Moisture plays a decisive role in the stability, performance and manufacturability of pharmaceutical ingredients and formulations. From hydrate formation and glass transitions to powder flow and long-term storage, understanding how moisture interacts with these materials is critical to ensuring product quality and regulatory compliance.
Moisture impacts every stage of the pharmaceutical lifecycle:
Pharmaceutical solids can undergo a range of moisture-driven transformations, including hydrate formation, polymorphic transitions, glass transitions, and hydrolytic degradation. These changes influence stability, manufacturability, and ultimately the performance of the final product.
Moisture affects how powders behave during processing and how dosage forms perform in use. It influences processes such as flowability, compaction and granulation as well as the stability of micronized or otherwise sensitive materials.
Common excipients such as lactose, MCC and trehalose exhibit moisture-dependent behaviour that can affect formulation robustness. How these excipients behave and their compatibility with active ingredients is significant for informing formulation decisions.
Even small levels of moisture can lead to physical and/or chemical changes of the drug product. Packaging materials such as blisters and polymer films must therefore provide reliable moisture protection throughout the product’s intended shelf-life. Understanding how moisture moves through these materials is essential for designing robust packaging systems and ensuring long-term stability.
Moisture-driven changes influence stability profiles, critical quality attributes, and overall product performance, making them central to ICH stability studies and Quality by Design (QbD) frameworks. A clear understanding of moisture sensitivity supports risk-based development and more reliable control strategies, ensuring that products remain safe and effective throughout their lifecycle.
The IGAsorp platform delivers high-precision gravimetric analysis of water and organic vapor sorption under controlled temperature and humidity. It is widely used across pharmaceutical R&D for:
We are also specialists in the measurement of interactions with less common species including, for example, the interactions of propellant pressurised gases with powders.
High accuracy gravimetric analyzer, for precise characterization of gas sorption equilibria and kinetics
