Inline monitoring and a PAT strategy for pharmaceutical hot melt extrusion

International Journal of Pharmaceutics

Volumn 455, Issue 1-2, 2013, Pages 159-168

  Wahl, Patrick R ^a   Treffer, Daniel ^b   Mohr, Stefan ^a,c   Roblegg, Eva ^a,c   Koscher, Gerold ^a   Khinast, Johannes G ^a,b  

^a RESEARCH CENTER PHARMACEUTICAL ENGINEERING GMBH   (Austria)

^b GRAZ UNIVERSITY OF TECHNOLOGY   (Austria)

^c UNIVERSITY OF GRAZ   (Austria)

Author keywords

API content; Hot melt extrusion; Near infrared spectroscopy (NIRS); Process analytical technology (PAT); Quality control

Indexed keywords

PARACETAMOL; STEARATE CALCIUM; STEARIC ACID DERIVATIVE; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; CALIBRATION; CHEMICAL MODIFICATION; CHEMOMETRIC ANALYSIS; CONCENTRATION (PARAMETERS); CONTROL STRATEGY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; NEAR INFRARED SPECTROSCOPY; PARTICLE SIZE; PREDICTION; PRIORITY JOURNAL; PROCESS DEVELOPMENT; QUALITY CONTROL; VEGETABLE; VELOCITY;

API CONTENT; HOT MELT EXTRUSION; NEAR-INFRARED SPECTROSCOPY (NIRS); PROCESS ANALYTICAL TECHNOLOGY (PAT); QUALITY CONTROL;

ACETAMINOPHEN; HOT TEMPERATURE; SPECTROSCOPY, NEAR-INFRARED; STEARIC ACIDS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84883875502     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2013.07.044     Document Type: Article

References (24)

1. Alig, I., Fischer, D., Lellinger, D., Steinhoff, B., 2005. Combination of NIR, Raman, ultrasonic and dielectric spectroscopy for in-line monitoring of the extrusion process. Macromol. Symp. 230, 51-58. (Pubitemid 43120137)
2. Barnes, S.E., Brown, E.C., Sibley, M.G., Edwards, H.G.M., Scowen, I.J., Coates, P.D., 2005. Vibrational spectroscopic and ultrasound analysis for in-process characterization of high-density polyethylene/polypropylene blends during melt extrusion. Appl. Spectrosc. 59, 611-619. (Pubitemid 40680315)
3. Breitenbach, J., 2002. Melt extrusion: from process to drug delivery technology. Eur. J. Pharm. Biopharm. 54, 107-117. (Pubitemid 34919382)
4. Coates, P.D., Barnes, S.E., Sibley, M.G., Brown, E.C., Edwards, H.G.M., Scowen, I.J., 2003. In-process vibrational spectroscopy and ultrasound measurements in polymer melt extrusion. Polymer 44, 5937-5949. (Pubitemid 37046101)
5. Conway, S.L., Lekhal, A., Khinast Johannes, G., Glasser Benjamin, J., 2005. Granular flow and segregation in a four-bladed mixer. Chem. Eng. Sci. 60, 7091-7107. (Pubitemid 41260621)
6. De Beer, T., Burggraeve, A., Fonteyne, M., Saerens, L., Remon, J.P., Vervaet, C., 2011. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. Int. J. Pharm. 417, 32-47.
7. Esbensen, K.H., Paasch-Mortensen, P., 2010. Process Sampling: Theory of Sampling - the Missing Link in Process Analytical Technology (PAT). In: Bakeev, K.A. (Ed.), Process Analytical Technology. John Wiley & Sons Ltd, pp. 37-80.
8. FDA, 2004. Guidance for Industry. PAT - a framework for innovative pharmaceutical development, manufacturing, and quality assurance. Quality Assurance. US Department of Health, Rockville, MD.
9. Fischer, D., Bayer, T., Eichhorn, K.J., Otto, M., 1997. In-line process monitoring on polymer melts by NIR-spectroscopy. Fresenius J. Anal. Chem. 359, 74-77. (Pubitemid 127713862)
10. Gendrin, C., Roggo, Y., Collet, C., 2008. Pharmaceutical applications of vibrational chemical imaging and chemometrics: a review. J. Pharm. Biomed. Anal. 48, 533-553.
11. Kohlgrüber, K., 2007. Co-Rotating Twin-Screw Extruder. Carl Hanser Verlag GmbH & CO. KG.
12. Mudalamane, R., Bigio, D.I., 2003. Process variations and the transient behavior of extruders. AIChE J. 49, 3150-3160. (Pubitemid 38009896)
13. Plumb, K., 2005. Continuous processing in the pharmaceutical industry. Chem. Eng. Res. Des. 83, 730-738.
14. Rauwendaal, C., 2001. Polymer Extrusion, 4th ed. Hanser Publishers, Munich.
15. Roblegg, E., Jäger, E., Hodzic, A., Koscher, G., Mohr, S., Zimmer, A., Khinast, J., 2011. Development of sustained-release lipophilic calcium stearate pellets via hot melt extrusion. Eur. J. Pharm. Biopharm. 79, 635-645.
16. Roggo, Y., Chalus, P., Maurer, L., Lema-Martinez, C., Edmond, A., Jent, N., 2007. A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed. Anal. 44, 683-700. (Pubitemid 47030775)
17. Saerens, L., Dierickx, L., Lenain, B., Vervaet, C., Remon, J.P., De Beer, T., 2011. Raman spectroscopy for the in-line polymer-drug quantification and solid state characterization during a pharmaceutical hot-melt extrusion process. Eur. J. Pharm. Biopharm. 77, 158-163.
18. Saerens, L., Dierickx, L., Quinten, T., Adriaensens, P., Carleer, R., Vervaet, C., Remon, J.P., De Beer, T., 2012. In-line NIR spectroscopy for the understanding of polymer-drug interaction during pharmaceutical hot-melt extrusion. Eur. J. Pharmaceut. Biopharmaceut. 81, 230-237.
19. Scheibelhofer, O., Balak, N., Wahl, P.R., Koller, D.M., Glasser, B.J., Khinast, J.G., 2013. Monitoring Blending of Pharmaceutical Powders with Multipoint NIR Spectroscopy. AAPS PharmSciTech 14, 234-244.
20. Scheibelhofer, O., Koller, D.M., Kerschhaggl, P., Khinast, J.G., 2012. Continuous powder flow monitoring via near-infrared hyperspectral imaging. In: Instrumentation and Measurement Technology Conference (I2MTC), 2012 IEEE International, pp. 748-753.
21. Schenck, L., Troup, G.M., Lowinger, M., Li, L., McKelvey, C., 2011. Achieving a Hot melt extrusion design space for the production of solid solutions. In: am Ende, D.J. (Ed.), Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing. John Wiley & Sons Ltd, pp. 819-836.
22. Tumuluri, V.S., Kemper, M.S., Lewis, I.R., Prodduturi, S., Majumdar, S., Avery, B.A., Repka, M.A., 2008. Off-line and on-line measurements of drug-loaded hot-melt extruded films using Raman spectroscopy. Int. J. Pharm. 357, 77-84.
23. Tumuluri, V.S., Prodduturi, S., Crowley, M.M., Stodghill, S.P., McGinity, J.W., Repka, M.A., Avery, B.A., 2004. The use of near-infrared spectroscopy for the quantitation of a drug in hot-melt extruded films. Drug Dev. Ind. Pharm. 30, 505-511. (Pubitemid 38821862)
24. Vankeirsbilck, T., Vercauteren, A., Baeyens, W., Weken, G. Van der, Verpoort, F., Vergote, G., Remon, J.P., 2002. Applications of Raman spectroscopy in pharmaceutical analysis. Trends Anal. Chem. 21, 869-877. (Pubitemid 35463178)