Polymer Blended Deproteinized Natural Rubber Reservoirs for Nicotine Transdermal Patches: In vitro Drug Release, Permeation Study, and Stability Test

Abstract

The objective of this research was to prepare reservoir-type nicotine transdermal patches (R-NTPs) using deproteinized natural rubber latex (DNRL) blends as the release control layer (RCL). Hydrophobic DNRL was blended with either hydrophilic hydroxypropylmethylcellulose or polyvinyl alcohol polymer, and either glycerin or dibutylphthalate as plasticizer, and the RCLs were made by plating technique. These RCLs were more hydrophilic compared to the original DNRL film. Nicotine was filled into the reservoir compartment between commercial backing layer and DNRL blended RCL, and was then heat sealed to ensure there was no leak from the R-NTPs. In vitro release and permeation studies of nicotine from the R-NTPs, drug stability, and irritation of the R-NTP devices were evaluated. DNRL blends provided a suitable controlled release and permeation rate for R-NTPs. The release and permeation rates of nicotine from the R-NTPs depended on types of polymer and plasticizer blends that increased the hydrophilicity of DNRL. The addition of an adhesive layer slightly decreased the nicotine release and permeation rates. The release and permeation behaviors of nicotine were described by first and zero order kinetics, respectively. Furthermore, these R-NTPs were stable when stored in a tight container for up to 90 d, and safe to apply to the skin without producing any irritation.