Hot melt extrusion technology refers to a technique of homogeneous mixing of drug and carrier excipients in molten state and extruding them at a certain pressure, speed and shape. This technology enables the drug to be dispersed in the carrier in molecular, amorphous or sub-stable forms, which can improve the solubility and bioavailability of insoluble drugs, and has a broad development prospect in the pharmaceutical field because of its low cost, simple process, good reproducibility and high production efficiency. CD Formulation provides hot melt extrusion technology for microsphere preparation, which can be prepared into different solid formulations, including tablets, capsules, films, danses and granules.
The drug is first premixed with a thermoplastic polymeric carrier and other excipients and then filled in a single or twin-screw extruder. The rotating screw drives the physical mixture for further extrusion, while the extruder jacket is heated at high temperature. Under the effect of strong heat and shear, the drug and the excipients achieve good compatibility and are converted from a multiphase state at the inlet to a single phase state at the outlet and extruded through the outlet die hole.
As a new formulation technology, HME has the advantages of good dispersion effect, no organic solvents, continuous and controllable process, etc. The application of this technology in different dosage forms of slow and controlled release formulations has developed considerably and has become the leading technology for preparing solid dispersions at home and abroad in recent years. In the process of hot melt extrusion, it is important to choose a suitable carrier, the compatibility of drug and carrier has a significant impact on the product performance, and the pores of the carrier material and its microporous structure have a significant impact on the release rate. With the continuous development, improvement and application research of the formulation process and new carriers, HME will gain more significant development in the pharmaceutical field.
The controllable process parameters in the hot melt extrusion process are mainly the barrel temperature and charging speed, and the related process parameters are retention time, filling degree, shear rate, etc.
The barrel temperature can be set in sections, and the temperature at the charging port is slightly lower than that of the melt section to prevent the material from melting and sticking at the charging port and causing the material to accumulate. The temperature of the melt section is set according to the composition of the prescription to ensure that its fluidity and thermal stability meet the requirements, while the viscosity and compatibility of the system should be considered.
The charging speed and screw speed need to be set to match to ensure that the material is effectively filled in the barrel. When the charging speed is faster than the screw speed, the material will accumulate in the charging port; when the screw speed is faster than the charging speed, the effective filling rate of the material in the barrel is low, which may cause the screw to idle and produce wear.
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