Hot Melt Extrusion and Its Pharmaceutical Application

Hot Melt Extrusion is a production technology that was first developed in the early 1930s for usage in the plastics and food sectors but is now gaining traction in other industries as well, including the pharmaceutical business.

After first being used in the pharmaceutical business in the 1930s, hot-melt extrusion has attracted increasing attention from the pharmaceutical industry and academia because it allows for the continuous production of a wide range of dose formulations.

Recently, the technique has been employed in the pharmaceutical business for the development of innovative medical devices and medications. The procedure can be used to make substances for the development of therapeutic drug-eluting devices, as well as to combine active pharmaceutical ingredients (APIs) with polymers, which increases the bioavailability of APIs while also masking their bitter taste.

 

Hot Melt Extrusion Pharmaceutical

 

What is Hot Melt Extrusion, and how does it assist us in the development of new medicines?

Hot-melt extrusion technology has gained considerable popularity in the pharmaceutical industry as a result of the advantages it provides over traditional manufacturing techniques, as well as the fact that it provides an efficient production process that improves the quality of the finished products. The approach is most commonly used in drug development for the molecular dispersion of active pharmaceutical ingredients (APIs) into polymer matrices, which results in the formation of solid solutions.

Because of this, hot-melt extrusion has been utilized for a variety of applications, including increasing the bioavailability of water-insoluble medications by making a solid solution, regulating drug release, disguising the taste of bitter active pharmaceutical ingredients (APIs), and manufacturing thin films.

Another advantage is the ability to incorporate analytical technologies into a quality-by-design strategy for continuous manufacturing; as a result, hot-melt extrusion has been recognized for the design, analysis, and quality control of the active extrusion process.

 

The Components of Hot Melt Extruder

Hot-melt extrusion is carried out with the help of an extruder, which is a barrel with a platform holding one or two revolving screws that are used to force things down the barrel. Four major components make up a hot melt extruder, which is as follows:

  1. An orifice that is used to introduce substances into the barrel; may include a container into which the substances to be extruded is placed, or it may be continually supplied with the substances by one or more external units.
  2. Process platform consisting of the barrel and screw(s) that move and, when required, combine the substance
  3. An opening through which the substance is shaped as it exits the extruder
  4. Additional apparatus for cooling, cutting, and/or collecting the finished product

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