OpenAIRE is about to release its new face with lots of new content and services.
During September, you may notice downtime in services, while some functionalities (e.g. user registration, login, validation, claiming) will be temporarily disabled.
We apologize for the inconvenience, please stay tuned!
For further information please contact helpdesk[at]

fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Maniruzzaman, Mohammed; Nair, Arun; Renault, Maxcene; Nandi, Uttom; Scoutaris, Nicholaos; Farnish, Richard; Bradley, Mike; Snowden, Martin J.; Douroumis, Dennis (2015)
Publisher: Elsevier B.V.
Languages: English
Types: Article
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 (Neusilin1-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.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • Dhenge, R.M., Cartwright, J.J., Houslow, M.J., Salman, A.D., 2012. Twin screw wet granulation: effect of properties of granulation liquid. Powder Technol. 229, 126-136.
    • Dhenge, R.M., Washino, K., Cartwright, J.J., Houslow, M.J., Salman, A.D., 2013. Twin screw granulation using conveying screws: effect of viscosity of granulation liquids and flow of powders. Powder Technol. 238, 77-90.
    • El Hagrasy, A.S., Hennenkamp, J.R., Burke, M.D., Cartwright, J.J., Litster, J.D., 2013. Twin screw wet granulation: influence of formulation parameters on granule properties and growth behaviour. Powder Technol. 238, 108-115.
    • El Hagrasy, A.S., Litster, J.D., 2013. Granulation rate processes in the kneading elements of a twin screw granulator. AlChE J. 59, 4100-4115.
    • Gryczke, A., Schminke, G.S., Maniruzzaman, M., Beck, J., Douroumis, D., 2011.
    • Development and evaluation of orally disintegrating tablets (ODTs) containing ibuprofen granules prepared by hot melt extrusion. Colloids Surf B Biointerfaces 86, 275-84.
    • Gupta, M.K., Tseng, Y-C., Goldman, D., Bogner, R.H., 2002. Hydrogen Bonding with Adsorbent during Storage Governs Drug Dissolution from Solid-Dispersion Granules. Pharm Res 19, 1663-72.
    • Gupta, M.K., Vanwert, V., Bogner, R.H., 2003. Formation of Physically Stable Amorphous Drugs by Milling with Neusilin. J Pharm Sci 92, 536-51.
    • Hédoux, A., Guinet, Y., Derollez, P., Dudognon, E., Correia, N.T., 2011. Raman spectroscopy of racemic ibuprofen: Evidence of molecular disorder in phase II. International Journal of Pharmaceutics 421, 45-52.
    • Keleb, E.I., Vermeire, A., Vervaet, C., Remon, J.P., 2002. Continuous twin screw extrusion for the wet granulation of lactose. Int. J. Pharm. 239, 69-80.
    • Keleb, E.I., Vermeire, A., Vervaet, C., Remon, J.P., 2004a. Single-step granulation/ tabletting of different grades of lactose: a comparison with higher shear granulation and compression.
    • Eur. J. Pharm. Biopharm. 58, 77-82.
    • Keleb, E.I., Vermeire, A., Vervaet, C., Remon, J.P., 2004b. Twin screw granulation as a simple and efficient tool for continuous wet granulation. Int. J. Pharm. 273, 183-194.
    • Kleinebudde, P., Lindner, H., 1993. Experiements with an instrumented twin-screw extruder using a single-step granulation/extrusion process. Int. J. Pharm. 94, 49-58.
    • Lee, K.T., Ingram, A., Rown, N.A., 2012. Twin screw wet granulation: the study of a continuous twin screw granulator using Positron Emission Particle Tracking (PEPT) technique. Eur. J. Pharm. Biopharm. 81, 666-673.
    • Lee, W. L., Loei, C., Widjaja , E., Loo, S.C.J., 2011. Altering the drug release profiles of double-layered ternary-phase microparticles. J. Control. Rel. 151, 229-238.
    • Leuenberger, H., 2001. New trends in the production of pharmaceutical granules: batch versus continuous processing. Eur. J. Pharm. Biopharm. 52, 289-296.
    • Lodaya, M., Mollan, M., Ghebre-Sellasie, I., 2003. Twin screw granulation. In: GhebreSellassie, I., Martin, C. (Eds.), Pharmaceutical Extrusion Technology. Marcel Dekker, New York, pp. 69-98.
    • Maniruzzaman, M., Boateng, J. S., Snowden, M.J., Douroumis, D., 2012. A review of hotmelt extrusion: process technology to pharmaceutical products. ISRN Pharmaceutics 2012, 436763.
    • Maniruzzaman, M., Morgan, D.J., Mendham, A.P., Pang, J., Snowden, M.J., Douroumis, D., 2013b. Drug-copolymer intermolecular interactions in hot-melt extruded solid dispersions.
    • Int J Pharm 443(1-2), 199-208.
    • Schmidt, C., Kleinebudde, P., 1998. Comparison between a twin-screw extruder and a rotary ring die press. Part II: influence of process variables. Eur. J. Pharm. Biopharm. 45, 173-179.
    • Tewes, F., Tajber, L., Corrigan, O.I., Ehrhardt, C., Healy, A,M.,2010. Development and characterisation of soluble polymeric particles for pulmonary peptide delivery. Eur. J Pharm.
    • Sci. 41, 337-52.
    • Thompson, M.R., Sun, J., 2010. Wet granulation in a twin-screw extruder: implications of screw design. J. Pharm. Sci. 99, 2090-2103.
    • Tu, W.D., Ingram, A., Seville, J.P.K., 2013. Regime map development for continuous twin screw granulation. Chem. Eng. Sci. 87, 315-326.
    • Vervaet, C., Remon, J.P., 2005. Continuous granulation in the pharmaceutical industry.
    • Chem. Eng. Sci. 60, 3949-3957.
    • Yu, S., Reynolds, G.K., Huang, Z., Matas, M.D., Salman, A.D., 2014. Granulation of increasingly hydrophobic formulations using a twin screw granulator. Int. J. Pharm. 475, 82- 96.
  • No related research data.
  • No similar publications.

Share - Bookmark

Cite this article

Cookies make it easier for us to provide you with our services. With the usage of our services you permit us to use cookies.
More information Ok