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Application of quality by design concepts in the development of fluidized bed granulation and tableting processes

Authorized Users Only
2013
Authors
Đuriš, Jelena
Medarević, Đorđe
Krstić, Marko
Đurić, Zorica
Ibrić, Svetlana
Article (Published version)
Metadata
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Abstract
This study illustrates the application of experimental design and multivariate data analysis in defining design space for granulation and tableting processes. According to the quality by design concepts, critical quality attributes (CQAs) of granules and tablets, as well as critical parameters of granulation and tableting processes, were identified and evaluated. Acetaminophen was used as the model drug, and one of the study aims was to investigate the possibility of the development of immediate- or extended-release acetaminophen tablets. Granulation experiments were performed in the fluid bed processor using polyethylene oxide polymer as a binder in the direct granulation method. Tablets were compressed in the laboratory excenter tablet press. The first set of experiments was organized according to PlackettBurman design, followed by the full factorial experimental design. Principal component analysis and partial least squares regression were applied as the multivariate analysis techni...ques. By using these different methods, CQAs and process parameters were identified and quantified. Furthermore, an in-line method was developed to monitor the temperature during the fluidized bed granulation process, to foresee possible defects in granules CQAs. Various control strategies that are based on the process understanding and assure desired quality attributes of the product are proposed.

Keywords:
fluid bed / granulation / tableting / regulatory science / factorial design / multivariate analysis / partial least squares / principal component analysis / dissolution rate
Source:
Journal of Pharmaceutical Sciences, 2013, 102, 6, 1869-1882
Publisher:
  • Elsevier Science Inc, New York
Funding / projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

DOI: 10.1002/jps.23530

ISSN: 0022-3549

PubMed: 23568772

WoS: 000319071200020

Scopus: 2-s2.0-84877925197
[ Google Scholar ]
16
12
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1996
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Đuriš, Jelena
AU  - Medarević, Đorđe
AU  - Krstić, Marko
AU  - Đurić, Zorica
AU  - Ibrić, Svetlana
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1996
AB  - This study illustrates the application of experimental design and multivariate data analysis in defining design space for granulation and tableting processes. According to the quality by design concepts, critical quality attributes (CQAs) of granules and tablets, as well as critical parameters of granulation and tableting processes, were identified and evaluated. Acetaminophen was used as the model drug, and one of the study aims was to investigate the possibility of the development of immediate- or extended-release acetaminophen tablets. Granulation experiments were performed in the fluid bed processor using polyethylene oxide polymer as a binder in the direct granulation method. Tablets were compressed in the laboratory excenter tablet press. The first set of experiments was organized according to PlackettBurman design, followed by the full factorial experimental design. Principal component analysis and partial least squares regression were applied as the multivariate analysis techniques. By using these different methods, CQAs and process parameters were identified and quantified. Furthermore, an in-line method was developed to monitor the temperature during the fluidized bed granulation process, to foresee possible defects in granules CQAs. Various control strategies that are based on the process understanding and assure desired quality attributes of the product are proposed.
PB  - Elsevier Science Inc, New York
T2  - Journal of Pharmaceutical Sciences
T1  - Application of quality by design concepts in the development of fluidized bed granulation and tableting processes
VL  - 102
IS  - 6
SP  - 1869
EP  - 1882
DO  - 10.1002/jps.23530
ER  - 
@article{
author = "Đuriš, Jelena and Medarević, Đorđe and Krstić, Marko and Đurić, Zorica and Ibrić, Svetlana",
year = "2013",
abstract = "This study illustrates the application of experimental design and multivariate data analysis in defining design space for granulation and tableting processes. According to the quality by design concepts, critical quality attributes (CQAs) of granules and tablets, as well as critical parameters of granulation and tableting processes, were identified and evaluated. Acetaminophen was used as the model drug, and one of the study aims was to investigate the possibility of the development of immediate- or extended-release acetaminophen tablets. Granulation experiments were performed in the fluid bed processor using polyethylene oxide polymer as a binder in the direct granulation method. Tablets were compressed in the laboratory excenter tablet press. The first set of experiments was organized according to PlackettBurman design, followed by the full factorial experimental design. Principal component analysis and partial least squares regression were applied as the multivariate analysis techniques. By using these different methods, CQAs and process parameters were identified and quantified. Furthermore, an in-line method was developed to monitor the temperature during the fluidized bed granulation process, to foresee possible defects in granules CQAs. Various control strategies that are based on the process understanding and assure desired quality attributes of the product are proposed.",
publisher = "Elsevier Science Inc, New York",
journal = "Journal of Pharmaceutical Sciences",
title = "Application of quality by design concepts in the development of fluidized bed granulation and tableting processes",
volume = "102",
number = "6",
pages = "1869-1882",
doi = "10.1002/jps.23530"
}
Đuriš, J., Medarević, Đ., Krstić, M., Đurić, Z.,& Ibrić, S.. (2013). Application of quality by design concepts in the development of fluidized bed granulation and tableting processes. in Journal of Pharmaceutical Sciences
Elsevier Science Inc, New York., 102(6), 1869-1882.
https://doi.org/10.1002/jps.23530
Đuriš J, Medarević Đ, Krstić M, Đurić Z, Ibrić S. Application of quality by design concepts in the development of fluidized bed granulation and tableting processes. in Journal of Pharmaceutical Sciences. 2013;102(6):1869-1882.
doi:10.1002/jps.23530 .
Đuriš, Jelena, Medarević, Đorđe, Krstić, Marko, Đurić, Zorica, Ibrić, Svetlana, "Application of quality by design concepts in the development of fluidized bed granulation and tableting processes" in Journal of Pharmaceutical Sciences, 102, no. 6 (2013):1869-1882,
https://doi.org/10.1002/jps.23530 . .

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