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Drug development & approval

Hot-melt extrusion

Like spray drying, hot melt extrusion is a process that creates amorphous solid dispersions. Hot melt extrusion is also used in the development of controlled release matrices. Extruded solids may have greater stability than those prepared by spray drying. Moreover no solvents are required.

Essential API properties for applying this technology:
For APIs with low melting point (<225°C) and high thermal stability. 
Your API  should be soluble in a pharma-grade polymer.

Minimum amount of API needed for feasibility study:
10-50 g