A priori performance prediction in pharmaceutical wet granulation: Testing the applicability of the nucleation regime map to a formulation with a broad size distribution and dry binder addition

International Journal of Pharmaceutics

Volumn 418, Issue 2, 2011, Pages 254-264

  Kayrak Talay, Defne ^a   Litster, James D ^a,b  

^a PURDUE UNIVERSITY   (United States)

^b PURDUE UNIVERSITY   (United States)

Author keywords

Gabapentin; Quality by design; Regime map; Wet granulation; Wetting and nucleation

Indexed keywords

GABAPENTIN; HYDROXYPROPYLCELLULOSE; WETTING AGENT;

ARTICLE; DISPERSION; DISSOLUTION; DRUG GRANULATION; IONIZATION; LASER DIFFRACTION; LIQUID; MEASUREMENT; PARTICLE SIZE; PREDICTION; PRIORITY JOURNAL; SURFACE PROPERTY;

AMINES; ANTICONVULSANTS; CELLULOSE; CHEMISTRY, PHARMACEUTICAL; CYCLOHEXANECARBOXYLIC ACIDS; DRUG COMPOUNDING; DRUG DESIGN; EXCIPIENTS; GAMMA-AMINOBUTYRIC ACID; MOLECULAR STRUCTURE; MOLECULAR WEIGHT;

EID: 80052968936     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.04.019     Document Type: Article

References (40)

1. A.A. Adetayo, and B.J. Ennis Unifying approach to modeling granule coalescence mechanisms AIChE J. 43 1997 927 934 (Pubitemid 127480981)
2. T. Allen Powder Sampling and Particle Size Determination first ed. 2003 Elsevier B.V. Amsterdam, The Netherlands
3. K. Ax, H. Feise, R. Sochon, M. Hounslow, and A. Salman Influence of liquid binder dispersion on agglomeration in an intensive mixer Powder Technol. 179 2008 190 194 (Pubitemid 350122614)
4. M. Benali, V. Gerbaud, and M. Hemati Effect of operating conditions and physico-chemical properties on the wet granulation kinetics in high shear mixer Powder Technol. 190 2009 160 169
5. C.A. Biggs, C. Sanders, A.C. Scott, A.W. Willemse, A.C. Hoffman, T. Instone, A.D. Salman, and M.J. Hounslow Coupling granule property and granulation rates in high-shear granulation Powder Technol. 130 2003 162 168 (Pubitemid 36293186)
6. A.M. Bouwman, M.J. Henstra, D. Westerman, J.T. Chung, Z. Zhang, A. Ingram, J.P.K. Seville, and H.W. Frijlink The effect of the amount of binder liquid on the granulation mechanisms and structure of microcrystalline cellulose granules prepared by high shear granulation Int. J. Pharm. 290 2005 129 136 (Pubitemid 40139052)
7. A.M. Bouwman, M.R. Visser, G.M.H. Meesters, and H.W. Frijlink The use of Stokes deformation number as a predictive tool for material exchange behaviour of granules in the "equilibrium phase" in high shear granulation Int. J. Pharm. 318 2006 78 85 (Pubitemid 43963304)
8. S.L. Cantor, S. Kothari, and O.M.Y. Koo Evaluation of the physical and mechanical properties of high drug load formulations: wet granulation vs. novel foam granulation Powder Technol. 195 2009 15 24
9. M. Cavinato, M. Bresciani, M. Machin, G. Bellazzi, P. Canu, and A.C. Santomaso Formulation design for optimal high-shear wet granulation using on-line torque measurements Int. J. Pharm. 387 2010 48 55
10. Freireich, B.; Li, J.; Litster, J.; Wassgren, C. Incorporating particle flow information from discrete element simulations in population balance models of mixer-coaters. Chem. Eng. Sci.; in press.
11. J.A. Gantt, and E.P. Gatzke High-shear granulation modeling using a discrete element simulation approach Powder Technol. 156 2005 195 212 (Pubitemid 41207714)
12. M.K. Ghorab, and M.C. Adeyeye High shear mixing granulation of ibuprofen and β-cyclodextrin: effects of process variables on ibuprofen dissolution AAPS PharmSciTech 8 2007 E1 E9
13. R. Gokhale, Y. Sun, and A.J. Shukla High-shear granulation D.M. Parikh, Handbook of Pharmaceutical Granulation Technology 2005 Taylor and Francis Group Boca Raton, FL 191 228
14. K.P. Hapgood, J.D. Litster, S.R. Biggs, and T. Howes Drop penetration into porous powder beds J. Colloid Interface Sci. 253 2002 353 366 (Pubitemid 35351914)
15. K.P. Hapgood, J.D. Litster, and R. Smith Nucleation regime map for liquid bound granules AIChE J. 49 2003 350 361 (Pubitemid 36228201)
16. K.P. Hapgood, R. Amelia, M.B. Zaman, B.K. Merrett, and P. Leslie Improving liquid distribution by reducing dimensionless spray flux in wet granulation - A pharmaceutical manufacturing case study Chem. Eng. J. 164 2010 340 349
17. J. Herder, A. Adolfsson, and A. Larsson Initial studies of water granulation of eight grades of hypromellose (HPMC) Int. J. Pharm. 313 2006 57 65
18. M.J. Hounslow, J.M.K. Pearson, and T. Instone Tracer studies of high-shear granulation: II. Population balance modeling AIChE J. 47 2001 1984 1999 (Pubitemid 36858798)
19. S.M. Iveson, and J.D. Litster Growth regime map for liquid bound granules AIChE J. 44 1998 1510 1518 (Pubitemid 128768958)
20. S.M. Iveson, P.A.L. Wauters, S. Forrest, J.D. Litster, G.M.H. Meesters, and B. Scarlett Growth regime map for liquid bound granules: further developments and experimental validation Powder Technol. 117 2001 83 87
21. S.M. Iveson Limitations of one-dimensional population balance models of wet granulation processes Powder Technol. 124 2002 219 229 (Pubitemid 34311809)
22. H.G. Kristensen, and T. Schaefer Granulation. A review on pharmaceutical wet-granulation Drug. Dev. Ind. Pharm. 13 1987 803 872 (Pubitemid 17096803)
23. A. Larsson, M.H. Vogt, J. Herder, and P. Luukkonen Novel mechanistic description of the water granulation process for hydrophilic polymers Powder Technol. 188 2008 139 146
24. P.K. Le, P. Avontuur, M.J. Hounslow, and A.D. Salman A microscopic study of granulation mechanisms and their effect on granule properties Powder Technol. 206 2011 18 24
25. L. Li, L. Tao, M. Dali, D. Buckley, J. Gao, and M. Hubert The effect of the physical states of binders on high-shear wet granulation and granule properties: a mechanistic approach toward understanding high-shear wet granulation process. Part II. Granulation and granule properties J. Pharm. Sci. 100 2011 294 310
26. L.X. Liu, R. Smith, and J.D. Litster Wet granule breakage in a breakage only high-hear mixer: effect of formulation properties on breakage behavior Powder Technol. 189 2009 158 164
27. J.D. Litster, K.P. Hapgood, J.N. Michaels, A. Sims, M. Roberts, and S.K. Kameneni Scale-up of mixer granulators for effective liquid distribution Powder Technol. 124 2002 272 280 (Pubitemid 34311814)
28. M.B. Mackaplow, L.A. Rosen, and J.N. Michaels Effect of primary particle size on granule growth and endpoint determination in high-shear wet granulation Powder Technol. 108 2000 32 45 (Pubitemid 30089750)
29. C. Mangwandi, M.J. Adams, M.J. Hounslow, and A.D. Salman Effect of impeller speed on mechanical and dissolution properties of high-shear granules Chem. Eng. J. 164 2010 305 315
30. C. Mangwandi, M.J. Adams, M.J. Hounslow, and A.D. Salman Effect of batch size on mechanical properties of granules in high shear granulation Powder Technol. 206 2011 44 52
31. J.N. Michaels, L. Farber, G.S. Wong, K. Hapgood, S.J. Heidel, J. Farabaugh, J.-H. Chou, and G.I. Tardos Steady states in granulation of pharmaceutical powders with application to scale-up Powder Technol. 189 2009 295 303
32. S. Palzer Influence of material properties on the agglomeration of water-soluble amorphous particles Powder Technol. 189 2009 318 326
33. J.M.-H. Poon, C.D. Immanuel, F.J. Doyle, and J.D. Litster A three dimensional population balance of granulation with a mechanistic representation of nucleation and aggregation phenomena Chem. Eng. Sci. 63 2008 1315 1329
34. R. Ramachandran, C.D. Immanuel, F. Stepanek, J.D. Litster, and F.J. Doyle III A mechanistic model for breakage in population balances of granulation: theoretical kernel development and experimental validation Chem. Eng. Res. Des. 87 2009 598 614
35. J.S. Ramaker, M.A. Jelgersma, P. Vonk, and N.W.F. Kossen Scale-down of a high shear pelletisation process: flow profile and growth kinetics Int. J. Pharm. 166 1998 89 97 (Pubitemid 28239742)
36. A. Realpe, and C. Velazquez Growth kinetics and mechanism of wet granulation in a laboratory-scale high shear mixer: effect of initial polydispersity of particle size Chem. Eng. Sci. 63 2008 1602 1611
37. N. Smirani-Khayati, V. Falk, N. Bardin-Monnier, and L. Marchal-Heussler Binder liquid distribution during granulation process and its relationship to granule size distribution Powder Technol. 195 2009 105 112
38. G.I. Tardos, M. Irfan Khan, and P.R. Mort Critical parameters and limiting conditions in binder granulation of fine powder Powder Technol. 94 1997 245 258 (Pubitemid 27515969)
39. K. Van den Dries, O.M. De Vegt, V. Girard, and H. Vromans Granule breakage phenomena in a high shear mixer; influence of process and formulation variables and consequences on granule homogeneity Powder Technol. 133 2003 228 236 (Pubitemid 36952176)
40. D. Verkoeijin, G.A. Pouw, G.M.H. Meesters, and B. Scarlett Population balances for particulate processes - a volume approach Chem. Eng. Sci. 57 2002 2287 2303 (Pubitemid 34838262)