Fabrication and Evaluation of Dimenhydrinate Taste Masked Granules Using Eudragit Polymer Coating

Background: Suitable taste is an important factor in the preparation of oral dosage forms. Polymer coating is one of the effective methods to improve the taste of the product. Objective: Different concentrations of Eudragit E polymer were sprayed on dimenhydrinate granules and the effectiveness of masking the bitter taste of the drug was investigated. Methods: Wet granulation method was used to prepare dimenhydrinate granules. The drug powder was uniformly mixed with starch and Avicel with a ratio of 0.5-0.5-1 and HPMC solution was used as binder. Then concentrations of 2.5%-15% of Eudragit E were used to cover the granules and 4 formulations were prepared. The flowability of the granules and the product taste improvement were evaluated. Also, the drug release test was performed at pH 6.8 and 1. Results: The results of the product taste showed that with the increase in the concentration of the coating polymer, the product taste improves significantly (P < 0.05). Solubility of Eudragit is pH dependent, hence, prevents the release of the drug in the oral cavity and the drug is released in the stomach environment. The highest release speed was related to formulation 1 (with the lowest thickness of polymer coating) and the lowest speed was related to formulation 4 (with the highest thickness of polymer coating) and after 90 minutes, between 84.334-96.359 % of the drug was released. Evaluation of the physical characteristics of the granules showed the flowability of the formulation improved. Also, the yield of pan coating technique was between 80 and 90% in different formulations. Conclusion: Eudragit E has the ability to mask the bitter taste of the drug. The techniques used to prepare the granules and coat them are low-cost and easily applicable, so they can be produced on an industrial scale.