Formulation strategies to minimize oxidative damage in lyophilized lipid/DNA complexes during storage

Journal of Pharmaceutical Sciences
Marion d C Molina, T J Anchordoquy

Abstract

It has been shown that degradation of lipid/DNA complexes (lipoplexes) continues in the dried state during storage. The goal of this study was to evaluate the ability of various strategies to minimize the formation of reactive oxygen species (ROS) in lyophilized lipoplexes during storage, including metal removal from reagents, air displacement, and fortification with chelator/antioxidant agents. Formulations containing individual chelator (DTPA) and antioxidants (L-methionine or alpha-tocopherol), or in combination, were subjected to lyophilization. Accelerated storage conditions were investigated and physico-chemical characteristics and biological activity of samples were monitored at different time intervals. Generation of ROS during storage was determined by adding proxyl fluorescamine to the formulations prior to freeze-drying. Lipid peroxidation was assessed by monitoring the formation of thiobarbituric reactive substances (TBARS) and lipid hydroperoxides. We also assessed the effect of increased moisture content on the chemical and biological stability of lipoplexes containing additives. Our results show that both ROS and TBARS are generated in lyophilized cakes during storage, and that agents such as DTPA or alpha-tocoph...Continue Reading

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Citations

Apr 10, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·N M PaytonT J Anchordoquy
Jun 25, 2013·International Journal of Pharmaceutics·Iris van der HeijdenBastiaan Nuijen
Mar 1, 2011·Biopreservation and Biobanking·Marthe ColotteJacques Bonnet
Jul 2, 2009·Journal of Pharmaceutical Sciences·Jinxiang Yu, Thomas J Anchordoquy
Jul 7, 2011·Journal of Pharmaceutical Sciences·Tyson J SmythThomas J Anchordoquy
Oct 14, 2014·Journal of Pharmaceutical Sciences·Nicole M PaytonThomas J Anchordoquy
Jan 12, 2012·Journal of Controlled Release : Official Journal of the Controlled Release Society·Peter J Quinn
Dec 17, 2011·International Journal of Pharmaceutics·Anup K KunduTarun K Mandal
Oct 3, 2019·Journal of Drug Targeting·Danilo Costa GeraldesLaura de Oliveira-Nascimento
May 31, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Eduard Trenkenschuh, Wolfgang Friess

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