What is sticking usually due to?
slight dampness of the granulation
What can a slight dampness of the granulation cause?
Sticking and picking
What may be causing picking?
- Improperly dried granules
- Scratch in punch
A scratch in the punch or improperly died granules may cause what?
What ways can you remedy picking and sticking?
- decrease moisture of granules
- add absorbent (microcrystalline cellulose)
- Clean/Polish the punch face
- Add mineral oil or chromium to punch faces
- reduce the fraction of low melting point components
What problem could you potentially solve by reducing the fraction of low melting point components of a tablet formulation?
What is Mottling?
An unequal distribution of color on a tablet
What is the term for an unequal distribution of color on a tablet?
How can Mottling be corrected?
- Reduce drying time
- Grind smaller particles
- Change the binder
- Change the solvent
What problem can be corrected by reducing the drying time, grinding smaller particles or changing the binder or solvent?
What can cause weight variation in tablets?
- Variations in granular size
- Sporadic flow
- Segregation of granules
What can cause tablet hardness issues?
same as those that cause weight variation (segregation, sporadic flow, variations in granular size)
What is double impression?
A duplicate impression of a n engraving on the lower punch
How can you avoid double impression?
incorporating anti-turning devices for the punches
What issue would incorporating anti-turning devices on the punches solve?
What four ways are tablets evaluated?
- Weight variation
How do you measure tablet thickness?
What is acceptable variation in tablet thickness?
+ or - 5%
Why is tablet thickness important?
It plays an important role in packing operations
What problems can occur, causing issues with tablet thickness?
- Changes in die fill
- Issues with particle size distribution
- Issues with packing of particle mix
Changes with die fill, Issues of particle size distribution and issues with packing or particles can all lead to what tablet problem?
How is tablet hardness expressed?
As the force required to crush a tablet in a diametric compression test
Is hardness a fundamental property of a tablet?
What test is performed to measure tablet hardness?
Diametric compression test
What is the Diametric compression test used for?
Testing the hardness of a tablet
What instruments are used to measure hardness?
- Monsanto tester
- Stong-cobb tester
- Pfizer tester
- Erweka tester
- Heberlein tester
What are Monsanto testers, Stong-cobb testers, pfizer testers, erweka testers and heberlein testers used to test?
What is friability?
- the tendency of a tablet to powder chip or fragment
- A measure of tablet strength
What is the term for a measure of tablet strength that evaluates the tendency for a tablet to powder, chip or fracture?
What machine would you use to measure friability?
What is the Roche Friabilator used for?
To measure friability
Describe how friability is tested:
- Tablets are placed in a friabilator for 4 minutes
- tablets are dusted and reweighed
- acceptable tablets do not lose more than .5-1% of their weight
What can alter the friability of tablets?
How is tablet weight monitored during production?
Ten tablets are removed from time to time and shown to be within range
What is the USP weight variation test?
- 20 tablets are weighed individually
- Individual weights are compared with the average weight
What qualifies as a pass in the USP weight variation test?
- No more than 2 of the 20 tablets are outside of the percentage limit
- No tablet varies by more than 2x the percentage limit
A tablet weighing 130 mg or less can have a maximum weight difference of what?
A tablet weighing between 120 and 324 mg can have a maximum allowable % difference of what?
A tablet weighing 120-324 mg can have maximum allowable % difference of what?
How much does a tablet have to weigh to have a 10% weight difference between tablets?
130mg or less
How much does a tablet have to weight to have a weight difference of no more than 7.5%?
How much does a tablet have to weight to have a weight difference of no more than 5.0%?
More than 324 mg
What parameter is evaluated by evaluating content uniformity?
Potency can be evaluated by evaluating what other parameter?
The weight variation test can be used to evaluate content uniformity for tablets with what characteristic?
The active ingredients make up 90% of the weight
What is the acceptable potency range for low dose highly potent drugs?
What is the acceptable potency range for large dose drugs?