Analysis of thin baked-on silicone layers by FTIR and 3D-Laser Scanning Microscopy

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V
Stefanie FunkeWolfgang Friess

Abstract

Pre-filled syringes (PFS) and auto-injection devices with cartridges are increasingly used for parenteral administration. To assure functionality, silicone oil is applied to the inner surface of the glass barrel. Silicone oil migration into the product can be minimized by applying a thin but sufficient layer of silicone oil emulsion followed by thermal bake-on versus spraying-on silicone oil. Silicone layers thicker than 100nm resulting from regular spray-on siliconization can be characterized using interferometric profilometers. However, the analysis of thin silicone layers generated by bake-on siliconization is more challenging. In this paper, we have evaluated Fourier transform infrared (FTIR) spectroscopy after solvent extraction and a new 3D-Laser Scanning Microscopy (3D-LSM) to overcome this challenge. A multi-step solvent extraction and subsequent FTIR spectroscopy enabled to quantify baked-on silicone levels as low as 21-325μg per 5mL cartridge. 3D-LSM was successfully established to visualize and measure baked-on silicone layers as thin as 10nm. 3D-LSM was additionally used to analyze the silicone oil distribution within cartridges at such low levels. Both methods provided new, highly valuable insights to characterize ...Continue Reading

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Citations

May 15, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Stefanie FunkeWolfgang Friess
Jun 22, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Stefanie FunkeWolfgang Friess
Oct 25, 2016·Journal of Pharmaceutical Sciences·Stefanie FunkeWolfgang Friess
Mar 27, 2019·The British Journal of Ophthalmology·Gustavo Barreto MeloRubens Belfort
Feb 15, 2019·Eye·Gustavo Barreto MeloMaurício Maia
May 16, 2020·Artificial Organs·Biswajit Kumar BiswasDebajyoti Das
May 26, 2018·Pharmaceutical Research·Dominique DitterAndrea Allmendinger
Apr 21, 2020·Progress in Retinal and Eye Research·Gustavo Barreto MeloEduardo Büchele Rodrigues
May 25, 2021·European Journal of Ophthalmology·Natasha Ferreira Santos da CruzGustavo Barreto Melo

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