Experimental and computational determination of blend time in USP dissolution testing apparatus II

Journal of Pharmaceutical Sciences

Volumn 96, Issue 11, 2007, Pages 3072-3086

  Bai, Ge ^a   Armenante, Piero M ^a   Plank, Russell V ^b  

^a NEW JERSEY INSTITUTE OF TECHNOLOGY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Dissolution; Dissolution rate; Mathematical model; Mixing; Solid dosage form

Indexed keywords

TRACER;

APPARATUS; ARTICLE; COMPUTATIONAL FLUID DYNAMICS; DRUG SOLUBILITY; QUANTITATIVE ANALYSIS; SIMULATION;

EID: 36849066339     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20994     Document Type: Article

References (34)

1. 2005. The United States Pharmacopeia & The National Formulary. The Official Compendia of Standards, USP 29-NF 24 2005, Pharmacopoeial Convention Inc., November, 2005.
2. Mauger J, Ballard J, Brockson R, De S, Gray V, Robinson D. 2003. Intrinsic Dissolution Performance of the USP Dissolution Apparatus 2 (Rotating Paddle) Using Modified Salicylic Acid Calibration Tablets: Proof of Principle, Dissol Technol. August 2003.
3. Moore TW, Hamilton JF, Kerner CM. 1995. Dissolution testing: limitation of USP prednisone and salicylic acid calibrator tablets. Pharmacopoeial Forum 21:1387-1396.
4. Qureshi SA, McGilveray IJ. 1999. Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug glibenclamide. Product Eur J Pharm Sci 7:249-258.
5. Qureshi SA, Shabnam J. 2001. Cause of high variability in drug dissolution testing and its impact on setting tolerances. Eur J Pharm Sci 12:271-276.
6. Costa P, Lobo JMS. 2001. Influence of dissolution medium agitation on release profiles of sustained-release tablets. Drug Dev Ind Pharm 27:811-817.
7. Bocanegra LM, Morris GJ, Jurewicz JT, Mauger JW. 1990. Fluid and particle laser Doppler velocity measurements and mass transfer predictions for USP paddle method dissolution apparatus. Drug Dev Ind Pharm 16:1441-1464.
8. Cox DC, Furman WB. 1982. Systematic error associated with Apparatus 2 of the USP Dissolution Test I: effects of physical alignment of the dissolution apparatus. J Pharm Sci 71:451-452.
9. Cox DC, Furman WB, Thornton LK. 1983. Systematic error associated with Apparatus 2 of the USP Dissolution Test III: limitation of calibrators and the USP suitability test. J Pharm Sci 72:910-913.
10. Kukura J, Arratia PC, Szalai ES, Muzzio FJ. 2003. Engineering tools for understanding hydrodynamics of dissolution tests. Drug Dev Ind Pharm 29:231-239.
11. Baxter JL, Kukura J, Muzzio FJ. 2005. Hydrodynamics-induced variability in the USP Apparatus II Dissolution Test Int J Pharm 292:17-28.
12. Kukura J, Baxter JL, Muzzio FJ. 2004. Shear distribution and variability in the USP Apparatus 2 under turbulent conditions. Int J Pharm 279:9-17.
13. McCarthy L, Bradley G, Sexton J, Corrigan O, Healy AM. 2004. Computational fluid dynamics modeling of the paddle dissolution apparatus: agitation rate mixing patterns and fluid velocities. AAPS Pharm Sci Tech 5: Article 31.
14. McCarthy L, Kosiol C, Healy AM, Bradley G, Sexton J, Corrigan O. 2003. Simulating the hydrodynamic conditions in the United States pharmacopeias paddle dissolution apparatus. AAPS Pharm Sci Tech 4: Article 22.
15. Bai G, Armenante PM, Plank RV, Gentzier M, Ford K, Harmon P. 2007. Hydrodynamics investigation of USP dissolution test Apparatus II. J Pharm Sci. Also published online in Wiley InterScience (www.interscience.wiley.com). DOI 10.1002/jps.20818.
16. Brown ARD, Jones NP, Middleton CJ, Papadopoulos G, Arik EB. 2004. Experimental methods. In: Paul LE, Atiemo-Obeng AV, Kresta MS, editors. Handbook of Industrial Mixing. Hoboken, NJ: John Wiley & Sons, Inc. (Chapter 4)
17. Hass VC, Nienow AW. 1989. A new axial pumping agitator for the dispersion of gas in liquids. Chem Ing Technik 61:152-154 (in German).
18. Manna L. 1997. Comparison between physical and chemical methods for the measurements of blend times. Chem Eng J 67:167-173.
19. Nienow WA. 1997. On impeller circulation and mixing effectiveness in the turbulent flow regime. Chem Eng Sci 52:2557-2565.
20. Nishikawa M, Ash wake K, Hashimoto N, Nagata S. 1979. Agitation power and blend time in off-centering mixing. Int Chem Eng 19:13-159.
21. Myers KJ, Reeder MF, Fusan JB. 2002. Optimize mixing by using the proper baffles. Chem Eng Prog 98:42-47.
22. Nere NK, Patwardhan AW, Joshi JB. 2003. Liquid-phase mixing in stirred vessels: turbulent flow regime. Ind Eng Chem Res 42:2661-2698.
23. Jaworski Z, Dudczak J. 1998. CFD modelling of turbulent macromixing in stirred tanks: effect of the probe size and number on mixing indices. Comput Chem Eng 22:S293-S298.
24. Murthy S, Jayanti S. 2002. CFD study of power and blend time for paddle mixing in unbaffled vessels. Chem Eng Res Des 80:482-498.
25. Zhou G, Shi L, Yu P2003. CFD study of mixing process in Rushton turbine stirred tanks. Proceedings of the Third International Conference on CFD in the Minerals and Process Industries, CSIRO, Melbourne, Australia, December 10-12, 2003.
26. Campolo M, Soldati A. 2004. Numerical evaluation of blend time in a tank reactor stirred by a magnetically driven impeller. Ind Eng.Chem Res 43:6836-6846.
27. Yeoh SL, Papadakis G, Yianneskis M. 2005. Determination of blend time and degree of homogeneity in stirred vessels with large eddy simulation. Chem Eng Sci 60:2293-2302.
28. FLUENT 6.2 User's Guide. 2005. Fluent Inc., New Hampshire.
29. Zhang Z, Kleinstreuer C. 2003. Low-Reynolds-number turbulent flows in locally constricted conduits: a comparison study. AIAA J 41:831-840.
30. Grenville KR, Nienow WA. 2004. Blending of miscible liquids. In: Paul LE, Atiemo-Obeng AV, Kresta MS, editors. Handbook of Industrial Mixing. Hoboken, NJ: John Wiley & Sons, Inc. (Chapter 9)
31. Kresta MS, Mao D, Roussinova V. 2006. Batch blend time in square stirred tanks. Chem Eng Sci 61:2823-2825.
32. Grenville RK. 1992. Mixing of viscous Newtonian and pseudo-plastic fluids, Ph.D. Dissertation, Cranfield Institute of Technology, Cranfield, Bedfordshire, England.
33. Armenante MP, Kirwan JD. 1989. Mass transfer to microparticles in agitated system. Chem Eng Sci 44:2781-2796.
34. Qureshi AA. 1996. Calibration - The USP Dissolution Apparatus Suitability Test. Drug Info J 30: 1055-1061.