Dry granulation using Sluggers, Roller compactors. How to determine end point of granulation and problems in granulation process.
Dry Granulation Process in Pharmaceutical Industry
Dry granulation using Sluggers, Roller compactors. How to determine end point of granulation and problems in granulation process.
The dry granulation process is used to form granules without using a liquid solution because the product to be granulated may be sensitive to moisture and heat. Forming granules without moisture requires compacting and densifying the powders. Dry granulation can be conducted on a tablet press using slugging tooling or on a roller compactor commonly referred to as a When a tablet press is used for dry granulation, the powders may not possess enough natural flow to feed the product uniformly into the die cavity.
The dry granulation process is used to form granules without using a liquid solution because the product to be granulated may be sensitive to moisture and heat. Forming granules without moisture requires compacting and densifying the powders.
Slugging operation
Sluggers
The dry powders can be compressed using a conventional tablet machine or, more usually, a large heavy-duty rotary press can be used. This process is often known as ‘slugging’, the compact made in the process (typically 25 mm diameter by about 10–15 mm thick) being termed a ‘slug’. A hammer mill is suitable for breaking the compacts.
Roller compactors
Roller compaction is an alternative gentler method, the powder mix being squeezed between two rollers to form a compressed sheet . The sheet normally is weak and brittle and breaks immediately into flakes. These flakes need gentler treatment to break them into granules. This can further be milled in to desired particle size.
To determine End point of granulation
Granulation is rather Art than science. There are following ways to determine the granulation end point.
To make a ball of granules in fist by applying little pressure. The resultant ball should not be too hard or soft. It should break after applying little pressure. The remains after breaking of ball should be granules and not fines.
To measure the amperage.
To measure the torque.
Problems in Granulation
Under granulated batch: This batch will have more percentage of fines. This will result into flow problem.
This batch may have capping, chipping, ejection and hardness problem.
Over Granulated batch may have uneven distribution of fines, hardness and compressibility problem.
This batch may have uneven colour distribution, DT and dissolution problem.