Clariant Plastics & Coatings Healthcare Polymer Solutions is adding a new oxygen-scavenging additive masterbatch to its MEVOPUR line of medical-grade materials and services for pharmaceutical packaging and medical devices. MEVOPUR ProTect is effective at limiting oxygen (O2) degradation of drugs and neutraceuticals stored in polyethylene terephthalate (PET) bottles, even in a transparent mono-layer construction.
The new masterbatch concentrate and other innovations are being introduced at Pharmapack Europe. Clariant is exhibiting in booth F54 at Porte de Versailles, Paris, France, on 5th and 6th February 2020.
“Just as in food and beverage packaging PET is becoming more widely used,” notes Steve Duckworth, Global Head of Marketing & Business Development for Clariant Healthcare Polymer Solutions, “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. And, 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.”
The year 2020 marks the 10th anniversary of the creation of the MEVOPUR product range, which helps manufacturers of pharmaceutical packaging and medical-devices reduce the risk of regulatory non-compliance throughout the product life cycle, while meeting the highest standards for performance and appearance. All MEVOPUR compounds and concentrates are produced in three dedicated EN:ISO13485-2016 certified facilities and use ingredients that have been pre-tested to ensure compliance with applicable standards for both medical devices and pharmaceutical packaging. For pharmaceutical packaging applications the MEVOPUR range offers one of the most comprehensive regulatory support services available, including testing ingredients in accordance to USP 661.1, EP3.1., ICHQ3D (USP<232>), and biocompatibility per USP<87>, <88>.
The MEVOPUR ProTect product is offered with the same regulatory test documentation.
TESTED AND PROVEN
Originally developed to overcome the deficiencies of existing oxygen barrier systems used in food and beverage packaging, the active molecules showed very high performance in scavenging oxygen permeating through container walls, and thereby maintains extremely low levels of O2 over extended periods even in a mono-layer and refrigerated storage. This makes it possible to meet the >2 years shelf-life required in 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 3 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. However, by way of illustration, Clariant testing of 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.
“Based on these test results,” Duckworth says, “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.”
APPLICATIONS BEYOND PACKAGING
Protection of the drug is not the only area where MEVOPUR ProTect could offer a solution in O2 protection. “In diagnostic applications, oxygen can interfere with the sample/reagent combination, affecting the accuracy of the analytics.” Duckworth commented. “Therefore, we expect some interest in MEVOPUR ProTect in these PET applications as well.”
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