RT Journal Article
T1 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
A1 Assegehegn, Getachew Weldeabezgi
A1 Brito de la Fuente, Edmundo
A1 Franco Gómez, José María
A1 Gallegos Montes, Críspulo
AB 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.
PB Elsevier
SN 0022-3549
SN 1520-6017 (electrónico)
YR 2020
FD 2020
LK http://hdl.handle.net/10272/18992
UL http://hdl.handle.net/10272/18992
LA eng
NO Assegehegn, G., Brito-de la Fuente, E., Franco, J. M., & Gallegos, C. (2020). 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. Journal of Pharmaceutical Sciences, 109(1), 785–796. https://doi.org/10.1016/j.xphs.2019.07.001
DS Repositorio Institucional de la Universidad de Huelva
RD 14 jul 2026