solid dispersion technology

Amorphous solid dispersions are a proven approach to alter the properties of APIs for improved dissolution rate, solubility and overall bioavailability. We are an established leader in solid dispersion technology utilizing both spray drying technology and hot-melt extrusion approaches.

Amorphous solid dispersions combine the increased solubility of an amorphous material and the improved stability of more stable solid form. Amorphous API material, which includes amorphous drug substances, amorphous solid dispersions and co-amorphous materials, have higher energy states versus crystalline API, but potentially lower physical and chemical stability.  Polymers are utilized in spray drying and hot-melt extrusion to improve solid state stability of amorphous solid dispersions.

Typical advantages of solid dispersions over other technologies for improving dissolution rate, solubility and bioavailability include:

• Broad applicability over a diverse compound property space
• Accommodates high dose applications for safety studies
• Applicable for either tableting or encapsulation as drug product formats
• Applicable for extended release and combination formulations
• Readily scalable processing

Expertise with solid dispersion technologies

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 a number of target product profile and commercial considerations including:

• physical and chemical stability 
• drug loading requirements
• food effect and variability
• combination versus single API products
• commercial consideration

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. We remain at the forefront of solid dispersion technology and processing, resulting in multiple advancements:

• technology selection
• polymer selection
• processing equipment advancements
• science of scale studies and phase-appropriate processing
• establishing optimized processing parameters and conditions
• scale up and technology transfer best practices
• best practices for drug product formulation with solid dispersions 

Our Center of Excellence for solid dispersions (Bend, OR) offers integrated capabilities from concept through commercial drug product, with phase-appropriate processing in place to support non-GMP feasibility studies, clinical trial manufacture and commercial-scale production of drug product intermediates. Contained processing is in place to support the safe and effective handling of potent and highly potent compounds. As part of our integrated services offer, we provide finished dosage form development and manufacturing for solid dispersion at both clinical and commercial scale.