Study Set Content:
for taste masking, enteric release, and barrier films
Top-spray fluidilized-bed coating
for sustained- and enteric-release products
Bottom-spray fluidized-bed coating
for layering coating and for sustained- and enteric-coated products
Tangential-spray fluidized-bed coating
appearance of small fragments flaking from
the tablet surface
Picking
appearance of large fragments flaking from the tablet surface
Peeling
roughness of the tablet surface
orange peel effect
uneven distribution of color on the tablet surface
mottling
filling-in of the score line or indented logo on the tablet by the film
bridging
disfiguration of the core tablet when subjected
for too long to the coating solution
erosion
10 tablets are weighed individually, and the
average weight is calculated
Tablet weight and USP weight variation test
10 samples are assayed for API content
Content uniformity
acceptable range: 85-115% of label claim; SD <
6%
Content uniformity
use of caliper
Tablet thickness
uses a tablet hardness tester (there are 5 types)
Tablet hardness
force is applied on the tablet until it breaks
Tablet hardness
minimum requirement for a good
tablet
4 kg
tendency to crumble, by allowing it to roll and fall
within the drum > measure loss of weight
Friability
tablet must first
disintegrate and discharge
the drug to the body fluids
for dissolution.
Tablet disintergration
Resistance to loss of weight indicates
the tablet's ability to withstand abrasion
in handling, packaging, and shipment
Friability
Friability Acceptable:
NMT 1% weight loss
