Orodispersible Film (ODF) Platform Based on Maltodextrin for Therapeutical Applications.

Orodispersible film (ODF) is a new dosage form that disperses rapidly in the mouth without water or swallowing. The main ingredient of an ODF is a polymer that can be both of natural or synthetic origin. Maltodextrin is a natural polymer, mainly used in pharmaceutical and nutraceutical fields. This review aims to examine the literature regarding ODFs based on maltodextrin as the platform for developing new products for therapeutical application. ODFs based on maltodextrin contain plasticizers that enhance their flexibility and reduce their brittleness. Surfactants; fillers, such as homopolymer and copolymer of vinylacetate; flavour and sweetener were introduced to improve ODF characteristics. Both water-soluble and insoluble APIs were introduced up to 100 mg per dosage unit. The solvent casting method and hot-melt extrusion are the most useful techniques for preparing ODFs. In particular, the solvent casting method allows manufacturing processes to be developed from a lab scale to an industrial scale. ODFs based on maltodextrin are characterized in terms of mechanical properties, dissolution rate, taste and stability. ODFs made of maltodextrin, developed by IBSA, were tested in vivo to evaluate their bioequivalence and efficacy and were demonstrated to be a valid alternative to the marketed oral dosage forms.

Nicotine fast dissolving films made of maltodextrins: a feasibility study.

This work aimed to develop a fast-dissolving film made of low dextrose equivalent maltodextrins (MDX) containing nicotine hydrogen tartrate salt (NHT). Particular attention was given to the selection of the suitable taste-masking agent (TMA) and the characterisation of the ductility and flexibility under different mechanical stresses. MDX with two different dextrose equivalents (DEs), namely DE 6 and DE 12, were selected in order to evaluate the effect of polymer molecular weight on film tensile properties. The bitterness and astringency intensity of NHT and the suppression effect of several TMA were evaluated by a Taste-Sensing System. The films were characterised in term of NHT content, tensile properties, disintegration time and drug dissolution test. As expected, placebo films made of MDX DE 6 appeared stiffer and less ductile than film prepared using MDX DE 12. The films disintegrated within 10 s. Among the tested TMA, the milk and mint flavours resulted particularly suitable to mask the taste of NHT. The addition of NHT and taste-masking agents affected film tensile properties; however, the effect of the addition of these components can be counterweighted by modulating the glycerine content and/or the MDX molecular weight. The feasibility of NHT loaded fast-dissolving films was demonstrated.

Fast dissolving films made of maltodextrins.

This work aimed to study maltodextrins (MDX) with a low dextrose equivalent as film forming material and their application in the design of oral fast-dissolving films. The suitable plasticizer and its concentration were selected on the basis of flexibility, tensile strength and stickiness of MDX films, and the MDX/plasticizer interactions were investigated by ATR-FTIR spectroscopy. Flexible films were obtained by using 16-20% w/w glycerin (GLY). This basic formulation was adapted to the main production technologies, casting and solvent evaporation (Series C) or hot-melt extrusion (Series E), by adding sorbitan monoleate (SO) or cellulose microcrystalline (MCC), respectively. MCC decreased the film ductility and significantly affected the film disintegration time both in vitro and in vivo (Series C<10s; Series E approximately 1min). To assess the film loading capacity, piroxicam (PRX), a water insoluble drug, was selected. The loading of a drug as a powder decreased the film ductility, but the formulation maintained satisfactory flexibility and resistance to elongation for production and packaging procedures. The films present a high loading capacity, up to 25mg for a surface of 6cm(2). The PRX dissolution rate significantly improved in Series C films independently of the PRX/MDX ratio.

Aminoacids as non-traditional plasticizers of maltodextrins fast-dissolving films.

This study explored the effect of aminoacids as non-traditional plasticizers of maltodextrins fast dissolving films. 5% w/w glycine and proline decreased the glass transition temperature (Tg) of maltodextrins from 102.6±2.0°C to 73.1±1.4°C and 76.1±0.7°C, respectively; meanwhile the binary mixture made with lysine had a Tg value of 83.6±2.2°C. At the same time, all aminoacids increased the ΔCp values. The shift of the thermal data were due to profound effect on the hydrogen bonding as evidenced by ATR-FTIR spectra since the OH stretching and scissoring bands decreased of about 15-26 cm(-1). A linear relationship was found (R(2)=0.9334) between HOH scissoring wavenumbers and Tg values. The addition of glycine and proline resulted effective in reducing the elastic modulus (about 50%) and tensile strength (about three times) and, therefore, can be used to increase the film ductility.