Design and optimization of process parameters of polyvinyl alcohol-graft-lactic acid films for transdermal drug delivery.

The objective was to apply a simplex lattice design to determine the properties of polyvinyl alcohol-graft-lactic acid (PVA-g-LA) with different values for two independent variables: curing time (X1) and LA ratio (X2). Each independent variable was varied among three levels: -1, 0, and +1. Three coded levels were 120 min, 150 min, and 180 min for X1 and 2.5 g, 5 g, and 7.5 g for X2. Dependent variables of swelling behavior in various swelling media and thermal analysis parameters were monitored. The optimal formulation was selected based on the desirability value. The prediction was accurate, showing a low value of percent error. The morphology of the selected formulation with the highest desirability value showed a compact and dense film. Propranolol hydrochloride used as a model drug, was loaded into PVA-g-LA film. The propranolol hydrochloride content was 4.19 ± 1.05 mg/cm2. The cumulative release and permeation of drug were 61.94 ± 8.03% and 59.96 ± 6.61%, respectively. Thus, response surface methodology can be used as a tool to predict or optimize the process parameters for PVA-g-LA transdermal films in an accurate manner. PVA-g-LA could control the release and permeation of drug from the film layer.