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Continuous twin-screw granulation for enhancing the dissolution of poorly water soluble drug.
Int J Pharm 2015; 496(1):52-62IJ

Abstract

The article describes the application of a twin-screw granulation process to enhance the dissolution rate of the poorly water soluble drug, ibuprofen (IBU). A quality-by-design (QbD) approach was used to manufacture IBU loaded granules via hot-melt extrusion (HME) processing. For the purpose of the study, a design of experiment (DoE) was implemented to assess the effect of the formulation compositions and the processing parameters. This novel approach allowed the use of, polymer/inorganic excipients such as hydroxypropyl methylcellulose (HPMC) and magnesium aluminometasilicate (Neusilin(®)-MAS) with polyethylene glycol 2000 (PEG) as the binder without requiring a further drying step. IBU loaded batches were processed using a twin screw extruder to investigate the effect of MAS/polymer ratio, PEG amount (binder) and liquid to solid (L/S) ratios on the dissolution rates, mean particle size and the loss on drying (LoD) of the extruded granules. The DoE analysis showed that the defined independent variables of the twin screw granulation process have a complex effect on the measured outcomes. The solid state analysis showed the existence of partially amorphous IBU state which had a significant effect on the dissolution enhancement in acidic media. Furthermore, the analysis obtained from the surface mapping by Raman proved the homogenous distribution of the IBU in the extruded granulation formulations.

Authors+Show Affiliations

Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK. Electronic address: M.Maniruzzaman@gre.ac.uk.Fuji Chemical Industry Co., Ltd., 12F The Front Tower Shiba Koen, 2-6-3 Shibakoen, Minato-Ward, Tokyo 105-0011 Japan.IUT De Rouen, IUT de Rouen, Bâtiment A-1er étage, rue Lavoisier, 76821 Mont-Saint-Aignan, CEDEX France.Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.Wolfson Centre of Bulk Solid Handling, Faculty of Engineering and Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.Wolfson Centre of Bulk Solid Handling, Faculty of Engineering and Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK. Electronic address: D.Douroumis@gre.ac.uk.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26387621

Citation

Maniruzzaman, Mohammed, et al. "Continuous Twin-screw Granulation for Enhancing the Dissolution of Poorly Water Soluble Drug." International Journal of Pharmaceutics, vol. 496, no. 1, 2015, pp. 52-62.
Maniruzzaman M, Nair A, Renault M, et al. Continuous twin-screw granulation for enhancing the dissolution of poorly water soluble drug. Int J Pharm. 2015;496(1):52-62.
Maniruzzaman, M., Nair, A., Renault, M., Nandi, U., Scoutaris, N., Farnish, R., ... Douroumis, D. (2015). Continuous twin-screw granulation for enhancing the dissolution of poorly water soluble drug. International Journal of Pharmaceutics, 496(1), pp. 52-62. doi:10.1016/j.ijpharm.2015.09.025.
Maniruzzaman M, et al. Continuous Twin-screw Granulation for Enhancing the Dissolution of Poorly Water Soluble Drug. Int J Pharm. 2015 Dec 30;496(1):52-62. PubMed PMID: 26387621.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous twin-screw granulation for enhancing the dissolution of poorly water soluble drug. AU - Maniruzzaman,Mohammed, AU - Nair,Arun, AU - Renault,Maxcene, AU - Nandi,Uttom, AU - Scoutaris,Nicholaos, AU - Farnish,Richard, AU - Bradley,Michael S A, AU - Snowden,Martin J, AU - Douroumis,Dennis, Y1 - 2015/09/18/ PY - 2015/08/19/received PY - 2015/09/11/revised PY - 2015/09/14/accepted PY - 2015/9/22/entrez PY - 2015/9/22/pubmed PY - 2016/9/16/medline KW - DVS KW - Dissolutions KW - DoE KW - Granulations KW - QbD KW - Raman KW - Twin screw SP - 52 EP - 62 JF - International journal of pharmaceutics JO - Int J Pharm VL - 496 IS - 1 N2 - The article describes the application of a twin-screw granulation process to enhance the dissolution rate of the poorly water soluble drug, ibuprofen (IBU). A quality-by-design (QbD) approach was used to manufacture IBU loaded granules via hot-melt extrusion (HME) processing. For the purpose of the study, a design of experiment (DoE) was implemented to assess the effect of the formulation compositions and the processing parameters. This novel approach allowed the use of, polymer/inorganic excipients such as hydroxypropyl methylcellulose (HPMC) and magnesium aluminometasilicate (Neusilin(®)-MAS) with polyethylene glycol 2000 (PEG) as the binder without requiring a further drying step. IBU loaded batches were processed using a twin screw extruder to investigate the effect of MAS/polymer ratio, PEG amount (binder) and liquid to solid (L/S) ratios on the dissolution rates, mean particle size and the loss on drying (LoD) of the extruded granules. The DoE analysis showed that the defined independent variables of the twin screw granulation process have a complex effect on the measured outcomes. The solid state analysis showed the existence of partially amorphous IBU state which had a significant effect on the dissolution enhancement in acidic media. Furthermore, the analysis obtained from the surface mapping by Raman proved the homogenous distribution of the IBU in the extruded granulation formulations. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/26387621/Continuous_twin_screw_granulation_for_enhancing_the_dissolution_of_poorly_water_soluble_drug_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(15)30223-4 DB - PRIME DP - Unbound Medicine ER -