Granulation laboratory scale

Schaefer, T., Holm, P., and Kristensen, H. G., Melt Granulation in a Laboratory Scale High Shear Mixer, Drug Development and Industrial Pharmacy, 16(8) 1249-1277 (1990)... 

In 2005, Rantanen et al. used on-line NIRS to monitor a laboratory-scale high shear wet granulation process. The study was a central-composite circumscribed design consisting of 17 runs and 3 variables ... 

Once the analytical method is validated for accuracy at the laboratory scale, it can be used to obtain extensive information on process performance (blend homogeneity, granulation particle size distribution, and moisture content) under various conditions (blender speed, mixing time, drying air temperature, humidity, volume, etc.). Statistical models can then be used to relate the observable variables to other performance attributes (e.g., tablet hardness, content uniformity, and dissolution) in order to determine ranges of measured values that are predictive of acceptable performance. 

Schaefer, T. Holm, P. Kristensen, H.G. Melt granulation in a laboratory scale high shear mixer. Drug Dev. Ind. Pharm. 1990, 16 (8), 1249-1277. 

Schmidt, W.G. Mehnert, W. Frdmming, K.-H. Controlled release from spherical matrices prepared in a laboratory scale rotor-granulator—release mechanism interpretation using individual pellet data. Eur. J. Pharm. Biopharm. 

Incipient wetness impregnation (Kp Vg) is appropriate for the preparation of granulated catalysts but can also be used for preparation of powdered catalysts on the laboratory scale. 

FIGURE 5 Laboratory-scale Diosna High shear granulator with 6-liter bowL (B) chopper and impeller inside the mixing bowl. 

Poly(acrylamidoxime) has been tested on laboratory scale as well as in test plants in the sea in form of cross-linked, macroporous resin granules called Duolite ES 346 153). We succeeded in loading this resin in natural sea water with more than 3600 ppm of uranium corresponding to the uranium content of uranium ores mined today. As in the case of hydrous titanium oxide, poly(acrylamidoxime) most probably accumulates the cation UO + without carbonate ligands via the displacement reaction ... 

The function and use of povidone K 30 and povidone K 90 as binders for wet granulation is shown in Tabs. 62-64 for several tablet formulations with drugs, developed on a laboratory scale. They were prepared by Method 1 in Table 60. 

Povidone K 25 and povidone K 30 are very good binders for effervescent tablets, as they dissolve rapidly in water to form a clear solution. This particularly applies to effervescent vitamin tablets, e.g. ascorbic acid tablets [368 b]. Tables 65 and 66 give formulations for ranitidine effervescent tablets and multivitamin effervescent tablets as typical examples that were developed on a laboratory scale. For the granulation of multivitamin preparations, it is always preferable to use a fluidized bed. 

Two formulations, for ampicillin and cimetidine tablets, that have been developed on a laboratory scale, are given in Table 173 as examples for the use of copovidone in the binder solution granulation. It is also highly suitable for producing preparations such as multivitamin granules [368 c]. 

Rajniak, R, Dhanasekharan, K Sdjka, C., MacPhail, N. Chern, R. 2008 Modeling and measurement of granule attrition during pneumatic conveying in a laboratory scale system. Powder Technology 185, 202-210. 

If the formulation is robust to variations in the process on the pilot or laboratory scale, this information supports the industrial scale validation. Consider, for example, a simple tablet formulation, with wet granulation, where the process study indicated that the process was fairly robust, but affected by the granulating liquid volume, granulation time, and lubrification time. There are two possible approaches. 

Laboratory-scale hammer mills are available from a number of equipment manufacturers. Any laboratory-scale unit would be suitable for the laboratory exercise. Suggested raw materials are granulated sugar and granulated salt. 

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