characteristics of the analysed silicone oils vary significantly not only among different brands but also among batches of the same manufacturer. Manufacturers should communicate the purity and quality characteristics of their products in an understandable and clear manner. This involves providing a complete certificate of analysis with special focus on quality characteristics, to enable the vitreoretinal surgeon to differentiate between the effects of the silicone oil itself and those of impurities.
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I would like to thank the analytical department of Pharmpur GmbH for the GMP-compliant performance of the silicone oil analyses.
L Miray Medikal
AU: Arbitrary unit
Best case: Sample with the best value in this analytical category
Educt: Substance separated from a mixture in which it already existed, as opposed to a product, which is newly generated by a chemical reaction
Headspace: Gaseous constituents of a closed space above liquids or solid emitting and vapours measured using headspace gas chromatography
Linearity: Linearity is the property of a mathematical relationship or function which means that it can be graphically represented as a straight line.
Number average molecular weight: Average of the molecular masses of the individual macromolecules.
Oligosiloxanes: Polysiloxane having a relatively small number of –Si–O– groups
Polydispersity: Measure for the broadness of a molecular weight distribution of a polymer.
Siloxanes: Functional group in organosilicon chemistry with the Si–O–Si linkage
Weight average molecular weight: Total weight of polymer divided by the total number of molecules.
Conflict of interest
Author is Chairman of Working Committee NA 027-01-20 of German Institute for Standardization (DIN) and Leader of project ISO 16672, Ophthalmic implants—Ocular endotamponades in the International Standardization Organization (ISO).
In the past, the author has been consulting for a variety of ophthalmic companies (Bausch and Lomb, Chauvin, Cromapharma, DORC, HumanOptics, Hyaltech, i.com medical, MIRO, Pharmpur, Second Sight, THEA, Technolas Perfect Vision, Valeant) in regulatory affairs, quality management, research and development.
This article does not contain any studies with human participants or animals performed by any of the authors.
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Dresp, J.H. Benchmarking different brands of silicone oils. Graefes Arch Clin Exp Ophthalmol (2020). https://doi.org/10.1007/s00417-020-04809-2