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How To Ensure Your API Is Compatible With Its Formulation

How To Ensure Your API Is Compatible With Its Formulation
14/03/2019

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 thereby reduce the product’s shelf life. Additionally, the processing method, such as freeze drying, must be factored for as this can cause many physical and chemical changes to the API.

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

The Importance Of Early Product Characterization The physical and chemical properties of an API have a direct impact on the formulation requirements,

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Solubility in physiological fluids How it reacts with other components of the formulation Dissolution rate in the body Powder properties like particle size and distribution Flow properties which can affect the manufacturing process The cost and time involved in conducting these kinds of tests prior to formulation development is a legitimate concern. However, the modest costs involved in gaining these kinds of critical insights into the characteristics of your API early on will save you a considerable degree of avoidable damage, liability, lost efficacy, costly interruptions, and, ultimately, will prevent risk to the patients and end users.

It may appear to be an easier option to go back and retro-develop the drug substance to fit with your final formulation, but the truth is that this would be a far more time-consuming, laborious and costly process. Even small changes to your API manufacturing process are likely to require a new clinical study to demonstrate that it is equally effective as the original substance in order to gain FDA approval.

There’s no doubt that it’s hard to break down existing organization silos in order to create a more aligned approach to API synthesis and formulation development, but the benefits of shortening the development timeline by getting things ‘right first time’ far outweigh the negatives. In addition, you’ll see a faster return on investment, and – most importantly – get potentially life-saving medicine to patients sooner.

For more information follow this link: How To Ensure Your API Is Compatible With Its Formulation

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