-
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?
Picking
-
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?
Mottling
-
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?
Mottling
-
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?
Double impression
-
What four ways are tablets evaluated?
- Thickness
- Hardness
- Friability
- Weight variation
-
How do you measure tablet thickness?
micrometer calipers
-
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?
Thickness issues
-
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?
No
-
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?
Tablet hardness
-
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?
Friability
-
What machine would you use to measure friability?
Roche Friabilator
-
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?
Moisture content
-
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
- AND
- 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?
10%
-
A tablet weighing between 120 and 324 mg can have a maximum allowable % difference of what?
7.5%
-
A tablet weighing 120-324 mg can have maximum allowable % difference of what?
5.0%
-
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%?
130-324 mg
-
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
-
Potency can be evaluated by evaluating what other parameter?
Content uniformity
-
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?
90-110%
-
What is the acceptable potency range for large dose drugs?
95-105%
|
|
