Characterizing The Effects Of Moisture On Pharmaceutical Materials Using The Discovery SA – Dynamic Vapor Sorption Analyzer

Moisture significantly affects the physical properties, stability, and efficacy of pharmaceutical ingredients, including active pharmaceutical ingredients (APIs) and excipients. Hygroscopicity, phase changes, and hydrate formation induced by humidity and temperature can influence a drug’s shelf life, bioavailability, and structural integrity. The Discovery Sorption Analyzer (SA) provides precise environmental control to quantify these effects and optimize drug formulation and storage.

Dynamic Vapor Sorption (DVS) experiments reveal moisture interactions with APIs like ibuprofen, which is classified as moderately hygroscopic due to a 5.5% weight gain from 0% to 80% RH. Moisture profiling enables the selection of less hygroscopic alternatives, improving drug stability. For excipients like lactose, the Discovery SA demonstrates phase transitions from amorphous to crystalline structures under rising humidity. Recrystallization decreases solubility, which could reduce bioavailability, emphasizing the need for accurate humidity characterization during formulation.

Sodium naproxen illustrates the complexities of hydrate formation under varying humidity and temperature conditions. Adsorption-desorption cycles at 25 °C reveal the formation of mono-, di-, and trihydrate forms depending on RH. At constant 65% RH, temperature changes trigger dehydration events, further showcasing the interplay of humidity and temperature in structural transitions.

The Discovery SA’s ability to analyze these interactions ensures comprehensive understanding of moisture effects, aiding in the development of stable, effective pharmaceutical products. Its precision and versatility make it a critical tool for identifying potential risks and optimizing drug production and storage.