Development of a Taste-Masked Orodispersible Film Containing Dimenhydrinate

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.

Formulation and in Vitro Evaluation of Bromocriptine Mesylate as Fast Dissolving Oral Film

“…The test is done by taking three films of each patch in a petri dish, and after adding 2 ml of distilled water for each film, the petri-dish was shaken continuously, then measure the time at which the ODFs start to break down or disintegrate. The determination of DT was done in triplicate for all the formulations [21].…”

In vitro/in vivo evaluation of an optimized fast dissolving oral film containing olanzapine co-amorphous dispersion with selected carboxylic acids

“…Owing to pregastric or oro-mucosal absorption, drugs can directly enter systemic circulation avoiding first-pass metabolism thus improving bioavailability with possibility of reduced dosing and fewer side effects (Saurabh et al, 2011). Many studies on orodispersible polymer films have been conducted for various reasons; as enhancing solubility of poorly soluble BCS class II drugs, taste masking of antihistamines, or increasing patient compliance for administration of antidepressant drugs (El-Setouhy & El-Malak, 2010;Preis et al, 2012;Sievens-Figueroa et al, 2012). Optimized formulations of orodispersible polymer films were also studied in the literature using simple methodologies such as solvent casting, hot-melt extrusion, and freeze drying (ElMeshad & El Hagrasy, 2011;Low et al, 2013;Kumria et al, 2016;Shamma & Elkasabgy, 2016).…”

Independent comparison study of six different electronic tongues applied for pharmaceutical analysis

“…Most of these reports are focused on the development of new drug formulations by choosing appropriate taste masking strategies. Besides, original and generic products were compared [12,13], products modified with commercially available beverages or jellies characterized [14,15], the effect of micro encapsula-tion [16] or oral film formulations [17] on taste-masking efficacy assessed and stability and dose uniformity studies [18] presented. In a recent study, the capability of HPLC and e-tongue analysis was compared with human taste panels regarding taste assessment and the applied e-tongue was proven to be even more sensitive than the human taste panels [19].…”