Harnessing the power of liquid solubilisation technologies

During early-stage pharmaceutical drug development, new drug molecules must be formulated into a delivery system that is suitable for administration in both pre-clinical animal models as well as early phase clinical studies. Rapid identification of an optimal formulation (or a lack thereof) can significantly impact the results of these studies and confer significant time-saving and cost benefits to the overall drug development program.

In order to help facilitate the development of poorly solubile compounds, the scientists at Synectix have developed a proprietary formulation screening platform, SOLENT™ (SOLubility ENhancement Technology) to support preclinical biovailability and toxicity testing investigations, as well as early-phase clinical trials.

The foundation of SOLENT™ lies in its utilisation of an innovative preformulation matrix, which incorporates a wide variety of liquid-based GRAS formulation excipients approved for both preclinical and clinical use (including pH adjustment, co-solvents and combination excipients, microemulsions, SEDDS, oils, lipids and cyclodextrins).

Using as little as 50 mg of API in total, we are able to rapidly screen up to 128 formulations in parallel at high dosage levels (up to 100 mg/ml), with the highest priority being to solubilise your poorly soluble compound and keep it in solution, either long enough for safe parenteral administration or alternatively until oral absorption can take place.

Benefits of the SOLENT™ screening platform include:

1. GRAS liquid formulations designed for maximum drug loading and exposure
2. Up to 128 formulation compositions analysed simultaneously (depending on route of administration)
3. 'Real-time' monitoring of drug kinetic solubility and solution stability
4. Rapid identification of formulations suitable for either oral or parenteral administration
5. Rapid delivery of test results using our novel high-throughput screening platform (results available in only 1 week)
6. Parenteral formulations of your API can be further developed for intravenous, subcutaneous, intramuscular and intraperitoneal delivery
7. Rapid delivery of successful test samples for in vivo investigations with supporting stability testing to match planned study timelines

Dosing Recommendations

All of the formulations in the SOLENT™ screen are designed for oral dosing. The formulations that are liquid at room temperature can be dosed to your animals via syringe (oral gavage). Larger animals may be easily dosed with hard gelatin capsules from Capsugel. Capsugel has a Licap™ capsule that seals, thus allowing dosing of liquid or semi-solid formulations in hard gelatin capsules.

Contact us today to find out how Synectix can assist you in reaching your dosing goals during preclincal toxicity testing and bioavailability screening studies.