Category: Formulation and Quality
Purpose: The low palatability of oral medicines leads to issues in their acceptability and was reported to be the cause of missing doses and/or difficulty in administration [1, 2]. Applying a physical barrier – a coating – onto a tablet is a simple method of taste-masking. This study investigated the taste-masking efficiency of five coating formulations in a healthy adult population.
Methods: A cross-over, single center study design was proposed to investigate oral perception of placebo 7.5 mm, round tablets with bespoke coatings (Table 1). Ethical approval for the study was obtained from the Ethical Review Committee of the University of Birmingham. The tablets contained low concentration of quinine as a bitter flavoring agent (all tablets were manufactured by Chrysalis Health & Beauty Ltd, UK). All participants completed a background questionnaire and then received the same 5 samples in a randomized order. They evaluated the tablets via a taste-and-spit test. The taste-masking effect was assessed in two ways: (1) self-reported the bitterness intensity (5-point scale; where 1 was ”extremely bitter” and 5 ”not bitter”) and (2) the time of bitterness onset. Statistical analysis was undertaken using Wilcoxon’s test with Bonferroni correction to determine differences between samples. Dissolution data was generated to compare to the in vivo study using a USP II small volume dissolution apparatus with 25ml of deionised water, at 50 rpm, 37°C.
Table 1 Formulations of film coatings included in the study (coating level: 4% weight gain).
HPMC, Lubritab, Capmul, Talcum, Titanium dioxide
HPMC, Glycerol, Xanthan gum, Talcum, Titanium dioxide
Eudragit EPO, Titanium dioxide
Ethyl cellulose : HPMC (80:20), Glycerol, Talcum, Titanium dioxide