Transfer and scale-up of the manufacturing of orodispersible mini-tablets from a compaction simulator to an industrial rotary tablet press.

Orodispersible mini-tablets (ODMTs) are a promising dosage form for the pediatric use showing increasing interest from pharmaceutical industry. However, a scale-up process for ODMTs from a compaction simulator to a rotary tablet press following FDA and EMA guidelines has not been performed and investigated yet. Isomalt (galenIQ™721) and Ludiflash® both excipients with proven suitability for the development of ODMTs have been investigated in transfer and scale-up from a compaction simulator to a rotary tablet press. ODMTs with isomalt and Ludiflash® were produced on the rotary tablet press monitoring the product temperature over time and assessing the properties of the residual powder in the feed shoe. Critical quality attributes like tensile strength, mass and disintegration time were evaluated. The transfer from compaction simulator to rotary tablet press succeeded as for both excipients similar disintegration times, tabletability and compactibility profiles were obtained. However, during scale-up, disintegration time significantly increases over time for both excipients. Monitoring of the product temperature revealed that with increasing batch size the product temperature increases as well having a significant impact on disintegration time. The properties of ODMTs produced with the residual powder are comparable in tabletability and disintegration time compared with ODMTs produced from fresh powder.