Optimization of the different phases of the freeze-drying process of solid lipid nanoparticles using experimental designs.

Autor: Elbrink K; University of Antwerp, Department of Pharmaceutical Technology and Biopharmacy, Universiteitsplein 1, 2610 Wilrijk, Belgium. Electronic address: Kimberley.Elbrink@uantwerpen.be., Van Hees S; University of Antwerp, Department of Pharmaceutical Technology and Biopharmacy, Universiteitsplein 1, 2610 Wilrijk, Belgium. Electronic address: Sofie.VanHees@uantwerpen.be., Holm R; University of Southern Denmark, Department of Physics, Chemistry, and Pharmacy, Campusvej 55, 5230 Odense, Denmark. Electronic address: reho@sdu.dk., Kiekens F; University of Antwerp, Department of Pharmaceutical Technology and Biopharmacy, Universiteitsplein 1, 2610 Wilrijk, Belgium. Electronic address: Filip.Kiekens@uantwerpen.be.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2023 Mar 25; Vol. 635, pp. 122717. Date of Electronic Publication: 2023 Feb 11.
DOI: 10.1016/j.ijpharm.2023.122717
Abstrakt: In this work, the effect of cryoprotectant type and concentration and freeze-drying process parameters were evaluated to determine an optimal freeze-drying process for celecoxib-loaded solid lipid nanoparticles. Different cryoprotectants were tested at different weight ratios (cryoprotectant:lipid). Trehalose, maltose, and sucrose at a 1:1 wt ratio were selected for further use in optimizing the freeze-drying process through experimental designs to accurately define the freezing, primary, and secondary drying conditions of the freeze-drying process. The optimal freeze-dried solid lipid nanoparticles were subjected to a 6-month stability study at either 4 °C or 25 °C/60% RH, resulting in significant growth when the nanoparticles were stored at 25 °C/60% RH. The best results were obtained with trehalose as a cryoprotectant and storage at 4 °C. Furthermore, the in vitro release data showed a significantly different release profile before and after optimization of the freeze-drying process, suggesting that the optimization of the freeze-drying process affected the quality of the freeze-dried cake. In conclusion, a successful lyophilization process was obtained due to rational cooperation between a good formulation and optimal conditions in the freezing and drying steps. This yielded an acceptable non-collapsed freeze-dried cake with good redispersibility, minimal changes in physicochemical properties, and long-term stability at 4 °C.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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