EMA: New Q&As for Co-processed Excipients Used in Solid Oral Dosage Forms
The EMA has published for consultation new Q&As for co-processed excipients (CoPEs) used in solid oral dosage forms. The document outlines the quality requirements for CoPEs used in solid oral dosage forms in both human and veterinary medicinal products.
A CoPE is a combination of two or more Ph. Eur. excipients, typically two, which are processed together using a physical process (e.g. spray-drying) without the formation of covalent bonds. CoPEs have intended functionalities such as improved compaction characteristics which cannot be achieved by e.g. blending during routine manufacturing (low energy).
The use of CoPEs in pharmaceutical formulations is considered to have a higher degree of risk than using individual excipients due to several factors: for example complexity of composition, quality control, formulation development and stability issues. The Q&A aims to harmonise and quality clarify dossier requirements for CoPEs using a risk-based approach.
The deadline for comments is 31 December 2024.
Source:
EMA: Questions and answers regarding co-processed excipients used in solid oral dosage forms
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