Optimization of an effervescent tablet formulation containing spray dried L-leucine and polyethylene glycol 6000 as lubricants using a central composite design.
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.
Rotthäuser
B
B
Eberhard-Karls-University Tübingen, Germany.
Kraus
G
G
Schmidt
P C
PC
D002626:Chemistry, Pharmaceutical; D007930:Leucine / Q000737:chemistry*; D008153:Lubrication; D010592:Pharmaceutic Aids / Q000737:chemistry*; D011092:Polyethylene Glycols / Q000737:chemistry*; D013607:Tablets / Q000737:chemistry*
D010592:Pharmaceutic Aids; D013607:Tablets; D011092:Polyethylene Glycols; D007930:Leucine