Study Set Content:
TYPE 7
CR (non disintegrating oral and transdermal)
SPECIFICATIONS:
Media temp
37 +/- 0.5 C
is the preferred medium. With no enzymes incorporated.
Distilled water
Sample size: _____ units- initial, Retest 1 _____, Retest 2 _____
6, +6, +12
Common Operating Speeds: _____ rpm for Basket, _____ rpm for paddle type.
100, 50
A small, loose piece of nonreactive material, such as not more than a few turns of wire helix, may be attached to dosage units that would otherwise float.
SINKERS
A Short List of Dissolution Media
Standard Compendial (in USP):
Simulated Gastric Fluid (with and without pepsin
Simulated Intestinal Fluid (with and without pancreatin)
Water
Their modifications (media with surfactants)
Additional Media (including patented “Biorelevant” media)
Fasted-State Simulated Gastric Fluid (FaSSGF)
Fed-State Simulated Gastric Fluid (FeSSGF)
Fasted State Simulated Intestinal Fluid (FeSSIF)
Blank Fasted and Fed (GF) and (IF)
And other (such as Ensure Plus for forecasting food-effect)
