Xinda Hot Melt Extruder PSHJ-16 Neo
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Application of Hot Melt Extrusion Technology Hot-melt extrusion is a proven manufacturing Statistics show that 40% of the drugs process that complies with FDA Process sold globally are poorly soluble drugs, Analytical Technology (PAT) goals for design- and the proportion of poorly soluble ing, analyzing and controlling manufacturing drugs among the drugs under research process programs. This technology can be used to produce granules, pellets, immedi- become a key factor affecting the devel- ate-release tablets, controlled-release tablets, opment and application of such drugs. and Pellicle. At present, many drugs have With the upgrading of the industry and been approved for marketing in foreign coun- the advancement of production technol- tries using HME technology. ogy, the "serial production" method may be gradually replaced by the "continuous production". Have her cake, and eat it, too - a technology that can not only improve the solubility of poorly soluble drugs but also realize continuous production mode - hot melt extrusion technology, has emerged. Technical principle of hot melt extrusion： Hot-melt extrusion is a technology that mixes drugs and polymers and other excipients in a molten state, and extrudes them at a certain pressure, speed, and shape to form products. Compounding · System

Homegeneous discharge Fig.1 Schematic diagram of hot melt extrusion process Feed the API and polymer into extruder Under the mechanical force of the extruder and the heating of the barrel, the material melts or softens in a certain temperature range Through the action of strong shearing and mixing by the screw, the multi-phase material undergoes symmetrical exchange and infiltration during the period, and finally it is highly uniformly dispersed in a single-phase Remove moisture or other solvents from the material Through screw conveying and pressurization, and further mixing at the same...

Hot melt extrusion equipment There are two main types of hot melt extrusion equipment, plunger type and screw type. Plunger extruders are gradually eliminated due to their weak mixing ability. Screw extruders are divided into single-screw, twin-screw and multi-screw. At present, single-screw and twin-screw extruders are most widely used in the formulation field. The single-screw extruder is an integral structure, which consists of cooling hopper area, solid conveying area, melting area, and melt conveying area. The twin-screw extruder is a combined structure, which consists of five parts:...

Table 1 Advantages of twin-screw extruder (compared with single-screw extruder) Advantages of twin-screw extruder Material residence time The residence time is short, generally between 1 and 10 minutes. The distribution range is narrow, Mixing effect Under the action of high shear and kneading force, the material mixing effect is better Material dosage The two screws mesh with each other and scrape each other, which has high self-cleaning ability and less material waste Parameter control Strong controllability, continuous operation for extrusion and mixing process, the screw in each section...

Preparation concerns Formula: Polymer + API, with no water to avoid API hydrolysis Process: The melting temperature is controllable, select the appropriate temperature to prevent API thermal degradation Add polymer excipient carrier, reduce particle size to form microcrystals, or amorphous solid dispersions, increasing drug solubility Forms a solid dispersion and improves compressibility Poor compressibility There is no need to add organic reagents during the process Amplify repeatability The same equipment can be selected for the small test and the medium test, and the repeatability is...