Low solubility and bioavailability are common and growing challenges for the pharmaceutical industry that can impede or prevent the progression of promising drugs to market.
Poor water solubility has been shown to affect approximately 40% of the top 200 oral drugs on the US market and 33% of drugs listed in the US Pharmacopeia.1
Furthermore, scientific and computational advancements are leading to the discovery of an increasing number of new chemical entities (NCEs) — up to 90% of which exhibit poor solubility and bioavailability.2
In this context, two classes of molecules are particularly problematic for formulators.
BCS Class II molecules are highly permeable, but their poor solubility limits bioavailability; BCS Class IV molecules exhibit low permeability and low solubility, resulting in low bioactivity.
These properties hinder both therapeutic potential and innovation, particularly in oral and injectable dosage products.
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