Solumer™
Solumer technology is based on a "bottom-Up" process, whereby components in a liquid feed self assemble into particles that demonstrate significantly improved API dissolution and bioavailability. Initial noncovalent interactions between pre-selected combinations of polymers and lipophilic drug occur in the liquid composition. A subsequent drying process ensures a strengthening of these interactions resulting in a self-assembled polymer-drug complex in powder with the drug encapsulated in a stabe crystalline state.
Technology benefits:
- An easily scaleable, continuous and simple 2-step process
- Process Uses only standard pharmaceutical equipment;
- Good repeatability, batch-to-batch consistency and robustness;
- Low risk of contamination (a common with multi-step nano-particle systems);
- Low process maintenance- smoother path to clinical batch and industrial production;
- No additional steps needed for residual organic solvent elimination (a problem with other nano-particle production technologies);
- Good In-process stability
- Long shelf life – Physico-chemical stability proven for more than two years
- A variety of oral dosage forms available from the powder;
Straightforward product approval
- Clinically proven increased bioavailability compared to commercial drugs; bioequivalence to best-in-market nano-formulations
- Use of regulatory approved or GRAS polymers
- Streamlined Regulatory Tracks (ANDA, 505(b)2)
- IP protected
The Solumer™ platform is offered on a fee for service basis for technology feasibility assessment as well as manufacture of batches for preclinical administration. If you would like to discuss this technology in more detail, please contact us directly.
If you would like a copy of the Solumerâ„¢ technology flyer, please contact us directly