Solid-dosage forms continue to play an essential role in the pharmaceutical marketplace despite the attention the COVID-19 pandemic has focused on parenteral products. Factors spurring demand for solid-dose products include the development of new chemical entities, especially in oncology; more complex formulations and formats; and the adoption of technologies such as micro-encapsulation, taste masking, and mini-tabs.
The solid-dose market also benefits from “the growth and continual rise in generic pharmaceutical companies and their impact on the accessibility and affordability of healthcare,” says Guy Calcagno, vice-president Global Sales, Films & Foils, ACG, a supplier of barrier packaging substrates.
Perhaps most importantly, consumers like the solid-dose format. “Many consumers still prefer [solid-dose] products because of their convenience for ease of dosing and portability,” explains Justin Schroeder, global vice-president, Product Development and Commercialization, PCI Pharma Services, a contract development and manufacturing organization (CDMO), which offers packaging and clinical trial services.
“Oral solid-dose products are … the easiest format to increase patient regimen compliance,” adds Francois Bidet, vice-president of Business Development EMEA for Aptar CSP Technologies, a supplier of drug delivery, consumer product dispensing, and active packaging products.
Demand for solid-dose products is more intense outside North America. “We are seeing strong growth in developing markets, such as the Middle East, Southeast Asia, India, and Latin America,” reports Calcagno.
Schroeder agrees, noting, “The pharmaceutical industry has capitalized on the opportunity to provide rest-of-world nations with more medicines and therapies, bringing life-saving treatments to new patient populations.” Delivering solid-dose products to isolated markets is much simpler than handling biologics, which require cold-chain storage.
Solid-dose packaging trends
Although bottles still account for the largest share of solid-dose packaging, the blister packaging format is showing strong growth worldwide. One forecast predicts pharmaceutical blister packaging will experience a 5.1% compound annual growth rate to reach $8.9 billion by 2031 (1). Unit-of-use blister packaging dominates in developing markets due to price-point advantages that make medication more affordable and barrier structures that can protect the shelf-life of sensitive drugs, even those destined for sale in markets with extremely hot and/or humid weather.
To protect product shelf life in these areas and expedite time-to-market, pharmaceutical manufacturers, contract packagers, and material suppliers devote considerable attention to selecting packaging with optimized barrier properties. “Given the increasing pressure to accelerate the timeline through the clinical phases and to commercialization, schedules for traditional drug formulation activities are often compressed, resulting in medicines that are sensitive to environmental degradants such as oxygen or moisture,” explains Schroeder. As a result, PCI Pharma Services offers a range of packaging options so drawbacks and benefits can be assessed for each material. With that information, the best match of product requirements and package structure can be made for the destination market, thereby enabling a seamless transition from clinical to commercial production. “This means … making our best recommendation to meet … timeline, budget, and current global supply-chain conditions,” says Schroeder.
In addition to emphasis on barrier structures, Calcagno says, “There is a move away from polyvinyl chloride (PVC) to more sustainable packaging solutions.” Serialization also is top-of-mind with a desire to meet US Drug Supply Chain Security Act (DSCSA) requirements (including aggregation) ahead of the Nov. 27, 2023 deadline for data exchange and product verification.
Other solid-dose trends include a strong interest in patient-centric packaging. Patient-centric packaging provides intuitive design and support that helps consumers take the medication as prescribed, maximize adherence, and ensure positive outcomes. It also can be a market differentiator for the product. A patient-centric package developed by PCI Pharma Services for a daily-dose preventative therapy, for example, combines intuitive instructions and labeling, ease-of-use, and portability while balancing child-resistant features and consumer-friendly access.
Active packaging will make it possible to tailor containers and substrates to the specific sensitivities of various APIs. As a result, Bidet says, “New chemical entities will be more stable and can be launched on a worldwide scale more efficiently and effectively.” Time to market will accelerate.
To prevent API degradation, enhance product stability, and extend shelf-life, Aptar CSP continues to develop its Activ-Blister technology. The Activ-Blister structure adds an engineering polymer film to lidstock to control moisture and oxygen levels in the headspace of each blister cavity. ““Activ-Blister also helps avoid complex and lengthy reformulations for oral-solid-dose products to withstand harsh climate conditions, such as ICH3 (hot and dry) and ICH4 (hot and humid) zones,” reports Bidet.
Sustainability is top-of-mind for everyone. “There’s currently a significant push in the pharmaceutical industry to consider sustainability and eco-friendliness when designing packages,” reports Schroeder. “Pharma companies will need to consider lifecycle assessments of various oral solid-dose products; [this] holistic perspective includes manufacturing, packaging, and transport,” adds Bidet.
“Many traditional high-barrier films are not easily separated for traditional recycling streams,” notes Schroeder. So, film manufacturers are working on materials that are easier to recycle. Thus, Calcagno says, “I believe we will see a huge influx of more cost-effective alternatives to PVC-based films.” Bidet predicts, “Monomaterial or compatible recycling stream material will be preferred.”
“With the introduction of these new materials, equipment will continue to evolve to properly accommodate them,” says Schroeder. He concludes, “By 2025, we’re going to continue to see the evolution of packages, with a continued focus on creating more patient-centric delivery to ensure successful health outcomes while also introducing a more sustainable approach for cradle-to-grave packaging lifecycles.
First published in Pharmaceutical Technology, March 8, 2022
Written by Hallie Forcinio