Characterization of Formulations for Freeze-Drying

Ward, Kevin; Matejtschuk, Paul

doi:10.1007/978-1-4939-8928-7_1

Cited by 5 publications

(5 citation statements)

References 24 publications

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“…It is understandable that a sound knowledge of a formulation and its critical properties are essential for the efficient and rational design of a freeze-drying process. [5][6][7][8][9] Formulation critical properties include the freezing behavior of the formulation (phase separation, protein denaturation, and pH shift), glass transition temperature of the maximally freeze-concentrated solution (T g '), collapse temperature of the amorphous formulation (T c ), eutectic temperature of the crystalline formulation (T eu ), stability of the active ingredients during preparation, and properties of the excipients. Knowledge of such formulation properties and the freeze-drying process itself significantly eases the design of a robust and optimum process.…”

Section: Introductionmentioning

confidence: 99%

An Experimental-Based Approach to Construct the Process Design Space of a Freeze-Drying Process: An Effective Tool to Design an Optimum and Robust Freeze-Drying Process for Pharmaceuticals

Assegehegn

Fuente

Franco

et al. 2020

Journal of Pharmaceutical Sciences

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The application of quality by design (QbD) is becoming an integral part of the formulation and process development for pharmaceutical products. An essential feature of the QbD philosophy is the design space. In this sense, a new approach to construct a process design space (PDS) for the primary drying section of a freeze-drying process is addressed in this paper. An effective customized design of experiments (DoE) is developed for freeze-drying experiments. The results obtained from the DoE are then used to construct the product-based PDS. The proposed product-based PDS construction approach has several advantages, including (1) eliminating assumptions on the heat transfer coefficient and dried product resistance, as it is constructed from experimental results specifically obtained from a given formulation, yielding more realistic and reliable results and (2) PDS construction based on a narrow range of product temperatures and considering the variations in product temperature and sublimation rate of vials across a shelf. This guarantees the effectiveness and robustness of the process and facilitates the process scale-up and transfer. The PDS developed herein was experimentally verified. The PDS predicted parameters were in excellent agreement with the experimentally obtained parameters.

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Section: Introductionmentioning

confidence: 99%

An Experimental-Based Approach to Construct the Process Design Space of a Freeze-Drying Process: An Effective Tool to Design an Optimum and Robust Freeze-Drying Process for Pharmaceuticals

Assegehegn

Fuente

Franco

et al. 2020

Journal of Pharmaceutical Sciences

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“…However, it is challenging to obtain intact aerogel blocks due to the cracking caused by the volume expansion during ice crystal growth. [44] Each of the above three methods for preparing aerogels has its advantages and disadvantages, thus necessitating the selection of appropriate drying techniques during the preparation of SiC aerogels.…”

Section: Sol-gel Methodsmentioning

confidence: 99%

Elastic SiC Aerogel for Thermal Insulation: A Systematic Review

Zhang,

Yu,

Zhao

et al. 2024

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SiC aerogels with their lightweight nature and exceptional thermal insulation properties have emerged as the most ideal materials for thermal protection in hypersonic vehicles; However, conventional SiC aerogels are prone to brittleness and mechanical degradation when exposed to complex loads such as shock and mechanical vibration. Hence, preserving the structural integrity of aerogels under the combined influence of thermal and mechanical external forces is crucial not only for stabling their thermal insulation performance but also for determining their practicality in harsh environments. This review focuses on the optimization of design based on the structure‐performance of SiC aerogels, providing a comprehensive review of the inherent correlations among structural stability, mechanical properties, and insulation performance. First, the thermal transfer mechanism of aerogels from a microstructural perspective is studied, followed by the relationship between the building blocks of SiC aerogels (0D particles, 1D nanowires/nanofibers) and their compression performance (including compressive resilience, compressive strength, and fatigue resistance). Moreover, the strategy to improve the high‐temperature oxidation resistance and insulation performance of SiC aerogels is explored. Lastly, the challenges and future breakthrough directions for SiC aerogels are presented.

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“…Additionally, freeze drying consumes less thermal energy in comparison to alternative drying methods. 92 However, the application of the freeze-drying technique is constrained by its elevated cost. Commonly, freeze drying is employed in the fabrication of natural hydrogels, with cell-derived materials like the extra-cellular matrix (ECM), collagen fibers, and alginate serving as essential constituents.…”

Section: Manufacturing Techniques 231 Freeze-drying Techniquementioning

confidence: 99%