In 2018 the global pharmaceutical labeling market reached $4.7 billion. That represents a decade of steady year over year gains, with an additional 5.5% growth expected by 2024.

Among the reasons for this surge is an increasing demand for pharmaceutical products overall, which in turn is at least partially attributed to a growing geriatric population. That’s easy math: more people needing more medicine means more labels. However, an aging population might be the only simplistic factor in pharma labeling’s consistent uptick.

Simply put, it’s complicated. While the worldwide supply chain gets more interconnected, expansive and diverse, novel and highly sophisticated formulations stream through the approval pipeline, onto the production floor and into the market. Meanwhile, regulations continue to be adopted, adapted and strengthened across a wide variety of regions, often in disparate, inconsistent fashions. New markets, new drugs and new rules combine to make the manufacturing and packaging processes exponentially more intricate, as the amount of information a medicine must communicate to pharmacists and end users expands despite limited packaging print space.

Considering this, it’s no wonder that one of the niches helping to drive pharma labeling’s global growth is a solution that addresses each of these issues with room to spare: Extended Content Labels (ECLs).

ECL 101
First, let’s define the parameters. Utilized in various facets of pharmaceutical packaging, extended content labels can range from as a few as two pages (think of “peel and reseal” labels commonly found on many OTC products) to full-fledged booklets of up to 60 pages, which are more typically used for clinical trials and prescription drug packaging. Their overarching benefit is space consolidation: ECLs allow for more information to be placed on a label where a package cannot support all preferred or necessary content on a simple, single-ply label.

With ECLs, you can do a lot with a little, as flipbook and fold-out styles allow print space to be multiplied several times over while taking up little more total space than the surface of an ordinary label. The result is ample room for a lengthy list of mounting mandatory information, including:

• Warnings and directives that comply with regulatory guidelines, not only in one country but often across multiple nations or trade regions, as the number of international customers on the ledgers of pharma companies, CMOs and contract packagers continues to climb.
• Serialization and traceability requirements, again with the mindset that different countries across the same manufacturer’s customer base may have differing mandates.
• Different languages. This accounts not only for international customers but also domestic ones. For example, Canada needs labels in English and French, while in the United States Spanish is quickly becoming an unofficial second national language.
• Specific, detailed instructions. More and more prescription pharmaceuticals require strict adherence regimens, which in turn necessitate detailed printed instructions for doctors, pharmacists and end users. Relatedly, clinical trials often need tight control, another condition that lends itself to more labeling content rather than less.

Overlapping this necessity for more printed information is a seemingly contradictory desire – and in some places, like Europe, even strongly recommended guidelines – for smaller, more environmentally friendly packaging. From a spatial standpoint, without ECLs this conundrum can be virtually impossible to square with reality; the math simply doesn’t add up.  From a sustainability standpoint, labels can generally be composed of more eco-conscious (and cost-effective) materials than, for example, plastic bottles.

Advanced ECL
So ECLs are just a straightforward, logical means of providing more content space for pharma products. Simple, right?

Not so fast. Much like the pharma landscape at large, issues surrounding ECLs can also be quite complex, with decisions that impact a product’s journey along the supply chain and effectiveness upon its final destination, the end user.

One of the challenges is inspection. It must be remembered that, with ECLs, at some point in the process pages will inevitably be covered, rendering the print unreadable until the label is opened by the customer. Because this printed information is often critical to FDA compliance, systems must be implemented that allow inspection to take place at various points in the production cycle.
Pharmaceutical production requires 100% inspection whether you are producing a one-page label or a 60-page label.

At Luminer, among the most complicated ECL applications we encounter is when a client needs to place a large number of pages around a small diameter vial. This is akin to wrapping a small book around a curved surface – try it, it’s not easy. Even if the paper used is exceedingly flexible, when the booklet is wrapped pages on top become shorter than pages on the bottom. This discrepancy requires systems designed to cut each page properly to get the correct wrap of the label on the container. As bottles get ever-smaller and pages ever-greater, we’ve had to continually develop new cutting, folding, and gluing technologies to yield a perfect ECL fit.

Certain aerosol applications also can be tricky, especially with requests for both the ECL instructional label and the front prime label to be on the same base, so that the entire product can be labeled in one pass.  We accomplish this by combining up to ten print heads and incorporating state-of-the-art reregistering capability – a process that allows us to place a folded preprinted book on a prime label in such a way that the pages will also fall into place as the label is wrapped on the aerosol can. This helps assure optimal aesthetic appeal on store shelves. 

Extended content labels are a solution to a conundrum. Even in an eco-conscious, message-cluttered landscape where less is more, in reality pharma companies know that more is more. They need more space for more information supplementing more products in more and more disparate end user regions. And as simple as “creating more space” sounds, the logistics can cause something they need less of: headaches.

To counteract this, pharma label manufacturers will need to step up and solve ECL issues before they start, using innovation to relieve medicine makers and contract packagers of the sort of simple yet complicated problems that arrive when more space is needed on a finite package. 

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Tom Spina is president and chief executive officer of Luminer, which specializes in combining adhesive coating technology with narrow web flexographic printing and converting expertise. The company serves several industry niches, chief among them extended content labels (ECLs) for clinical trial and other pharmaceutical applications. Located in Lakewood, NJ and Red Lion, PA, Luminer’s two facilities are each ISO 9001:2015 certified, operate under cGMP guidelines, and regularly undergo audits from high-profile pharmaceutical, cosmetics and health & beauty aid clients.