MALTODEXTRINS AS FILM FORMER MATERIALS FOR THE DESIGN OF ORAL DISPERSIBLE FILMS AND TRANSDERMAL PATCHES

This work aimed to study maltodextrin as main film forming material and their application in the design of oral dispersible films and pressure sensitive adhesives. Maltodextrins (MDX), having dextrose equivalent (DE) in the 6-12 range plasticized with 16–20% w/w glycerine (GLY), are suitable to produce fast-dissolving films by casting and solvent evaporation or hot-melt extrusion. Compared to the hot-melt extrusion method, the casting method appeared more reliable for the production of fast-dissolving films since the dosage forms exhibited the best performances in terms of in vitro and in vivo disintegration time. The active ingredient can be loaded either as a powder or in solution. In both cases the loaded drug modified the mechanical properties of the films but such alteration can be easily counterweighted by changing the MDX DE or the MDX/GLY ratio. The films can also incorporate taste masking agents such as flavours or sweeteners which did not significantly modify the film mechanical properties. The feasibility of analyzing bitterness suppression of taste masking agents in MDX dissolving films containing diclofenac or nicotine by a taste sensor system, i.e. electronic tongue was demonstrated. Hydrolyzed starches with DE of 38 resulted suitable for the preparation of adhesive swollen hydrogels. The polysaccharide could be used as the main component but the addition of other polymers was necessary to optimize the adhesive properties. In particular, the use of a high molecular weight alginate cross-linked by calcium permitted to obtain a patch characterized by a very high water vapour permeability and suitable water uptake. These characteristics suggest that this matrix could be advantageously used in wound healing.