Optimization of an effervescent tablet formulation using a central composite design optimization of an effervescent tablet formulation containing spray dried l-leucine and polyethylene glycol 6000 as lubricants using a central composite design

Abstract A rotatable central composite design is used to evaluate the effects of lubricants and compression force on the physical characteristics of effervescent tablets. Effervescent tablets lubricated with a combination of spray dried l -leucine and polyethylene glycol 6000 are prepared by direct compression and examined. Residual force, crushing strength and disintegration time are considered as response variables and related to the l -leucine and polyethylene glycol concentrations and to the compression force. The calculated models are used to assess the influence of the production factors on tablet properties. As increasing amounts of l -leucine, showing good lubricating properties, reduce the crushing strength and prolong tablet disintegration, the l -leucine concentration is kept at a low level. An optimum tablet formulation contains 2% l -leucine and 3% polyethylene glycol 6000. The tablets have a tensile strength of 0.47 MPa and disintegrate in less than 2 min. Predicted and experimental results are in agreement within a 95% CI.