DESIGN OF EXPERIMENTS FOR PREPARATION OF POLYVINYL ALCOHOL–BASED OPTIMIZED FILMS FOR NICOTINE TRANSDERMAL DELIVERY

Optimized polyvinyl alcohol (PVA)-based films were prepared by blending with other excipients: deproteinized natural rubber, glycerin, and poloxamer 407. The properties of the developed optimized PVA-based film: thickness, weight variable, folding endurance, swelling ratio, and moisture content, were predicted by the Design-Expert® program. The thickness and weight variables were not found to be significantly different, but folding endurance, swelling ratio, and moisture content had significant differences. The predicted mathematical models for dependent variables were quadratic, linear, and special cubic. The linear relationships of the model conditions for optimized PVA-based films were 0.5099–0.8521 within a 95% confidence interval. The selected optimized PVA-based film was evaluated for all parameters again. The thickness, weight variable, folding endurance, swelling ratio, and moisture content were 0.209 ± 0.025 mm, 27.660 ± 3.446 mg/cm2, 1646.667 ± 45.092 times, 100.575 ± 17.121%, and 5.337 ± 0.319%, respectively. The obtained optimal formulation was then mixed with nicotine drug, and subsequently applied for transdermal delivery systems. The nicotine could be released as 1.60 ± 0.30 mg/cm2 from the film, in accordance with Higuchi’s model (R2 = 0.9701). The constant rate for nicotine release was 0.373 ± 0.049 mg/ Thus, it was concluded that the film was an effective polymer for controlling the nicotine release behavior.