Application of mini ODTs and coin shaped ODTs with high performance excipients for pediatric preparation

Pediatric formulations are strongly demanded from healthcare professionals and caregivers. Currently, solid dosage forms have been studied as pediatric preparations.

In this article, we report the development of orally disintegrating tablets (ODTs) which shape are suitable for pediatric formulations containing high performance excipients, GRANFILLER-D^TM and HiSORAD^TM.

Mini tablet is an excellent formulation in terms of ease of administration and measurability. Mini ODTs were prepared using GRANFILLER-D^TM and HiSORAD^TM, and their compactability was good with the coefficient of variation (CV) for tablet weight ≤ 1.2%. Both tablets achieved disintegration time of < 3 seconds, which exhibited sufficient hardness and friability for any mini tablet measuring devices.

Coin-shaped ODTs are large in diameter, at approximately 14 mm, and thin, with a thickness of ≤ 1 mm. They are expected to disintegrate very rapidly due to their large surface area. The disintegration time of the placebo tablet was < 5 seconds. Moreover, they exhibited practical friability values of < 0.5%, and drop tests of 50 tablets detected no cracking or chipping.

In conclusion, mini ODTs and coin-shaped ODTs prepared with GRANFILLER-D^TMand HiSORAD^TM disintegrate in several seconds, indicating excellent disintegratability more than that of conventional ODTs. The Daicel’s products enable realizing well balanced property between compactability and disintegratability of ODTs. Furthermore, the distinctive properties also allow tablets to be miniaturized and made thinner.