The stability of an API 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, heat or can become unstable upon contact with biological fluids. These characteristics can limit the shelf life of a formulation, performance and hinder its marketability.
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.
At Pensatech Pharma we have the scientific expertise in stability with the ability to develop stability-indicating methods and solutions to improve the stability of the compound and the product.
Contact us to learn more about our capabilities and to discuss how we can solve your stability-related problems.