Improved Palatability of Gummy Drugs of Epinastine Hydrochloride Using Organoleptic Taste-Masking Methods

抄録

Gummy drugs are dried jelly formulations prepared by adding a gelling agent to saccharides, which are then cooled and solidified. Epinastine hydrochloride (Epi) is commonly used to treat allergic diseases as a prescription and over-the-counter drug. However, the extremely bitter taste of Epi would affect its acceptability among patients. In this study, we aimed to improve the palatability of a gummy drug containing Epi (Epi-G) via organoleptic masking. Epi-G (10 mg of Epi/3.5 g of gummy drug) with two different organoleptic masking formulations, namely aspartame, cocoa powder, and chocolate flavoring (C-Epi-G) or aspartame, L-menthol, and lemon flavoring (L-Epi-G). The gustatory sensation test included six healthy adult volunteers (23.3 ± 1.8 years). We used a visual analogue scale (VAS) to evaluate bitterness, sweetness, and the overall palatability of each Epi-G formulation during chewing and after spitting out the drugs. In the gustatory sensation test, the VAS scores for bitterness and sweetness were decreased and increased for C-Epi-G and L-Epi-G, respectively, compared with the values for Epi-G without organoleptic masking. The VAS scores for overall palatability during chewing for C-Epi-G and L-Epi-G were significantly increased by 2.3- and 2.0-fold, respectively, versus the value for Epi-G. The score after spitting out C-Epi-G remained higher than that of Epi-G. These data illustrated that Epi-G with organoleptic masking had good palatability, which could improve patient adherence to treatment. The gummy drugs could represent an alternative dosing formulation for pediatric and geriatric patients by allowing them to take the drugs more easily than other oral formulations.