Applying design of experiments (DoE) on the properties of buccal film for nicotine delivery

Design of experiments is used to optimize ratios between deproteinized natural rubber latex, Eudragit (R) NM 30 D, and pectin for nicotine buccal film with dependent variables as moisture content, moisture uptake, and swelling index in simulated saliva 3 and 5 h. Mathematical models were linear for moisture content and moisture uptake, while swelling index in simulated saliva 3 and 5 h was a quadratic model. Optimized polymer ratio was 0.319:0.362:0.319, respectively. Experimental values were 13.17 +/- 0.92%, 3.96 +/- 0.84%, 112.58 +/- 22.63%, and 124.69 +/- 8.01% for dependent variables, respectively. The buccal film showed high swelling at pH 7 and swelling-deswelling behaviors in a water/ethanol environment. The surface pH, weight, and thickness were 8.11, 63.28 +/- 6.18 mg, and 219.87 +/- 44.28 mu m, respectively. Nicotine content was found as 10.22 +/- 0.46 mg/4 cm(2). Maximum cumulative nicotine release was 9.82 +/- 0.94 mg/4 cm(2). Kinetic model fitted to the Korsmeyer-Peppas model and release exponent was 0.36, representing that release mechanism was controlled by Fickian diffusion release.