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

A method of decreasing a rate of formation of, or decreasing an amount of, an N-nitroso compound contaminant in an enclosure of a pharmaceutical drug package to inhibit a potential adverse health effect on a patient associated with the N-nitroso compound contaminant, the method comprising:

• (a) providing at least one pharmaceutical dosage form unit in the enclosure of the pharmaceutical drug package, thereby forming a headspace in the enclosure in a portion of the enclosure not occupied by the at least one pharmaceutical dosage form unit, the at least one pharmaceutical dosage form unit comprising or forming the N-nitroso compound contaminant;
• and
• (b) providing an entrained polymer within the headspace, the entrained polymer comprising a blended form of a base polymer and an active agent, the active agent consisting essentially of sodium bicarbonate in a granular, particulate, or powdered form;
• wherein the entrained polymer is provided in an amount that is effective in decreasing the rate of formation of, or decreasing the amount of, the N-nitroso compound contaminant, thereby inhibiting the potential adverse health effect on the patient associated with the N-nitroso compound contaminant.

A drug delivery system for mitigating a potential adverse effect on a patient that is associated with an N-nitroso compound contaminant, the system comprising:

• a package comprising:
• i. an enclosure;
• ii. at least one pharmaceutical dosage form unit housed within the enclosure, wherein a headspace is formed within a volume of the enclosure that is not occupied by the at least one pharmaceutical dosage form unit;
• and
• iii. an entrained polymer comprising a blended form of a base polymer and an active agent, the active agent consisting essentially of sodium bicarbonate in a granular, particulate, or powdered form, the entrained polymer being provided in an amount within the headspace that is effective in decreasing a rate of formation of, or an amount of, the N-nitroso compound contaminant in the headspace and/or in the at least one pharmaceutical dosage form unit, thereby mitigating the potential adverse effect on the patient associated with the N-nitroso compound contaminant.