Major Industry Trends Impacting Pharmaceutical Packaging

Pharmaceutical manufacturing organizations label and package all kinds of drug products every year and do so with increasing levels of complexity.  From adding package inserts that focus on patient compliance, to blister packs, closure systems, plastic containers with medicine packaging purposely designed to safeguard tablets and capsules, pharmaceutical packagers are using their skills and resources to meet complex challenges.

FDA DSCSA and EU Falsified Medicines Directive (FMD) Compliance and Serialization

Drug manufacturers are facing new challenges posed by regulations across the globe.  To date, there still is not one global serialization standard.  Serialization data then must vary according to the respective regulation.  Pharma companies now must used highly specialized software to handle this higher level of complexity.

Serialized printing is now being done on primary packaging as well as on finished dosage, even printing 2D barcodes onto pills and capsules.  This extremely small print represents a significant challenge to the pharmaceutical industry.  Experts explain that it is likely that new printing capabilities will facilitate the interpretation and tracking of drug dosages using microscopic serialization codes.

The Rise of Biologics Introduces Pharma Packaging Concerns

Along with the introduction of the Affordable Care Act (ACA) came a wave of thirty million newly insured American consumers.  This has impacted the global demand for pharmaceutical products.  This includes biologics which are now commonly prescribed to treat chronic health conditions as well as illnesses resulting from lifestyle choices such as obesity, cardiovascular problems and diabetes.  Biologics, often cell-or gene-based therapies are used for illnesses for which treatments are either not available or have been found to be ineffective.  Biologics use tissue or cells from microorganisms, human, animal or plant cells.  Because of this, biologics tend to be fragile, temperature sensitive and easily contaminated.

There have been instances of biologic drugs interacting with packaging materials, resulting in a demand for new materials and formats.  For example, glass vials are undergoing changes related to market demand.  Because some novel biologics contain properties that delaminate glass causing it to flake in solutions, manufacturers are actively working on troubleshooting how glass vials are formed in the heating process to eliminate the flaking.

Increase in Interest in Packaging for Personalized and Self-Care Drug Products

One of the most significant trends in healthcare and pharmaceuticals is personalized medicine and patient-oriented medicine.  Biologics are expected to play a huge role in this regard.  The drug therapy regimen would be delivered directly to the patient from the pharma company and patients would also ship biologic materials in return.

Pharmaceutical packaging could be customized to meet patient needs.  This would entail having the pharma packager make smaller batches of custom printed boxes as well as research diagnostic boxes with shorter lead time.   This is likely to result in a shift of packaging goods close to the sale to streamline efficiency in the distribution process.

Ensuring the Safety of Children with Child-Resistant Packaging

One of the main drivers of packaging changes to child-resistant packaging designs is due to the introduction of cannabis-based medicinal products.  The issue with the cannabis-based medicinal products is that if a child ingests larger quantities of concentrated cannabis oil, the impact may be life-threatening.  Packaging manufacturers are now duty bound to label tamper-resistant packaging for potential customers, increasing terms to the package rather than using abbreviations and including information in a special spot as “how supplied and handling section”.  Currently, industry best practice deems the addition of separate adhesive labels for this purpose rather than on-packaging designs.

Sustainable Packaging

Across the world, people are starting to take the threat of plastic in our environment seriously, yet even though there is considerable will, the problem remains elusive to solve.  Pharmaceutical companies and pharmaceutical packaging companies are trying to identify and reduce waste during production and find high value in sustainable packaging.  This is being done through efficiency improvements, material optimization and use of modernizing technologies designed to eliminate the use of resources or packaging if unnecessary.

The search for alternative packaging materials is underway and sustainable packaging solutions are in the works for pharmaceutical clients.

Smart Packaging of Drug Products

What is “smart packaging”?  Smart packaging is one of the standout pharma industry trends.  With all the new biologic and specialty pharmaceutical products, pharma companies need the means to ensure that these goods are handled, stored and transported in optimal conditions to safeguard the drug product. 

Drug products that are not stored at the correct temperature can be damaged and can even be dangerous for human consumption.

There are a myriad of ways and tools that can be used for these purposes including temperature-oriented indicators, time-measured indicators, smart, ultra-thin ICS that can be embedded in packaging.

Smart packaging can be used to encourage adherence to the prescription instructions and can provide patients with additional information to assure that the drug is being taken as intended.

Conclusion

Across the pharma industry, pharmaceutical products are experiencing a revolution in packaging solutions to meet consumer expectations, safeguard products and patients and ensure government regulatory compliance.  Pharmaceutical packaging is about far more than product protection of prescription medications and meeting regulatory requirements.

The pharmaceutical packaging industry is using innovative new materials, smart packaging and packaging components to provide intelligence about the drug products and patient adherence well beyond what was possible years ago with only the bar coding of medication packaging.  Packaging requirements now are extensive, especially when dealing with biologics that have undergone extensive, costly drug development processes to produce fragile therapeutics.

Pharmaceutical packaging trends involving personalized care, new methodologies for drug administrations such as for specialty pharmaceuticals and product protection make medicine packaging especially problematic.

The process of packaging and labeling for the global drug supply is more complicated and utilizes more high end technologies, packaging machines and innovation than at any time in history.  It is no longer about mere track and trace and tamper resistant packages any more.

Resources:

https://www.packagingdigest.com/pharmaceutical-packaging/5-pharma-trends-and-their-impact-packaging