Oxygen Sensitive Drug Products

By Dr. Thomas S. Ingallinera, R.Ph., Ph.D.

Oxygen is the second leading cause for quality degradation of pharmaceuticals, water being the first. While we typically think of packaging as the primary resource used to protect drugs from the negative effects of oxygen, there are things to consider during development and manufacturing to make sure excess oxygen isn’t simply packaged or bottled with the drug product.

Oxygen Sensitive Pharmaceuticals

There are classes of drugs that are more susceptible to adulteration from exposure to oxygen. They include most biologics, DEA Schedule II and IV drugs, parenterals, and drugs that require an extended shelf life. Unintended oxygen exposure during production can set the conditions for quality degradation even though the drug may have passed all initial quality testing.