Study Set Content:
six open-ended
transparent tubes
of USP- specified
dimensions
Tablet disintegration
basket is raised
and lowered in the
immersion fluid (water at 37 ± 1 °C) at
29 to 32 cycles per minute
Tablet disintegration
complete disintegration
Tablet disintegration
Soft mass having no
palpably firm core
Pass
The goal of in vitro dissolution testing is to
provide a reasonable prediction of or correlation
with the product's in vivo bioavailability.
Tablet dissolution
correlation of tablet dissolution
In vitro in vivo correlation
High solubility and high permeability
class 1
High solubility and low permeability
Class 3
Low solubility and high permeability
Class 2
Low solubility and low permeability
Class 4
37°C ±
0.5°C
Must follow monograph spec, e.g., “not less than
85% of the labeled amount is dissolved in 30
minutes.”
Apparatus 1-7
Basket, paddle, reciprocating cylinder, flow thru cell, paddle over disk, rotating cylinder, reciprocating holder
In tight containers, in places of low humidity, and
protected from extreme temp
PACKAGING AND STORING
add desiccant packet
Sensitive to moisture
amber-colored /
light-resistant container
Sensitive to light
- aluminum
hydroxide, sodium salicylate, and
phenylbutazone
Drugs that harden over time
prone to migration
Special care for NTG
Dispense in the original unopened
container
Special care for NTG
“normal” release; immediate release
Conventional
