Systematic evaluation of a spraying method for preparing thin Eudragit-drug films by Design of Experiments

The purpose of this study was to develop a spraying method to manufacture thin films with a drug (perphenazine (PZZ)) incorporated as a solid dispersion. The effect of formulation (type of polymer, PZZ concentration, amount of excipients) and process variables (feed rate, spraying distance) on the mechanical and drug release properties of the thin films were studied by Design of Experiments (DoE). The mechanical properties of elongation, mechanical strength, thickness, handling and endurance were measured. Drug release rates from the thin films were determined in side-by-side diffusion cells. Models were created to illustrate the effects of variables on responses by multi-linear regression (MLR) -analysis. It was shown that it is possible to manufacture thin polymer-PPZ-films with good mechanical and release properties by the spraying method. The amount of PPZ and the film thickeners were the main variables affecting film mechanical properties. Increasing the amount of PVP was found to enhance the dissolution rate of PPZ. Dissolution profiles follow Peppas' equation with exponent n around 0.5 indicating square root of the time kinetics.

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