Protecting the efficacy of pharmaceutical products through packaging solutions typically requires a combination of active agents and passive barriers. Packaging experts have turned to various types of protective packaging to safeguard drug products against degradation, which can lead to loss of stability, shortened shelf life or an ineffective drug delivery. These agents, primarily moisture, oxygen and odor adsorbents, complement and enhance passive barriers.
Although sorbents are essential to the quality, stability and appearance of packaged pharmaceuticals, such products can increase the complexity of the manufacturing process. The added steps can slow cycle times and provide opportunities for errors and rejects. They also involve multiple materials and components that must be sourced and managed, impacting the supply chain. Some technologies may even require proprietary equipment that ties the manufacturer to a single provider.
Thus, it is key that pharmaceutical packagers utilize active packaging solutions that minimize complexity and enhance efficiency, and pharmaceutical packaging innovators such as Clariant have developed technologies to do just that.
Universalized Platforms Offer Flexibility
In all types of containers, desiccants play an active role in controlling the impact of humidity on drugs, which can affect degradation, dissolution or the therapeutic properties of APIs. Because the plastic containers used for most drug products are semi-permeable, they allow some moisture to enter through the container walls.
Placing “drop-in” style desiccant packets and canisters in plastic containers is an affordable and effective way to take advantage of plastic’s cost advantages and resilience, while maintaining the necessary conditions inside the product package.
To accelerate the speed and improve the efficiency of adding drop-in desiccants, high-speed insertion technology, such as desiccant packets on a continuous strip, have been developed. These packets are automatically cut and dropped during the packaging process. As a further enhancement to reliability and efficiency, strip packets with holes in each seal facilitate optical detection of the cut point. Clariant’s Continu-Strip® Hole Punch packets feature a hole in between every seal to avoid mis-cuts during automatic insertion.
The pharmaceutical industry’s demand for even faster insertion is driving increased use of desiccant canisters, which offer a rigid, uniform shape to enable high-speed processing. Because canisters are already separate parts, they allow the use of a fast, efficient hopper system for continuous, seamless insertion, and eliminate the step of cutting desiccants from a reel.
Because of process optimization advantages - potentially doubling insertion speeds compared to packets - desiccant canisters have become the gold standard for protection.
Further, the industry has developed canister-style oxygen scavengers, such as PharmaKeep® humidity-neutral oxygen scavengers, to provide active absorption of oxygen within the drug package. Like desiccants, these canisters can be inserted using high-speed equipment.
Care should be taken with manufacturers who have taken a proprietary approach to their canister/equipment solutions, requiring packagers to use only their desiccants on their specific insertion machinery. A more prudent strategy is to choose a universalized platform combining standard equipment and desiccants that can be used on any insertion machine.
Integrating Protection into the Polymer
Another strategy for process optimization is integrating protection such as desiccants and barriers directly into the plastic structures of containers. This approach can be seen in the use of multi-layer blow-molded bottles that incorporate passive barriers to oxygen, ultraviolet light and other threats. By customizing the layers, materials and design, packagers can create bottles that will work on any line, using standard equipment.
Active polymers can be molded into various shapes and sizes to provide protection directly into container walls or devices. Applications include vials, dosers, dispensers, inhalers and bottles. Plastic housings and delivery device components can be molded from these polymers to maintain low humidity levels and protect sensitive reagents from moisture.
The main advantage of integration is avoiding the cost and complexity of sourcing, purchasing, inserting and verifying the presence of a separate desiccant. Designing packaging using polymers with integrated sorbents can lower material and processing costs and reduce the number of suppliers involved. Fewer packaging components also lighten the burden posed by change management - including regulatory review.
Integrated actives eliminate the possibility that drop-in desiccants will be removed from the packaging by a pharmacist or consumer, leaving the contents without protection. They also conserve space, allowing smaller packages to be used or enabling more product to be put in an existing container.
Other advancements in pharmaceutical packaging take integration a step further, building active protection directly into the package closure for part consolidation and other production benefits. Integration of a desiccant into a cap or other closure device, for example, can reduce a three- or four-component package down to just two pieces: the container and the closure. This approach reduces part handling and the burden of managing changes in materials, components and suppliers. Multi-function closures with integrated active agents can deliver production advantages to pharmaceutical companies and packagers, beginning with the elimination of desiccant insertion. An example is Clariant’s IDC® Integrated Desiccant Closure, a screw-on or snap-on pharmaceutical cap that combines tamper-evident, child-resistant and twist-off functionalities with a built-in desiccant, while eliminating the induction seal.
As with polymer integration, including the desiccant in the closure avoids the equipment and processing time needed to insert a drop-in desiccant separately. Both methods can reduce cycle time because there is no longer a need for quality checks to verify that a desiccant was placed in each bottle.
Pharmaceutical manufacturers rely on active and passive protection to maintain the efficacy of their products. Innovative packaging options such as high-speed desiccant insertion and integration of protective elements into the packaging itself are making a significant contribution to streamlined processing and overall cost reduction.