Spray-Dried Dispersion (SDD)
Bend Research's spray-dried dispersion (SDD) technology offers a solution to an estimated 60 percent of compounds that, in early development, have poor solubility. Our 17-year long history and proven track record with SDDs make us an ideal partner for advancing low-solubility compounds:
- > 700 compounds formulated as SDDs
- > 450 compounds in preclinical studies
- > 65 compounds advanced to the clinic
- > 50 unique clients have used our SDD technology
- Predictive model based approaches to performance and stability assessment and process definition minimize development time and risk to your program
An SDD is a single-phase, amorphous molecular dispersion of a drug in a polymer matrix. It is a solid solution with the compound molecularly "dissolved" in a solid matrix. As the name suggests, SDDs are obtained by dissolving drug and polymer in an organic solvent and then spray-drying the solution. The formulation and process conditions are chosen so that the solvent quickly evaporates from the droplets, allowing insufficient time for phase separation or crystallization.
In addition to their proven performance, SDDs have demonstrated long-term stability and excellent manufacturability.
- Bend Research has formulated several hundred compounds as SDDs for in vivo testing.
- Over 50 drug compounds have been formulated as SDDs and manufactured at Bend Research from advancement to Phase 1 - 3 clinical studies.
- Shelf lives of more than 2 years have been consistently demonstrated with SDDs. Validated physical-stability models allow reliable identification of stable formulations from short-term data.
- SDD manufacturing has been reproducibly demonstrated at scales from milligrams to metric tons, enabling production of development quantities through Phase 3 clinical supplies and product launch. Process development, technology transfer, and scale up are successfully achieved using a comprehensive set of experimental tools and fundamental models. This results in low bulk-drug requirements for early-stage testing and rapid turnaround times to support fast-paced projects.
Download the PDF below to view the spray-drying equipment available at Bend Research.
SDD technology provides key advantages:
- It enhances oral bioavailability of poorly water-soluble compounds.
- It is suitable for delivery using traditional solid dosage forms such as tablets and capsules.
- It allows for a reproducible, controllable, and scalable manufacturing process.
- It is broadly applicable to structurally diverse insoluble compounds with a wide range of physical properties.
Contact us today for help with your challenging compounds.