Suggested Experimental Conditions
for Crescent-Shaped Spindle

 

Apparatus:
Any vessel based dissolution tester.
Spindle:
Crescent-shaped, as substitute of Paddle/Basket
RPM:
25
Dissolution Medium:
Distilled water (900 mL). For poorly soluble drugs a small amount of solublizer (e.g. SLS) may be used to ensure that expected amount of drug from the test product be freely soluble in the medium.

The medium is to be equilibrated at 37 °C. De-aeration of the medium is to be avoided.
Run Times:
For exploratory purposes, 3 hours for immediate-release (IR) products, and 24 hours for extended-release (ER) products or until plateau (100% drug release) is achieved.

For routine/QC purposes, one may select four sampling times reflecting 25, 50, 75 and 100% drug release. For faster drug release products, say 100% release in less than 30 minutes, single sampling time at 100% may be sufficient.