Investigation of the effects of certain formulation factors on release properties of paracetamol tablets using 23 factorial design

Abstract

Objective: To study the effects of three formulation variables (PVP, stearic acid and Avicel PH101) on disintegration time and release properties of paracetamol tablets using a 23 factorial experimental design.Methodology: Three formulation variables; Polyvinyl pyrrolidone (factor A), Stearic acid (factor B) and Avicel PH 101 (factor C) were used at two concentrations levels in paracetamol tablet formulation. The estimated effects of increasing the factors from a low to a high level were testedfor significance by analysis of variance. The release properties of the tablets- measured by the disintegration and the dissolution times were used as assessment parameters.Results: Changing the concentration of factor A from” low” to “high” led to an increase in the disintegration time of the tablets. The disintegration of the tablets is not affected by factor B or C. All investigated factors in 23 factorial design had a significant effect on dissolution time. Theranking of the factors was C > B > A.Conclusion: The results suggest that factorial design could be useful to produce tablets with particular drug release profiles and there was a considerable interaction between the variables employed on the tablet dissolution rate.