SimpliFiH™ Solutions is specifically designed to reduce phase I timelines by at least 3 months vs traditional approaches. This service is also designed for the flexibility required to fit your molecule and drug program:
- API to OEL 4 – dedicated kilo-labs and teams in place to provide the quantities necessary for preclinical and early clinical trials
- Solid state characterization – API physicochemical characterization, aqueous solubility, salt and polymorph screening services
- Solubility and solubility rate enhancement – proprietary modeling / technology selection services and manufacture of enabled phase I drug product with required dissolution rate and/or aqueous solubility
- Drug product in phase-appropriate format: powder-in-capsule (PIC), powder-in-bottle (PIB), liquid-filled hard capsules (LFHC) or tablets
SimpliFiH™ Solutions centers on a rapid technology selection methodology that requires a single gram of API to identify a phase I appropriate approach to address poor bioavailability and solubility: particle size reduction, spray dried dispersion (SDD) technology or liquid/lipid based technology. Eliminating parallel technology evaluations saves precious API and time in reaching phase I clinical trials.
To learn more about SimpliFiH™, please download our technical brief.