A Factorial Study on the Individual and Combined Effects of-Cyclodextrin and Poloxamer on the Solubility and Dissolution Rate of NimesulideAuthor(s): 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.