An Opportunity with Printed Cold Form Foil
It has long been known that when patients recognise the brand of the drug being prescribed, and are confident that it is genuine, they are much more likely to take the medicines correctly, improving their effectiveness, and therefore the patients’ health outcome.
Packaging is the key carrier of information to the patient, and numerous measures have been taken to add anti-counterfeit and brand identity features, but so far with very limited success, as the burgeoning global trade in fake drugs, and poor patient adherence data will testify.
This article discusses a simple option for those drugs packed in Cold Form Foil, which could be implemented in short order for minimal cost.
A Brief History of Cold Form Foil
Since its introduction by Alusuisse in the 1970s with Bayer, Cold Form foil (CFF), also known as alu-alu, has been used by most Pharmaceutical companies in Europe, the Americas and more recently Asia-Pacific, as the preferred blister base for their most sensitive oral dose products.
As this once-innovative product approaches its 50th anniversary, it is surprising that the original specification remains almost unchanged since its invention. Although there have been a number of variants, providing additional rigidity, halogen-free, or extreme barrier, the basic structure of 60 micron PVC // 45-50 micron aluminium // 25 micron oPA (oriented polyamide, or nylon), still accounts for well over 90% of global usage.
Fig 1. Global “standard” Cold Form Foil structure
With worldwide production now approaching 60,000 tonnes and $500M annually, this single product is responsible for protecting around 20% of the world’s pharmaceutical blister-packed solid doses.
It is therefore remarkable that there are still only a handful of CFF manufacturers that are capable of delivering the consistency and quality required for global regulated markets, with the top 10 manufacturers sharing over 80% of the worldwide demand, and fewer than 5 of them that sell significantly outside of their own region.
Until around 2005, only two major producers, Amcor (then Alcan Packaging) and Constantia Flexibles, were sharing around 90% of the European demand, and over 80% of the global total. As the Healthcare industries of Asia began to flourish at this time, first Korean foil manufacturers developed their own CFF, then Indian and Chinese converters followed suit. This coincided with a rapid growth in demand for Pharmaceutical packaging in China and India, driven by governmental policy, such as India aligning with the TRIPS intellectual property agreement, expanding access to health insurance, and China promoting the move from Traditional Chinese Medicine to Western Medicine.
The Growth of Cold Form Foil in Asia
The manufacture of CFF is technically challenging, with quality and consistency of raw materials, production equipment and processes, and skilled engineers and operators all required to deliver a product that runs consistently well on blister packing lines.
The first few years saw a rapid climb up the learning curve for these new entrants, and the results were not without quality problems. However, in the past decade, the demand pull in Asia has led to a corresponding improvement in local equipment, labour skills and raw materials – foils, films, adhesives and lacquers – that has led to a number of Asian suppliers now producing a consistent quality and performance that rivals the global leaders. Asia now represents over half of the global usage of CFF.
Fig.2 Global Annual Cold Form Usage
As noted in the introduction, CFF is used to protect solid dose pharmaceuticals most sensitive to moisture, oxygen and light. It has a further significant benefit that it is opaque – a pre-requisite for child-resistant qualification. Transparent blisters are not considered suitable for child-resistance, as the visible tablet may be mistaken as a candy by a child. This incidental feature is another reason that has seen CFF blisters grow faster than all other blister formats in recent years.
Brand Security and Differentiation
In parallel to, and possibly related to the emergence of Asian countries as leading producers and users of CFF (and consequently also the lid foil), there has been an increasing need for Pharmaceutical companies to protect their products against counterfeiters. Whether it is the illegal re-importation of genuine drugs to circumvent licensing, or cheap, inadequate and dangerous copies sold in lookalike packs, the packaging is a key tool to fight against these illegal traders.
Due to its easier implementation, the secondary carton has so far been the preferred choice for enhancing security, such as tamper-evident seals, and overt and covert printed features. However, this is barely a sticking plaster on an industry wound estimated at $20-30B, which kills at least 200,000 people each year. The secondary pack only provides minimum protection, as it is still too easy to place a counterfeit blister into a genuine carton, as well as many drugs in Asia being sold by the pharmacist without a carton. Anti-counterfeit features on primary blister foils represent little more than 3% of a global market of close to $1.5B.
The challenge of providing security features on the primary blister is threefold:
In most developed countries, the blister is packed in a carton, so the primary security feature is not visible at point of dispensing. The healthcare professional or patient can only tell if a pack is genuine once the carton is opened.
Common print features on lid foil are not difficult for counterfeiters to copy, and there have been incidents of counterfeit drugs being sold in a blister containing a security print, when the genuine product had none!
More sophisticated features such as RFID or embedded taggants have been prohibitively expensive and complex to implement.
Fig.3 N’CRYPT© Security Blister (image courtesy Amcor)
Recent developments in printed electronics, digital watermarks, Near Field Communication, mass customised QR codes, etc. are bringing down the unit cost as well as the effort of implementation, making the introduction by Pharmaceutical companies more attractive, as well as allowing the blister pack to be digitally read whilst still in the carton.
As these technologies vie for their place as the solution of the future, it is somewhat surprising that a more simple, existing technology has yet to find popularity outside India.
Printed Cold Form Foil
CFF is almost entirely used in its standard specification, showing the silver-coloured aluminium on both the PVC and oPA sides of the blister. However, coloured CFF has long been available, such as blue for some of Novartis’ products, and gold often used in Middle East. Pigment added to the layers between films and foil is relatively simple and cheap to produce. Similarly, there have been several examples of CFF with a print design applied in US and Europe, but only on rare occasions.
Across Asia, and in particular in India, the use of coloured and printed CFF is much more common, representing as much as 20% of the overall demand in India. Pharmaceutical companies there have realised that due to the low number of qualified producers of CFF, a print feature here provides an effective security feature, as well as an immediate brand recognition for patients and healthcare providers alike.
Technical concerns existed in the past about the pigments reducing the bond between the layers, and causing early delamination, or potential migration of inks into the drug. Material and technology improvements have long allayed these fears, and printed and coloured CFF is now commonplace in India as a low-cost feature to enhance brand identity and security.
The following images show some commercial examples of printed and coloured CFF in commercial usage in India. These have either been reverse printed (printing on oPA or PVC prior to lamination) or surface printed with a protective overcoat.
The first set of images show a design that is visible under normal light, and which contains UV-sensitive inks, as an additional security measure.
Fig 4 Formed blister under normal light
Fig 5 Printed flat sheet under UV light
Fig 6 Formed blister under UV light
The next images show examples of blisters combining an easily-recognisable, colourful design to enhance patient recognition and brand differentiation, as well as security features such as UV-sensitive inks and printing on the inside of the blister.
Fig 7 Both sides printed
Blister Images courtesy of Bilcare Research Ltd
It is surprising, therefore, that 98% of CFF in Europe and the Americas is uncoloured, with printed CFF almost unknown. With most of the Pharmaceutical companies trying to identify ways of reducing cost, enhancing security and patient adherence, as well as differentiating their brands, the usage of this low-tech, cost-effective solution seems like an opportunity for the taking.
The benefits demonstrated by India customers are simple. Firstly, there is an immediate brand recognition by doctors, nurses, pharmacists and patients, which gives an enhanced confidence in the efficacy of the drug. Secondly, the fact that few manufacturers can produce printed CFF in a good quality automatically creates a level of security that counterfeiters cannot imitate.
Conclusion
The leading Pharmaceutical companies appear to be focusing on emerging technologies to gain broad acceptance as the solution for brand identity and security, with most seemingly focusing on the lid foil as the carrier of the information. This is perhaps unsurprising, as lid foil is used on 100% of blisters, whether the base is shared between PVC, PVC/PVdC, Aclar, PP or CFF.
However, the most sensitive, and therefore valuable oral dose medicines are commonly packed in CFF, and the off-the-shelf, cost-effective solution of printed CFF has so far been overlooked. As pressure grows on Pharmaceutical companies to act on the threat of counterfeit drugs, as well as demonstrating the effectiveness of their products, it would seem to be worth exploring this more low-tech but readily-available option.
Statistics from WHO and OECD Data sources: Allied Devt, MnM, HCPC, Reap Consulting
Comments