GRANFILLER-DExcipient for Orally Disintegrating Tablet

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White paper: The bitterness-masking effect of β-Cyclodextrin in the formulation of ODTs using Granfiller-D

CycloLab Cyclodextrin R&D Laboratory, Ltd, Hungary and Daicel Corporation have jointly published a white paper on the bitterness masking effect of β-cyclodextrin in the formulation of orally disintegrating tablets (ODTs) using GRANFILLER-D.

Please refer to the attached file. article210531[Daicel].pdf

In this paper, we report the preparation of an ODT including a β-CD-masked active pharmaceutical ingredient (API). We selected Mitiglinide Ca (MIT) as a bitter API. The complex of MIT and β-CD was prepared with by the kneading method. DSC measurement and organoleptic evaluation indicated that the inclusion was successful. The ODT was prepared with the complex and GRANFILLER-D. The ODT showed excellent tablet hardness and disintegration even when high content of β-CD/MIT complex was applied. Furthermore, the ODT showed similar disintegration time with higher tablet hardness than the originator's drug. The combination of β-CD and GRANFILLER-D appears to be one of the best solutions for manufacturing palatable ODTs.