The effect of alkylpolyglycoside surfactants on the crystallization of spray-dried salbutamol sulphate: a GravimetricNear-Infrared Spectroscopy Study.

Abstract

This study monitored the effect of a series of structurally related surfactants on the crystallization of amorphous salbutamol sulphate. Amorphous salbutamol sulphate was prepared by spray drying from a solution in water and in the presence of various alkylpolyglycosides (APGs) at different concentrations. The particles were then analyzed using isothermal microcalorimetry and water vapor sorption (Dynamic Vapour Sorption, DVS) analysis combined with near-infrared spectroscopy (DVS-NIR). Both isothermal microcalorimetry and DVS-NIR were able to detect the transition from the amorphous to the crystalline state. The presence of APG surfactants modified the shape of the crystallization peak obtained using isothermal microcalorimetry. The gravimetric study combined with NIR revealed that while the crystallization was similar for the particles with or without surfactant, there was a great difference in the release of water from the newly formed crystal. In the presence of some of the surfactants tested, salbutamol sulphate released the water much faster than in the absence of surfactant. These results helped to explain the differences found in the isothermal microcalorimeter data. Differences were observed in the shapes of the NIR water peaks related to water due to the presence of the surfactant. In conclusion, the use of DVS combined with NIR has helped to analyze and understand the effect of APGs on the crystallization of amorphous salbutamol sulphate.