Pharmacopoeial testing

Question 1

what are the official pharmacopoeia tests?

Answer 1

unifromity of weight
uniformity of drug content
disintegration test
dissolution rate
friability

Question 2

what is the uniformity of weight test?

Answer 2

to ensure a constant dose of drug between each tablet
two separate tests:
weight uniformity
content uniformity

Question 3

what is dissolution?

Answer 3

the process by which a solid becomes a solute forming a solution

Question 4

what is the purpose of dissolution testing?

Answer 4

‘assessment of production quality
assessment of bioequivalence
Prediction of in-vivo availability
Optimisation of therapeutic effectiveness during product development’

Question 5

what is the Whitney-Noyes equation?

Answer 5

dW/dt = k (Cs-C)
where k=DA/h

Question 6

what is rate-limited dissolution

Answer 6

‘When dissolution is significantly slower than absorption than the drug absorption’

Question 7

what happens if the drug is the greater part of the tablet?

Answer 7

then change in tablet weight changes active ingredient

Question 8

what happens if the drug is potent?

Answer 8

then excipients form make up most of the weight then bad correlation between tablet weight and active ingredient

Question 9

methods for testing weight variations in tablets?

Answer 9

weigh 20 tablets that were selected randomly or determine average weight of 20 tablets

Question 10

how is uniformity of drug content tested?

Answer 10

30 drugs weighed
10 assayed
tablets pass if 9/10 are in the range