Preparation and Characterization of Diclofenac Sodium-Purolite A430MR Complexes for Taste Masking
Abstract
The taste of a drug impacts the compliance of patients for oral administration. In this study, the bitter taste of diclofenac sodium (DS) was masked with purolite A430MR through ion exchange. The DS-A430MR complexes (DACs) were prepared at a 1:1 (w/w) drug to resin through a simple aqueous binding process. The key factors affecting release behaviors were identified by optimized experiments. The taste masking effect of the DACs was evaluated by human taste panel studies and simulated saliva release.
The physical characterization proved successful preparation of DACs. The released experiments demonstrated that the pH values, types, and strengths of counter ions were important factors affecting the DS release from the DACs. The simulated saliva release profiles demonstrated that the DS concentration in oral cavity was lower than its bitterness threshold. The bitter taste of DS was almost completely masked by the IERs, which provided guidance for the development of palatable oral preparations using IERs.
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Materials
DS was supplied by Shanghai Jindi Jiuzhou Pharmaceuti-cal (Anyang) Co., Ltd. (Shanghai, China). A430MR was purchased from Purolite Co., Ltd. (Hangzhou, China,). Sodium hydroxide, sodium chloride, sodium bicarbonate, and sodium acetate were purchased from Tianjin Hengx-ing Chemical Reagent Co., Ltd. (Tianjin, China). Sodium dihydrogen phosphate and phosphoric acid were provided by Tianjin Kermel Chemical Reagent Co., Ltd. (Tianjin, China).
Ye, G., Wang, Q., Shang, Y. et al. Preparation and Characterization of Diclofenac Sodium-Purolite A430MR Complexes for Taste Masking. AAPS PharmSciTech 26, 158 (2025). https://doi.org/10.1208/s12249-025-03138-z
Read also our introduction article on Taste Masking here:
