Protecting from Oxidation: The Use of Antioxidants in Biologics
Oxidation is a major degradation pathway for many biologic drugs, especially those with sensitive amino acid residues. This process can lead to the formation of new, unwanted compounds or the loss of the active ingredient's function, compromising the drug's safety and efficacy. To combat this, formulators often include antioxidants as a crucial class of biologic excipients.
Antioxidants, such as methionine, ascorbic acid, and glutathione, are added to a formulation to prevent or slow down oxidation reactions. They work by scavenging free radicals and other reactive oxygen species that can cause damage to the biologic molecule. This is particularly important for injectable or liquid formulations, where the drug is more exposed to oxygen.
The inclusion of an antioxidant can significantly extend the drug's shelf life and ensure its potency remains stable over time. As the biopharmaceutical industry continues to develop more complex and sensitive molecules, the role of antioxidants in formulation will become even more critical for ensuring product integrity and patient safety.
FAQs
What is the purpose of an antioxidant excipient? Its purpose is to prevent or slow down oxidation reactions in a drug formulation, which can degrade the active ingredient.
Why are antioxidants important for biologics? Biologic molecules are highly susceptible to damage from oxidation, so antioxidants are essential for maintaining the drug's stability and shelf life.