A formulation is developed to allow the drug to be dosed via the chosen administration route, at the right dose, and resulting in the desired pharmacokinetic profile in the patient.

The drug needs to be stable in the formulation under the chosen storage conditions, to allow for appropriate shelf life. Additionally, stability needs to be demonstrated during the preparation of the drug for patient administration. The formulation may need to be changed during development, for example, when new clinical information suggests a different dose is required.

As development enters late stage, it becomes necessary to understand more about the formulation, for example how changes in pH or excipient concentration or grade affect stability. Coupled with more data becoming available, this leads to a better understanding of the molecule: a fundamental part of demonstrating control over the manufacturing process.

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with our Xpert

Bert-Jan Haijema

Managing Consultant CMC