Nicotine Fast Dissolving Films Made of Maltodextrins: A Feasibility Study |
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Authors: | Francesco Cilurzo Irma E Cupone Paola Minghetti Susanna Buratti Francesca Selmin Chiara G M Gennari Luisa Montanari |
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Institution: | 1.Department of Pharmaceutical Sciences “Pietro Pratesi”,Milan,Italy;2.Department of Food Science and Technologies,Università degli Studi di Milano,Milan,Italy;3.Dipartimento di Scienze Farmaceutiche “P. Pratesi”,Università degli Studi di Milano,Milan,Italy |
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Abstract: | 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. |
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