Pre-formulation studies are aimed at new active pharmaceutical ingredients (APIs) and carried out to elucidate their physicochemical properties and thereby develop an appropriate dosage form. Each API will have particular physical and chemical characteristics and it is vital to understand these intrinsic properties, particularly under stress conditions, in order to provide a solid foundation for development of a sufficiently robust dosage form that can survive processing and provide an appropriate shelf life.
Insufficient, or ill-conceived pre-formulation studies can lead to increased costs, wasted time, or real health risks. Proteins in particular, discovered through traditional medical research methods, or the newer fields of genomics or proteomics, have often been used in drug development without a comprehensive knowledge of their mechanisms of action, biochemical properties and structural characteristics.
As proteins are likely to be unstable, there is a high possibility that their form could be altered from the required configuration, affecting any drug’s efficacy and even patient safety.
Efficiently conducted pre-formulation studies are a much better option than costly errors and can provide a faster route to market.
In addition, over the past fifteen years in particular, a reduction in the development of new, first-in-class molecules alongside patent expirations has occasioned the strategy of drug repurposing as a serious development option; another reason for conducting pre-formulation studies.
Comprehensive pre-formulation studies are more than repaid via cost and time savings which is why many companies outsource pre-formulation studies to expert service providers such as the R&D consultancy division of Biopharma Group.
If you would like more information about how Biopharma can help you or to discuss your requirements in detail, simply contact Dr. Roberto Castangia: btl@biopharma.co.uk
