Back Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures

EDQM Strasbourg, France 01/02/2023
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Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures

The European Pharmacopoeia (Ph. Eur.) contains quality standards that are applied in a constantly evolving environment and it is therefore essential that its texts and the procedures they describe consistently reflect current practices. As is the case for any other text, where procedures relating to pharmaceutical technology are concerned, this is achieved through the efforts of the Ph. Eur.’s experts, who update existing texts so they remain state-of-the-art or elaborate new chapters to cover additional procedures. Two texts dealing with pharmaceutical technology, one revised and one new, have recently been published in Pharmeuropa 35.1 for public consultation.

Revision of the harmonised general chapter 2.9.3. Dissolution of tablets and capsules

The text on dissolution testing of oral solid dosage forms, already harmonised within the Pharmacopoeial Discussion Group (PDG), has been revised essentially to provide a more detailed description of the two possible ways of operating Apparatus 3 – reciprocating cylinder. The PDG also took this opportunity to edit the text for greater clarity and to harmonise the terminology used. In particular, the number of significant digits for pH and temperature has been corrected.

New general chapter 2.9.55. Characterisation of powder behaviour during compression

Powder compression is a critical process in tablet manufacturing. Problems during compression are numerous and include capping and lamination, friability or powder sticking to punch surfaces of the die wall, to name but a few. It is important to characterise tablet compression in order to control the compression process well.

The detailed new general chapter on characterisation of powder behaviour during compression provides guidance for standardised compression test procedures such as evaluation of compressibility, tabletability and compactibility profiles.

All interested stakeholders are strongly encouraged to review the proposed general chapters and submit their comments before the deadline (31 March 2023) via the appropriate channel to their National Pharmacopoeial Authority (contacts as published in Pharmeuropa) or the European Directorate for the Quality of Medicines & HealthCare.