pharmaceutical testing
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name the 4 main physical tests done on tablets
uniformity of dosage form (weight an content), dissolution, disintegration, friability
what is the point of doing a uniformity of dosage form test and what are the two types
ensures consistent dose of drug, weight and content uniformity
how to decide whether to use weight of content uniformity test
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
how to carry out a uniformity of weight test and the results
• weigh 20 tablets chosen randomly • find average weight -not more than 2 tablet weights should deviate from the average by more than the % given by the pharmacopeia
how to carry out uniformity of drug content test and its results
• randomly select 30 tablets • 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
what is dissolution
process which the solid becomes a solute (dissolved), forms a solution of the solid in the solvent
why do dissolution tests
measure rate of drug release from dosage form, assess product quality, optimise therapeutic effectiveness during product development
what is disintegration
time required for a tablet to break into particles
what liquids are used in disintegration tests
water, simulated gastric fluid, simulated intestinal fluid
learn what each test looks like
what is friability
tendency of tablets to turn into powder/chip/fragment when handling
what can the friability of a tablet affect
appearance, consumer acceptance of tablet, weight variation, content variation
what machine is used to test the friability
friabilator, tests ability of tablet to withstand abrasion in packaging, handling and shipping
how to test a tablets friability
• weigh 10 tablets all together • put in friabilator and let it turn for 100 rounds • weigh tablets again • friability is percentage weight loss (must be less than or equal to 1% to pass test)