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1  University of Düsseldorf - Institute of Pharmaceutics and Biopharmaceutics, Düsseldorf, Germany

Abstract: Orodispersible dosage forms are promising new approaches in drug administration. They enable an easy application, as there is no need to drink high amounts of liquids or swallow large solid dosage forms. The aim of the study was to develop an orodispersible film (ODF) as an alternative to tablets, syrups or suppositories for the treatment of vomiting and nausea, especially for the paediatric population. Formulations were investigated by x-ray-diffraction, scanning electron and polarized light microscopy. Disintegration time of the films was determined by performing petri dish, drop and clip weight method. Additionally, two commercially available electronic taste sensing systems (electronic tongues) were used to investigate the applied taste-masking strategies. Different excipients enhancing the solubility of dimenhydrinate were investigated to avoid recrystallization in the film. Furthermore, they are discussed to improve the taste attributes of the formulation by interacting with the drug substance. Results obtained from x-ray-diffraction and polarized light microscopy showed no recrystallization of dimenhydrinate in the formulation when cyclodextrin or maltodextrin were used as solubilizing agent. All ODFs disintegrated in an appropriate time (< 120 s) depending on the characterization method. In order to get information on taste, the dimenhydrinate formulations were analytically compared to pure drug and drug-free formulations by the electronic tongues. Results obtained from both systems are comparable but can also be used complementary. In addition, possible taste masking effects by reduction of the free amount of drug could be detected by both electronic tongues. Merging data of both systems by multivariate data analysis showed improved discrimination between different drug formulation. It was possible to develop an orodispersible film of dimenhydrinate that is fast disintegrating even in small amounts of liquid. Moreover, a non-human taste assessment by two electronic tongues was successfully performed.
Keywords: orodispersible film, taste masking, electronic tongues