Once a screening is completed, each solid form is further investigated. After a small scale-up, we proceed to full solid state and physico-chemical characterization (stability, solubility, dissolution) aiming at form selection.
Relative stability of selected phases (stable/metastable polymorphs, salt hygroscopicity, …) are investigated vs. temperature, relative humidity, solvents and more.
We perform investigations from evaluation to full solubility profile vs. temperature in solvent mixtures or biologic media (e.g. SGF, Fessif, Fassif).
We can measure pure API dissolution by IDR (Eu. Ph. 2.9.29), providing relevant comparisons of dissolution for various polymorphs/salts/co-crystals.
We support our customers to select the most suitable solid form according to the objectives: bioavailability, dissolution, stability, yield, processability, formulation development, IP…