Available from Lonza Pharma & Biotech
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 OEB 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 dissolution 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, powder-in-bottle, liquid-filled hard capsules 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.