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Equipment and Processing Report
Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.
Changes in primary packaging for drugs are being driven by industry trends. For example, sales of biologics are growing at double the rate of the pharmaceutical market overall, and these more complex compounds involve high viscosities and concentrations and larger dosages, said Riccardo Prete, product management specialist at Ompi, part of Stevanato Group, in a presentation at Stevanato Group’s seminar on developments in drug delivery devices (1). These factors affect primary packaging requirements. At the same time, there is a move to shift injectable drug administration from hospital to home. Home administration improves adherence, which in turn results in better outcomes and lower healthcare costs, explained Prete. Drug-device combination products for self-injection, however, require more complex delivery systems, which can present challenges.
For example, prefilled syringes, micro-vials, and cartridges for combination products require precise production and handling to control critical dimensions and ensure accurate doses, said Prete. A stringent inspection process is needed during production and assembly, and glass-to-glass and metal-to-glass contact should be avoided (1).
For micro-vials, shapes and configuration must be optimized to guarantee full compatibility with different devices and controlled to ensure processability on filling lines. For syringes, auto-injector compatibility depends on tight dimensional control, optimized flange formation, and precise siliconization for optimum glide performance. Cartridges for pen injectors have similar requirements and must offer the appropriate level of mechanical resistance (1).
The benefits of self-injection, especially for chronic disease management, have spurred strong gains in market share. Today, eight of the top 10 drugs are injectables, and a look at the development pipeline reveals an approaching surge of injectable products, said Robin Hwang, principal at ICP Consulting, in another presentation, citing statistics from PharmaCircle. “There’s a clear trend for user convenience,” he reported, noting auto-injectors dominate for subcutaneous injection for biologics, and on-body injectors are gaining ground for high-dose delivery. Interest in add-on connective devices and/or electromechanical injectors with connectivity also is growing (2).
However, Hwang warned, devices reduce margins due to the increased cost of development and add complexity to the manufacturing process, supply chain, and compliance risk. Combination products also require device expertise and partnership management as well as significant levels of customer support, training, and complaint handling. “Training the customer is extremely important-otherwise a $5 device can ruin the future of a $1000 product,” he explained.
“So, why do devices?” he asked. “Very simple,” he said, “competition. If there’s no competition, a syringe and vial work just fine. First-in-class drugs have more leeway.”
If a combination product is needed to provide a competitive edge and/or preserve market share, leveraging an existing device platform and partnering with a system provider can reduce risk, development time, and cost. Otherwise, Hwang advised, be prepared to spend at least five years and $50 million to develop a new device and cover the costs of clinical development, subassembly and final assembly, and testing (2).
Another speaker at the seminar, Valerie Otte, market development manager at Aptar Pharma, discussed the trend for injectable drugs moving to nasal delivery. This conversion is particularly suitable for drug repurposing, which reformulates an existing product for new routes of administration, new indications, or new therapy areas (3). “There are advantages if you can avoid injection,” she noted.
Stevanato Group, which specializes in glass packaging for pharmaceuticals, and Duoject Medical Systems formed a partnership to collaborate on an emergency-use auto-injector, the companies announced in a Nov. 5, 2019 press release (4). The Maverick auto-injector designed by Duoject is a cartridge-based system with a two-step automatic injection and needle retraction. Although most auto-injectors are designed for use with prefilled syringes, the cartridge-based system has advantages in some uses, according to the press release. The companies expect to refine the design through user discussions and design for manufacturing and design for assembly processes.
1. R. Prete, “Primary Packaging - Dedicated Solutions for Drug Delivery Devices,” presentation at New Developments in Drug Delivery Devices (Chicago, IL, Oct. 17, 2019).
2. R. Hwang, “Market Requirements and Impact on the Devices Market,” presentation at New Developments in Drug Delivery Devices (Chicago, IL, Oct. 17, 2019).
3. V. Otte, “New Insights in Nasal Delivery Systems,” presentation at New Developments in Drug Delivery Devices (Chicago, IL, Oct. 17, 2019).
4. Stevanato Group, “Stevanato Group and Duoject Medical Systems Agree on Exclusive Partnership to Promote and Manufacture the Emergency-use ‘Maverick’ Auto-injector,” Press Release, Nov. 5, 2019.