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In Vitro Drug Dissolution: Compendial Testing Models I

In Vitro Drug Dissolution: Compendial Testing Models I

Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...

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Updated: Dec 18, 2025

Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution

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Published on: July 4, 2014

Machine-Vision-Enabled Salt Dissolution Analysis.

Jernej Štukelj^1,2, Mikael Agopov², Jouko Yliruusi²

¹Drug Research Program and Division of Pharmaceutical Chemistry and Technology, University of Helsinki, Viikinkaari 5E, 00790 Helsinki, Finland.

Analytical Chemistry

|June 17, 2020

Summary

This summary is machine-generated.

Drug salt selection requires understanding dissolution behavior. A machine-vision single-particle analysis (SPA) method rapidly characterizes salt dissolution, including disproportionation, using minimal sample amounts for improved drug development.

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Area of Science:

Pharmaceutical Sciences
Physical Chemistry
Materials Science

Background:

Salt formation enhances solubility of ionizable drugs.
Drug salt disproportionation can drastically alter solubility and bioavailability.
Understanding salt dissolution behavior is crucial for drug salt selection.

Purpose of the Study:

To introduce a machine-vision-based single-particle analysis (SPA) method for characterizing drug salt dissolution.
To demonstrate SPA's ability to analyze dissolution behavior with low sample consumption.
To investigate the disproportionation process and its impact on drug solubility and solid-state form.

Main Methods:

Utilized machine-vision-based single-particle analysis (SPA).
Performed simultaneous screening of small sample amounts (<1 mg).
Analyzed pH-solubility profiles, intrinsic solubility, common-ion effect, pKa, pHmax, and Ksp values.

Main Results:

SPA successfully determined key dissolution parameters for three model compounds.
Observed in situ disproportionation processes at particle-scale resolution.
Identified a high-energy form of diclofenac free acid and liquid verapamil free base upon disproportionation.

Conclusions:

SPA provides a low sample consumption platform for rapid and detailed characterization of drug salt dissolution behavior.
SPA enables in situ observation of disproportionation and its effects on morphology and solubility.
This method aids in understanding and optimizing drug salt selection processes.