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Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration(1). This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
To promote patient safety and the stability and efficacy of protein-based drugs, including mAbs, it is important to store the drugs in compatible container and delivery systems. From the time of storage until the drug reaches the patient, the protein interacts with the surfaces of these systems, which can impact the drug’s stability. The drug also can be affected by the various mechanical stresses and elevated temperatures to which it may be exposed during shipping, handling, and delivery.
Considering the world of commercial transparent polymers, Daikyo Crystal Zenith® cyclic olefin polymer (COP) clearly stands out – having very good resistance to oxygen/water and compatibility with drug product (it comprises only carbon and hydrogen). Other transparent polymers may suffer limitations, in one or more ways. For example, poly(vinylidene chloride) has outstanding resistance to oxygen/water, but lacks compatibility; sterilization can result in release of HCl. For parenteral drug products, polymer-based containment/delivery systems have many advantages compared to glass.
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration(1). This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
To promote patient safety and the stability and efficacy of protein-based drugs, including mAbs, it is important to store the drugs in compatible container and delivery systems. From the time of storage until the drug reaches the patient, the protein interacts with the surfaces of these systems, which can impact the drug’s stability. The drug also can be affected by the various mechanical stresses and elevated temperatures to which it may be exposed during shipping, handling, and delivery.
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