Pharmeuropa: Two Revised Chapters on Dissolution Testing published for comments

In the Pharmeuropa issue 36.3, two draft chapters related to dissolution testing were published.

The revised chapters align the dissolution testing for lipophilic dosage forms with the general chapter 2.9.3. Dissolution test for solid dosage forms. The structure of the texts have been updated to align both with current Ph. Eur. style and with the structure of 2.9.3 and some editorial changes have been made throughout the text.

2.9.42. Dissolution test for lipophilic solid dosage forms

According to the briefing notes, key updates include:

• "Apparatus: a description and schematic presentation of the two possible configurations have been added; an option to use suitable heating devices other than a water-bath has been added.
• Sampling: the filtration step has been deleted since it is deemed unnecessary for lipophilic dosage forms."

2.9.43. Apparent dissolution

The briefing notes mention the following key changes:

• "Apparatus: description and schematic presentation of the two possible configurations added; option to use suitable heating devices other than a water-bath added. New figure to display the insert added.
• Procedure: aperture size and the wire diameter of the wire cloth screens used corrected."

The deadline for submitting comments is 30 September 2024. The full text and further details on the revision and can be found, after registration, on the Pharmeuropa website.