Clariant launches new ‘EP’ masterbatch range for pharmaceutical packaging at Pharmapack Europe 2014 Paris

• New white and additive masterbatch range targeted for the use in production of pharmaceutical containers for parenteral, ocular, and nasal drugs
• Masterbatch now produced with raw materials tested to European Pharmacopeia 3.1.3 in addition to US Pharmacopeia 23 parts 87, 88
• Helps support innovative use of materials to enhance packaging processes and protect pharmaceutical products
• Increased regulatory support and change control supports leachable and extractable studies

Muttenz, February 12, 2014 – Clariant, a world leader in specialty chemicals, Since the launch of the MEVOPUR® range of masterbatch and compounds for Healthcare applications at the end of 2010, Clariant has been active in bring new ideas and products to the market, with the objective of ‘Enhancing Products and Process’ and ‘Protecting the Patient and the Drug’. In particular in the last 12 months, new additive masterbatches have attracted high interest because Clariant had pre-tested the raw materials for the masterbatches using the extraction and biological evaluation protocols of US Pharmacopeia (USP) 23 parts 87 and 88. However initial feed-back raised the question of whether the substances were also listed European Pharmacopeia chapter 3.1.3 (EP 3.1.3). Clariant has reacted to this feed-back and recently completed a test programme on raw materials of its masterbatches, and is now offering products that use raw materials that have been pre-evaluated to both the above USP and EP standards.

EP 3.1.3 (Polyolefin Materials for Pharmaceutical Packaging) is a reference for the industry, but has limitations in that, apart from a few substances such as antioxidants, there are few substances that might offer opportunities for development of the plastics materials used for pharmaceutical packaging. To list a new substance in EP is not a viable route, but the guidelines open an alternative for packaging specifiers, based on the information that Clariant can provide.

In addition, existing polyolefin bottles often use white masterbatch containing titanium dioxide (TiO2). Since TiO2 has its own monograph in EP, this reason is often used to demonstrate ‘compliance’ to EP. This is highly theoretical in many cases, because the TiO2 in the EP monograph is a high purity anatase form used in tableting of drugs, and is quite different from the coated rutile grades used in plastics. These coatings are often proprietary to the TiO2 pigment supplier and can change between grades and suppliers. Apart from the weak link to the requirements of the EP, these difference produce interesting discussion points for ‘change control’ and potential differences in leachables testing.

Clariant has addressed both these concerns by recently concluding independent test program on a range of raw materials and included the extraction testing of EP3.1.3 ,which added to data already generated from the extraction and biological evaluation in USP 23 parts 87 and 88, an evaluation that often forms the base information demanded for packaging materials used for parenteral, ocular and nasal drugs, and is an indication of potential for leachables. The raw materials evaluated included a global platform of, polymers, selected grades of titanium dioxide and a several substances such as nucleants, clarifiers, lubricants, and laser marking additives. ‘The successful conclusion of this test program removes a barrier to use new innovations that could improve performance and/or productivity’ stated Roland Maartensson, European Head of Segment Medical and Pharmaceutical at Clariant Masterbatches.

Using this knowledge Clariant has created a new ’EP’ range of polyethylene (PE) and polypropylene (PP)-based white masterbatches, where the raw materials have been tested using the EP 3.1.3 standard, rather than relying on the theoretical compliance previously described. The new white ‘EP range’ consists of four low and high density PE grades and one PP grade and are offered with supporting documentation to EP3.1.3, USP23 parts 87 and 88, a Drug Master File (DMF) and a Change Control Agreement.

‘Whilst we do not (yet) intend to phase out the older grades,’ comments Steve Duckworth, Global Head of Segment Medical and Pharmaceutical, ‘the regulatory support benefits are very clear, particularly for parenteral, ocular, and inhalation applications where risk of leachables is higher.’ Referring to MEVOPUR additives that Clariant believe could drive productivity gains, Duckworth adds, ‘the pharmaceutical packaging industry is under same pressures as many other industries. By helping to reduce the regulatory barriers, we could bring to our partners experience and well tried solutions to address these pressures’.