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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

1998; Elsevier BV; Volume: 46; Issue: 1 Linguagem: Inglês

10.1016/s0939-6411(97)00154-9

1873-3441

Bärbel Rotthäuser, Gerolf Kraus, Peter Schmidt,

Optimal Experimental Design Methods

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.