Commercial Packaging: Understanding Challenges and Avoiding Common Mistakes

What are some of the most common challenges related to commercial packaging of drug products?

Some of the most common packaging challenges when launching a commercial product is the difficulty clients face in striking the right balance between the functions of packaging with market, compliance and sustainability concerns whilst also meeting patient needs for user-friendly, age-specific dispensing solutions. The biggest challenge is addressing and meeting these requirements without unnecessarily increasing the complexity and cost of the pack presentation. 

What is one of the most common mistakes made when attempting to address these challenges?

Often attempts to address these challenges result in an unnecessarily complex and subsequently expensive pack prototype. Packaging should be kept as simple as possible without impacting the quality of the product. A complex pack not only increases costs in terms of materials, but also in terms of labour and processing.  

U.S. packaging and patient information leaflets are typically in a single language (English), whereas when launching drug product in the EU clients are faced with complexities such as multilingual packs, bluebox labels and serialisation requirements. Some clients are unaware of these additional elements which can complicate or extend the critical path to launch. 

What are some best practices for addressing these challenges?

Selecting an established, reliable CDMO with teams that have significant experience with similar product launches will provide enhanced awareness of potential challenges and pitfalls before they occur. An integral part of any launch plan is a comprehensive packaging risk assessment. The risk assessment should review factors such as:  

• Product Value vs. Material Cost 
• Sustainability 
• Environmental 
• Physical 
• Microbiological 
• Regulatory 
• End User & Compliance 
• Timeline for Launch 
• Target Markets & Cultural Precedents
• Equipment/Tooling Requirements 

Once the packaging risk assessment has been completed, the lead packaging prototypes will be identified, feasibility batches will be manufactured, and a stability program initiated. The next step is to identify the lead packaging prototype. If for any reason a lead candidate cannot be clearly identified, the packaging risk assessment process should be widened and restarted. 

What are the differences between clinical trial packaging and commercial packaging? 

Due to the high number of drug products that do not progress beyond clinical trials, pharma companies are reluctant to invest heavily in packaging designs preferring flexible packaging which will meet the individual clinical trial protocols. However, the most obvious difference between the two are the batch sizes. While clinical batches are much smaller, they still present challenges, such as, dosage titrations, randomisation, multiple country groups and supply chain pressures to meet ‘first patient in’ dates. Commercial packaging requires a lot of upfront work with packaging selection and design taking place for regulatory submission/ market approval. The packaging is moving beyond blank clinical packs to a commercial pack that requires product and prescribing information, as well as company branding and design. Once the product is approved and launch strategy is implemented, the product’s packaging remains the same with changes only being made when regulatory or product indication updates are required. 

When should packaging planning commence?

We recommend this should commence as early in the process as possible. Using a similar pack format to your planned commercial pack during Phase III trials provides an opportunity for feedback from physicians and patients which can influence later designs. 

What are some of the considerations that should be taken into account regarding packaging of different classification drugs, (i.e., controlled substance or a potent compound)?

One of the main considerations is balancing child resistance with accessibility for the patient. It is essential that the pack design is correct by enabling and restricting access to the drug product, making the packaging child resistant and/or senior friendly. Another key consideration is patient compliance especially given the potency of the drug products and the increased risk of overdose/underdose. This issue can be addressed with compliance packaging such as blister cards that are marked with day/morning/ evening/week etc. 

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