Practical Aspects of Solubility Determination Article – Some Thoughts

I’ve just finished reading a nice review article in American Pharmaceutical Review discussing practical aspects of solubility determination.  I am an extremely practical scientist and am drawn to articles with the word “practical” in the title!

This article touches on a few nice discussion points that affect our early small molecule formulation work greatly.  When we develop a toxicology formulation for an early stage compound, we try to note to our clients that this formulation may only be applicable to the current lot of Active Pharmaceutical Ingredient (API).    Most often, the formulation works for several lots, but that isn’t always the case.

In early drug development, there can be immense variation in each lot of drug substance.  It is not uncommon for two lots of lab scale API to even be different colors.  Causes of this variability include solid form (polymorph, hydration status) and presence/absence of impurities.

Unfortunately, when a formulation is developed for an early compound to just “get it into animals and see what happens”, it may not be appropriate for future studies with different API lots.  That is a risk that many small pharma companies (without the resources for early stage full drug characterization) must take in order to start gathering important data.

Check out the article here.

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