Development and evaluation of mosapride citrate orally disintegrating tablets for dogs

Abstract

ABSTRACT: The purpose of the study was to prepare orally disintegrating tablets (ODTs) of mosapride citrate for dogs with fast disintegration and low cost. The ODTs were developed by varying the components and the ratio of excipients. A direct compression method was used. The properties of the ODTs, including hardness, friability, active ingredient content, and in vitro disintegration time, were investigated, and an economic analysis of the formulations was performed. For all formulations, friability was less than 1%, and the hardness varied from 37.69±4.08 to 48.73±5.62 N, which indicated that the tablets had sufficient mechanical integrity to withstand packaging and carrying. Results showed that Formulation (F) 2, containing 5% sodium carboxymethyl starch; F3, containing 5% low-substituted hydroxypropylcellulose; and F5 had not only shorter disintegration times but also lower costs, which were suitable for mosapride citrate ODTs. Although F1, contained 5% croscarmellose sodium, and F4, contained 5% crospovidone, with shorter disintegration times, the costs of F1 and F4 were 25.8% and 22.6% higher than that of F5, respectively. Results also revealed that the disintegration time of F5 was not significantly different from those of F1, F2, F3, and F4 (p>0.05), all of which contained superdisintegrants. Without superdisintegrants, F5, which contained a mixture of microcrystalline cellulose, mannitol, and lactose, was also able to achieve a short disintegration time and to meet the requirements of ODTs for dogs.