Technical Note: Comparison of USP Apparatus 5 and 7 for In Vitro Drug Release from Nicotine Transdermal Systems 

ABSTRACT

To monitor in vitro drug release in nicotine transdermal systems, USP Apparatus 5 (paddle over disc) and Apparatus 7 (reciprocating holder) were selected for comparison. Two nicotine transdermal systems marketed in United States for the controlled release of 7.0 mg of nicotine in a 72-hour period were evaluated. The results demonstrate that the drug release profiles obtained using USP Apparatus 5 and 7 are equivalent. Repeatability was measured using Apparatus 7 and found acceptable.

KEYWORDS

 Dissolution, nicotine, USP apparatus 5, USP apparatus 7