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A quality by design (QbD) twin–screw extrusion wet granulation approach for processing water insoluble drugs

A quality by design (QbD) twin–screw extrusion wet granulation approach for processing water insoluble drugs

Maniruzzaman, Mohammed, Ross, Steven A., Dey, Tumpa, Nair, Arun, Snowden, Martin J. and Douroumis, Dennis (2017) A quality by design (QbD) twin–screw extrusion wet granulation approach for processing water insoluble drugs. International Journal of Pharmaceutics, 526 (1-2). pp. 496-505. ISSN 0378-5173 (doi:10.1016/j.ijpharm.2017.05.020)

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Abstract

In this study, a Quality by Design (QbD) approach was used to identify the effect of formulation parameters in a twin screw wet extrusion granulation process for the manufacturing of ibuprofen (IBU) granules with increased dissolution rates. A fractional factorial Design of Experiment (DoE) was used to investigate the effect of the excipient composition, binder amount and liquid to solid (L/S) ratio (independent variables) on drug dissolution rates, median particle size diameter and specific surface area (dependent variables). The intra-granular addition of the binder in inorganic/polymer blends processed with ethanol as granulating liquids facilitated the formation of granules at various particle sizes. DoE regression analysis showed that all formulation parameters affect the dependent variables significantly. The enhanced dissolution rates were attributed not only to the IBU particle size reduction and adsorption in the porous inorganic network but also to the high specific surface area of the produced granules. Dynamic vapour sorption showed increased water absorption for granules with small particle size distribution and high specific surface area.

Item Type: Article
Uncontrolled Keywords: Wet granulation; DoE; QbD; Dissolution rate; Specific surface area; Water sorption
Subjects: Q Science > QD Chemistry
Faculty / Department / Research Group: Faculty of Engineering & Science
Faculty of Engineering & Science > Department of Pharmaceutical, Chemical & Environmental Sciences
Last Modified: 12 May 2018 00:38
Selected for GREAT 2016: None
Selected for GREAT 2017: None
Selected for GREAT 2018: None
URI: http://gala.gre.ac.uk/id/eprint/17324

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