Beyond pH: Acid/Base Relationships in Frozen and Freeze-Dried Pharmaceuticals

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14310%2F23%3A00131885" target="_blank" >RIV/00216224:14310/23:00131885 - isvavai.cz</a>

Výsledek na webu

<a href="https://link.springer.com/chapter/10.1007/978-3-031-12634-5_3" target="_blank" >https://link.springer.com/chapter/10.1007/978-3-031-12634-5_3</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/978-3-031-12634-5_3" target="_blank" >10.1007/978-3-031-12634-5_3</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Beyond pH: Acid/Base Relationships in Frozen and Freeze-Dried Pharmaceuticals

Popis výsledku v původním jazyce

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areas which are underrepresented in the pharmaceutical literature, with both overview of the literature and previously unpublished data presented.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.

Název v anglickém jazyce

Beyond pH: Acid/Base Relationships in Frozen and Freeze-Dried Pharmaceuticals

Popis výsledku anglicky

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.

Druh

C - Kapitola v odborné knize

CEP obor

—

OECD FORD obor

10403 - Physical chemistry

Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název knihy nebo sborníku

Principles and Practices of Lyophilization in Product Development and Manufacturing - AAPS Advances in the Pharmaceutical Sciences Series

ISBN

9783031126338

Počet stran výsledku

23

Strana od-do

39-61

Počet stran knihy

623

Název nakladatele

Springer Nature

Místo vydání

Cham

Kód UT WoS kapitoly

—