COMPATIBILITY STUDIES BETWEEN PACLITAXEL AND EXCIPIENTS IN THE PREFORMULATION PHASE OF NANOCRYSTAL FORMULATION

Paclitaxel is one of the best anti-cancer drugs and recently known as the best anti-cancer products of natural origin. The purpose of the present work was to study the physicochemical properties and compatibility of paclitaxel with the selected surfactants employed in nanocrystal formulations. The melting point and loss on drying of paclitaxel were found 216 °C and 0.11% respectively. A log P value of paclitaxel in different solvent systems like Octanol-Water, Dichloromethane-Water, Hexane-Water, and Oleyl Alcohol-Water was found 2.66, 2.91, 3.02 and 3.42 respectively. Paclitaxel is insoluble in water, soluble in ethanol, dichloromethane, and DMSO (dimethyl sulphoxide). The compatibility analysis of Paclitaxel with Egg lecithin, Poly Vinyl Pyrrolidine (PVP) and Poly (L‐lactic acid‐co‐glycolic acid) (PLGA) was studied by employing Fourier transform infrared spectroscopy (FTIR), X-Ray Powder Diffraction (XRPD) and Differential Scanning Calorimetry (DSC) techniques. FTIR, XRPD and DSC methods applied to the mentioned physical mixtures did not show evidence of interactions in the solid state. Based on these results supplied by FTIR, DSC, and XRPD, all the surfactants were found to be compatible with paclitaxel so that they can be further used in the formulation of nanocrystals.