Directly compressible excipient for orally disintegrating tablets
Orally disintegrating tablets (ODTs) are one of the most popular dosage forms for improving medication adherence. ODTs disintegrate in saliva in the oral cavity without requiring water. This allows patients with dysphagia, as well as geriatric and pediatric populations, to easily swallow the medication. Currently, several co-processed excipients for ODTs have been launched to produce ODTs more easily using direct compression. Co-processed excipients provide not only good performance as ODTs, but also applicability for the direct-compression process.
In this study, a novel co-processed excipient for ODTs, HiSORAD, was evaluated from the viewpoints of suitability as an ODT and applicability for direct compression. As the results, the placebo ODTs with HiSORAD showed satisfactory rapid disintegration and compactability, maintaining the practical hygroscopic stability. Additionally, HiSORAD demonstrated the ability to load a high dose of APIs while maintaining high hardness and rapid disintegration. On the other hand, the content uniformity of direct-compression ODTs with HiSORAD was evaluated using a lab-scale rotary tablet press. The result showed adequate content uniformity for the direct-compression process. Therefore HiSORAD provides not only good performance as ODTs, but also applicability for the direct-compression process.