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Volatilization

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Volatilization gravimetry is an analytical technique that measures the mass lost due to the volatilization of the substance. This technique is used to estimate the amount of volatile material in a sample. To perform this method, heat a known amount of the sample to a high temperature in a crucible or other suitable vessel. The volatile substance in the sample evaporates, and the vapor is completely expelled from the crucible either by heating the sample or bubbling a stream of inert gas through...

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Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying.

Michel Y Louge¹, Jasdeep Mandur², Plamen Grigorov³

¹Sibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, 14853, NY, USA. MYL3@cornell.edu.

The AAPS Journal

|August 16, 2024

Summary

A novel capacitance instrument non-invasively monitors residual solvents in pharmaceutical powders during vacuum drying. This in situ technique offers advantages over indirect methods for real-time process control.

Keywords:

capacitance probe spray-dried powder tray drying vacuum drying

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Area of Science:

Pharmaceutical Science
Chemical Engineering
Analytical Chemistry

Background:

Monitoring residual solvents in pharmaceutical powders is crucial for product quality and safety.
Current indirect methods like mass spectrometry have limitations, including probe fouling and delayed results.

Purpose of the Study:

To develop and validate a non-invasive in situ capacitance instrument for continuous monitoring of residual solvents in pharmaceutical powders during vacuum drying.
To model vapor sorption kinetics and electric field interactions for improved understanding and application of the technique.

Main Methods:

Embedding a capacitance instrument in a vacuum-drying tray base.
Validating the instrument with Microcrystalline Cellulose and spray-dried Copovidone powder containing water and water/acetone mixtures.
Developing a vapor sorption model to analyze kinetic and diffusion limits based on powder thickness.
Modeling the electric field to interpret signals related to solvent mass fraction.

Main Results:

The capacitance instrument successfully monitored residual solvent content in real-time.
Vapor sorption modeling revealed kinetic limits for thin powder layers and diffusion limits for thicker layers.
The developed model aids in interpreting capacitance signals for variable solvent content.

Conclusions:

The non-invasive capacitance instrument provides a reliable and advantageous in situ method for monitoring residual solvents in pharmaceutical powders.
This technique offers real-time data, avoiding issues associated with indirect methods and probe fouling.
The study provides a foundation for designing and implementing this technology in pharmaceutical manufacturing.