Study Set Content:
Quantity
Solubility
Is a standardized method for measuring the rate of drug release from a dosage form
Tablet Dissolution
of therapeutic effectiveness during product development and stability assessment.
Optimization
Routine (blank) quality to ensure uniformity between production lots.
assessment of production
Assessment of (blank)’, that is to say, production of the same biological availability from discrete batches of products from one or different manufacturers.
‘bioequivalence
Prediction of
in-vivo availability,
amount of active ingredient in a solid dosage form dissolved in a unit time under standardized condition of liquid or solid interface temperature and media composition
Dissolution Rate
Basket
100ml resin flask
Cover
High-torque stirring motor
Dissolution Test, apparatus 1, USP 18
1970
Dissolution Test, apparatus 2, USP 19
1976
Apparatus 1 and 2 samples
Immediate-rellease, extended-release, and delayed-release dosage forms
Apparatus 1 and 2 test parameters
Temperature, rotation, speed, dissolution, medium
Primary use is for semi-solid topical dosage forms but has also been used for drug release and skin membrane permeation for transdermal patches
Apparatus 5
Transdermal system
Apparatus 6
Apparatus 5 and 6 test parameters
Temperature, rotation, speed, dissolution medium
Apparatus 1
Basket
Apparatus 2
paddle
