PHA 327 - Exam 2 - Tablets 5
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Describe the method of determining content uniformity:
30 tablets are selected randomly
10 are assayed individually
If the first ten do not meet the criteria, the rest are assayed as well
What is the criteria for content uniformity testing?
9 of 10 tablets must contain between 85-115% of labeled drug content
The 10th tablet must contain between 75-125%
If the conditions of the uniformity test are not met in the first 10 tablets, what must happen?
the remaining 30 must be tested and not fall outside of the range of 85-115%
What are common causes of variable content uniformity in tablets?
Non-uniform distribution of powder or granules
Segregation
Tablet weight variation
What is the name of the machine that measures Tablet disintigration?
USP disintigration apparatus
What are the mediums used in the USP disintegration apparatus?
Water
Simulated gastric fluids
Simulated intestinal fluid
What temperature is disintegration tested at?
37 + or - 2 degrees
What should the disintegration time be for compressed tablets?
5-30 minutes
All particles must pass through what at the bottom of a disintegration test tube?
10 mesh screen
For enteric coated tablets what disintegration pattern should you expect?
No disintegration within 1 hour in simulated gastric fluids
Complete disintegration within 2 hours in simulated intestinal fluid
What factors affect the disintegration rate of a tablet?
Media
Temperature of test media
Nature of drug
Diluent used
Type and amount of binder/detergent
compression load
What are the goals of dissolution?
The drug is close to 100% released
The drug is uniformly released from batch to batch
What is the Noyes Whitney equation?
Describes the dissolution rate
What equation describes the dissolution rate?
Noyes Whitney
What is the Noyes Whitney equation?
(dc/dt)V=dm/dt = dissolution rate
D = diffusions coefficient of the solute in solution
A = Surface area of the exposed solid
h = thickness of the diffusion layer
Cs = the solubility of the solid
C = concentration of the solute at time t
V = volume of the solution
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kyleannkelsey
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PHA 327 - Exam 2 - Tablets 5
Updated:
2013-04-20 02:49:19
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PHA 327 Exam Tablets
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PHA 327 - Exam 2 - Tablets 5
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