Release liner removal method for transdermal drug delivery systems (TDDS).
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 rate-controlling 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 degrees , and a peel speed of 300 mm/min.
Wokovich
Anna M
AM
Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri, USA. anna.wokovich@fda.hhs.gov
Shen
Meiyu
M
Doub
William H
WH
Machado
Stella G
SG
Buhse
Lucinda F
LF
D000268:Adhesiveness; D000279:Administration, Cutaneous; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*
D004364:Pharmaceutical Preparations