Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2486282 | Journal of Pharmaceutical Sciences | 2010 | 11 Pages |
Abstract
A release liner removal test is a valuable test for assessing the quality of a transdermal drug delivery system (i.e., TDDS, patch). This test measures the force required to remove the release liner from a patch. The objective of the present study was to establish sample preparation and instrument parameters for measuring release liner removal adhesion for TDDS. Ten TDDS were evaluated (six drugs for a total of 29 lots). Patches which had a ratecontrolling membrane were run as-is, since they could not be cut to a precise width without sacrificing their structural integrity. Patches that were square or rectangular in shape were run as-is, and the width of these patches was determined using a digital caliper. Patches which were not square or rectangular in shape and did not have a rate-controlling membrane were cut to a precise width using a specimen cutter. Double-sided tape was used to adhere the liner side of the transdermal system to a clean stainless steel test panel. A release liner peel adhesion method for TDDS is proposed using a dwell time of approximately 3 min, a peel angle of 90°, and a peel speed of 300 mm/min.
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Authors
Anna M. Wokovich, Meiyu Shen, William H. Doub, Stella G. Machado, Lucinda F. Buhse,