26 Testing Tablet quality Flashcards
How can raw materials be tested? (7)
- MP
- thin layer chromatography
- infrared spectum
- drug-specific reactive essay
- HPLC
- gas chromatography
- mass spectroscopy
After preparation, what are tablets evaluated for?
- visual defects
- mechanical strength
- weight variation
- content uniformity
Name the two perfomance tests used to evaluate a tablet
- disintergration
- dissolution
Describe what visual evaluation occurs
Both the tablet and press are monitored for physical and cosmetic defects.
Physical defects:
- Tablet breaking (capping, lamination, cracking/chipping
- Tablet sticking to press
- Wrong size or shape
Cosmetic effects:
- Wrong or non-uniform colour
*Indicates that the manufacturing process needs to be fixed.
How is mechanical strength evaluated?
Hardness: how hard it is to crush a tablet
Friability: tendency of a finished tablet to chip, crumble or break.
How is weight variation evaluated?
20 tablets are weighed individually, and average weight is calculated to compare these weights. There is a standard by which weight can deviate.
How is content uniformity evaluated?
Individual or a group of tablets are crushed and drug is extracted. The content is then measured by HPLC to assess against label claims.
Criteria usually indicates that samples should be within 85-115% of label claims.
What does disintergration studies evaluate and how is this done?
Evaluates the time taken for tablets to break down in liquid.
What do dissolution studies evaluate and how is this done?
Dissolution quanitfies the rate at which drug is released from the tablet. This is to ensure that dissolution rates are consistent in the body.
This is done by using a basket or paddle apparatus.
what do stability studies evaluate and how is this done?
Stability studies test for how the drug decomposes over time. This is accelerated and packaging and storage conditions are considered.
They test for chemical, physical and microbial stability.
