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Amorphous solid dispersions combine the increased solubility of amorphous material and the improved stability for a more stable solid form. Amorphous API material have higher energy states versus crystalline API but potentially lower physical and chemical stability. Polymers are utilized in spraydrying and hot-melt extrusion to improve the solid-state stability of amorphous solid dispersions. Typical advantages of solid dispersions over other technologies for improving dissolution rate, solubility and bioavailability include:
When a solid dispersion is determined to be the proper approach for addressing bioavailability issues, the choice between spray drying and hot-melt extrusion technologies is typically based on several target product profile and commercial considerations including:
Best practices have also been developed for technology transfer between spray drying and hot-melt extrusion. Spray drying is often used for feasibility, preclinical and phase I studies due to lower API requirements versus HME approaches.
Solid dispersion technologies: