Abstract
Stressed stability testing is crucial to the understanding of mechanisms of degradation and the effects of external stress factors on adjuvant stability. These studies vastly help the development of stability indicating tests and the selection of stabilizing conditions for long term storage. In this chapter, we provide detailed protocols for the execution of forced degradation experiments that evaluate the robustness of adjuvant formulations against thermal, mechanical, freeze-thawing, and photo stresses.
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References
Reed SG, Orr MT, Fox CB (2013) Key roles of adjuvants in modern vaccines. Nat Med 19(12):1597–1608
Fox CB, Kramer RM, Barnes VL, Dowling QM, Vedvick TS (2013) Working together: interactions between vaccine antigens and adjuvants. Ther Adv Vaccines 1(1):7–20
Dey AK, Malyala P, Singh M (2014) Physicochemical and functional characterization of vaccine antigens and adjuvants. Expert Rev Vaccines 13(5):671–685
Hasija M, Li L, Rahman N, Ausar SF (2013) Forced degradation studies: an essential tool for the formulation development of vaccines. Vaccine (Auckl) 3:11–33
Hem SL, HogenEsch H, Middaugh CR, Volkin DB (2010) Preformulation studies—The next advance in aluminum adjuvant-containing vaccines. Vaccine 28(31):4868–4870
Clénet D, Imbert F, Probeck P, Rahman N, Ausar SF (2014) Advanced kinetic analysis as a tool for formulation development and prediction of vaccine stability. J Pharm Sci 103(10):3055–3064
Gupta RK (1998) Aluminum compounds as vaccine adjuvants. Adv Drug Deliv Rev 32(3):155–172
Ghosh S, Coupland JN (2008) Factors affecting the freeze–thaw stability of emulsions. Food Hydrocoll 22(1):105–111
Crommelin DJA, van Bommel EMG (1984) Stability of liposomes on storage: freeze dried, frozen or as an aqueous dispersion. Pharm Res 1(4):159–163
Kerwin BA, Remmele RL Jr (2007) Protect from light: photodegradation and protein biologics. J Pharm Sci 96(6):1468–1479
ICH Q1B (1997) Guidelines for photostability testing of new drug substances and products. Fed Regis 62: 27115–27122
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Hasija, M., Sheung, A., Rahman, N., Ausar, S.F. (2017). Stressed Stability Techniques for Adjuvant Formulations. In: Fox, C. (eds) Vaccine Adjuvants. Methods in Molecular Biology, vol 1494. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-6445-1_16
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DOI: https://doi.org/10.1007/978-1-4939-6445-1_16
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Online ISBN: 978-1-4939-6445-1
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