EFFECT OF PEG 6000 ON INCREASING DISSOLUTION PROFILE AND FLOW PROPERTIES OF ERDOSTEINE BY SPRAY CONGEALING METHOD

• Main Author: Nazar Arrahman, Ikhsan
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/80289
• Institution: Institut Teknologi Bandung

Erdosteine is a mucolytic agent that has poor physicochemical properties, especially the dissolution rate and flow properties, so it needs to be improved, in this case through the formation of a solid dispersion with the help of polymers. This research aims to improve the poor dissolution profile and flow properties of erdosteine by adding polymer. The excipient in the form of polymer used is polyethylene glycol 6000 which is made in 5 ratios with active pharmaceutical ingredients in different compositions. By considering the physicochemical properties of erdosteine and polyethylene glycol 6000, a solid dispersion was prepared using the spray congealing method using liquid nitrogen. Furthermore, characterization of Powder X-ray Diffractometry (PXRD), Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), Particle Size Analysis (PSA), powder dissolution test, and powder angle of repose. From the preparation results, the degree of crystallinity (DOC) in EP1-SC (50.20%), EP2-SC (49.80%), EP3-SC (48.75%), EP4-SC (47.87%), and EP5-SC (47.33%) with significance between solid dispersions showing no significant difference (p > 0.005). Meanwhile, ER-RM compared to ER-SC shows that there is an influence of the preparation method on crystallinity with a decrease of 13.03%. DSC data shows a decrease in the melting point of ER-RM (154.64°C) to 118.62°C (EP5-SC). The IR spectrum shows a shift in wave numbers in the O-H stretching vibrations (carboxylic acid groups). The powder dissolution test produced a dissolution percentage in the 30th minute of ER-RM powder of 29.59%, EP1-SC (45.31%), EP2-SC (61.12%), EP3-SC (80.80%), EP4-SC (98.18%), and EP5-SC (98.86%). From SEM testing, the morphology of the particles is in the form of spherical agglomerates with a size distribution of around 300?m and improvements in flow properties make it easier to flow when calculating the angle of repose.