Local analysis of the tablet coating process: Impact of operation conditions on film quality

Chemical Engineering Science

Volumn 65, Issue 21, 2010, Pages 5699-5715

  Suzzi, Daniele ^a   Radl, Stefan ^a,b   Khinast, Johannes G ^a,b  

^a RESEARCH CENTER PHARMACEUTICAL ENGINEERING GMBH   (Austria)

^b GRAZ UNIVERSITY OF TECHNOLOGY   (Austria)

Author keywords

Mass transfer; Multiphase flow; Pharmaceuticals; Simulation; Spray; Tablet coating

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; CFD MODELS; COATING PROCESS; COATING UNIFORMITY; DEPOSITION BEHAVIOR; DISCRETE DROPLETS; EULER-LAGRANGE; EXPERIMENTAL WORKS; FILM EVAPORATION; FILM QUALITY; FUNCTIONAL PROPERTIES; GASPHASE; INDUSTRIAL COATINGS; INTERFACIAL SHEAR FORCES; LOCAL ANALYSIS; LOCAL INTERACTIONS; MULTICOMPONENTS; OPERATION CONDITIONS; PARTICLE SIMULATIONS; PHARMACEUTICAL INDUSTRY; PHARMACEUTICALS; PHYSICAL PARAMETERS; SCALE-UP; SIMULATION; SOLID WALL; SPRAY; SPRAY COATING; SPRAY DROPLET; SPRAY SIMULATION; SUBMODELS; TABLET COATINGS; TWO DIMENSIONAL MODEL; WALL-FILMS;

COATING TECHNIQUES; COMPUTATIONAL FLUID DYNAMICS; DROP FORMATION; DRUG PRODUCTS; DRUG PRODUCTS PLANTS; EVAPORATION; FLOW SIMULATION; LIQUID FILMS; MASS TRANSFER; MULTIPHASE FLOW;

COATINGS;

EID: 77957370133     PISSN: 00092509     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ces.2010.07.007     Document Type: Article

References (54)

1. Abramzon, B., Sirignano, W.A., 1988. Droplet vaporization model for spray combustion calculations. AIAA 26th Aerospace Sciences Meeting.
2. Alexander A., Shinbrot T., Muzzio F.J. Scaling surface velocities in rotating cylinders as a function of vessel radius, rotation rate, and particle size. Powder Technology 2002, 126:174-190.
3. Aliseda A., Hopfinger E.J., Lasheras J.C., Kremer D.M., Berchielli A., Connolly E.K. Atomization of viscous and non-Newtonian liquids by a coaxial, high-speed gas jet. Experiments and droplet size modeling. Int. J. Multiphase Flow 2008, 34:161-175.
4. Attarakih M., Abu Fara D., Sayed S. Dynamic modeling of a packed-bed glycerol-water distillation column. Industrial and Engineering Chemistry Research 2001, 40:4857-4865.
5. Aulton, M.E., Twitchell, A.M., Hogan, J.E., 1986. Proceedings of the Fourth International Conference on Pharmaceutical Technology. APGI, Paris, France, V, pp. 133-140.
6. AVL GmbH, 2008. FIRE v2008 User Manual.
7. Baumann W.W., Thiele F. Heat and mass transfer in evaporating two-component liquid film flow. International Journal of Heat and Mass Transfer 1990, 33:267-273.
8. Bindschaedler C., Gurney R., Doelker E. Theoretical concepts regarding the formation of films from aqueous microdispersions and application to coating. Labo-pharma, Problemes et Techniques 1983, 31:389-394.
9. Brenn, G., Deviprasath, L.J., Durst, F., 2003. Computations and experiments on the evaporation of multi-component droplets. In: Proceedings of the Ninth International Conference on Liquid Atomization and Spray Systems (ICLASS), Sorrento, Italy.
10. Cebeci T., Bradshaw P. Momentum Transfer in Boundary Layers 1977, Hemisphere Publishing Corporation, McGraw-Hill Book Company, Washington, London.
11. Chen D.H.T., Thompson A.R. Isobaric vapor-liquid equilibria for systems glycerol-water and glycerol-water saturated with sodium chloride. Journal of Chemical and Engineering Data 1970, 15. 471-474.
12. Cole, G., Hogan, J., Aulton, M., 1995. Pharmaceutical Coating Technology. Informa HealthCare, ISBN:10:0136628915.
13. Denis C., Hemati A., Chulia D., Lanne J.Y., Buisson B., Daste G., Elbaz F. A model of surface renewal with application to the coating of pharmaceutical tablets in rotary drums. Powder Technology 2003, 130:174-180.
14. Dubey, A., Portillo, P.M., Muzzio, F.J., 2008. Study of tablet coating thickness uniformity using LIBS, DEM and Compartment Modeling. 2008 AIChE Annual Meeting, Philadelphia, US.
15. Dukowicz J.K. A particle fluid numerical model for liquid sprays. Journal of Computational Physics 1980, 35:229-253.
16. Edelbauer, W., Suzzi, D., Sampl, P., Tatschl, R., Krueger, C., Weigand, B., 2006. New concept for simultaneous coupling of 3D Eulerian spray and Lagrangian engine simulations. In: Proceedings, ICLASS'06, ILASS, ISBN:4-9902774-1-4 C0053, E2-05-234.
17. Eliassi A., Modarress H., Mansoori G.A. Measurement of activity of water in aqueous poly(ethylene glycol) solutions (Effect of excess volume on the Flory-Huggins chi-parameter). Journal of Chemical and Engineering Data 1999, 44:52-55.
18. Freireich B., Wassgren C. Intra-particle coating variability: analysis and Monte-Carlo simulations. Chemical Engineering Science 2010, 65:1117-1124.
19. Gaube J., Pfennig A., Stumpf M. Vapor-liquid-equilibrium in binary and ternary aqueous-solutions of poly(ethylene glycol) and dextran. Journal of Chemical and Engineering Data 1993, 38:163-166.
20. Hammer S., Pfennig A., Stumpf M. Liquid-liquid and vapor-liquid-equilibria in water plus poly(ethylene glycol) plus sodium-sulfate. Journal of Chemical and Engineering Data 1994, 39:409-413.
21. Hirleman E.D. History of development of the phase-doppler particle-sizing velocimeter. Particle and Particle Systems Characterization 1996, 13(2):59-67.
22. Hogan J.E. Aqueous versus organic solvent film coating. International Journal of Pharmaceutical Technology and Production Manufacturing 1982, 3:17-20.
23. Holman J.P. Heat Transfer. SI Metric Edition 1989, McGraw-Hill, New York.
24. IMS Midas Database, 2007. IMS Health, CT, USA.
25. Joseph D.D., Beavers G.S., Funada T. Rayleigh-Taylor instability of viscoelastic drops at high Weber numbers. Journal of Fluid Mechanics 2002, 453:109-132.
26. Kalbag A., Wassgren C., Penumetcha S.S., Perez-Ramos J.D. Inter-tablet coating variability: residence times in a horizontal pan coater. Chemical Engineering Science 2008, 63:2881-2894.
27. Kazemi S., Zafarani-Moattar M.T., Taghikhani V., Ghotbi C. Measurement and correlation of vapor-liquid equilibria of the aqueous poly(ethylene glycol) plus sodium citrate and poly(ethylene glycol) plus potassium citrate systems. Fluid Phase Equilibria 2007, 262:137-148.
28. Lefebvre, A.H. (Ed.), 1989. Aotomization and Sprays. Hemisphere Publishing Corporation, New York.
29. Mansour A., Chigier N. Air-blast atomization of non-Newtonian liquids. Non-Newtonian Fluid Mechanics 1995, 58:161-194.
30. Muliadi, A.R., Sojka, P.E., 2009. Implementation of quality-by-design principles: modeling of spray tablet coating using a CFD approach. Abstract 2009 AIChE Meeting, Nashville, TN.
31. Muller R., Kleinebudde P. Comparison study of laboratory and production spray guns in film coating: effect of pattern air and nozzle diameter. Pharmaceutical Development and Technology 2006, 11:425-435.
32. Mundo C., Sommerfeld M., Tropea C. Droplet-wall collisions: experimental studies of the deformation and breakup process. International Journal of Multiphase Flow 1995, 21:151-173.
33. Nakamura H., Iwasaki T., Watano S. Numerical simulation of film coating process in a novel rotating fluidized bed. Chemical and Pharmaceutical Bulletin 2006, 54:839-846.
34. Pandey P., Turton R., Joshi N., Hammerman E., Ergun J. Scale-up of a pan-coating process. AAPS PharmSciTech 2006, 7:E1-E8.
35. Pandey P., Song Y.X., Kayihan F., Turton R. Simulation of particle movement in a pan coating device using discrete element modeling and its comparison with video-imaging experiments. Powder Technology 2006, 161:79-88.
36. Peres A.M., Macedo E.A. Thermodynamic properties of sugars in aqueous solutions: correlation and prediction using a modified UNIQUAC model. Fluid Phase Equilibria 1996, 123:71-95.
37. Peres A.M., Macedo E.A. A modified UNIFAC model for the calculation of thermodynamic properties of aqueous and non-aqueous solutions containing sugars. Fluid Phase Equilibria 1997, 139:47-74.
38. Porter S.C. Scale-up of film coating. Pharmaceutical Process Scale-Up 2006, 435-485. Taylor & Francis, New York. M. Levin (Ed.).
39. Prandtl L., Oswatitisch K., Wieghardt K. Führer durch die Strömungslehre 1990, 9 Auflage. Vieweg-Verlag, Braunschweig.
40. Ranz W.E., Marshall W.R. Evaporation from drops: part I+II. Chemical Engineering Progress 1952, 48. 141-146 and 173-180.
41. Roache P.J., Ghia K., White F. Editorial policy statement on the control of numerical accuracy. ASME Journal of Fluids Engineering 1986, 108(1):2.
42. Sandadi S., Pandey P., Turton R. In situ, near real-time acquisition of particle motion in rotating pan coating equipment using imaging techniques. Chemical Engineering Science 2004, 59:5807-5817.
43. Schiller L., Naumann A.Z. VDI 1993, 77:318-320.
44. Suzzi, D., Krueger, C., Blessing, M., Wenzel, P., Weigand, B., 2007. Validation of Eulerian spray concept coupled with CFD combustion analysis. SAE Paper 2007-24-004.
45. The Dow Chemical Company. OPTIM™ Glycerine-Physical Properties, 〈〉, homepage visited January 2009. http://www.dow.com/glycerine/resources/physicalprop.htm.
46. Tobiska S., Kleinebudde P. A simple method for evaluating the mixing efficiency of a new type of pan coater. International Journal of Pharmaceutics 2001, 224:141-149.
47. Tobiska S., Kleinebudde P. Coating uniformity and coating efficiency in a Bohle Lab-Coater using oval tablets. European Journal of Pharmaceutics and Biopharmaceutics 2003, 56:3-9.
48. Varga C.M., Lasheras J.C. Initial breakup of a small-diameter liquid jet by high speed gas stream. Journal of Fluid Mechanics 2003, 497:405-434.
49. Worthington A.M. A Study of Splashes. 1908, Longmans, Green, and Co., London.
50. Wurster, D.E., 1953. US Patent 2,648,609. Alumini Research Foundation, Winsconsin.
51. Yamane K., Sato T., Tanaka T., Tsuji Y. Computer-simulation of tablet motion in coating drum. Pharmaceutical Research 1995, 12:1264-1268.
52. Yarin A.L. Drop impact dynamics: splashing, spreading, receding, bouncing. Annual Review of Fluid Mechanics 2006, 38:159-192.
53. Yecko P., Zaleski S. Transient growth in two-phase mixing layers. Journal of Fluid Mechanics 2005, 528:43-52.
54. Yih S.M. Modeling heat and mass transport in falling liquid films. Handbook of Heat and Mass Transfer 1986, 2:111-210.