OperationModel 2500 75
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5.3.3 Modified Paddles
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 must be 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. In general, researchers have found that Apparatus 5, the modified
paddle method, is simpler and is applicable to most types, sizes, and shapes of
transdermal delivery systems.
Use the paddle and vessel assembly from
A ppa ra tu s 2
as described in
Disso lutio n <
711>, with the addition of a stainless steel disk assembly designed
for holding the transdermal system at the bottom of the vessel. The
temperature should be maintained at 32+0.58. During the test maintain a
distance of 25+2 mm between the paddle blade and the surface of the disk
assembly.
Height setting using Modified Paddles:
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
N eutra l
by positioning the Quick Height Adjustment block to
horizontal position. See figure below for reference.
Height adjustment block in horizontal position
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