Profound Strategies to Improve API Stability

API stability must be guaranteed not only in the final dosage form but also during manufacturing and analysis activities, and upon storage. This can sometimes be challenging since many APIs are sensitive to external conditions like moisture, oxygen or heat, or become unstable upon contact with biological fluids. These characteristics can also limit the shelf life of a product, result in expensive packaging requirements and limitations in commercialization potential.

Different strategies can be applied to improve the stability of the compound, including the use of excipients, processing techniques and functional packaging. The correct selection and application of these strategies requires a deep understanding of drug degradation pathways and knowledge about analytical method and stress tests development.