European Journal of Chemistry 2017, 8(3), 265-272. doi:10.5155/eurjchem.8.3.265-272.1608

Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy


Ahmed Shawky Abouzaid (1,*) , Maissa Yacoub Salem (2) , Eman Saad Elzanfaly (3) , Ahmed Emad El Gindy (4) , Stephen Hoag (5) , Ahmed Ibrahim (6)

(1) Analytical Chemistry Department, Faculty of Pharmacy, Misr International University, Cairo, 11562, Egypt
(2) Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, 11562, Egypt
(3) Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, 11562, Egypt
(4) Analytical Chemistry Department, Faculty of Pharmacy, Misr International University, Cairo, 11562, Egypt
(5) School of Pharmacy, University of Maryland, Baltimore, Maryland, 21201, USA
(6) School of Pharmacy, University of Maryland, Baltimore, Maryland, 21201, USA
(*) Corresponding Author

Received: 03 Jul 2017, Accepted: 05 Aug 2017, Published: 30 Sep 2017

Abstract


The fluid bed granulation (FBG) is a wet granulation technique for producing granules. It is a complex process because many process variables can influence the granule properties. Therefore, an understanding of the influence of the granulation process variables is necessary for controlling the process. The moisture content of granule also plays a critical role in determining the outcome of the batch. The purpose of this work was to apply Plackett-Burman design for screening of process variables in FBG, study the influence of the process variables on granules properties and the use of NIR spectroscopy and partial least squares (PLS) regression to predict the moisture content of the granules. In order to study the influence of the process variables on the granules properties, Plackett-Burman design with six factors, two levels and three replicates at the center point (15 runs) was used. The results revealed that the atomizing pressure and the airflow rate are the process variables that have strong influence on the granules properties. The NIR spectroscopy in conjunction with PLS was used to determine the moisture content of granule in the FBG. The proposed PLS model was fitted and its predictive performance was evaluated by traditional chemometric criteria. The root mean square error of prediction (RMSEP) was 4.15% with 2 latent variables (LVs). The proposed NIR method was validated and the results obtained were compared with those of the reference LOD method using a paired t-test.


Keywords


Moisture content; NIR spectroscopy; Fluid bed granulation; PLS regression model; Plackett-Burman design; Granulation process variables

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DOI: 10.5155/eurjchem.8.3.265-272.1608

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[1]. M. Razuc, A. Grafia, L. Gallo, M. V. Ramírez-Rigo, R. J. Romañach
Near-infrared spectroscopic applications in pharmaceutical particle technology
Drug Development and Industrial Pharmacy  45(10), 1565, 2019
DOI: 10.1080/03639045.2019.1641510
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[2]. Shashank Muddu, Ashutosh Tamrakar, Preetanshu Pandey, Rohit Ramachandran
Model Development and Validation of Fluid Bed Wet Granulation with Dry Binder Addition Using a Population Balance Model Methodology
Processes  6(9), 154, 2018
DOI: 10.3390/pr6090154
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How to cite


Abouzaid, A.; Salem, M.; Elzanfaly, E.; El Gindy, A.; Hoag, S.; Ibrahim, A. Eur. J. Chem. 2017, 8(3), 265-272. doi:10.5155/eurjchem.8.3.265-272.1608
Abouzaid, A.; Salem, M.; Elzanfaly, E.; El Gindy, A.; Hoag, S.; Ibrahim, A. Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy. Eur. J. Chem. 2017, 8(3), 265-272. doi:10.5155/eurjchem.8.3.265-272.1608
Abouzaid, A., Salem, M., Elzanfaly, E., El Gindy, A., Hoag, S., & Ibrahim, A. (2017). Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy. European Journal of Chemistry, 8(3), 265-272. doi:10.5155/eurjchem.8.3.265-272.1608
Abouzaid, Ahmed, Maissa Yacoub Salem, Eman Saad Elzanfaly, Ahmed Emad El Gindy, Stephen Hoag, & Ahmed Ibrahim. "Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy." European Journal of Chemistry [Online], 8.3 (2017): 265-272. Web. 17 Nov. 2019
Abouzaid, Ahmed, Salem, Maissa, Elzanfaly, Eman, El Gindy, Ahmed, Hoag, Stephen, AND Ibrahim, Ahmed. "Screening the fluid bed granulation process variables and moisture content determination of pharmaceutical granules by NIR Spectroscopy" European Journal of Chemistry [Online], Volume 8 Number 3 (30 September 2017)

DOI Link: https://doi.org/10.5155/eurjchem.8.3.265-272.1608

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