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

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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
Schools and Departments: School of Life Sciences > Chemistry
Depositing User: Mohammed Maniruzzaman
Date Deposited: 12 May 2017 07:40
Last Modified: 12 Jul 2017 16:56
URI: http://sro.sussex.ac.uk/id/eprint/68065

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