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Excipients for Hot Melt Extrusion

Hot melt extrusion has gained importance in the pharmaceutical industry as far as its applicability has been demonstrated for many purposes, such as:

• Enhancement of the dissolution rate and bioavailability of the drug
• Control or modulation of the drug release
• Taste masking
• API stabilization

How can hot melt extrusion achieve the purposes above mentioned?

Increasing dissolution rate and bioavailability of poorly water-soluble APIs is one of the important challenges at the development of solid dosage forms (Fig. 1). One effective approach is the solid solution formation with the drug and hydrophilic excipients. The stable solid solution is the ideal form of increasing the drug release. In this formulation of Fig. 1, the drug is molecularly dissolved and has a lower thermodynamic barrier for dissolution.

Fig. 1: Steps applied from a crystalline drug to a finished product in a solid solution formation.

Solid solutions can be effectively prepared via hot melt extrusion, which is a reliable and robust process.

Compared to other possible processes used to prepare a solid solution, hot melt extrusion is, by far, less complex and more cost-effective, since the manufacturing process requires only a few steps. Hot melt extrusion also presents advantages against solvents-based processes when processing solid solutions:

• The handling of explosive solvents is not necessary
• Possibility of continuous process
• High product density
• Non-dusty granules
• Water-free process

Click here and learn more about how to use the BASF excipients for hot melt extrusion.