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Research Article

In-process rheometry as a PAT tool for hot melt extrusion

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Pages 670-676 | Received 04 Aug 2017, Accepted 15 Nov 2017, Published online: 04 Dec 2017

References

  • Crowley MM, Zhang F, Repka MA, et al. Pharmaceutical applications of hot-melt extrusion: part I. Drug Dev Ind Pharm. 2007;33:909–926.
  • Qi S, Gryczke A, Belton P, et al. Characterisation of solid dispersions of paracetamol and EUDRAGIT prepared by hot-melt extrusion using thermal, microthermal and spectroscopic analysis. Int J Pharm. 2008;354:158–167.
  • Follonier N, Doelker E, Cole ET. Evaluation of hot-melt extrusion as a new technique for the production of polymer-based pellets for sustained release capsules containing high loadings of freely soluble drugs. Drug Dev Ind Pharm. 1994;20:1323–1339.
  • Tran PH, Tran TT, Park JB, et al. Controlled release systems containing solid dispersions: strategies and mechanisms. Pharm Res. 2011;28:2353–2378.
  • Crowley MM, Schroeder B, Fredersdorf A, et al. Physicochemical properties and mechanism of drug release from ethyl cellulose matrix tablets prepared by direct compression and hot melt extrusion. Int J Pharm. 2004;269:509–522.
  • Bhardwaj R, Blanchard J. In vitro evaluation of poly (D,L-lactide-co-glycolide) polymer-based implants containing the alpha-melanocyte stimulating hormone analog, melanotan-I. J Control Release. 1997;45:49–55.
  • Aitken-Nichol C, Zhang F, McGinity JW. Hot melt extrusion of acrylic films. Pharm Res. 1996;13:804–808.
  • Repka MA, Battu SK, Upadhye SB, et al. Pharmaceutical applications of hot-melt extrusion: part II. Drug Dev Ind Pharm. 2007;33:1043–1057.
  • Repka MA, Shah S, Lu J, et al. Melt extrusion: process to product. Expert Opin Drug Deliv. 2012;9:105–125.
  • US Food and Drug Administration. Process Analytical Technology Initiative, Guidance for Industry PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance; 2004.
  • De Beer T, Burggraeve A, Fonteyne M, et al. Near infra red and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. Int J Pharm. 2010;417:32–47.
  • Ishikawa T, Kihara S, Funatsu K. 3-D non-isothermal flow field analysis and mixing performance evaluation of kneading blocks in a co-rotating twin srew extruder. Polym Eng Sci. 2001;41:840–849.
  • Malik M, Kalyon DM, Golba JC. Simulation of co-rotating twin screw extrusion process subject to pressure-dependent wall slip at barrel and screw surfaces: 3D FEM analysis for combinations of forward and reverse conveying screw elements. Int Polym Process. 2014;29:51–62.
  • Eitzlymayr A, Khinast J. Co-rotating twin-srew extruders: Detailed analysis of conveying elements based on smoothed particle hydrodynamics. Part 1: hydrodynamics. Chem Eng Sci. 2015;134:861–879.
  • Luypaert J, Massart DL, Vander Heyden Y. Near-infrared spectroscopy applications in pharmaceutical analysis. Talanta. 2007;72:865–883.
  • Kelly A, Halsey SA, Bottom RA, et al. A novel transflectance near infrared spectroscopy technique for monitoring hot melt extrusion. Int J Pharm. 2015;496:117–123.
  • Saerens L, Dierickx L, Quinten T, et al. In-line NIR spectroscopy for the understanding of polymer-drug interaction during pharmaceutical hot-melt extrusion. Eur J Pharm Biopharm. 2012;81:230–237.
  • Collyer AA. Techniques in rheological measurement. London: Chapman and Hall; 1993.
  • Cogswell FN. Polymer melt rheology: a guide for industrial practice. Cambridge: Woodhead Publishing; 1981.
  • Paradkar A, Kelly A, Coates PD, et al. Shear and extensional rheology of hydroxypropyl cellulose melt using capillary rheometry. J Pharm Biomed Anal. 2008;49:304–310.
  • Bahramian B, Motlagh GH, Majidi SS, et al. Evaluation of melt rheology of lactose-filled polyethylene glycol composites by means of capillary rheometry. Pharm Dev Tech. 2013;18:98–105.
  • Maru SM, de Matas M, Kelly A, et al. Characterization of thermal and rheological properties of zidovidine, lamivudine and plasticizer blends with ethyl cellulose to assess their suitability for hot melt extrusion. Eur J Pharm Sci. 2011;44:471–478.
  • Sarode AL, Sandhu H, Shah N, et al. Hot melt extrusion (HME) for amorphous solid dispersions: predictive tools for processing and impact of drug-polymer interactions on supersaturation. Eur J Pharm Sci. 2012;48:371–384.
  • Liu HJ, Zhang XY, Suwardie H, et al. Miscibility studies of indomethacin and Eudragit E PO by thermal, rheological, and spectroscopic analysis. J Pharm Sci. 2012;101:2204–2212.
  • Suwardie H, Wang P, Todd DB, et al. Rheological study of the mixture of acetaminophen and polyethylene oxide for hot-melt extrusion application. Eur J Pharm Biopharm. 2011;78:506–512.
  • Han CD. Measurement of the rheological properties of polymer melts with a slit rheometer. J Appl Polym Sci. 1971;15:2267–2577.
  • Rauwedaal C, Fernandez F. Experimental study and analysis of a slit die viscometer. Polym Eng Sci. 1985;25:765–771.
  • Pabedinskas A, Cluett WR, Balke ST. Development of an in-line rheometer suitable for reactive extrusion processes. Polym Eng Sci. 1991;31:365–375.
  • Fleming DJ. In-line rheometry studies in reactive extrusion. Bradford: Department of Mechanical and Manufacturing Engineering, University of Bradford; 1993.
  • Coates PD, Rose RM, Woodhead M, et al. Sensitivity of in-line rheometry for extrusion of Mg(OH)2 filled LDPE compounds. Int Polym Process. 1998;13:172–182.
  • Horvat M, Emin MA, Hochstein B, et al. A multiple-step slit die rheometer for rheological characterisation of extruded starch melts. J Food Eng. 2013;116:398–403.
  • Rauwedaal C. Polymer Extrusion. 2nd ed. Munich: Hanser Publishing; 1990.
  • Cox WP, Merz EH. Correlation of dynamic and steady flow viscosities. J Polym Sci. 1958;28:619–622.
  • Al-Hadithi TSR, Barnes HA, Walters K. The relationship between the linear (oscillatory) and nonlinear (steady-state) flow properties of a series of polymer and colloidal systems. Colloid Polym Sci. 1992;270:40–46.
  • Treffer D, Troiss A, Khinast J. A novel tool to standardize rheology testing of molten polymers for pharmaceutical applications. Int J Pharm. 2015;495:474–481.
  • Okubu S, Hori Y. Shear stress at wall and mean normal stress difference in capillary flow of polymer melts. J Rheol. 1979;23:625–649.

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