Manufacture of Granules

Part-I
 INTRODUCTION
• Granules are aggregations of fine particles of powders in a mass of
about spherical shape.
• Granules are prepared agglomerates of smaller particles of powder.
• They are irregularly shaped but may be prepared to be spherical.
• They are usually in the 4- to 12-mesh sieve size range, although
granules of various mesh sizes may be prepared depending upon their
application.
 MANUFACTURE OF GRANULES
• WET METHOD
• DRY METHOD
 Wet method
• One basic wet method is to moisten the powder or powder mixture
and then pass the resulting paste through a screen of the mesh size to
produce the desired size of granules.
• The granules are placed on drying trays and are dried by air or under
heat.
• The granules are periodically moved about on the drying trays to
prevent adhesion into a large mass.
• Another type of wet method is fluid bed processing, in which particles
are placed in a conical piece of equipment and are vigorously dispersed
and suspended while a liquid excipient is sprayed on the particles and
the product dried, forming granules or pellets of defined particle size
Granule prepared with fluid bed technology
 DRY GRANULATION METHODS
• Roll Compactor
• Slugging
• The dry powder is passed through a roll compactor and then through a granulating
machine.(see the below fig)
• A roll compactor, also called a roll press or roller compactor, processes a fine
powder into dense sheets or forms by forcing it through two mechanically rotating
metal rolls running counter to each other
• The surface of the compacting rolls may be smooth or may have pocket
indentations or corrugations that allow compaction of different forms and textures.
• The compacted powder is granulated to uniform particle size in a mechanical
granulator.
• Powder compactors are generally combined in sequence in integrated compactor–
granulation systems.
High-speed granulator-mixer.
 SLUGGING METHOD
• Slugging is the compression of a powder or powder mixture into large
tablets or slugs on a compressing machine under 8,000 to 12,000 lb of
pressure, depending on the physical characteristics of the powder.
• The slugs are generally flat-faced and are about 2.5 cm (1 in.) in diameter.
• The slugs are granulated into the desired particle size, generally for use in
the production of tablets.
• The dry process often results in the production of fines, that is, powder
that has not agglomerated into granules.
• These fines are separated, collected, and reprocessed.
• The wet and dry granulation methods as they pertain to tablet making.
CONT……
• Granules flow well compared to powders.
• For comparison, consider the pouring and flowing characteristics of granulated sugar
and powdered sugar.
• Because of their flow properties, granulations are commonly used in tablet making to
facilitate the free flow of material from the feeding container (or hopper) into the
tablet presses.
• Granules have other important characteristics. Because their surface area is less than
that of a comparable volume of powder, granules are usually more stable to the
effects of atmospheric humidity and are less likely to cake or harden upon standing.
• Granules also are more easily wetted by liquids than are certain light and fluffy
powders (which tend to fl oat on the surface) and are often preferred for dry products
intended to be constituted into solutions or suspensions.
CONT………
• Granulations of effervescent products may be compressed into tablet
form, as Zantac EFFERdose tablets (Glaxo Wellcome).
• Effervescent granules and tablets are dissolved in water before use.