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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.

CharacterisationPhysical formFormulationStability
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 solvatesPharmaceutical 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.

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