Hydrodynamic investigation of USP dissolution test apparatus II

Journal of Pharmaceutical Sciences

Volumn 96, Issue 9, 2007, Pages 2327-2349

  Bai, Ge ^a   Armenante, Piero M ^a   Plank, Russell V ^b   Gentzler, Michael ^b   Ford, Kenneth ^b   Harmon, Paul ^b  

^a NEW JERSEY INSTITUTE OF TECHNOLOGY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Computational fluid dynamics, CFD; Coning; Dissolution; Hydrodynamics; Laser doppler velocimetry, LDV; Pharmaceutical testing; Testing; USP dissolution test apparatus

Indexed keywords

ANALYSIS; ARTICLE; COMPUTATIONAL FLUID DYNAMICS; DEVICE; DISSOLUTION; DISTRIBUTION VOLUME; DRUG INDUSTRY; HYDRODYNAMICS; LASER DOPPLER FLOWMETRY; MATERIALS TESTING; TABLET; USP DISSOLUTION TEST APPARATUS II; VARIANCE; VELOCITY; VESSEL;

EID: 34748831887     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20818     Document Type: Article

References (32)

1. The United States Pharmacopeia & The National Formulary. The Official Compendia of Standards, USP 29-NF 24 2005, Pharmacopial Convention, Inc., November 2005.
2. Moore JW, Flanner HH. 1996. Mathematical comparison of dissolution profiles. Pharm Technol 20:64-74.
3. Cohen JL, Hubert BB, Leeson LJ, Rhodes CT, Robinson JR, Roseman TJ, Shefter E. 1990. The development of USP dissolution and drug release standards. Pharm Res 7:983-987.
4. 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 10:6-15.
5. Moore TW, Hamilton JF, Kerner CM. 1995. Dissolution testing: Limitation of USP prednisone and salicylic acid calibrator tablets. Pharmaopeial Forum 21:1387-1396.
6. Qureshi SA, McGilveray IJ. 1999. Typical variability in drug dissolution testing: Study with USP and FDA calibrator tablets and a marketed drug glibenclamide. Product Europ J Pharm Sci 7:249-258.
7. Qureshi SA, Shabnam J. 2001. Cause of high variability in drug dissolution testing and its impact on setting tolerances. Europ J Pharm Sci 12:271-276.
8. Costa P, Lobo JMS . 2001 . Influence of dissolution medium agitation on release profiles of sustained-release tablets. Drug Devel Ind Pharm 27:811-817.
9. 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 Devel Ind Pharm 16:1441-1464.
10. 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.
11. 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.
12. Kukura J, Arratia PC, Szalai ES, Muzzio FJ. 2003. Engineering tools for understanding hydrodynamics of dissolution tests. Drug Dev Ind Pharm 29:231-239.
13. Baxter JL, Kukura J, Muzzio FJ. 2005. Hydrodynamics-induced variability in the USP Apparatus II Dissolution Test. Int J Pharmaceutics 292:17-28.
14. FDC Reports. 2001. Recalls prompted by FDA on the increase. The Gold Sheet 35.
15. FDC Reports. 2002. Counterfeits pose special recall challenge. The Gold Sheet 36.
16. FDC Reports. 2003. Spike in potency-related problems contributes to overall rise in 2002 recalls. The Gold Sheet 37.
17. Kukura J, Baxter JL; Muzzio FJ. 2004. Shear distribution and variability in the USP Apparatus 2 under turbulent conditions. Int J Pharmaceutics 279:9-17.
18. 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.
19. 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.
20. Akiti O, Armenante PM. 2004. Experimentally-validated micromixing-based CFD model for fed-batch stirred-tank reactors. AIChE J 50:566-577.
21. Schäfer M, Höfken M, Durst F. 1997. Detailed LDV measurements for visualization of the flow field within a stirred-tank reactor equipped with a rushton turbine. Chem Eng Res Des 75:729-736.
22. Armenante PM, Chou CC, Hemrajani RR. 1994. Comparison of experimental and numerical fluid velocity distribution profiles in an unbaffled mixing vessel provided with a pitched-blade turbine. IChemE Symp Ser 136:349-356.
23. Armenante PM, Luo C, Chou CC, Fort I, Medek J. 1997. Velocity profiles in a closed unbaffled vessel: Comparison between experimental LDV data and numerical CFD predictions. Chem Eng Sci 52:3483-3492.
24. GAMBIT 2.2 User's Guide. 2005. Fluent, Inc. New Hampshire.
25. FLUENT 6.2 User's Guide. 2005. Fluent, Inc. New Hampshire.
26. Wilcox DC. 1998. Turbulence modeling for CFD. La Canada, California: DCW Industries, Inc.
27. Hanjalic K, Nagano Y, Tummers M. 2003. Turbulence Heat and Mass Transfer 4. Redding, CT: Begell House, Inc. pp 625-632.
28. Armenante PM, Chou CC. 1994. Experimental LDV measurement and numerical CFD determination of the fluid velocity distribution in an unbaffled mixing vessel. AIChE Symp Ser 90:33-40.
29. Ciofalo M, Brucato A, Grisafi F, Torraca N. 1996. Turbulent flow in closed and free-surface unbaffled tanks stirred by radial impellers. Chem Eng Sci 51:3557-3573.
30. Dong L, Johansen ST, Engh TA. 1994. Flow induced by an impeller in an unbaffled tank-I experimental. Chem Eng Sci 49:549-560.
31. Dong L, Johansen ST, Engh TA. 1994. Flow induced by an impeller in an unbaffled tank-II numerical modeling. Chem Eng Sci 49:3511-3518.
32. Murthy S, Jayanti S. 2002. CFD study of power and mixing time for paddle mixing in unbaffled vessels. Chem Eng Res Des 80:482-498.