Raman spectroscopy for the in-line polymer-drug quantification and solid state characterization during a pharmaceutical hot-melt extrusion process

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 77, Issue 1, 2011, Pages 158-163

  Saerens, L ^a   Dierickx, L ^a   Lenain, B ^b   Vervaet, C ^a   Remon, J P ^a   Beer, T De ^a  

^a GHENT UNIVERSITY   (Belgium)

^b Kaiser Optical Systems   (France)

Author keywords

Hot melt extrusion (HME); In line measurements; Process Analytical Technology (PAT); Raman spectroscopy; Solid dispersions; Solid solutions

Indexed keywords

EUDRAGIT RS; METOPROLOL TARTRATE;

ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DRUG DETERMINATION; HOT MELT EXTRUSION; PHARMACEUTICAL ENGINEERING; PROCESS ANALYTICAL TECHNOLOGY; RAMAN SPECTROMETRY;

CALIBRATION; CALORIMETRY, DIFFERENTIAL SCANNING; DRUG COMPOUNDING; EXCIPIENTS; HOT TEMPERATURE; METOPROLOL; MODELS, CHEMICAL; PHARMACEUTICAL PREPARATIONS; POLYMERS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SPECTRUM ANALYSIS, RAMAN; TABLETS;

EID: 78650709887     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2010.09.015     Document Type: Article

References (26)

1. R. Chokshi, and H. Zia Hot-melt extrusion technique: a review Iranian J. Pharm. Res. 3 2004 3 16
2. J. Breitenbach Melt extrusion: from process to drug delivery technology Eur. J. Pharm. Biopharm. 54 2002 107 117
3. M.M. Crowley, F. Zhang, M.A. Repka, S. Thumma, S.B. Upadhye, S. Battu, J.W. McGinity, and C. Martin Review article: pharmaceutical applications of hot-melt extrusion: part I Drug Dev. Ind. Pharm. 33 2007 909 926 (Pubitemid 47463803)
4. M.A. Repka, S. Battu, S.B. Upadhye, S. Thumma, M.M. Crowley, F. Zhang, C. Martin, and J.W. McGinity Review article: pharmaceutical applications of hot-melt extrusion: part II Drug Dev. Ind. Pharm. 33 2007 1043 1057 (Pubitemid 350034836)
5. M.A. Repka, S. Majumdar, S. Battu, R. Srirangam, and S.B. Upadhye Applications of hot-melt extrusion for drug delivery Expert. Opin. Drug Deliv. 5 2008 1357 1376
6. Food and Drug Administration, Process Analytical Technology Initiative, Guidance for Industry PAT - A Framework for Innovative Pharmaceutical development, Manufacturing and Quality Assurance, 2004.
7. S.E. Barnes, M.G. Sibley, H.G.M. Edwards, and P.D. Coates Process monitoring of polymer melts using in-line spectroscopy Trans. Inst. Meas. Control 29 2007 453 465
8. S.E. Barnes, E.C. Brown, M.G. Sibley, H.G.M. Edwards, and P.D. Coates Vibrational spectroscopic and ultrasound analysis for the in-process monitoring of poly(ethylene vinyl acetate) copolymer composition during melt extrusion Analyst 130 2005 286 292
9. V.S. Tumuluri, M.S. Kemper, I.R. Lewis, S. Prodduturi, S. Majumdar, B.A. Avery, and M.A. Repka Off-line and on-line measurements of drug loaded hot-melt extruded films using Raman spectroscopy Int. J. Pharm. 357 2008 77 84
10. S.E. Barnes, E.C. Brown, M.G. Sibley, H.G.M. Edwards, I.J. Scowen, and P.D. Coates Vibrational spectroscopic and ultrasound measurements for in-process characterisation of high density polyethylene/polypropylene mechanical blends during melt extrusion Appl. Spectrosc. 59 2005 611 619
11. P.D. Coates, S.E. Barnes, M.G. Sibley, E.C. Brown, H.G.M. Edwards, and I.J. Scowen In-process vibrational spectroscopy and ultrasound measurements in polymer melt extrusion Polymer 44 2003 5937 5949
12. I. Alig, D. Fischer, D. Lellinger, and B. Steinhoff Combination of NIR, Raman, ultrasonic and dielectric spectroscopy for in-line monitoring of the extrusion process Macromol. Symp. 230 2005 51 58
13. L. Li, O. AbuBaker, and Z.J. Shao Characterization of poly(ethylene oxide) as a drug carrier in hot-melt extrusion Drug Dev. Ind. Pharm. 32 2006 991 1002
14. L.S. Taylor, and G. Zografi Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions Pharm. Res. 14 1997 1691 1698
15. Z. Dong, A. Chatterji, H. Sandhu, D.S. Choi, H. Chokshi, and N. Shah Evaluation of solid state properties of solid dispersions prepared by hot-melt extrusion and solvent co-precipitation Int. J. Pharm. 355 2007 141 149
16. T. Vasconcelos, B. Sarmento, and P. Costa Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs Drug Discov. Today 12 2007 1068 1075
17. J. Breitkreutz Prediction of intestinal drug absorption properties by three-dimensional solubility parameters Pharm. Res. 15 1998 1370 1375
18. L. Eriksson, E. Johansson, N. Kettaneh-Wold, J. Trygg, C. Wikström, and S. Wold Multi- and megavariate data analysis part I: basic principles and applications 2006 Umetrics Academy Sweden pp. 63-101
19. A. Gryczke, Physical-chemical characterisation of polymers and actives to model and understand the changes the chances of successful extrusion, in: 2009 AAPS Annual Meeting, Los Angeles, California, 2009
20. A. Forster, J. Hempenstall, I. Tucker, and T. Rades Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis Int. J. Pharm. 226 2001 147 161
21. Y. He, B. Zhu, and Y. Inoue Hydrogen bonds in polymer blends Prog. Polym. Sci. 29 2004 1021 1051
22. M. De Veij, P. Vandenabeele, T. De Beer, J.-P. Remon, and L. Moens Reference database of pharmaceutical excipients J. Raman spectrosc. 40 2008 297 330
23. G. Socrates Infrared and Raman Characteristic Group Frequencies: Tables and Charts 2004 John Wiley & Sons Ltd. England
24. C. Wu, and J.W. McGinity Influence of methylparaben as a solid state plasticizer on the physicochemical properties of Eudragit® RS PO hot-melt extrudates Eur. J. Pharm. Biopharm. 56 2003 95 100
25. V.B. Mathot Calorimetry and Thermal Analysis of Polymers 1994 Hanser Publishers New York, NY
26. S. Qi, A. Gryczke, P. Belton, and D.Q.M. Craig Characterisation of solid dispersions of paracetamol and EUDRAGIT® E prepared by hot-melt extrusion using thermal, microthermal and spectroscopic analysis Int. J. Pharm. 354 2008 158 167