Formulation design and development to produce orodispersible tablets by direct compression

Orodispersible tablets (OTs) are uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed. The object of the present work is to develop an OT formulation able to disintegrate in less than 30 s, characterized by acceptable technological properties and suitable for an industrial production. We tested how the characteristics of different direct-compression excipients can influence tablet disintegration and technological properties. The results show that mannitol guarantees the shortest disintegration time and the best technological and organoleptic properties. Starting from this excipient, to verify which is the effect of the tablets size and shape on the performance and the technological properties of the dosage form, an OT formulation, containing a slightly soluble non-steroidal anti-inflammatory drug has been scaled up preparing the tablets by direct compression and using punches of different size. The developed OT formulation maintains adequate organoleptic, technological characteristics and disintegration ability, sizes ranging from 6.5 to 13 mm in diameter and it is possible to adapt this formulation to different production needs.