Moisture control is a basic requirement in pharmaceutical packaging, directly influencing drug formulations’ chemical and physical stability.
Desiccants help to maintain moisture equilibrium within pharmaceutical packaging. By adsorbing water vapour within containers or blister packs, desiccants help prevent degradation pathways such as oxidation, microbial proliferation, and dissolution profile shifts.
In this article, we explore the best desiccants for pharmaceutical applications and how to choose the right one for different packaging needs.
Why Moisture Requires Careful Management
Moisture presents a challenge to the stability and safety of pharmaceutical products. Water vapour can initiate or accelerate degradation processes that compromise both the efficacy and shelf life of medications.
Many active pharmaceutical ingredients (APIs) are hygroscopic or chemically reactive in the presence of moisture, making them susceptible to hydrolysis and oxidation. These reactions can lead to the formation of impurities, altered dissolution rates, and reduced therapeutic effect.
High humidity levels can also facilitate microbial growth, particularly in formulations with organic excipients or semi-permeable packaging. Mould contamination presents a safety concern and may render entire product batches unusable.
In addition, excessive moisture can physically alter dosage forms—softening capsules, clumping powders, or disrupting film coatings—which affects the product’s performance and patient acceptability.
Regulatory expectations for product stability
In controlled environments, the absence of effective moisture management can ultimately lead to regulatory non-compliance, recalls, and increased quality control costs. As such, minimising moisture ingress is essential for ensuring pharmaceutical product integrity during storage and distribution.
Regulatory authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH), mandate robust stability data to support the shelf life and storage conditions of pharmaceutical products.
These guidelines emphasise the need for packaging systems to ensure product integrity under designated climatic zones. The selection and integration of desiccants must align with regulatory expectations, ensuring consistent performance throughout the product’s shelf life.