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Lyophilisation (revision 1)

Old revision·14:40, 30 Aug 2024·SupplyWatchSuri

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Lyophilisation
Also known asFreeze-drying
ClassDehydration by sublimation
Physical requirementPressure below the triple point of water
Typical cycle length20–70 hours
Analytical method infobox · conventions

Lyophilisation, also called freeze-drying, is a dehydration process in which a solution is frozen and the ice is then removed by sublimation at a pressure below the triple point of water, leaving a porous solid whose volume approximates that of the original fill. It is the standard final step in the isolation of synthetic peptides after preparative purification, and the reason a research peptide is distributed as a dry cake in a sealed vial rather than as a solution.[1]

The process is used because peptides in aqueous solution degrade by hydrolytic routes — deamidation of asparagine and glutamine, backbone cleavage, aggregation — whose rates depend strongly on molecular mobility and on the availability of water. Removing water and holding the residue in an amorphous glass suppresses those routes by orders of magnitude, converting a product with a shelf life of days at ambient temperature into one with a shelf life measured in years.[2][3]

References

  1. ^ Nail SL, Jiang S, Chongprasert S, Knopp SA. "Fundamentals of freeze-drying." Pharmaceutical Biotechnology 14:281–360 (2002).
  2. ^ Wang W. "Lyophilization and development of solid protein pharmaceuticals." International Journal of Pharmaceutics 203(1–2):1–60 (2000).
  3. ^ Chang LL, Pikal MJ. "Mechanisms of protein stabilization in the solid state." Journal of Pharmaceutical Sciences 98(9):2886–2908 (2009).