pharmaceutical testing

Question 1

name the 4 main physical tests done on tablets

Answer 1

uniformity of dosage form (weight an content), dissolution, disintegration, friability

Question 2

what is the point of doing a uniformity of dosage form test and what are the two types

Answer 2

ensures consistent dose of drug, weight and content uniformity

Question 3

how to decide whether to use weight of content uniformity test

Answer 3

if the drug forms a greater part of the tablet then use weight uniformity test as any variation in weight indicates variation in active ingredient, if excipients form greater part then use content uniformity

Question 4

how to carry out a uniformity of weight test and the results

Answer 4

1. weigh 20 tablets chosen randomly
2. find average weight

-not more than 2 tablet weights should deviate from the average by more than the % given by the pharmacopeia

Question 5

how to carry out uniformity of drug content test and its results

Answer 5

1. randomly select 30 tablets
2. assay 10 individually using HPLC (?) (high performance liquid chromatography)

-passes if 9/10 tablets contain 85%<x<115% of the drug content, if failed then the remaining 20 tablets are assayed and none of them can fall outside of the range

Question 6

what is dissolution

Answer 6

process which the solid becomes a solute (dissolved), forms a solution of the solid in the solvent

Question 7

why do dissolution tests

Answer 7

measure rate of drug release from dosage form, assess product quality, optimise therapeutic effectiveness during product development

Question 8

what is disintegration

Answer 8

time required for a tablet to break into particles

Question 9

what liquids are used in disintegration tests

Answer 9

water, simulated gastric fluid, simulated intestinal fluid

Question 10

learn what each test looks like

Question 11

what is friability

Answer 11

tendency of tablets to turn into powder/chip/fragment when handling

Question 12

what can the friability of a tablet affect

Answer 12

appearance, consumer acceptance of tablet, weight variation, content variation

Question 13

what machine is used to test the friability

Answer 13

friabilator, tests ability of tablet to withstand abrasion in packaging, handling and shipping

Question 14

how to test a tablets friability

Answer 14

1. weigh 10 tablets all together
2. put in friabilator and let it turn for 100 rounds
3. weigh tablets again
4. friability is percentage weight loss (must be less than or equal to 1% to pass test)