Deproteinised natural rubber used as a controlling layer membrane in reservoir-type nicotine transdermal patches

Reservoir-type nicotine transdermal patches (NTPs), composed of a concentrated nicotine solution embedded between a backing layer and a controlling layer membrane, were constructed by a heat-sealing technique. The aim of this research was the preparation of a novel controlling layer membrane from deproteinised natural rubber latex (DNRL). The ultimate tensile strength and percentage of elongation at breakage of the DNRL membrane were 0.23 ± 0.04 MPa and 604.46 ± 95.38%, respectively. The DNRL membrane existed as an amorphous phase and was poorly hygroscopic and dense. FT-IR and DSC analysis demonstrated that the membrane consisted almost entirely of isoprene functional groups with a T_g of −64.79 °C. The effects of the DNRL membrane thickness (100–300 μm) and different nicotine concentrations in the reservoir (1.75–4.25 mg/cm²) on the nicotine release rate and nicotine permeation through a pig skin membrane were studied in vitro. The in vitro nicotine release rate and skin permeation rate increased with decreasing membrane thickness and increasing nicotine content in the reservoir. The release and permeation profiles followed first- and zero-order kinetics, respectively. The release and permeation performance was similar to a commercially available Nicotinell TTS-20 patch. The newly developed NTPs were stable under storage in a tightly sealed container at 4 °C or at ambient temperature for up to 3 months. Thus, DNRL is suitable for use as a controlling layer membrane in NTPs in transdermal drug delivery systems.