Industry experts explain why polymer structures and functionalities are important considerations in formulation development.

Poor solubility is one of the major problems hindering a molecule from progressing through the drug development pipeline. Approximately 70% of new chemical entities (NCEs) have been reported to be poorly soluble (1), which is not surprising given that modern drug-discovery techniques select compounds based on their binding affinities to target receptors. The most promising candidates are often highly lipophilic, hence, leading to solubility and bioavailability issues. Even for marketed drugs, it is estimated that 40% consists of APIs that fall into class II (low solubility, high permeability) or class IV (low solubility, low permeability) categories of the biopharmaceutics classification system (BCS) (2). Of 45 NCEs approved in 2016, 32 were small molecules and a significantly large number of them were poorly soluble (3).

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