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Important
Don’t want some tablets to weigh 150
mg and others to weigh 250 mg even
though they average out to 200 mg
WHY?
Obviously want to have a uniform dose
per tablet
USP sets limits to weight variation for
different products
Dosage Uniformity
1 - Weight variation
For uncoated tablets:
Thickness
Hardness
Friability
Disintegration (also a performance test)
Dissolution (also performance test as
well as a chemical quality test –
strength, amount per time )
Tablet thickness
Friabilator
Determines tablets tendency to
crumble
Picks up and drops tablet a defined
number of times (set speed and
duration of test)
Weigh tablets initially
Weigh after tumbling
Determine amount lost as powder
Tablet disintegration
Why?
- 000,00,0,1,2,3,4,5
Formulation
Encapsulated liquids: