Rat Palatability Study for Taste Assessment of Caffeine Citrate Formulation Prepared via Hot-Melt Extrusion Technology

Abstract

Developing a pediatric oral formulation with an age-appropriate dosage form and taste masking of naturally bitter active pharmaceutical ingredients (APIs) are key challenges for formulation scientists. Several techniques are used for taste masking of bitter APIs to improve formulation palatability; however, not all the techniques are applicable to pediatric dosage forms because of the limitations on the kind and concentration of the excipients that can be used. Hot-melt extrusion (HME) technology is used successfully for taste masking of bitter APIs, and overcomes some of the limitations of the existing taste masking techniques. Likewise, analytical taste assessment is an important quality control parameter evaluated by several in vivo and in vitro methods, such as the human taste panel, electrophysiological methods, electronic sensor, and animal preference tests to aid in selecting a taste-masked formulation. However, the most appropriate in-vivo method to assess the taste-masking efficacy of pediatric formulations remains unknown, because it is not known to what extent the human taste panel/electronic tongue can predict the palatability in the pediatric patients. The purpose of this study was to develop taste-masked caffeine citrate extrudates via HME, and to demonstrate the wide applicability of a single bottle-test rat model to record and compare the volume consumed of the taste-masked solutions to that of the pure API. Thus, this rat model can be considered as a low-cost alternative taste-assessment method to the most commonly used expensive human taste panel/electronic tongue method for pediatric formulations.

Exploitation of enrofloxacin-loaded docosanoic acid solid lipid nanoparticle suspension as oral and intramuscular sustained release formulations for pig

“…This palatability evaluation referred to the report of Tiwari et al. In the study, the daily intake amount of water was used to evaluate palatability of caffeine citrate formulation in mice (Tiwari et al., 2017 ). According to the clinic, maximum dosage of 5 mg/kg B.W.…”

“…The palatability referred to the report of Tiwari et al. (Tiwari et al., 2017 ) Nine pigs from the same litter were randomly divided into three groups: control, enrofloxacin powder and nanosuspension groups with three pigs for each group. All pigs before the experiment were provided ad libitum access to pure water for 3 days to determine the normal water intake of each pig.…”

Electronic Tongue—A Tool for All Tastes?

“…In a more ethical approach, traditional behavioural studies can be used to develop a model for assessment of taste masking of pharmaceuticals [ 69 ], more examples of which are reviewed in [ 42 ].…”

Pediatric Drug Development and Dosage Form Design

“…However, multiple aspects such as the viscosity and pH value but also fat and sugar contents have to be considered and evaluated. To avoid cost-intensive human sensory panels, studies in this theme issue address animal models and electronic sensors to assess the taste of pediatric formulations (13,14).…”