October 1, 2016 PAP-Q04-16-VP-001
Of the upwardly climbing global pharmaceutical packaging market, which was valued at close to $52 billion in 2014 and is expected to reach upwards of $80 billion by 2020,1 plastic bottle and parenteral containers are the top two segments, respectively. The combined sectors accounted for 36% of the market in 2014. However, it is blister packaging, closures and labels that are expected to witness the fastest growth through to 2020. Driving this growth are the industry’s demands for packaging that is increasingly sophisticated, integrated and consumer-friendly. Safety is another leading concern, both from the standpoint of package/drug compatibility and from a supply chain perspective. Currently, counterfeiting accounts for annual losses estimated at $75 billion.2 To address these issues, drug manufacturers are demanding a variety of value-added services, making packaging as important as the drug it is tasked with protecting.
Although it may seem that all proofing-packaging is sufficient, the need for child-resistant (CR) packaging can clash with senior-friendly packaging. Packaging companies must resolve this paradox, creating a package that children cannot open but older adults can. CSP Technologies Inc. designs, engineers and manufactures child-resistant/senior-friendly containers. “It isn’t easy to engineer these solutions given the inherent challenge of finding the proper balance required,” says Craig Voellmicke, Vice President, Business Development, CSP. “Many of our customers want the consumer to be able to open the package using only one hand to make the package as user-friendly as possible. We have met and exceeded our customers’ expectations by providing user-friendly CR packaging solutions while ensuring the fit, form and function of the package is consistent with their brand equity and overall value proposition, while staying within budgetary constraints.”
The importance of child-resistant packaging goes beyond the primary container. Bemis Healthcare Packaging offers a line of flexible foil laminations with increased puncture and tear resistance, which can be incorporated into child-resistant packaging. “In addition to primary packaging, we have taken the additional precautions of designing a child-resistant, self-seal, disposable pouch for the safe disposal of transdermal patches and inhalers to help prevent accidental exposure to highly toxic drugs,” says Georgia Mohr, Marketing Director — Pharmaceuticals, Bemis Healthcare Packaging.
Counterfeiting is no shrinking matter. The issue is defined by the World Health Organization (WHO) as a major problem in all pharma markets globally. In order to remain ahead of the game, anti-counterfeiting solutions (AC) are needed. An innovation from SCHOTT Ampoules AC includes colored rings, laced with luminescent nanoparticles inside their ink. These rings are indistinguishable from normal rings, which are often and easily counterfeited. A small detector, however, reveals the presence of the nanoparticles and confirms the authenticity of the product. “In this way doctors and patients, as well as retailers, pharmacies and customs authorities, are able to quickly establish whether a drug is genuine,” explains Christopher Cassidy, VP Sales & Marketing — North America, SCHOTT Pharmaceutical Packaging. “A multitude of combinations — ampoule shape and size, type of glass as well as color, shape and number of identification rings or dots, including luminescent particles — make it easier for manufacturers to protect their products against counterfeiting.”
Countries like China and Brazil already have implemented track-and-trace procedures, yet serialization will not be required in the U.S. until next year, with the EU to follow. By February 2019, all prescription drugs for sale in the EU will need to be serialized and to have tamper-proof features that clearly distinguish an original from a counterfeit. Yet, some industry insiders claim that many companies are not that far along in their serialization programs.
One company that is taking the regulations seriously is Bespak, which works with its sister company, Aesica, to offer a comprehensive serialization solution across all packaging locations. “Having serialization incorporated into packaging is spreading,” says Steve Kaufman, Global Business Development Lead, Bespak. “Our colleagues have developed a flexible and scalable module that enables them to meet the serialization requirements of a wide range of countries.” The module is capable of high-resolution printing at fast line speeds, with an advanced communication protocol for remote operation and high-speed serialization.
Additionally, as an increasing number of high-value injectable biologics enter the market, Bespak is collaborating with pharmaceutical partners to look at options that address their packaging needs. “Some autoinjectors and self-injection devices are now being embedded with anti-counterfeiting and anti-tampering solutions and specially designed labels,” says Kaufman. “Difficult-to-reproduce holograms are being embedded in designs to dissuade potential counterfeiters.”
Bemis also offers a fleet of security and authentication features that can be built into the packaging products it supplies to healthcare companies. All print-related technologies can be applied via rotogravure or flexographic printing processes. Technologies are available for primary packaging systems, secondary packaging systems and labeling. Security features verify authenticity throughout product distribution, including the point of sale, explains Mohr.
Constantia Flexibles International GmbH has developed a range of overt and covert solutions. One of the most secure overt features is security foil. Involving a rolling mill and engraving technology, this represents a barrier that is very difficult for counterfeiters to overcome, and it is also one of the most affordable security solutions for primary packaging, says Dr. Pierre-Henri Bruchon, Executive Vice President Pharma, Constantia Flexibles International GmbH, a manufacturer of flexible packaging and labels. Covert features are made possible using security graphics. “These are complex print designs that are extremely difficult to reproduce without expert printing technology and knowledge.”
As drug products are manufactured, packaged and stored, they come into direct contact with packaging systems. Such contact may result in interactions between the drug product and its packaging system. For example, minute glass flakes might detach from the inner surface layers of pharmaceutical vials during a drug’s shelf life. This phenomenon is known as “delamination.” It is rare and only occurs under certain circumstances, but still poses a danger for patients if glass flakes are injected into the bloodstream.
SCHOTT, a parenteral packaging supplier, launched a new generation of pharmaceutical vials that keep the risk of delamination under control. “We optimized the hot-forming process in a way that the inner glass surface of the vials is more homogeneous and thus chemically very stable and less susceptible to delamination,” explains Cassidy.
Bemis’ focus is on issues of solubility and diffusion in relation to the drug/packaging interaction. “Our material scientists partner with the pharmaceutical companies, not only to understand the interaction between the drug and the package, but to develop a package format that is consumer friendly with sustainable features,” explains Mohr. “Drawing on our material science expertise, our scientists take a theoretical, analytical and practical application approach to understanding the solubility and diffusion characteristics with many drugs and excipients. Through these advanced modeling techniques, we have developed a strong understanding of drug solubility and diffusion into the packaging/drug contact layer.”
Packaging integrity can also include headspace management. CSP, for example, integrates Activ-Polymer™ technology into primary packages, which control moisture, oxygen and other gases that can affect the stability and shelf life of a given compound, while minimizing product impurities. “We can injection-mold the
polymer technology into components for drug delivery devices (e.g., dry-powder inhalers, or large-molecule transdermal drug delivery systems) and we can extrude the technology into a film that can be heat-staked onto foil substrates to absorb moisture and/or oxygen to protect transdermal patches,” explains Voellmicke.
And sometimes a drug and its packaging can work together to improve patient compliance and treatment efficacy. Pharmacy benefit manager Express Scripts estimates that prescription nonadherence costs the country roughly $330 billion annually.3 Products that combine a drug or biologic with a device, such as drug-eluting stents and drug delivery systems, can offer valuable approaches for treating disease. The number of product categories and individual product offerings in the drug-device combination market has grown to be relatively large. According to BCC Research, sales of drug-device combination products reached $22 billion in 2014 and the market is expected to grow to $31 billion in 2019.4
The biotech industry is particularly interested in drug-device combination products such as autoinjectors, pen injectors and wearable injection devices, because these drugs tend to be highly viscous and require high dosing. While some companies have device and packaging capabilities internally, others outsource to companies like Bespak. “With the push towards self-administration, packaging has become an integral factor,” says Kaufman. “We offer a range of autoinjector devices powered by our patented compact energy source, delivering drugs at high viscosity and high volumes.”
As medical devices become more sophisticated and sensitive, using packaging that protects the high-value device and still appeals to consumers is critical. Constantia Flexibles developed Safemax for this purpose. The deep-draw aluminum container not only protects against moisture and gas ingress, but features customer-friendly foil lidding that is easy to open. Adding digital printing also allows the data on every individual unit to be read and exploited in order to ensure that the patient is taking the right drug and receiving the right dose, at the right time, says Bruchon.
As proper drug delivery becomes increasingly critical going forward, pharmaceutical and biopharma packaging must remain patient-centric by being safer, simpler and smarter. Novel packaging is likely going to be a key differentiator between companies. Manufacturers should keep in mind that the right packaging has the potential to increase brand loyalty and ultimately improve market sales.
Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.
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