Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. II. Transdermal drug delivery systems.
In a previous study on peel adhesion for medical tapes, it was shown that a stainless steel (SS) substrate better discriminated among medical tapes than a high-density polyethylene (HDPE) substrate. The objective of this study was to determine if a SS substrate would also better distinguish among transdermal drug delivery systems (TDDSs). Five TDDSs (Vivelle Dot, Climara, Catapres-TTS, Duragesic, and Mylan Fentanyl) were evaluated on three different substrates (SS, HDPE, and human cadaver skin). All measurements were made using a dwell time of approximately 3 min, a peel angle of 90 degrees, and a peel speed of 300 mm/min. Differences among TDDSs were greater for SS than for HDPE, using the F statistic for testing for differences among TDDSs means as a measure of heterogeneity, thereby indicating greater discrimination by SS.
Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis, Missouri, USA. anna.wokovich@fda.hhs.gov
Anna M
AM
Wokovich
Stanley A
SA
Brown
Meiyu
M
Shen
William H
WH
Doub
Bing
B
Cai
Nakissa
N
Sadrieh
Mei Ling
ML
Chen
Stella
S
Machado
Lucinda F
LF
Buhse
D000268:Adhesiveness; D000279:Administration, Cutaneous; D001672:Biocompatible Materials / Q000737:chemistry*; D002102:Cadaver; D002448:Cell Adhesion; D003000:Clonidine / Q000008:administration & dosage; D016503:Drug Delivery Systems; D004958:Estradiol / Q000008:administration & dosage; D005283:Fentanyl / Q000008:administration & dosage; D006801:Humans; D008422:Materials Testing / Q000379:methods*; D020959:Polyethylene / Q000737:chemistry; D011786:Quality Control; D012867:Skin / Q000187:drug effects*; D053832:Surgical Tape
D001672:Biocompatible Materials; D004958:Estradiol; D020959:Polyethylene; D003000:Clonidine; D005283:Fentanyl