Managing the natural variability and contaminants of plant-based pharmaceutical ingredients
Director R&D and Regulatory
ADM – SIO
Why managing variability? Pharmaceutical ingredients play a key role in drug formulation. Variations in their composition and physicochemical properties can have significant impact on the final drug product performances like safety, physical and chemical stability and bioavailability. In the recent past, ingredient variability has been at the origin of FDA recalls. Natural-based products are by definition subject to a certain degree of variability but appropriate solutions can be developed to manage this variability and propose consistent plant-based pharmaceutical ingredients. As a manufacturer of highly purified vegetable oils, SIO has implemented a full management of this natural variability. Risk assessment can be used to understand variability of naturally-derived pharmaceutical ingredients and identify which material attributes have an impact on the performances of the final dosage form.