Colchicine is used in the therapy of gout, but recent studies indicate that colchicine may have therapeutic effect in the treatment of Alopecia Areata, a common, non-scarring reversible disorder of hair loss. In the present study a topical delivery system in the form of film was developed to minimize the undesired side effects of systemic colchicine. The components used in the formulations, such as polymers and plasticizers were screened and their concentrations were optimized in order to obtain a film with in vitro release rate suitable for sustained drug release and with optimal physical properties such as short drying time, low outward stickiness, high cosmetic attractiveness, high folding endurance, low moisture content, low moisture uptake and suitable swelling index. Further optimization was made to select a film formula which exhibited good flow properties required for spraying and was non-irritant to the skin. The optimized film formula was employed to conduct clinical studies using patients suffering from Alopecia Areata. The results showed that the polymeric film composed of Eudragits, RSPO+RL100 (4:1) exhibited higher therapeutic efficacy of colchicine in the majority of the patients vis-à-vis the ethanol solution of the drug and the placebo. In conclusion the selected film provided more effective carrier for colchicine than the solution, exhibited a controlled drug release, improved the cosmetic attractiveness and led to better patient compliance. The selected film formulation developed in this study can represent a novel topical delivery of the drug for treatment of Alopecia Areata
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