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 OTs formulation able to disintegrate in less than 30 seconds, characterized by acceptable technological properties and suitable for an industrial production. We tested how the characteristics of different direct-compression excipients can influence tablets 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 on the technological properties of the dosage form, an OTs formulation, containing a slightly soluble non-steroidal antinflammatory drug has been scaled up preparing the tablets by direct compression and using punches of different size. The OTs formulation developed maintains adequate organoleptic, technological 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.
Formulation desig and development to produce orodispersible tablets by direct compression
SEGALE, LORENA;MAGGI, LAURETTA;OCHOA, EVELYN;CONTI, STEFANIA;CONTE, UBALDO;
2007-01-01
Abstract
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 OTs formulation able to disintegrate in less than 30 seconds, characterized by acceptable technological properties and suitable for an industrial production. We tested how the characteristics of different direct-compression excipients can influence tablets 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 on the technological properties of the dosage form, an OTs formulation, containing a slightly soluble non-steroidal antinflammatory drug has been scaled up preparing the tablets by direct compression and using punches of different size. The OTs formulation developed maintains adequate organoleptic, technological 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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
