Application of quality by design concepts in the development of fluidized bed granulation and tableting processes
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 rateSource:
Journal of Pharmaceutical Sciences, 2013, 102, 6, 1869-1882Publisher:
- Elsevier Science Inc, New York
Funding / projects:
- Advanced technologies for controlled release from solid drug delivery systems (RS-MESTD-Technological Development (TD or TR)-34007)
DOI: 10.1002/jps.23530
ISSN: 0022-3549
PubMed: 23568772
WoS: 000319071200020
Scopus: 2-s2.0-84877925197
Collections
Institution/Community
PharmacyTY - 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 . .