Ensuring your API is Compatible with its Formulation 

Years of hard work and research go into developing new APIs, so when it comes to developing one into a new formulation for mass production, careful attention must be paid to its physical and chemical properties. Thorough consideration must go into the excipients to be used, as these can affect how the active ingredient will be released, and they can also react with the API and reduce the product’s shelf life.  Additionally, the processing method, such as freeze drying, must be factored as this can cause many changes to the API. 

However, there is often a disconnect between the API synthesis and formulation development stages. The API manufacturing process will be almost complete when the formulators begin work on a final commercial formulation, with little or no communication between the two lines of work - leaving formulators with a drug substance that is less than optimal for product development. So, it’s vital to characterise API properties early in order to produce the best possible final formulation.

The physical and chemical properties of an API have a direct impact on formulation requirements, such as solubility in physiological fluids, how it reacts with other components, dissolution rate, powder properties and flow properties which can affect the manufacturing process.

The costs and time involved in conducting these kinds of tests prior to formulation development is a concern. However, the modest costs involved in gaining these insights will save a considerable degree of avoidable damage, lost efficacy, liability and will prevent risks to patients and end users.

It’s hard to break down organisation silos, in order to create a more aligned approach to API synthesis and formulation development, but the benefits of getting things ‘right first time’ far outweigh the negatives. The Biopharma Group will help you see a faster return on investment, and most importantly, get medicine to patients sooner.

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