Transdermal Patch Testing (Drug Release)
Section <724> lists three methods of testing Transdermal Delivery Systems.
The “Paddle over Disk” version is a modified version of Method 2 (Paddle Method). It comprises a 35 mm diameter 40 mesh stainless steel screen designed to hold the transdermal patch at the bottom of the vessel.
A second and larger version of the disk comprising a 90 mm diameter watch glass-patch-PTFE assembly is available to accommodate larger patches.
An alternative method for the testing of transdermal patches, employs the same dissolution equipment as Method 1 simply substituting a cylinder stirring element in place of the standard basket.
In this method, the protective liner of the transdermal patch is first removed and the adhesive side placed on a Cuprophan support that is not less than 1 cm larger on all sides than the system.
The assembled system is then attached to the exterior of the cylinder using a suitable adhesive to the exposed borders of the Cuprophan support.
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