Formulation of Irbesartan by Microcrystal Technology for Enhancing the Solubility and Dissolution Properties

Abstract

The aim of this study was to develop the formulation of irbesartan by microcrystal technology to enhance the solubility and dissolution property of the drug. The area of interest in the study carried out is Class II drugs cited in the Biopharmaceutical Classification System. Microcrystal technology is a new carrier-free colloidal drug delivery system with reduced drug particle size and is considered a viable strategy in drug delivery to develop formulations of poorly soluble drugs. In the present study, an attempt was made to enhance the solubility of the drug irbesartan compared to its pure form by microcrystal technology. Drug microcrystals were prepared by the anti-solvent precipitation process. The specified amount of drug was dissolved in methanol and PVP K30 was dissolved in water. The two phases were mixed instantaneously, wherein the drug solution was kept on continuous stirring and the aqueous phase was added to this continuous phase. The particle size of the drug was not reduced, but enhancement in solubility and dissolution properties of the drug were still observed. This could be due to the wettability property of PVP K30. The FT-IR spectra and DSC thermograms confirmed no interference of drug and the stabilizer. XRD studies confirmed the formation of crystals of the drug irbesartan. Thus, it could be concluded that microcrystal technology is a promising approach for solubility enhancement of irbesartan.