Pharmaceutical Forced Degradation Studies with Regulatory Consideration

Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stabilityindicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. These experiments generally expose the material to an external stress to assess the stability of the constituents or formulation. External Stress mainly includes temperature, pH, light, moisture, and even exposure to other materials within the product formulation, and their degradation products. Conventionally, degradation tests can take very long periods of time, because standard test methods require the materials to be exposed to stress factors for periods of weeks or longer, and then tested using standard analytical methods. Accelerated testing is of clear benefit, as use of elevated temperature to increase the rate of interactions is the most powerful factor to shorten the length of time required for these tests. Forced degradation studies ensure appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development.