Sorbents represent a class of active packaging components that can be used to guard against the effects of degradation, ensuring the integrity of packaged pharmaceuticals and other environmentally sensitive products. The author answers some common questions and discusses the benefits of active packaging to ensure product stability.

Q: What are some of the key threats to product stability?

A: Pharmaceuticals and other products are subject to a variety of degradation pathways that compromise safety and shelf-life. By far the greatest degradation is caused by hydrolysis and oxidation. There are a number of packaging components available to help maintain product integrity; however, determining the optimal solution requires a calculated analysis drawing on diverse areas of expertise.

It’s critical when determining a degradation-prevention program that manufacturers consider the whole manufacturing and packaging process, from the pharmaceutical formulation to the packaging environment and to the distribution chain. What might work in one part of the operation may not work at another end — solutions determined upstream may have unintended consequences downstream.

When developing the optimum package protection, the best approach to take is a multidisciplinary one that considers the knowledge and experience of packaging engineers, formulation chemists, analytical chemists, and the sorbent supplier.

Q: How do companies implement moisture management into their packaging?

A: Protecting a product from degradation is a critical component of manufacturing success, and packaging considerations are key. Choosing your packaging components requires careful strategy and considering the “big picture.” The bottom line is to consider the whole spectrum of factors involved in product degradation, and every aspect of upstream and downstream processing. Calculating these factors with a modeling system, supported by a knowledgeable partner, can lead to a more shelf-stable and safer product.

Q: Can a sorbent solution be customized to meet the specific demands of customers?

A: Certainly. As part of a systems approach, every aspect of moisture control can be customized to meet the needs of a customer. Packaging solutions must consider all facets of the manufacturing and development processes.

To optimize package protection for solid-dose formulations, pharmaceutical manufacturers need to employ a technique of moisture and oxygen ingress modeling to analyze the rates of degradation for a given pharmaceutical. Chemical degradation pathways can cause a loss of pharmaceutical potency after several weeks, whereas two to three years of shelf-life may be required depending on distribution channels. Modeling also determines steady-state levels of oxygen within bottles and moisture permeation across bottle walls, and material permeability.