99
Views
4
CrossRef citations to date
0
Altmetric
Original Article

Air-dictated bottom spray process: impact of fluid dynamics on granule growth and morphology

, &
Pages 866-876 | Received 24 Jun 2008, Accepted 10 Dec 2008, Published online: 26 May 2009

References

  • Kristensen HG, Schaefer T. (1993). Granulations. In: Swarbrick J, Boylan JC, eds. Encyclopedia of pharmaceutical technology, vol. 7. New York: Marcel Dekker, 121–60.
  • Summers M, Aulton M. (2001). Granulation. In: Aulton ME, ed. Pharmaceutics. The science of dosage form design. 2nd ed. Spain: Churchill Livingstone, 364–78.
  • Wurster DE. (1959). Air suspension technique of coating drug particles: A preliminary report. J Am Pharm Assoc, 48:451–4.
  • Haldar R, Gangadharan B, Martin D, Mehta A. (1989). Fluid bed granulation of ibuprofen. Drug Dev Ind Pharm, 15:2675–9.
  • Yuksel N, Karatas A, Baykara T. (2003). Comparative evaluation of granules made with different binders by a fluidized bed method. Drug Dev Ind Pharm, 29:387–95.
  • Menon A, Dhohi N, Mandella W, Chakrabarti S. (1996). Identifying fluid-bed parameters affecting product variability. Int J Pharm, 140:207–18.
  • Abberger T. (2001). The effect of powder type, free moisture and deformation behaviour of granules on the kinetics of fluid-bed granulation. Eur J Pharm Biopharm, 52:327–36.
  • Cryer SA, Scherer PN. (2003). Observations and process parameter sensitivities in fluid-bed granulation. AIChE J, 49:2802–9.
  • Davies WL, Gloor WT. (1972). Batch production of pharmaceutical granulations in a fluidized bed II. Effects of various binders and their concentrations on granulations and compressed tablets. J Pharm Sci, 61:618–22.
  • Rohera BD, Zahir A. (1993). Granulations in a fluidized-bed: Effect of binders and their concentrations on granule growth and modeling the relationship between granule size and binder concentration. Drug Dev Ind Pharm, 19:773–92.
  • Wan LSC, Heng PWS, Ling BL. (1996). Effect of polyvinylpyrrolidone solutions containing dissolved drug on characteristics of lactose fluidized bed granules. Int J Pharm, 141:161–70.
  • Kokubo S, Nakamura S, Sunada H. (1995). Effect of several cellulosic binders on particle size distribution in fluidized bed granulation. Chem Pharm Bull, 43:1402–6.
  • Rajniak P, Mancinelli C, Chern RT, Stepanek F, Farber L, Hill BT. (2007). Experimental study of wet granulation in fluidized bed: Impact of the binder properties on the granule morphology. Int J Pharm, 334:92–102.
  • Stepanek F, Rajniak P, Mancinelli C, Chern RT, Ramachandran R. (2008). Distribution and accessibility of binder in wet granules. Powder Technol, doi:10.1016/j.powtec.2008. 04.015.
  • Merkku P, Lindqvist A, Leiviska K, Yliruusi J. (1994). Influence of granulation and compression process variables on flow rate of granules and on tablet properties, with special reference to weight variation. Int J Pharm, 102:117–25.
  • Wan LSC, Heng PWS, Ling BL. (1995). Fluidized bed granulation with PVP K90 and PVP K120. Drug Dev Ind Pharm, 21:857–62.
  • Gao JZH, Jain A, Motheram R, Gray DB, Hussain MA. (2002). Fluid bed granulation of a poorly water soluble, low density, micronized drug: Comparison with high shear granulation. Int J Pharm, 237:1–14.
  • Schaefer T, Worts O. (1978). Control of fluidized bed granulation V. Factors affecting granule growth. Arch Pharm Chem Sci, 6:69–82.
  • Schaafsma SH, Vonk P, Kossen NWF. (2000). Fluid bed agglomeration with a narrow droplet size distribution. Int J Pharm, 193:175–87.
  • Lin K, Peck GE. (1995). Development of agglomerated talc. I: Evaluation of fluidized bed granulation parameters on the physical properties of agglomerated talc. Drug Dev Ind Pharm, 21:447–60.
  • Bouffard J, Kaster M, Dumont H. (2005). Influence of process variable and physicochemical properties on the granulation mechanism of mannitol in a fluid bed top spray granulator. Drug Dev Ind Pharm, 31:923–33.
  • Wang X, Cui F, Yonezawa Y, Sunada H. (2003). Preparation and evaluation of high drug content particles. Drug Dev Ind Pharm, 29:1109–18.
  • Lipps DM, Sakr AM. (1994). Characterization of wet granulation process parameters using response surface methodology. 1. Top-spray fluidized bed. J Pharm Sci, 83:937–47.
  • Rambali B, Baert L, Thone D, Massart DL. (2001). Using experimental design to optimize the process parameters in fluidized bed granulation. Drug Dev Ind Pharm, 27:47–55.
  • Boerefijn R, Hounslow MJ. (2005). Studies of fluid bed granulation in an industrial R&D context. Chem Eng Sci, 60:3879–90.
  • Cameron IT, Wang FY, Immanuel CD, Stepanek F. (2005). Process systems modeling and applications in granulation: A review. Chem Eng Sci, 60:3723–50.
  • Reynolds GK, Fu JS, Cheong YS, Hounslow MJ, Salman AD. (2005). Breakage in granulation: A review. Chem Eng Sci, 60:3969–92.
  • Shelukar S, Dumont H, Ho J, Mancinelli C. (2005). Process for granulating particles. US Patent Application .
  • Rajniak P, Stepanek F, Dhanasekharan K, Fan R, Mancinelli C, Chern RT. (2008). A combined experimental and computational study of wet granulation in a Wurster fluid bed granulator. Powder Technol doi:10.1016/j.powtec.2008. 04.027.
  • Walter K. (2002). Precision granulation. United States Patent 6,492,024.
  • Cheng XX, Turton R. (2000). The prediction of variability occurring in fluidized bed coating equipment. I. The measurement of particle circulation rates in a bottom-spray fluidized bed coater. Pharm Dev Tech, 5:311–22.
  • Christensen FN, Bertelsen P. (1997). Qualitative description of the Wurster-based fluid-bed coating process. Drug Dev Ind Pharm, 23:451–63.
  • Chan LW, Tang ESK, Heng PWS. (2006). Comparative study of the fluid dynamics of bottom spray fluid bed coaters. AAPS PharmSciTech, 7, article 37.
  • Tang ESK, Wang L, Liew CV, Chan LW, Heng PWS. (2008). Drying efficiency and particle movement in coating—impact on particle agglomeration and yield. Int J Pharm, 350:172–80.
  • Kokubo H, Sunada H. (1997). Effect of process variables on the properties and binder distribution of granules prepared in a fluidized bed. Chem Pharm Bull, 45:1069–72.
  • Faure A, York P, Rowe RC. (2001). Process control and scale-up of pharmaceutical wet granulation processes: A review. Eur J Pharm Biopharm, 52:269–77.
  • Hemati M, Cherif R, Saleh K, Pont V. (2003). Fluidized bed coating and granulation: Influence of process-related variables and physicochemical properties on the growth kinetics. Powder Technol, 130:18–34.
  • Iveson SM, Litster JD, Hapgood KB, Ennis J. (2001). Nucleation, growth and breakage phenomena in agitated granulation processes: A review. Powder Technol, 117:3–39.
  • Batchelor GK. (2000). Kinematics of the flow field. In: Batchelor GK, ed. An introduction to fluid dynamics. New York: Cambridge University Press, 71–124.
  • Lewis GA, Mathieu D, Phan-Tan-Luu R. (1999). Factor influence studies. In: Lewis GA, Mathieu D, Phan–Tan-Luu R eds. Pharmaceutical experimental design. New York:Marcel Dekker, Inc 70–150.
  • Becher RD, Schlunder EN. (1998). Fluidized bed granulation—the importance of a drying zone for particle growth mechanism. Chem Eng Proc, 37:1–6.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.