Pre-Clinical Package for Small Molecules
Identifying Candidates and Highlighting Potential Pitfalls
Our pre-clinical package for small molecules offers an intelligent, rapid, and economical approach for lead identification. Designed to identify candidates with drug product-like characteristics, it will also highlight the potential pitfalls associated with the molecules.
Experimental efforts concentrate on establishing the physical / chemical, solubility, stability and polymorphic characteristics of each candidate. The information generated can then be used to make a rational decision for lead identification.
| Characterisation | Physical form | Formulation | Stability |
| Crystallinity (XRPD, PLM) Melting point (DSC) Hygroscopicity (DVS) Particle size and shape (microscopy) Moisture/Solvent content(TGA) Log P, pKa and lipophilicity profile Permeability (Caco-2) | A lean polymorph screen on each candidate to establish the polymorphic landscape and determine the tendency to form hydrates or solvates | Pharmaceutical solvents Water SGF SIF Saline | Development of stability indicating LC-MS methodSolid state stability (heat, humidity, light)Solution stability (pH, oxidation, heat, light) |
Timelines and Costs
It is anticipated that the pre-clinical package will be completed in 4 weeks. Typically, we customise studies to our clients’ needs and budget. Quotations are available on request.