The purpose of this study was to investigate the influence of spiral jet-milling process on the physicochemical characteristics of alpha polymorphic active pharmaceutical ingredient, using Carbamazepine form III as a model drug, and taking into consideration Quality by Design (QbD) approach to pharmaceutical development. A 2((4-1)) factorial screening design was implemented to identify the spiral jet-milling process variables that significantly affect the particle size distribution of milled samples. Diameter of injector nozzles, diameter of ring nozzles and air pressure were selected for further analysis using a 2((3-1)) factorial experimental design. Particle size distribution of additional samples was determined, while physicochemical properties were examined by differential scanning calorimetry (DSC), hot-stage polarized microscopy (HSPM), attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR), and compared to those of un-milled drug. The gathered results s...hown that applied experimental design approach is capable to predict material behavior and could help in better understanding of material behavior during jet-milling process. Created design space (DS) provides assurance of product quality, expressed as the powder particle sizes lower than 5 mu m, as well as, in initial polymorph form existence after jet-milling through combination and interaction of input variables.
TY - JOUR
AU - Đokić, Marija
AU - Đuriš, Jelena
AU - Solomun, Ljiljana
AU - Kachrimanis, Kyriakos
AU - Đurić, Zorica
AU - Ibrić, Svetlana
PY - 2014
UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2159
AB - The purpose of this study was to investigate the influence of spiral jet-milling process on the physicochemical characteristics of alpha polymorphic active pharmaceutical ingredient, using Carbamazepine form III as a model drug, and taking into consideration Quality by Design (QbD) approach to pharmaceutical development. A 2((4-1)) factorial screening design was implemented to identify the spiral jet-milling process variables that significantly affect the particle size distribution of milled samples. Diameter of injector nozzles, diameter of ring nozzles and air pressure were selected for further analysis using a 2((3-1)) factorial experimental design. Particle size distribution of additional samples was determined, while physicochemical properties were examined by differential scanning calorimetry (DSC), hot-stage polarized microscopy (HSPM), attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR), and compared to those of un-milled drug. The gathered results shown that applied experimental design approach is capable to predict material behavior and could help in better understanding of material behavior during jet-milling process. Created design space (DS) provides assurance of product quality, expressed as the powder particle sizes lower than 5 mu m, as well as, in initial polymorph form existence after jet-milling through combination and interaction of input variables.
PB - Inst Chemical Engineers, Rugby
T2 - Chemical Engineering Research & Design
T1 - The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach
VL - 92
IS - 3
SP - 500
EP - 508
DO - 10.1016/j.cherd.2013.09.011
ER -
@article{
author = "Đokić, Marija and Đuriš, Jelena and Solomun, Ljiljana and Kachrimanis, Kyriakos and Đurić, Zorica and Ibrić, Svetlana",
year = "2014",
abstract = "The purpose of this study was to investigate the influence of spiral jet-milling process on the physicochemical characteristics of alpha polymorphic active pharmaceutical ingredient, using Carbamazepine form III as a model drug, and taking into consideration Quality by Design (QbD) approach to pharmaceutical development. A 2((4-1)) factorial screening design was implemented to identify the spiral jet-milling process variables that significantly affect the particle size distribution of milled samples. Diameter of injector nozzles, diameter of ring nozzles and air pressure were selected for further analysis using a 2((3-1)) factorial experimental design. Particle size distribution of additional samples was determined, while physicochemical properties were examined by differential scanning calorimetry (DSC), hot-stage polarized microscopy (HSPM), attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR), and compared to those of un-milled drug. The gathered results shown that applied experimental design approach is capable to predict material behavior and could help in better understanding of material behavior during jet-milling process. Created design space (DS) provides assurance of product quality, expressed as the powder particle sizes lower than 5 mu m, as well as, in initial polymorph form existence after jet-milling through combination and interaction of input variables.",
publisher = "Inst Chemical Engineers, Rugby",
journal = "Chemical Engineering Research & Design",
title = "The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach",
volume = "92",
number = "3",
pages = "500-508",
doi = "10.1016/j.cherd.2013.09.011"
}
Đokić, M., Đuriš, J., Solomun, L., Kachrimanis, K., Đurić, Z.,& Ibrić, S.. (2014). The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach. in Chemical Engineering Research & Design
Inst Chemical Engineers, Rugby., 92(3), 500-508.
https://doi.org/10.1016/j.cherd.2013.09.011
Đokić M, Đuriš J, Solomun L, Kachrimanis K, Đurić Z, Ibrić S. The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach. in Chemical Engineering Research & Design. 2014;92(3):500-508.
doi:10.1016/j.cherd.2013.09.011 .
Đokić, Marija, Đuriš, Jelena, Solomun, Ljiljana, Kachrimanis, Kyriakos, Đurić, Zorica, Ibrić, Svetlana, "The influence of spiral jet-milling on the physicochemical properties of carbamazepine form III crystals: Quality by design approach" in Chemical Engineering Research & Design, 92, no. 3 (2014):500-508,
https://doi.org/10.1016/j.cherd.2013.09.011 . .
