Your Crystallisation, Solid State and Preformulation Partner

· Crystallinity and initial diffraction pattern by XRPD

· Thermal analysis by TGA and DSC to detect any phase changes and/or desolvation events

· Hygroscopicity and hydration behaviour by DVS

· Morphology assessment by PLM and Hot Stage microscopy for added understanding of thermal events

· Purity and identification by LC and NMR

· Counter-ion selection according to measured or predicted pKa of the parent compound

· Structure based selection of co-formers for co-crystal screening

· Full characterisation of any hits including salt/co-crystal stoichiometry

· Dissolution rate and equilibrium solubility assessment using the Pion MicroDISS platform

· Chemical and physical stability of new versions

· Recommendation of a lead version with data-based rationale for the choice

· Targeted manual screening approach

· Solvent based methods including slurry, cooling crystallisation, evaporation, and anti-solvent addition

· Thermal and vapour stressing

· Water activity studies to uncover and characterise hydrates

· Full characterisation of any novel XRPD patterns

· Competitive slurrying of characterised forms to determine the most thermodynamically stable form

· Solvent screening including solubility and stability testing

· Temperature solubility profiling of selected solvent systems using Technobis Crystal16

· Process Modelling in Dynochem to create initial process design including initial and final temperatures and solvent compositions, as well as seeding temperature and composition

· Small scale testing of process designs using Technobis Crystalline

· Particle size distribution measurement using Malvern Mastersizer 3000

· Morphological assessment using PLM

· Powder Flowability assessment by Tap Density

· Full interaction mapping to determine if a more stable form is likely to exist

· Hydrate and Solvate analyser to assign probability of a stable solvate based on voids within the crystal lattice

· Hydrogen Bond Propensity to predict interactions between solvents and API

· Small scale API micronisation experiments

· Determination of effect of grinding pressure, venturi pressure, and feed rate through design of experiments approach

· Chemical and physical stability testing of micronised API

· In-depth review of available data on API and particle properties, as well as a more holistic approach view of the project and intended use case to identify risks early in the timelines and work on mitigation strategies

· Binary Excipient Compatibility testing

· Powder flow properties assessment

· Intrinsic Dissolution Profiling and equilibrium solubility in biorelevant media using Pion MicroDISS platform