Draft of new Ph. Eur. Chapter "Co-Processed Excipients" published

Recommendation

17-19 September 2024

Granulation & Tableting - Live Online Training
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms

A draft of a new Ph. Eur. chapter  "Co-Processed Excipients" has been published in Pharmeuropa 27.4 with deadline for comments on December 31, 2015.

In the proposed chapter a co-processed excipient is defined as "any combination of two or more excipients obtained by physical co-processing that does not lead to the formation of covalent bonds".

The individual components of a co-processed excipient have to comply with the requirements of any corresponding individual Ph. Eur monograph and of the general Ph. Eur. monograph Substances for pharmaceutical use.  Additionally, the co-processed excipients comply  with the requirements of the general Ph. Eur. monograph Substances for pharmaceutical use.

Co-processed excipients can be produced by processings that produce only a physical interaction between the components like for example co-drying, spray drying, granulation, extrusion, and high-shear dispersion. They may be batch or continuous processes.

The proposed monograph includes sections on Characters, Identification, Tests, Assay, Labelling, and Functionality-Related Characteristics.

The section on "Tests" proposes that "specifications are defined for the final co-processed material as a whole" and "if the co-processed excipient includes impurities not controlled by the monographs of the individual components, these must be specified and suitably controlled".

Following your registration on the Pharmeuropa website you can get to the complete Draft Chapter "Co-Processed Excipients".