DDS & FORMULATION PLATFORMS

In addition to expert design and development of a broad range of formulations for different drug delivery formats, LATITUDE offers its clients proprietary drug delivery technologies derived from our many years of experience as drug formulators.

These innovative dosage platforms, which have patents issued or pending, can solve particularly challenging formulation issues as well as provide new intellectual property for API.

LATITUDE’s latest drug delivery technology is a powerful yet safe, broad-spectrum solubilizer called ClearSol.  The ClearSol™ vehicle forms stable, one-phase aqueous solutions with about 80% of insoluble APIs tested, much greater than achieved by other solubilizers such as cyclodextrins, polysorbates, and organic solvents.  Furthermore, ClearSol™ formulations can be freely diluted in water or IV infusion fluids without any precipitation of the API, and can be sterile-filtered through standard 0.2-micron filters.  ClearSol™ is made up of three Generally Regarded As Safe (GRAS) excipients that are FDA-approved for injection, and safety of the ClearSol™ technology has been demonstrated in several animal models and a U.S. Phase 1 human clinical trial under an FDA-approved IND.