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A Factorial Study on the Individual and Combined Effects of-Cyclodextrin and Poloxamer on the Solubility and Dissolution Rate of Nimesulide

K. P. R. Chowdary, K. Surya Prakasa Rao and Sindhu Prabha Bonam

The objective of the study is to evaluate the individual and combined effects of β-cyclodextrin (β- CD) and surfactant (Poloxamer 407) on the solubility and dissolution rate of nimesulide, a BCS class II drug in a series of 22 factorial experiments. The solubility of nimesulide in four selected fluids containing β-CD and poloxamer 407 as per a 22 factorial study was determined. β-CD alone gave a marginal increase (1.47 fold) in the solubility of nimesulide. Whereas poloxamer 407 alone and combination of β-CD and Poloxamer 407 gave a significantly higher enhancement in the solubility of nimesulide, 2.5 and 7.6 folds respectively. Solid inclusion complexes of nimesulide- β-CD were prepared with and without poloxamer 407 by kneading method as per a 22 -factorial design. Both; the individual and combined effects of β-CD and Poloxamer 407 on the solubility, dissolution rate and dissolution efficiency (DE30) of nimesulide were highly significant (P < 0.01). β-CD and poloxamer 407 alone gave 5.15 and 5.08 fold increase in the dissolution rate of nimesulide. Combination of β-CD and poloxamer 407 gave a markedly higher enhancement (7.72 fold) in the dissolution rate of nimesulide. Β-CD in combination with poloxamer 407 gave much higher enhancement in the solubility and dissolution rate of nimesulide than is possible with them individually. Hence, a combination of β-CD and poloxamer 407 is recommended to enhance the solubility and dissolution rate of nimesulide.