Materials and methods for mitigating the presence of nitrosamines in packaging using an active agent

Abstract

Disclosed herein are materials, articles of manufacture, and methods for decreasing, mitigating, removing or precluding formation of an amount of a nitrosating agent and/or an N-nitroso compound, including an N-nitrosamine, in an enclosure of a pharmaceutical drug package to inhibit a potential adverse health effect on a patient associated with the nitrosating agent or N-nitroso compound. The package contains an active agent and a pharmaceutical dosage form in an enclosure of the package. The active agent, consisting essentially of sodium bicarbonate in a granular, particulate or powdered form, is effective to decrease, mitigate, remove or preclude the formation of an amount of the nitrosating agent and/or N-nitroso compound in the enclosure and/or in the pharmaceutical dosage form. Also provided are drug delivery systems including a blister pack configured to house multiple pharmaceutical dosage forms, the blister pack including an active agent as discussed above.