Study On Key Technologies Of Hot Melt Extruder For Indomethacin Mixing

Indomethacin(INM)is a non-steroidal anti-inflammatory drug that has antipyretic and analgesic effects,because of its poor water solubility,its bioavailability is extremely low,and it cannot be used clinically well.The application of solid dispersion technology to the preparation of such drugs and water-soluble polymer carriers into solid dispersions can increase the dissolution of drugs and improve their bioavailabilityThis article taked indomethacin as a model drug and polyethylene glycol as a polymer carrier to study the key technologies of hot melt extruders for indomethacin mixing,on the basis of meeting the requirements of the"Pharmaceutical Production Quality Management Specification(2010 Revision)",the drugs is mixed well to improve its bioavailability.According to th e GMP standard and co-rotating twin screw plastic extruder standard,the main structure of hot melt extruder was designed and researched.In order to facilitate the cleaning and disinfection of the equipment,the designed hot-melt extruder needs to realize the quick disassembly and assembly of the barrel and screw.In order to improve the bioavailability of drugs,the screw configuration of the hot melt extruder was designed to achieve a better mixing effect of the drug and the carrier.In this paper,sixteen screw elements were designed,and the flow field under each screw element was numerically simulated using POLYFLOW software to analyze the weighted average shear stress,cumulative maximum shear stress,cumulative residence time,and average reflux coefficient of each flow field.By analyzing the simulation calculation results,the screw component with strong mixing performance was selected.Based on the analysis of the mixing performance of each screw element,seven screw configurations of the mixing section were designed to study the mixing performance of the screw configuration of each mixing section in the flow field,and the screw mixing configuration of the hot melt extruder was selected.The process parameters of the hot melt extruder were changed,the screw flow field of the mixing section was numerically simulated,and the influence of the screw speed and the amount of feed on the drug mixing effect was summarized.Through the extrusion experiment,the influence of the screw speed on the mixing flow field was verified.Scanning electron microscope observation(SEM)and in vitro dissolution test method were used to evaluate the quality of extruded samples.