Mevopur ProTect claims to be effective at limiting oxygen degradation of drugs and nutraceuticals stored in PolyEthylene Terephthalate (PET) bottles, even in a transparent mono-layer construction.
Steve Duckworth, global head of marketing and business development for Clariant Healthcare Polymer Solutions commented: “Just as in food and beverage packaging, PET is becoming more widely used, but while food and beverages require a relatively short shelf life, pharmaceuticals often need to maintain their potency even when stored for a year or more.
“Although HDPE has been the material of choice, PET offers several advantages, including transparency, and the Mevopur ProTect additives help to combine transparency with long-term shelf-life. While recycling is not yet a major topic in pharma, PET is considered a highly recyclable material, and any oxygen barrier that does not require multiple layers is going to be an advantage.”
It was originally developed to overcome the deficiencies of existing oxygen barrier systems used in food and beverage packaging as the active molecules showed very high performance in scavenging oxygen permeating through container walls, and thereby maintained extremely low levels of oxygen over extended periods even in a mono-layer and refrigerated storage. This made it possible to achieve a shelf-life of more than two years - the requirement for pharmaceutical packaging, even with low concentrations of the active ingredient compared to alternative products. In addition, tests have shown that PET pre-forms do not need special storage conditions, still maintaining activity after three months.
The protection offered by the oxygen scavenging system depends on a number of factors including packaging design, additive loading, and target oxygen levels over time.
Recent tests by Clariant reportedly showed that when testing 500ml monolayer PET bottles with 3.6% loading of the masterbatch, concentrate was able to maintain oxygen levels below 1 ppm for more than 590 days, compared to just 22 days for untreated PET, and 63 days for a competitive oxygen scavenger.
Talking about these test results, Duckworth added: “Based on these test results, we believe that this is one of the most powerful oxygen-scavenging systems available for pharmaceutical packaging. However, it is also just one element in the process of bringing a pharma bottle to market. Complying with standards related to light transmission, extraction and leachables, and so on must be considered in the final materials formulation. It is important to take a total system approach to pharmaceutical packaging applications and the healthcare polymer solutions team has the extensive formulation and regulatory know-how to help customers avoid potential problems.”
Mevopur ProTect could also offer a solution in oxygen protection. Duckworth concluded: “In diagnostic applications, oxygen can interfere with the sample/reagent combination, affecting the accuracy of the analytics. Therefore, we expect some interest in Mevopur ProTect in these PET applications as well.”
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