Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes

Journal of Pharmaceutical Sciences
Alana GerhardtTheodore W Randolph

Abstract

Silicone oil is used as a lubricant in glass pre-filled syringes (PFS) but can contribute to the generation of particles within protein formulations in PFS. To mitigate the production of such particles, various silicone oil coating processes have been proposed. In this study, three siliconization methods (the "covalent" method, the "baked silicone oil" method, and the "liquid silicone oil" method) were used to coat glass syringes with silicone oil. Glide forces were determined for syringes coated by each method. Then, a monoclonal antibody formulation or a buffer solution were incubated in the coated syringes in either the presence or absence of an air bubble, and the syringes were rotated end-over-end to induce air bubble movement within the syringe. The particle concentrations were measured throughout the incubation period using flow microscopy. The coating method did not affect particle concentrations measured in buffer alone, nor did the coating method affect particle concentrations measured in antibody formulations in the absence of an air bubble. Particle concentrations were influenced by the syringe coating method in protein formulations agitated in the presence of an air bubble, with the most particles formed in syringe...Continue Reading

References

Nov 1, 1991·Proceedings of the National Academy of Sciences of the United States of America·V SluzkyR Langer
Nov 25, 2004·Advanced Drug Delivery Reviews·Tazio StorniPål Johansen
Mar 1, 2005·Journal of Pharmaceutical Sciences·Latoya S JonesC Russell Middaugh
Sep 26, 2006·Methods : a Companion to Methods in Enzymology·Sue D XiangMagdalena Plebanski
Sep 26, 2006·Methods : a Companion to Methods in Enzymology·Derek T O'HaganJeffrey B Ulmer
Oct 10, 2006·The AAPS Journal·Amy S Rosenberg
Dec 15, 2007·Molecular Immunology·Vaheh OganesyanWilliam F Dall'Acqua
Feb 2, 2008·Journal of Pharmaceutical Sciences·Sylvia KieseHanns-Christian Mahler
Feb 7, 2008·Expert Review of Vaccines·Gunther Spohn, Martin F Bachmann
Aug 16, 2008·Journal of Pharmaceutical Sciences·John F CarpenterBarry Cherney
Apr 11, 2009·Journal of Pharmaceutical Sciences·Renuka ThirumangalathuJohn F Carpenter
Nov 7, 2009·Journal of Pharmaceutical Sciences·D Brett LudwigTheodore W Randolph
Jan 22, 2010·Pharmaceutical Development and Technology·Gregory A SachaMichael J Akers
Aug 11, 2010·Langmuir : the ACS Journal of Surfaces and Colloids·Robert Walder, Daniel K Schwartz
Feb 15, 2011·Journal of Pharmaceutical Sciences·Sumit MajumdarAjit Joseph M D'souza
Mar 5, 2011·Journal of Pharmaceutical Sciences·Bruce EuZai-Qing Wen
Apr 19, 2011·International Journal of Pharmaceutics·Nitin DixitDevendra S Kalonia
Dec 14, 2011·Journal of Pharmaceutical Sciences·Sarah ZöllsAndrea Hawe
Apr 12, 2012·PDA Journal of Pharmaceutical Science and Technology·Edwin ChanYuh-Fun Maa
Sep 1, 2012·AAPS PharmSciTech·Nitin DixitDevendra S Kalonia
Sep 19, 2012·Journal of Pharmaceutical Sciences·Keith A BrittTheodore W Randolph
Mar 20, 2013·Expert Opinion on Drug Delivery·Jan JezekIain Simpson
May 29, 2013·Journal of Pharmaceutical Sciences·Lu LiuJohn F Carpenter
Apr 15, 2014·Journal of Pharmaceutical Sciences·Alana GerhardtTheodore W Randolph

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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
Jan 19, 2020·Scientific Reports·Maria Olga KokornaczykStephan Baumgartner
Sep 9, 2020·Pharmaceutical Research·Christian WeinmannDhananjay Jere
Apr 21, 2020·Progress in Retinal and Eye Research·Gustavo Barreto MeloEduardo Büchele Rodrigues
Mar 4, 2021·Molecular Pharmaceutics·Aadithya KannanGerald G Fuller
Mar 10, 2021·Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft·Lukas Bisorca-GassendorfAnnekatrin Rickmann
Oct 23, 2020·Journal of Colloid and Interface Science·Zhenhuan ZhangYun Liu
Mar 13, 2021·AAPS PharmSciTech·Ashwin C ParenkyMohammed Shameem
Nov 7, 2020·Journal of Pharmaceutical Sciences·Marvin M MecwanBuddy D Ratner
Aug 30, 2019·Journal of Pharmaceutical Sciences·Yoann Le BasleValérie Sautou
Jul 17, 2018·The Journal of Physical Chemistry Letters·David S BullAndrew P Goodwin

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