Solubility of sodium phenytoin in propylene glycol + water mixtures in the presence of β-cyclodextrin

Abstract

Background: Poor aqueous solubility of drugs is still a challenging aspect in drug discovery and development. Solubilization techniques such as cosolvency and complexation are used to solubilize poorly soluble drugs. A number of mathematical models presented for predicting the solubility of drugs in water+cosolvent mixtures and the Jouyban-Acree model promises more accuracy when compared with other algorithms. Methods: Solubility of sodium phenytoin in binary mixtures of propylene glycol + water in the presence of beta-cyclodextrin (β-CD) along with the solubility of sodium phenytoin in this solvent mixture in the absence of β-CD using saturating shake flask method were studied. The generated solubility data was fitted to the Jouyban-Acree model and the solubility profile of drug in the presence of β-CD was compared with solubility data in the absence of β-CD. Results: The solubility was increased by addition of propylene glycol and was decreased by addition of beta-cyclodextrin. The measured solubility data were used to evaluate the correlation ability of the Jouyban-Acree model employing the solubility data in monosolvent. These findings are supported by acceptable mean relative deviations values obtained when comparing the estimated and experimental solubilities. Conclusion: The addition of β-CD was decreased the solubilization power of propylene glycol.