European Journal of Chemistry 2017, 8(3), 265-272 | doi: https://doi.org/10.5155/eurjchem.8.3.265-272.1608 | Get rights and content






  OPEN ACCESS | PEER-REVIEWED | RESEARCH ARTICLE | DOWNLOAD PDF | VIEW FULL-TEXT PDF | TOTAL VIEWS

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 | Revised: 31 Jul 2017 | Accepted: 05 Aug 2017 | Published: 30 Sep 2017 | Issue Date: September 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

Full Text:

PDF /    /


DOI: 10.5155/eurjchem.8.3.265-272.1608

Links for Article


| | | | |

| | | | | | |

Related Articles




Article Metrics

This Abstract was viewed 516 times | PDF Article downloaded 287 times

Funding information


Faculty of Pharmacy, Misr International University, Cairo, 11562, Egypt and School of Pharmacy, University of Maryland, Baltimore, Maryland, 21201, USA.

Citations

/


[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
/


[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
/


References

[1]. Appelgren, C. Drug Dev. Ind. Pharm. 1985, 11(2-3), 725-741.
https://doi.org/10.3109/03639048509056897

[2]. Burggraeve, A.; Monteyne, T.; Vervaet, C.; Remon, J. P.; De Beer, T. Eur. J. Pharm. Biopharm. 2013, 83(1), 2-15.
https://doi.org/10.1016/j.ejpb.2012.09.008

[3]. Aulton, M. E. The science of dosage form design, Churchill Livingstone, Spain, 2002.

[4]. Bouffard, J.; Dumont, H.; Bertrand, F.; Legros, R. Int. J. Pharm. 2007, 335(1), 54-62.
https://doi.org/10.1016/j.ijpharm.2006.11.022

[5]. Tomuta, I.; Alecu, C.; Rus, L. L.; Leucuta, S. E. Dev. Ind. Pharm. 2009, 35(9), 1072-1081.
https://doi.org/10.1080/03639040902774149

[6]. Djuris, J.; Medarevic, D.; Krstic, M.; Vasiljevic, I.; Masic, I.; Ibric, S. Sci. World J. 2012, 2012, 1-10.

[7]. Martens, H.; Naes, T. Multivariate Calibration, John Wiley & Sons. Chichester, UK, 1989.

[8]. Tabasi, S. H.; Fahmy, R.; Bensley, D.; O'Brien, C.; Hoag, S. W. J. Pharm. Sci. 2008, 97(9), 4052-4066.
https://doi.org/10.1002/jps.21307

[9]. Siesler, H. W.; Ozaki, Y.; Kawata, S.; Heise, H. M. Near-infrared spectroscopy: principles, instruments, applications, John Wiley & Sons, 2008.

[10]. Williams, P.; Norris, K. Near-infrared technology in the agricultural and food industries. 1987: American Association of Cereal Chemists Inc., 1987.

[11]. Osborne, B. G.; Fearn, T.; Hindle, P. H. Practical NIR spectroscopy with applications in food and beverage analysis, Longman Scientific and Technical, 1993.

[12]. Frake, P.; Greenhalgh, D.; Grierson, S. M.; Hempenstall, J. M.; Rudd, D. R. Int. J. Pharm. 1997, 151(1), 75-80.
https://doi.org/10.1016/S0378-5173(97)04894-1

[13]. Rantanen, J.; Lehtola, S.; Rämet, P.; Mannermaa, J. P.; Yliruusi, J. Powder Technol. 1998, 99(2), 163-170.
https://doi.org/10.1016/S0032-5910(98)00100-4

[14]. Findlay, P. W.; Peck, G. R.; Morris, K. R. J. Pharm. Sci. 2005, 94(3), 604-612.
https://doi.org/10.1002/jps.20276

[15]. Hartung, A.; Knoell, M.; Schmidt, U.; Langguth, P. Drug Dev. Ind. Pharm. 2011, 37(3), 274-280.
https://doi.org/10.3109/03639045.2010.509725

[16]. Obregon, L.; Quinones, L.; Velazquez, C. Control Eng. Pract. 2013, 21(4), 509-517.
https://doi.org/10.1016/j.conengprac.2012.11.002

[17]. Kona, R.; Qu, H.; Mattes, R.; Jancsik, B.; Fahmy, R. M.; Hoag, S. W. Int. J. Pharm. 2013, 452(1), 63-72.
https://doi.org/10.1016/j.ijpharm.2013.04.039

[18]. USP 30 - NF 25. United States Pharmacopeial Convention, Rockville, MD, 2007.

[19]. Shawky, A.; Ibrahim, A.; Salem, M. Y.; El Gindy, A. E. Am. Chem. Sci. J. 2014, 4(1), 24-37.
https://doi.org/10.9734/ACSJ/2014/6087

[20]. Szostak, R.; Mazurek, S. J. Mol. Struct. 2004, 704(1), 235-245.
https://doi.org/10.1016/j.molstruc.2004.01.058

[21]. Mazurek, S.; Szostak, R. J. Pharmaceut. Biomed. 2006, 40(5), 1235-1242.
https://doi.org/10.1016/j.jpba.2005.09.019

[22]. International Conference on Harmonisation (ICH) of technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures, Geneva, 2005.

[23]. Peinado, A.; Hammond, J.; Scott, A. J. Pharmaceut. Biomed. 2011, 54(1), 13-20.
https://doi.org/10.1016/j.jpba.2010.07.036

[24]. De Bleye, C.; Chavez, P. F.; Mantanus, J.; Marini, R.; Hubert, P.; Rozet, E.; Ziemons, E. J. Pharmaceut. Biomed. 2012, 69, 125-132.
https://doi.org/10.1016/j.jpba.2012.02.003

[25]. Hu, X.; Cunningham, J.; Winstead, D. J. Pharm. Sci. 2008, 97(4), 1564-1577.
https://doi.org/10.1002/jps.21133

[26]. Otsuka, T.; Iwao, Y.; Miyagishima, A. Int. J. Pharm. 2011, 409(1), 81-88.
https://doi.org/10.1016/j.ijpharm.2011.02.044

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. 25 Jan. 2020
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

| | | | |

| | | | | |

Save to Zotero Save to Mendeley

European Journal of Chemistry 2017, 8(3), 265-272 | doi: https://doi.org/10.5155/eurjchem.8.3.265-272.1608 | Get rights and content

Refbacks

  • There are currently no refbacks.




Copyright (c)




© Copyright 2019  Atlanta Publishing House LLC All Right Reserved.

The opinions expressed in all articles published in European Journal of Chemistry are those of the specific author(s), and do not necessarily reflect the views of Atlanta Publishing House LLC, or European Journal of Chemistry, or any of its employees.

Copyright 2019 Atlanta Publishing House LLC. All rights reserved. This site is owned and operated by Atlanta Publishing House LLC whose registered office is 4614 Lavista road, Tucker, GA, 30084, USA. Registered in USA.

hatay escort hatay escort corlu escort corum escort burgaz escort giresun escort aydin escort ordu escort erzincan escort hatay escort sivas escort rize escort edirne escort aksaray escort kibris escort isparta escort erzurum escort tekirdag escort usak escort urfa escort kastamonu escort kibris escort manisa escort giresun escort urfa escort nevsehir escort sivas escort yalova escort ordu escort hatay escort yalova escort amasya escort kayseri escort ordu escort maras escort canakkale escort yalova escort balikesir escort manisa escort urfa escort mugla escort trabzon escort bolu escort corlu escort diyarbakir escort isparta escort kutahya escort elazig escort erzurum escort sakarya escort afyon escort kutahya escort konya escort agri escort cesme escort sinop escort sivas escort konya escort kibris escort adapazari escort luleburgaz escort adana escort kibris escort rize escort sakarya escort alanya escort isparta escort burdur escort konya escort bitlis escort canakkale escort sivas escort amasya escort mus escort aydin escort van escort yalova escort kastamonu escort mardin escort bolu escort afyon escort sakarya escort isparta escort tokat escort trakya escort bayburt escort urfa escort mardin escort