Design, Formulation and Physicochemical Evaluation of Dimenhydrinate Orally Disintegrating Tablets

Abstract

Background: Design, formulation and physicochemical evaluation of dimenhydrinate 25 mg oral tablets that disintegrate in oral cavity in a proper time. This product is easy to use for babies, geriatrics and people who have difficulty in swallowing. Materials and Methods: 31 formulations were designed in 3 categories via Design-Expert software version 7. Group 1 consist of super-disintegrating bases, group 2 consist of effervescent bases and group 3 consist of super-disintegrating and effervescent bases together. Proposed by Design-Expert software, the optimum formulations were selected in each category and the tablets were produced by direct compression method. Tablets evaluated by friability, thickness, hardness, weight variation, drug content, content uniformity, disintegration time, wetting time, dissolution and moisture uptake tests. Results: The angle of repose and compressibility index of formulations were in the range of 24.65-29.08 and 5.02-9.01 respectively. Thickness, hardness, wetting time, friability and content uniformity of formulations were in the range of 3.36-3.84 mm, 33.25-38.03 N, 19-37 seconds, 0.31-0.42 and 96.44-99.02 respectively. Disintegration time of the groups 1, 2 and 3 were in the range of 16-70, 47-72 and 12-35 seconds respectively. Conclusion: Mixture of powders and orally dispersible tablets passed all tests. The results showed that formulations containing both of super-disintegrants and effervescent bases had better disintegration time compare to other formulations.