OperationModel 2500 73
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5.3.2 Modified Baskets
Overview
As with topical drug products, a performance test for transdermal drug
products also must have the ability to measure drug release from the finished
dosage form, must be reproducible and reliable, and capable of detecting
changes in the finished product’s drug release characteristics that have the
potential to alter the desired pharmacologic effect(s) of the active ingredient.
Use the vessel assembly from
A ppa ra tu s 1,
the modified basket method,
as
described in USP
Disso lutio n <
711>, but replace the basket with a stainless
steel cylinder stirring element and maintain the temperature at 32±0.58 during
the test. The shaft and cylinder components of the stirring element are
fabricated from stainless steel. The dosage unit is placed on the cylinder at the
beginning of each test. The distance between the inside bottom of the vessel
and the cylinder is maintained at 25±2 mm during the test.
Height Setting for USP Apparatus 6 (Modified Baskets)
1 Turn the Easy Drive Lift knob about 1/2 turn following the direction of the "Released"
indicator.
2 Fully raise the drive head and turn the Easy Drive Lift knob following the direction of the
"Lock" indicator, to lock the drive head in place.
3 Position the height setting to
Ba skets
. See figure below for reference.
Height adjustment block position for modified baskets
4 Gently slide each shaft halfway up through each spindle. If shafts are hard to to slide, a
very thin film of vacuum grease applied on the top end of the shaft will allow it to slide
smoothly.
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