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.

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