Comparison of properties on Orally Disintegrating Tablets (ODTs) produced by direct compression or fluid bed granulation

Abstract: Orally disintegrating tablets (ODTs) is a popular drug delivery system as they dissolve in the mouth, usually within seconds which enables easy medication for patients with problem swallowing. In this thesis properties of ODTs were compared when produced with direct compression of the excipients or the excipients were pretreated to form granules in a fluid bed granulator prior to tableting. By altering the excipients used and the process parameters during fluid bed granulation it was concluded that the choice of polyol as the main filler in the tablet mostly affected the properties of both the granules and the produced tablets. This was also concluded for the tablets produced with direct compression. The granulation process increased the flowability of the particles. The disintegration time was also mostly affected by the filler and not the used super disintegrants. Tablets containing mannitol disintegrate faster than tablets with isomalt or xylitol and is also less friable. From the measured in vivo disintegration times an in vitro method was developed with the aim to give a better in vitro-in vivo correlation (IVIVC) compared to existing methods. The developed method is applicable for tablets containing mannitol as they swell when disintegrating. For this a texture analyzer was used which applied and measured the force on tablets when swelling.