Abstract
Orodispersible dosage forms are promising new approaches for drug delivery. 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 pediatric population. Formulations were investigated by X-ray diffraction, scanning electron and polarized light microscopy. Additionally, two commercially available electronic taste sensing systems were used to investigate the applied taste-masking strategies. 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 and complexing agent. All ODFs showed fast disintegration depending on the characterization method. In order to get taste information, the dimenhydrinate formulations were analytically compared to pure drug and drug-free formulations by electronic tongues. Results obtained from both systems are comparable and were used together for the first time. It was possible to develop an ODF of dimenhydrinate that is fast disintegrating even in small volumes of liquid. Furthermore, in vitro taste assessment by two electronic tongues revealed taste-masking effects by the excipients.
Highlights
Disintegrating dosage forms are promising new approaches to improve and simplify drug administration
Since 2008 an expert committee of the World Health Organization (WHO) proposed a benefit of solid dosage forms in pediatric medicines, this study aims to develop a solid dosage form containing
Captisol®, HP-β-CD (Kleptose® HPB oral grade) and maltodextrin (Kleptose® linecaps 17) were able to improve the solubility of dimenhydrinate and could prevent the recrystallization of the drug substance in solid state of the film
Summary
Disintegrating dosage forms are promising new approaches to improve and simplify drug administration. Risk of choking is minimized in oromucosal preparations, such as orodispersible films or buccal tablets and films, due to their possible adhesion to the oral mucosa or their fast disintegration [2]. The development of orodispersible films (ODF) containing dimenhydrinate (DMH) offers an alternative to conventional tablets, syrups and suppositories for the treatment of vomiting and nausea. DMH is a salt of diphenhydramine and 8-chlorotheophylline (Figure 1). Diphenhydramine is an antihistamic drug that is antagonistic at the H1 receptor in order to prevent and treat nausea and motion sickness [3]. 8-chlorotheophylline is added to counteract drowsiness triggered by diphenhydramine. The science information of a marketed syrup containing DMH claims a single dose of
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