Domperidone Maleate Orodispersible Tablet Formulation Using Primojel® Superdisintegrant with the Wet Granulation Method

Abstract

Orodispersible tablets are a solution for people who have problems swallowing drugs because they will break down instantly in the mouth without having to be swallowed. Objective: The aim of this research was to formulate orodispersible tablets using Primojel® as a superdisintegrant and domperidone male ate as an active compound to achieve the best disintegration time in the oral cavity by a wet granulation method had been carried out. Method: The tablet of 180 mg in weight was made with variation of concentration as followed 7, 2 mg (F1); 9 mg (F2); 10,8 mg (F3); 12,6 mg (F4); 14,4 mg (F5). F1, F3, F4, and F5 were qualified based on uniformity of weighing. Results: All of the formulas (F1, F2, F3, F4, and F5) were qualified based on the disintegrating time of orodispersible tablets (below three minutes). F2 has a quickest disintegration time and F1 has the longest disintegration time. Statistical analysis at α = 0, 05 showed that the concentration variation of Primojel® affected the disintegration time of the tablet. Hedonic test with five parameters included likeness, flavor, taste after taste showed that F5 was the most favorite formula. Conclusion: All formulas met the requirements of the Indonesian Pharmacopoeia IV crush time that was no more than 3 minutes. The results of the statistical analysis stated that F5 was the most preferred formula of domperidone maleate orodispersible tablets.

Keyword: Orodispersible tablets, Primojel®, Wet granulation, Domperidone maleate, Tablet formulation.