Understanding and optimization of the secondary drying step of a freeze-drying process: a case study

Assegehegn, Getachew; Fuente, Edmundo Brito-de la; Franco, J.M.; Gallegos, C.

doi:10.1080/07373937.2020.1739065

Cited by 10 publications

(5 citation statements)

References 34 publications

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“…In most cases, the optimization step is not performed and as a result, most materials are not freeze-dried under ideal conditions. In any case, the product temperature, which is dependent on the product’s composition features, the temperature of shelves, the pressure of the chamber, and the container system, cannot be precisely adjusted during primary drying and this lack of control is another major hurdle in the optimization of this process [ 44 , 45 , 46 , 47 , 48 , 49 , 50 ].…”

Section: Freeze Dryingmentioning

confidence: 99%

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Freeze-Drying Process for the Fabrication of Collagen-Based Sponges as Medical Devices in Biomedical Engineering

Katrilaka,

Karipidou,

Petrou

et al. 2023

Materials

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This paper presents a systematic review of a key sector of the much promising and rapidly evolving field of biomedical engineering, specifically on the fabrication of three-dimensional open, porous collagen-based medical devices, using the prominent freeze-drying process. Collagen and its derivatives are the most popular biopolymers in this field, as they constitute the main components of the extracellular matrix, and therefore exhibit desirable properties, such as biocompatibility and biodegradability, for in vivo applications. For this reason, freeze-dried collagen-based sponges with a wide variety of attributes can be produced and have already led to a wide range of successful commercial medical devices, chiefly for dental, orthopedic, hemostatic, and neuronal applications. However, collagen sponges display some vulnerabilities in other key properties, such as low mechanical strength and poor control of their internal architecture, and therefore many studies focus on the settlement of these defects, either by tampering with the steps of the freeze-drying process or by combining collagen with other additives. Furthermore, freeze drying is still considered a high-cost and time-consuming process that is often used in a non-optimized manner. By applying an interdisciplinary approach and combining advances in other technological fields, such as in statistical analysis, implementing the Design of Experiments, and Artificial Intelligence, the opportunity arises to further evolve this process in a sustainable and strategic manner, and optimize the resulting products as well as create new opportunities in this field.

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Section: Freeze Dryingmentioning

confidence: 99%

“…The influence of residual water on the drying rate and the final drying time is remarkable. The time needed to eliminate the remaining water might be as much as, or even more than, the time required to remove free water [ 34 , 44 , 46 , 49 ].…”

Section: Freeze Dryingmentioning

confidence: 99%

Freeze-Drying Process for the Fabrication of Collagen-Based Sponges as Medical Devices in Biomedical Engineering

Katrilaka,

Karipidou,

Petrou

et al. 2023

Materials

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“…The optimal time and temperature for secondary drying is still unknown, and it is usually decided on a case-by-case basis through trial and error. Efforts to improve the efficiency of this process have been attempted, and many studies have worked towards creating a predictive model of secondary drying parameters [ 112 , 113 , 114 ]. However, at the time of this review, there is no agreed upon gold standard for secondary drying conditions.…”

Section: Factors Affecting the Lyophilization Of Nanoparticlesmentioning

confidence: 99%

Lyophilization of Nanoparticles, Does It Really Work? Overview of the Current Status and Challenges

Gatto,

Najahi-Missaoui

2023

IJMS

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Nanoparticles are being increasingly used as drug delivery systems to enhance the delivery to and uptake by target cells and to reduce off-target toxicity of free drugs. However, although the advantages of nanoparticles as drug carriers are clear, there are still some limitations, especially in maintaining their long-term stability. Lyophilization, also known as freeze-drying, has been heavily investigated as a solution to this problem. This strategy has been shown to be effective in increasing both the long-term stability of nanoparticles and the shelf life of the drug product. However, the process is still in need of improvement in several aspects, such as the process parameters, formulation factors, and characterization techniques. This review summarizes the advantages and limitations of nanoparticles for the treatment of disease, advantages and limitations, and the status of the lyophilization of nanoparticles for therapeutic use and provides insight into both the advantages and the limitations.

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“…J; t is the drying time, s. The residual moisture content differs at the different operating conditions. 38 It is inappropriate to take the experimental case's residual moisture content as the end criteria for other operating conditions. In this paper, the saturation descent rate at the end for the experimental case was taken to be the basis for judging the process end.…”

Section: Design Spacementioning

confidence: 99%

Comparison of the Design Space of Products with Different Initial Saturation

Luo

Liu

et al. 2022

Journal of Pharmaceutical Sciences

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Understanding and optimization of the secondary drying step of a freeze-drying process: a case study

Cited by 10 publications

References 34 publications

Freeze-Drying Process for the Fabrication of Collagen-Based Sponges as Medical Devices in Biomedical Engineering

Freeze-Drying Process for the Fabrication of Collagen-Based Sponges as Medical Devices in Biomedical Engineering

Lyophilization of Nanoparticles, Does It Really Work? Overview of the Current Status and Challenges

Comparison of the Design Space of Products with Different Initial Saturation

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