Application of selected diffractive and microscopic methods to evaluate the physical state of drug and morphology of microspheres obtained by spray drying of furosemide with Eudragit L30 D-55

Abstract

In pharmaceutical technology, the analysis of physicochemical properties of raw materials, intermediates and products is part of quality control testing at each stage of designing formulations and in the routine evaluation of the final product. The aim of the study was to analyse the physical state of drug and the morphology of microspheres obtained by spray drying, in which furosemide was incorporated into the polymeric matrix of Eudragit L30 D-55. The following optimal parameters of the spray-drying process were established: aspirator capacity of 80%, Tin: 140OC, pump capacity: 10%. The laser diffraction method was used to analyse the size distribution of microspheres in the following furosemide-Eudragit L30 D-55 systems: 1 : 1, 1 : 3, 1 : 5. X-ray powder diffraction was applied to compare the degrees of crystallinity of the final product and the starting material. Furosemide has crystal structure both before and after spray drying, it exists in polymorphic forms (form I crystals). No reflection from the crystalline phase has been found on the diffraction pattern of Eudragit. This is an amorphous substance.