Development of mucoadhesive films for buccal administration of flufenamic acid: Effect of cyclodextrin complexation.

A new mucoadhesive film for topical administration in the oral cavity of flufenamic acid, a poorly soluble anti-inflammatory drug, has been developed, using complexation with hydroxypropyl-beta-cyclodextrin (HPbetaCD) to improve drug dissolution and release rate. Buccal films were prepared utilising chitosan as mucoadhesive polymer, KollicoatIR as film-forming polymer and glycerol as plasticiser. Different combinations of these components were used and the obtained films were characterised for weight, thickness, swelling, mucoadhesive and mechanical properties. The film containing chitosan 2%, glycerol 7.5% and KollicoatIR 1% showed the best properties for the development of the film formulation. The selected film was loaded with the plain drug and its colyophilised and coground products with HPbetaCD, and in vitro release studies in simulated saliva were performed. The improved drug dissolution properties, obtained by complexation with HPbetaCD, were critical to achieve complete release from film formulation during 4-5 h. On the contrary, film loaded with the plain drug showed incomplete release, not exceeding 70% release after 5 h. The developed film formulation containing the drug as complex with HPbetaCD can assure a prolonged drug release directly at the inflammation site and can be proposed as a new therapeutic tool in the treatment of oral mucosa inflammations. (c) 2010 Wiley-Liss, Inc. and the American Pharmacists Association