Dexter Tjoa, CEO of Tjoapack explores the innovations set to transform secondary pharmaceutical packaging from 2024 onwards.
Tjoapack
Enhancing the patient experience
Patient centricity is one of the major themes in both drug formulation development and in packaging at the moment, particularly for injectable medications.
Historically, administering injectable medications posed significant challenges for patients, leading to risks of medication errors and contamination due to manual syringe preparation. In response to these challenges, the pharmaceutical sector has invested in patient-centric solutions to make self-administration easier and safer, resulting in the development of pre-filled syringes (PFS).
PFS have several advantages over traditional vial and syringe methods. They contain precisely measured single doses of medication, eliminating the risk of under- or over-dosing and ensuring a safer and more convenient user experience.
Optimising patient safety
Drug counterfeiting is another key trend in the industry, due to the threat to patient safety and supply chain integrity. Oral solid dose (OSD) medications, not just injectables, are at risk. An estimated 13.6% of medicines in low- and middle-income countries are substandard or falsified, with this percentage rising to 19.1% for antimalarials.
Governments have mandated serialisation on all drug units to prevent falsified medicines from entering the supply chain. Legal frameworks, such as the EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA), phase II, establish the legal requirements for authenticity and traceability.
Tampering is another risk to patient safety. OSD packaging has made use of blister packs in the EU for many years as a means of tackling this issue by allowing patients to easily see whether doses have been touched or replaced since they left the factory.
Secondary packaging innovations to meet the trends
To unleash the full potential of drug products, it’s crucial to have appropriate packaging. This ensures patients have what they need for accurate and safe treatment. Recent innovations in secondary packaging can support pharmaceutical companies to meet the changing needs of the market:
- Kitting advances for patient convenience: Efficient kitting is facilitated by suitable secondary packaging, enabling the inclusion of additional materials such as swabs and replacement needles - particularly useful for PFS - as well as usage instructions, and informative content. This enhances the usability of treatments such as injectables and expands the range of treatments that patients can self-administer. Ongoing developments in kit packaging and associated manufacturing equipment focus on making PFS more user-friendly, especially for vulnerable patients. Alternative ergonomic grips can be included in kits, providing diverse options for patients, particularly older individuals with manual dexterity issues.
- Improvements in smart labelling for safety and information provision for convenience: Clear labelling and easily comprehensible instructions are crucial for patients to prepare, inject, and safely dispose of PFS, and to administer OSD. Kitting innovations facilitate the provision of this additional information and support in the patient's language without compromising manufacturing productivity or cost-effectiveness. Smart labels featuring radio-frequency identification (RFID) or near-field communication (NFC) technology are being increasingly considered to support serialisation requirements for both PFS and OSD. These labels provide more robust information than traditional counterparts, including unique identifiers and serialisation data critical for compliance with the latest regulations while facilitating seamless scanning during transport. Smart labels have the potential to harmonise data systems across the pharmaceutical supply chain, aligning serialisation compliance with operational efficiency. In addition, smart labels can potentially aid pharmaceutical companies manufacturing temperature-sensitive drug products, such as biologics, by allowing real-time monitoring of temperature conditions during product transport. Processor cores within these labels can enable data transmission to a central database, allowing the identification and disposal of units with temperature excursions. This system aids in understanding the root cause of excursions, preventing future occurrences.
- OSD and PFS packaging seals to protect vulnerable populations and address tampering: Child-proof secondary packaging is being increasingly considered to prevent unsupervised access and ensure safety. These include innovations in secondary packaging seals and closures that are difficult for children to access. An expansion in the use of blister packs is also underway to protect patients from tampering for nefarious reasons. They have been mandated in the EU for prescription medicines since February 2019. Innovations over the next few years aim to enhance these devices, ensuring any alterations are visible to patients and streamlining installation during filling and packaging.
The importance of expert secondary packaging support
In the pharmaceutical industry, the adoption of cutting-edge packaging solutions often requires substantial capital investment, which can be daunting for companies. As a result, many pharmaceutical companies are forging strategic alliances with expert contract packaging organisations (CPOs).
CPOs can provide infrastructure, capacity, and expertise to efficiently finish and package drug products, meeting regulatory standards and ensuring safe, high-quality products. Beyond infrastructure, CPOs offer insights into product-specific packaging needs, developing customised services that add tangible value to customers. This collaboration can extend beyond operational efficiencies, as CPOs also assist in designing packaging that resonates with target audiences, enhancing branding and product promotion.
Taking advantage of these partnerships in 2024 and beyond, more companies can take advantage of incoming secondary packaging innovations to keep on top of emerging market trends. This will ensure more patients benefit from treatments that are not just effective, but safe and convenient to use.