High-shear granulators

The granulation techniques can affect the physical properties of the resulting granules, which then subsequently affect the tableting process, the quality, and the performance of the finished tablets, as illustrated in the following examples. 

High-shear granulation has been one of the most commonly used methods to produce granules since the early 1980s (4). Hence, this chapter discusses in detail, the equipment, process variables, formulation requirements, granulation end-point determination, and scale-up considerations of the high-shear granulation process. 

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D. Daniher, L. Briens, A. Tallevi, End-point detection in high-shear granulation using sound and vibration signal analysis. Powder Technol., 181, Issue 2, 130-136 6 (2008). 

Figure 13.4 Experimental set-up for high shear granulation control system. Reprinted from Watano et al. (200 with permission from Elsevier Science.

M. Whitaker, G.R. Baker, J. Westrup, PA. Gonlding, D.R. Rndd, R.M. Belchamber and M.P Collins, Apphcation of aconstic emission to the monitoring and end point determination of a high shear granulation process, Int. J. Pharm., 205, 79-91 (2000). 

R Luukkonen, M. Fransson, I.N. Bjorn, J. Hautala, B. Lagerhohn and S. Folestad, Real-time assessment of granule and tablet properties using in-line data from a high-shear granulation process, J. Pharm. Sci., 97(2), 950-959 (2008). 

Figure 15 shows a fluidized bed dryer vertically integrated with a high-shear granulator, a wet mill, bottom discharge, and a dry mill. The basic components of the machine will be described, beginning with the entrance of the... 

Figure 15 Fluid bed dryer with integrated high-shear granulator and mills.

Menning M, Ju TR, Kim D. Monitoring In-process Particle Behavious During High-Shear Granulation with the Lasentec D600L Focussed Beam reflectance Measurement (FBRM), Lasentec Technical Note, March 2005. 

Acoustic methods Active or passive X Solid, semisolid, and high viscose sample High shear granulation monitoring Crystallization monitoring... 

Wet high-shear granulator subclasses primarily are distinguished by the geometric positioning of the primary impellers impellers can be top, bottom, or side driven. 

Product-process relationships in high-shear granulation... 

Vromans H, Poels-Jassen HGM, Egermann H. 1999. Effect of high-shear granulation on granulate homogeneity. Pharm. Dev. Technol. 4(3) 297-303. 

Gao J, Motheram A, Hussain D. 2002. Fluid bed granulation of poorly water soluble, low density, micronized drug comparison with high-shear granulation. Int. J. Pharm. 237 1-14. 

Wet granulators can be divided into three main types low-shear granulators, high-shear granulators, and fluidized bed granulators.1-4,6 The third type is the focus of another chapter in this book and will not be discussed in details here. Table 5.1 provides a summary of some of the different granulators that are commonly used in the pharmaceutical industry. 

Sirois PJ, Craig GD. 2000. Scale-up of a high-shear granulation process using a normalized impeller work parameter. Pharm. Dev. Technol. 5(3) 365-374. 

Scott AC, Hounslow MJ, Instone T. 2000. Direct evidence of heterogeneity during high-shear granulation. Powder Technol. 113 205-213. 

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