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@inbook{2324819,
author = {Heger, Dominik and Govindarajan, R. and Lu, E. and Ewing, S. and LayandFortenbery, A. and Yuan, X. and Veselý, Lukáš and Munson, E. and Gatlin, L. and Hancock, B. and Suryanarayanan, R. and Shalaev, E.},
address = {Cham},
booktitle = {Principles and Practices of Lyophilization in Product Development and Manufacturing - AAPS Advances in the Pharmaceutical Sciences Series},
doi = {http://dx.doi.org/10.1007/978-3-031-12634-5_3},
edition = {1},
editor = {Feroz Jameel},
keywords = {Acid-base relationships; Freeze-drying; Freezing; Freezing potential; Hammett acidity function; pH indicators; Stability},
howpublished = {tištěná verze "print"},
language = {eng},
location = {Cham},
isbn = {978-3-031-12633-8},
pages = {39-61},
publisher = {Springer Nature},
title = {Beyond pH: Acid/Base Relationships in Frozen and Freeze-Dried Pharmaceuticals},
url = {https://link.springer.com/chapter/10.1007/978-3-031-12634-5_3},
year = {2023}
}
TY - CHAP
ID - 2324819
AU - Heger, Dominik - Govindarajan, R. - Lu, E. - Ewing, S. - Lay-Fortenbery, A. - Yuan, X. - Veselý, Lukáš - Munson, E. - Gatlin, L. - Hancock, B. - Suryanarayanan, R. - Shalaev, E.
PY - 2023
TI - Beyond pH: Acid/Base Relationships in Frozen and Freeze-Dried Pharmaceuticals
VL - 59
PB - Springer Nature
CY - Cham
SN - 9783031126338
KW - Acid-base relationships
KW - Freeze-drying
KW - Freezing
KW - Freezing potential
KW - Hammett acidity function
KW - pH indicators
KW - Stability
UR - https://link.springer.com/chapter/10.1007/978-3-031-12634-5_3
N2 - Stability of the majority of pharmaceuticals and biopharmaceuticals depends on acidity/basicity of the environment. In aqueous solutions, acidity/basicity is commonly expressed using proton activity scale, pH, while definition and experimental measurements of acid-base relationships in frozen and freeze-dried materials are less straightforward. The chapter starts with a brief summary of the current understanding of several critical aspects of pH and apparent acidity/basicity as related to freezing and freeze-drying, whereas the main part of the chapter is focused on areas which are underrepresented in the pharmaceutical literature, with both overview of the literature and previously unpublished data presented. In particular, the following topics are covered: (i) Hammett acidity function and pH-equivalent (pHeq); (ii) Factors which impact apparent solid-state acidity in lyophiles; (iii) Solid-state acidity and chemical instability of lyophiles; (iv) Freezing fundamentals: quasi-liquid layer, polarity of the freeze-concentrated solution, and the Workman-Reynolds potential. Potential directions for future studies in this field are also outlined.
ER -
HEGER, Dominik, R. GOVINDARAJAN, E. LU, S. EWING, A. LAY-FORTENBERY, X. YUAN, Lukáš VESELÝ, E. MUNSON, L. GATLIN, B. HANCOCK, R. SURYANARAYANAN and E. SHALAEV. Beyond pH: Acid/Base Relationships in Frozen and Freeze-Dried Pharmaceuticals. In Feroz Jameel. \textit{Principles and Practices of Lyophilization in Product Development and Manufacturing - AAPS Advances in the Pharmaceutical Sciences Series}. 1st ed. Cham: Springer Nature, 2023, p.~39-61. 59. ISBN~978-3-031-12633-8. Available from: https://dx.doi.org/10.1007/978-3-031-12634-5\_{}3.
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