Solid form is becoming increasingly important within drug development, driven in particular by the fact that a growing number of APIs being developed fall within class II/IV of the BCS classification system, indicating that they are likely to prove problematic when it comes to pre-formulation and formulation development. It may then prove challenging to develop a formulation strategy that delivers sufficient in vivo exposure to elicit the desired therapeutic response.
This emphasis also manifests within process development (pR+D), where a thorough understanding of solid forms of an API can expedite crystallisation development/purification work throughout development. A good understanding of solid form variability and the potential for generating new versions of the API (salts or cocrystals) can bolster the IP position.
Upon lead selection, the shared goal of outsourcing managers and suppliers is to expedite the lead candidate through chemical development and ultimately to the first-in-man batch. A common phrase heard on both sides of the table these days is that said development has to be ‘fit for purpose’. This means that to mitigate the risk of clinical failure at such an early stage, any chemical development work needs to be carried out efficiently, providing chemical solutions that are scaleable and a robust (preferably the most stable thermodynamically ) solid form candidate, and leaving non-essential development work until the programme has been derisked somewhat by a successful Phase I trial.
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