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Practical Advice on Scientific Design of Freeze-Drying Process: 2023 Update

Tchessalov, Serguei ; Maglio, Vito ; Kazarin, Petr ; Alexeenko, Alina ; Bhatnagar, Bakul ; Sahni, Ekneet ; Shalaev, Evgenyi

Pharmaceutical research, 2023-10, Vol.40 (10), p.2433-2455 [Periódico revisado por pares]

New York: Springer US

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Título:
Practical Advice on Scientific Design of Freeze-Drying Process: 2023 Update
Autor: Tchessalov, Serguei ; Maglio, Vito ; Kazarin, Petr ; Alexeenko, Alina ; Bhatnagar, Bakul ; Sahni, Ekneet ; Shalaev, Evgenyi
Assuntos: Biochemistry ; Biomedical and Life Sciences ; Biomedical Engineering and Bioengineering ; Biomedicine ; Chemical properties ; Cooling ; Desiccation ; Drug Compounding ; Freeze Drying ; Freezing ; Heat ; Ice nucleation ; Mass transfer ; Mathematical models ; Medical Law ; Models, Theoretical ; Original Research Article ; Pharmaceuticals ; Pharmacology/Toxicology ; Pharmacy ; Technology, Pharmaceutical ; Temperature ; Weather forecasting
É parte de: Pharmaceutical research, 2023-10, Vol.40 (10), p.2433-2455
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
Descrição: Objective The purpose of this paper is to re-visit the design of three steps in the freeze-drying process, namely freezing, primary drying, and secondary drying steps. Specifically, up-to-date recommendations for selecting freeze-drying conditions are provided based on the physical–chemical properties of formulations and engineering considerations. Methods and Results This paper discusses the fundamental factors to consider when selecting freezing, primary drying, and secondary drying conditions, and offers mathematical models for predicting the duration of each segment and product temperature during primary drying. Three simple heat/mass transfer primary drying (PD) models were tested, and their ability to predict product temperature and sublimation time showed good agreement. The PD models were validated based on the experimental data and utilized to tabulate the primary drying conditions for common pharmaceutical formulations, including amorphous and partially crystalline products. Examples of calculated drying cycles, including all steps, for typical amorphous and crystalline formulations are provided. Conclusions The authors revisited advice from a seminal paper by Tang and Pikal (Pharm Res. 21(2):191-200, 2004) on selecting freeze-drying process conditions and found that the majority of recommendations are still applicable today. There have been a number of advancements, including methods to promote ice nucleation and computer modeling for all steps of freeze-drying process. The authors created a database for primary drying and provided examples of complete freeze-drying cycles design. The paper may supplement the knowledge of scientists and formulators and serve as a user-friendly tool for quickly estimating the design space.
Editor: New York: Springer US
Idioma: Inglês

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Practical Advice on Scientific Design of Freeze-Drying Process: 2023 Update

Tchessalov, Serguei ; Maglio, Vito ; Kazarin, Petr ; Alexeenko, Alina ; Bhatnagar, Bakul ; Sahni, Ekneet ; Shalaev, Evgenyi

New York: Springer US

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