Understanding the Dynamic Vapor Sorption Characterization of Pharmaceuticals

The water sorption qualities of a material can be defined through Dynamic Vapor Sorption, a method which provides quantitative gravimetric observations obtained from monitoring mass alterations following environmental changes.

Recently developed dynamic vapor sorption devices allow the environment to be determined, including the humidity, gas flow, and temperature. This ensures that the data obtained is accurate, which is especially useful in pharmaceutical applications, allowing the user to obtain reliable equilibration curves and diffusion coefficients.

One of the main metrics for pharmaceutical applications is the characterization of moisture sorption. This quality is important as it determines both the mechanical stability and chemical composition of the product material. Medicine is very susceptible to moisture uptake during every step of development, reacting to form hydrates and lead to impure products, lower fields, and inaccurate dosage calculations. Furthermore, it can also lead to phase alterations which impact both the efficacy and stability of the drug.

Previously utilized methods for analyzing the vapor sorption of pharmaceuticals are not accurate and are very labor intensive. Therefore, development of new methods has allowed the user to obtain results faster, whilst also improving the accuracy and minimizing the labor intensity.

Overall, these methods can obtain the amorphous phase content, diffusion coefficients, hydration analysis, moisture vapor transmission rates and surface area and porosity.

Pharmaceutical Measurements with IGAsorp Dynamic Vapor Sorption Analyzer

An example of a reliable vapor sorption analyzer is the Hiden Isochema’s IGAsorp. This device is very accurate and fully automated, able to obtain many results from equilibration capacity to uptake kinetics.

Pre-determined temperature and relative humidity changes are programmed with stability of +/- 0.01 °C and +/- 0.01 %RH in a range of 5 – 85 °C and 0 – 98 %RH.

This instrument constantly surveys a product for moisture-related alterations in mass. It can be programmed for a specific temperature and humidity, with impressive stability. Using the IGAsorp’s software, the equilibration period is determined for each temperature and humidity through real-time kinetic measurements.

This, therefore, means that the repeatability is first-rate, ensuring that pharmaceutical applications will produce outstanding batch-to-batch consistency and comply with regulatory and market specifications.

This instrument has been applied for uses in many regions of pharmaceutical development, including MVTR, diffusivity determinations, hydrate analysis, and amorphous phase detection. Each of these measurements is vital in the development of medicines, such as hydrate analysis which can aid the development of packaging from informative observations of a drugs polymorphism in specific humidity and pressure.

Dynamic Vapor Sorption from Hiden Isochema

Hiden Isochema are principal inventors and providers of gravimetric devices suitable for many applications. For example, their IGAsorp can determine drug characteristics in many different environments at a high degree of accuracy to ensure that they are suitable for release into the market.

This information has been sourced, reviewed and adapted from materials provided by Hiden Isochema.

For more information on this source, please visit Hiden Isochema.

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