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Tablet Manufacture Formulation and Processing
Tablet Manufacture Formulation and Processing
FORMULATION AND
PROCESSING
TABLET MANUFACTURE
FORMULATION AND PROCESSING
• Why are tablets the most popular dosage form for medicines?
• Tablet compression
• Tablet constituents
• Direct Compression
• Granulation
• Sieving/milling
• Blending
• Questions
WHY TABLETS?
90% of medicines are taken orally with the
majority being tablets.
› The tablet must be able to be ejected freely from the die without damage
TABLET COMPRESSION
Lower punch drops as
die passes feed frame
Pass between
compression roller
1. Direct Compression
2. Wet Granulation
3. Dry Granulation
DIRECT COMPRESSION
• This is the ideal option but is rarely achievable
due to:
Dispense
Security Sieve
Lubricant Blend
Compress
Problems Associated With
Direct Compression
If the material is a powder rather than a granule:
› it will have poor flow characteristics, which can lead to uneven tablet weights.
› The pressure transmission through a powder mass is poor, due to low packing
density. Consequently particles do not ‘knit’ together very readily.
› Powders, especially fine ones tend to blow out of the die at the top and seep
out at the bottom
› Dusty powders tend to mix with oil/grease and eventually cause sticking of the
punches in the dies or turret bores.
• Examples include:
– Micro-crystalline cellulose
– Lactose
– Di-calcium phosphate
LUBRICANTS
• Lubricants are materials that lubricate powder mixes
and aid tablet ejection.
• Examples include:
– Magnesium Stearate
– Stearic Acid
– Talc
GLIDANTS
• Glidants are materials that improve the flow of powder mixes
• Most powders, without the aid of flow agents, simply cannot flow at
speeds required for high speed tabletting.
• Increases porosity
• Examples include:
– Starch
– Croscarmellose
– Sodium Starch Glycollate
– Crospovidone
BINDERS
• A material that imparts cohesiveness to the formulation
• Examples include:
To improve compressibility.
To reduce fines.
To control density.
Security Sieve
Granulate
Sieve/Mill
Lubricant Blend
Compress
TRADITIONAL WET
GRANULATION
Most commonly performed using
a high shear mixer e.g. ‘Fielder’
but can be performed using low
shear e.g. ‘Hobart’.
Fielder Granulator:
Process relies on the binder and/or water soluble elements dissolving upon
granulation, then on drying forming a solid bridge between particles.
ADVANTAGES OF WET
GRANULATION
• Increases cohesiveness
• Intra-granular disintegrant
– Croscarmellose sodium
DRYING
• The removal of water or liquid to form a dry solid
• 2 main methods
– Tray drying
– Fluidised Bed Drying
– Manual handling
– Labour intensive
However
• Capping • Picking
• Laminating • Binding
• Chipping
WEIGHT VARIATION
• Weight variation can be caused by a number of factors:
– Low hardness
• Tablet press set-up
• Overblending
– Poor granule
• Too dry
• undergranulated
• insufficient binder
• too many fines
• Reason: Capping is usually due to the air–entrapment in a compact during compression, and
subsequent expansion of tablet on ejection of a tablet from a die.
– Machine setup
• Insufficient dwell time
• Compression force too low
– Tooling wear
• worn punches
– Poor granule
• too much fines
• Granule too dry
• Insufficient binder
• Excessive lubricant
• Not homogenous mix
The problem is more prevalent on the upper punch faces. The problem worsens with time into
the run because more and more material is added to the already stuck material on the punch
face.
Any Questions