A flexible platform
Pioneered by Bend Research, the SDD platform incorporates compositions, processes and dosage forms designed and proven to meet performance, stability and manufacturability requirements for a diverse range of compounds. With our integrated product development approach, we can manufacture SDD formulations for all stages of development, from preclinical to late-stage development and commercial production. Drug product intermediates can be formulated into capsules, tablets and other forms.
A streamlined formulation process
Our approach provides rapid and reliable advancement of low-solubility compounds.
A proven technologySDD technology has been proven in thousands of compounds, resulting in significantly improved bioavailability, typically from three to 15-fold.
Particle size reduction through micronization is our core capability. Decades of jet milling experience with more than 1000 drug compounds has led to substantial capabilities and expertise in micronization and particle classification. Specialized and phase-appropriate jet mills and labs are in place to support early stage development studies. Clinical and commercial scale production leverages the processing and process validation from early stage studies.
Proven technology: while there are several platform technologies and manufacturing techniques to produce amorphous solid dispersions, hot-melt extrusion (HME) is a leading approach based on mature process understanding, small process footprint and continuous operation. It is readily scalable. These attributes allow for more of a plug-and-play unit operation, resulting in relatively lower manufacturing costs and making it a more appealing commercial process train.
Extensive experience: by combining our depth of solubilization technologies with our fundamental understanding of pharmacokinetics, we can rapidly identify, prototype and optimize an amorphous solid dispersion formulation that improves the bioavailability of a low aqueous solubility drug substance.