Application of DOE to API ingredient concentrations

presented by Samd Guizani

The control of ingredients quantities in pharmaceutical formulations is critical to a drug product quality. Often, the Active Pharmaceutical Ingredient (API), and sometimes specific excipients, concentrations testing in the final product is required to release a batch.

On an existing marketed product, 2 liquid chromatography methods have been developed and are currently used to test the API and an antioxidant concentration in an aqueous injectable solution. These methods are time-consuming and labor-intensive. The lead time to receive the results is in the range of days.

By applying Design of Experiments (DoE) and Multi-Variate Data Analysis (MVDA), a UV-Vis spectroscopy chemometric model has been developed which is capable of measuring simultaneously both ingredients contents in the formulation. The test can easily be applied to finished or bulk product and the results are immediately available.

Such method can be used in Quality Control lab to reduce the workload and batch release lead time. More interestingly, it can be implemented on-line to test the bulk product, opening the door to real-time process control and product release.

June 15 at 9:00am Central Time