PHARMACEUTICAL

GRANULATION
EQUIPMENT

• WET GRANULATORS • EXTRUSION/SPHERONIZATION • ROTORGRANULATION • DRY GRANULATORS .

WET GRANULATORS • Shear granulators • High-speed mixer/granulators • Fluidized-bed granulators • Spray driers • Spheronizers/pelletizers .

EXTRUSION/SPHERONIZATION ROTOGRANULATION DRY GRANULATORS • Slugging • Roller compaction .

WET GRANULATORS • SHEAR GRANULATORS • HIGH-SPEED MIXER/GRANULATORS • Fluidized-bed granulators • Spray driers • Spheronizers/pelletizers .

SHEAR GRANULATORS • Also called planetary granulators • Have largely disappeared • Have been replaced by the much more efficient high-speed mixer/granulators • Dry powder blending usually has to be performed as a separate initial operation using different powder-mixing equipment .

• Major disadvantages: – Long duration – Need for several pieces of equipment – High material losses which can be incurred because of transfer or stages between the different equipment • This process served the industry well for many years but the advantages of modern mixer/granulators proved too attractive .

Diosna) • Developed from traditional planetary mixers in order to: – speed up the process. HIGH-SPEED MIXER/GRANULATORS • Used extensively for pharmaceutical granulation (e. and – to reduce the number of pieces of equipment and separate process steps required .g.

• Machines have a stainless steel mixing bowl containing a three-bladed main impeller which revolves in the horizontal plane (breaker blade) which revolves in either the vertical or horizontal plane • Main blade: 150-300 rpm • High-speed chopper: 1500 and 3000 rpm .

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which breaks up any large aggregates. into the bowl of a fluidized-bed drier . passing through a wire mesh.• The unmixed dry powders are placed in the bowl and mixed by the rotating impeller for a few minutes • Granulating liquid is then added via a port in the lid of the granulator whilst the impeller is turning • The chopper is usually switched on when the moist mass is formed as its function is to break up the wet mass to produce a bed of granular material • Once a satisfactory granule has been produced. the granular product is discharged.

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• Wide range of sizes: Often designed to have similar geometric and powder movement characteristics in an attempt to minimize scale-up problems when a product moves from development to production • The weight of powder a bowl holds will depend on its bulk density and the optimum fill capacity (working volume) of each bowl • Bowls are manufactured from high-quality polished stainless steel .

• Advantage: Powder blending. overmassed system – Use a suitable monitoring system . wet massing and granulation are all performed in a few minutes in the same piece of equipment • The process needs to be controlled with care as the granulation progresses rapidly that a usable granule can be transformed very quickly into an unusable.

Collette-Gral type of granulator • A variation of the Diosna type of design • This is based on the bowl and overhead drive of the planetary mixer but the single paddle of a planetary mixer but the single paddle of a planetary mixer is replaced with two mixing shafts • One of these carries three blade arms which rotate in the horizontal plane at the base of the bowl ands the second carries smaller blades which act as a chopper and rotate rapidly in the upper regions of the granulating mass .

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• The rotational speed variation of the different model is to attempt to maintain the same linear velocity of movement of the blades as this has been found to help scale-up • In all models the high-speed chopper rotates at 1500-3000 rpm .

• Attractive feature: Product is usually granular and a separate step to granulate the wet mass is avoided (granules being produced by the action of high- speed chopper) • Occasionally this is not fully satisfactory and the moist mass has then to be transferred to a granulator such as an oscillating granulator .

the size of which determines the granule size • The mass should be sufficiently moist to form discrete granules when sieved – Excess liquid: strings of material will be formed – Too dry: mass will be sieved to powder .• The rotor bars of the granulator oscillate at an adjustable rate between 60 and 100 rpm and force the moist mass through the sieve screen.