Granulation process

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By : Mohseen Shaikh Nilesh Tribhuvan Abhijeet Bagal Girish Sukre AISSMS COLLEGE OF PHARMACY, PUNE, INDIA.

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Granulation Need To prevent segregation of the constituents of the powder mix. To improve the flow properties of the mix To improve the compaction characteristics of the mix Other reasons: Toxic, Slightly hygroscopic, denser. Methods Dry granulation Wet granulation Effect of granulation methodon granule structure.

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Granulation technology on large scale by various techniques

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Mechanisms of Granulation There are Five Particle Bonding Mechanisms, Adhesion and cohesion forces in the immobile liquid films Interfacial forces in mobile liquid films within the granules Formation of solid bridges after solvent evaporation Attractive forces between solid particles Mechanical interlocking

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Adhesion and cohesion forces in immobile liquid films between individual primary powder particles. Interfacial forces in mobile liquid films Solid bridges Partial mellting , Binder hardening, crystalization of dissolved sub. Attractive forces between solid particles Mechanism of granule formation Mechanisms of Granulation

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6 Steps to make powder ready for compression

Granulation Equipments (Granulators): 

Granulation Equipments (Granulators) 7 Dry granulator Wet granulator

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8 Effective dose of drug is too high for direct compression Drug is sensitive to heat or moisture or both. Dry granulators: Sluggers Roller Compactors Is used when……

Wet granulators: 

Wet granulators 9 Shear mixer granulator High speed granulator Fluidized bed granulator Spray driers

WET GRANULATION: some equipment….: 

WET GRANULATION: some equipment…. High Shear Granulator Littleford Lodige Mixer/Granulator Littleford MGT Granulator Diosna Granulator Gral Mixer/Granulator Granulator with Drying Facility Fluidized Bed Granulator Day Nauta Mixer Processor Double cone/Twin Shell Processor Topo Granulator Special Granulator Roto Granulator Marumerizer 10

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Wet granulation equipment shear granulator

SOP Of Shear Mixture Granulator:: 

SOP Of Shear Mixture Granulator: Mixed powder are fed in to the bowl Granulating liquid is added The moist mass has then transferred to a granulator such as oscillating granulator

Disadvantage: 

Disadvantage Long duration Large number of equipment are needed High material loss Advantage Not very sensitive to the material End point can be determined by inspection

High speed granulator : 

High speed granulator Widely used in pharmaceutical SS mixing bowl containing a three blade main impeller, revolves in horizontal plane, and a three blade auxiliary chopper –revolves vertical or horizontal plane Unmixed powder –in the bowl mixed for few minute with rotating impeller Granulation

High speed granulator : 

High speed granulator

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16 Typical Time Sequence Mixing – 2 minutes Granulation – 8 minutes Discharge – 1 minutes Gives more normal PSD with lesser fines. Diosna Mixer / Granulator Rapid Mixer Granulator (RMG) blade chopper

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17 Rapid Mixing Granulator: (RMG)

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Advantage Mixing,Massing,Granulation in a single equipment within few minutes Disadvantage End point monitor needed

Designs of FB granulators: 

Designs of FB granulators Top spray Bottom spray Rotating disc granulator Suction Fan Fabric Filter Bag Granulating solution Product Bed Spray Nozzle Air Filter Air Heater

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Fluidized Bed Granulator

Fluidized Bed Granulator: 

Fluidized Bed Granulator Advantage One unit so saving labour cost, transfer loses and time 2-6 time greater heat transfer than tray dryer Uniform drying….prevent mottling. Process can be automated once parameters optimized Disadvantage Expensive Multiple process variable Filter clocking, demixing , electrostatic charge, solvent explosion

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22 Fluidized Bed Granulator (Industrial Equipment)

Merumizer (spheronizer): 

Merumizer ( spheronizer ) Wet mass containing drug , diluents and binder is pass through extruder to get rod shaped segments. Cylinder Screw-feed Extruder Segments are placed in MERUMIZER where they are shaped into sphere by centrifugal and frictional forces produced by rotating plates/blades and form granules Advantage Granules with regular size, shape with lower friability, so less amount of fines.

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Other More Specialized Granulators Spray Driers

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Pelletizers