Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures

Recommendation

27/28 June 2023
Heidelberg, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

The European Directorate for the Quality of Medicines & HealthCare (EDQM) indicated in a press release dated 01 February 2023 that the public consultation on two Ph. Eur. chapters on pharmaceutical technology procedures has been started. These are the revised general chapter 2.9.3 "Dissolution of tablets and capsules" and the new chapter 2.9.55 "Characterisation of powder behaviour during compression". Both texts were recently published in Pharmeuropa 35.1.

General Chapter 2.9.3. Dissolution of Tablets and Capsules

The aim of the revision was to improve comprehensibility and to harmonize the terminology used. In particular, the number of significant digits for pH and temperature has been adjusted. Further information on the changes made can also be found in a summary that we recently published.

New General Chapter 2.9.55. Characterisation of Powder Behaviour during Compression

The new chapter is divided into the following five main sections:

• 1. Introduction
• 2. Description of the powder compression phases
• 3. Compression equipment
• 4. Characterisation of the compaction behaviour
• 5. Conclusion and recommendations

In the introduction to the new chapter, it is pointed out that powder compression is a critical process in tablet manufacturing. Despite extensive experience, many problems, including capping, lamination, friability and sticking, are still encountered during the compression stages.

The complete texts and further details on the revision as well as the possibility to comment can be found on the Pharmeuropa Website after registration. The deadline for submitting comments is 31 March 2023 in both cases.