Immobilization of nonviral vectors during the freezing step of lyophilization

Journal of Pharmaceutical Sciences
Taylor K C Armstrong, T J. Anchordoquy

Abstract

The development of nonviral vectors as commercial therapeutics will require formulations that are sufficiently stable to allow shipping and storage for prolonged periods. Given the well-known instability of these systems as aqueous suspensions, it would be desirable to develop lyophilized formulations that are resistant to shipping stress and can be stored for extended periods at ambient temperatures. Previous studies have shown that aggregation and structural changes resulting in reduced transfection rates can occur during the freezing step of lyophilization. While it has been clearly demonstrated that freezing-induced damage is promoted by vector crowding that results from the reduced volume of unfrozen solution, the precise mechanism of damage has yet to be fully elucidated, i.e., damage may occur due to ice formation and/or during incubation in the frozen state. In this study, we investigate the time- and temperature-dependence of damage during freezing and demonstrate that aggregation can occur while frozen vector suspensions are incubated at a constant temperature. Aggregation is not seen during incubation at temperatures below T(g)', and can also be avoided above the glass transition temperature under some conditions. Ou...Continue Reading

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Citations

Jun 4, 2005·Biotechnology Progress·Raino K HansenNigel K H Slater
Jul 2, 2009·Journal of Pharmaceutical Sciences·Jinxiang Yu, Thomas J Anchordoquy
Sep 11, 2008·Journal of Pharmaceutical Sciences·Jinxiang Yu, Thomas J Anchordoquy
Jan 13, 2011·Journal of Controlled Release : Official Journal of the Controlled Release Society·Julia Christina KasperWolfgang Friess
Jun 28, 2008·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Jan C ZilliesConrad Coester
Jan 6, 2018·Pharmaceutics·María E Aranda-BarradasElizabeth García-García
Nov 28, 2013·Chemical Communications : Chem Comm·Gregory G LewisScott T Phillips
May 31, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Eduard Trenkenschuh, Wolfgang Friess
Jul 27, 2021·International Journal of Pharmaceutics·Eduard Trenkenschuh, Wolfgang Friess

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