Granulation high-shear mixer

FIG. 20-85 (a) Horizontal and (h) vertical high-shear mixer granulators for pharmaceutical granule preparation for subse-... 

Tardos, G. I., A Review of High Shear Mixer Granulation, Proc. of the First Israel Conf. for Conveying and Handling of Particulate Solids, Herzliya, Israel (1995)... 

Liquid and solids Size enlargement High shear mixer granulator, fluidized granulator (bubbling bed, spouted bed)... 

Use fluidized granulator to obtain granules of higher relative density (0.6 - 0.8), and high shear mixer granulator lower relative density (0.3 - 0.5) and thus faster solubility or easier dispersion. 

Prefer fluidized granulator over high shear mixer granulator if better temperature control for processing heat-sensitive materials is desired. 

High shear mixer granulator Typical rotational speed -3,000 rpm Product granule size = 0.1 - 2 mm [34]... 

In order to combine the advantages of a batch type and continuous production, a prototype for a quasi-continuous production line was developed (15-18,33-35). The principle of this quasi-continuous production line is based on a semi-continuous production of mini-batches in a specially designed high-shear mixer/granulator which is connected to a continuous multicell-fiuidized (Glatt Multicell ) bed dryer (Fig. 10). 

Kopcha M, Roland E, Bubb G, Vadino WA. Monitoring the granulation process in a high shear mixer/granulator an evaluation of three approaches to instrumentation. Ind Pharm 1992 18 1945. 

Operational Qualification The OQ document certifies that the equipment works as desired and defined by the manufacturer and the purchaser. An example is the acquisition of a new high-shear mixer/granulator where the paddle is put on rotation with a real calibrated rotation speed tester and, if the value obtained meets the specifications, the mixer paddle rotation passes the OQ test. If not, additional requalification must be performed. All the test results must be introduced and verified in the OQ report that is approved by the company at the end. The OQ document must describe several tests and related specifications to perform on the equipment in order to evaluate if it is working well, and the test to be performed must be described and approved by the manufacturer and the purchaser. Therefore, tests must be performed on the equipment, and for each one a description and signature of who performed and verified the test are required. Usually the tests are performed by the manufacturer and verified by the purchaser. These tests usually consist of evaluating if the mechanical and electric components of the equipment are working as desired. 

Holm P, Lundbeck H. 1997. High shear mixer granulators. In Parikh DM, editor. Handbook of pharmaceutical granulation technology. New York Marcel Dekker. 

Faure A, Grimsey IM, Rowe RC, York P, Cliff MJ. 1999. Process control in a high shear mixer-granulator using wet mass consistency the effect of formulation variables. J. Pharm. Sci. 88(2) 191-195. 

Vertommen, J. Michoel, A. Rombaut, P. Kinget, R. Production of Pseudophedrine HCI Pellets in a High Shear Mixer-Granulator. Eur. J. Pharm. Biopharm. 1994, 40 (1),... 

Holm, P. High shear mixer granulators Chapter 7. In Handbook of Pharmaceutical Technology, Parikh, D., Ed. Marcel Dekker New York, NY, 1997 151-204. 

Faure, A. Grimsey, I.M. Rowe, R.C. York, P. Chff, M.J. Apphcability of a scale-up methodology for wet granulation processes in coUette gral high shear mixer-granulators. Eur. J. Pharm. Sci. 1999, 8, 85-93. 

Martino PD. Censi R, Malaj L. et al. Influence of metronidazole particle properties on granules prepared in a high-.shear mixer-granulator. Drug Dev Ind Pharm 2(X)7 33(2) 121-31. Lantz RJ. Size reduction. In Licberman HA, Schwartz JB, eds. Pharmaceutical Dosage Forms, 2nd ed. Vol. 2. New York Marcel Dekker, Inc., 1990 107-2(X). 

Di Martino P. Censi R. Malaj L. Martelli S. Barthelemy C. Influence of metronidazole particle properties on granules prepared in a high-shear mixer-granulator. Drug Dev Ind Pharm 2007 33(2) I21-31. 

The rotor in.sert (Fig. 7) was conceived as a combination of a high shear mixer/granulator and fluidized bed dryer. In contrast with a traditional fluid bed dryer, the base of the product container is fitted with a solid rotating disc as oppo.sed to a perforated air distribution plate and fine screen. The disc height may be adjustable to allow the control of... 

FIG. 21-123 Granule diameter as a function of impeller speed for both initial nonequilibrium and final equibbrium growth bmits for high-shear mixer granulation, data from Fig. 21-124. [Ennis, Powder Technol, 88, 203 (1996), with permission.]... 

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