Why Pre-formulation Studies are Crucial to Successful Drug Development

It is vital to understand the behaviour of a new active pharmaceutical ingredient (API) under various stress conditions to provide a solid foundation for development of a robust dosage form which can survive processing and a prolonged shelf live. The result of a poor, or no, pre-formulation study could be increased time and cost of drug development, an unstable product, or worse. Efforts taken on comprehensive pre-formulation studies are more than repaid via cost and time savings.

Newly discovered proteins identified through genomics, proteomics, or traditional medical research have historically been utilised in drug development with minimal knowledge about their mechanisms of action, structural characteristics and biochemical properties.

Proteins are inherently unstable, which has potential to alter its desired form, which could significantly compromise not only the drug’s efficacy, but patients’ safety. This is why pre-formulation is such an essential part of the drug development process. It is the group of studies undertaken in early biopharmaceutical development, prior to formulation development, focused on discovering the physicochemical properties of a new drug molecule which could affect its performance and consequent dosage form. It provides a scientific sketch of the drug in development.

Having a clear understanding of a protein’s behaviour and awareness of any adverse effects related to a product, demonstrates the worth of conducting pre-formulation studies. Getting things right the first time is much more preferable to making costly mistakes and it is also a much faster route to market. Furthermore, patent expirations and a reduction in the development of new, first-in-class molecules over the past 15 years has occasioned the strategy of drug repurposing. This is yet another reason to conduct comprehensive pre-formulation studies. Many companies outsource pre-formulation studies to service providers such as the R&D consultancy division of the Biopharma Group.

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