Tablet Defects Lecture Flashcards
QC for tablets
Weigh variation Content Uniformity Tablet thickness Friability Hardness Disintegration Dissolution
Tests for weight variation
Within 5%
Sample through out
Content Uniformity test
85-115%
Pulverized and dissolved to analyze the drug content
Tablet thickness test
Thickness or diameter is measured by micrometer calipers, thickness gauge, Ames Dial Comparator
5%
Tablet hardness test
Hard enough to resist breaking down during normal handleing but soft enough to disintegrate in a timely fashing
Lozenges, buccal, chewable tablets
Hard to dissolve slowly
Hypodermic, compressed tablet triturates, rapidly disintegrating tablets
Soft
Friability test
Resistance to abrasion or tendency of a tablet to crumble
Loss in weight = friability
Disintegration Test
Time required by tablets to break up into particles that are small enough to pass through #10 mesh screen
Must disintegrate within 30 minutes
Dissolution Test
Measure the proportion of drug dissolved in a stated time under standardized condition in vitro