How to register co-processed excipients – MEGGLE Excipients & Technology

Co-processed Excipients:
Drug approval process | Compendial vs. Novel Excipients

Common Technical Documentation Format – CTD

Throughout a drug approval process a team of drug regulatory experts needs to compile mandatory documentation, which comply with the common technical documentation format.
Reference: ICH Topic M 4 QCommon Technical Document for the Registration of Pharmaceuticals for Human Use; CPMP/ICH/2887/99 – Quality).

The CTD format section 3.2.P.4 Control of Excipients covers the mandatory description of the excipients used.
Such as:

• Excipient´s specification and its justification
• Excipient´s analytical procedures and corresponding validation
• Excipient´s origin (human or animal origin)

The workload for filling in this excipient section will depend on the excipient actually being used (compendial / traditional or novel).

Compendial Excipients

Compendial excipients comply with monographs published in compendias such as Ph. Eur., USP-NF, JP, CP, etc. These excipients are well accepted by the regulatory bodies. Thus, the risk of a delayed drug approval process is small or negligible for the prospective marketing authorization holder.

Novel Excipients

In this context the use of novel excipients (including also co-processed excipients) requires additional documentation (pertaining to co-processed excipients as well). In 2017, the International Pharmaceutical Excipients Council (IPEC) has published its “Co-processed Excipient Guide for Pharmaceutical Excipients” acknowledging co-processed excipients as novel excipients.

Novel excipients are defined by the International Council for Harmonisation (ICH) as follows: “Novel Excipients…excipient(s) used for the first time in a drug product or by a new route of administration”.

Regardless of the current development, MEGGLE has been producing co-processed excipients for more than 30 years, which have found their way into approved drugs (oral route of administration) throughout various countries, whose health authorities are members or observers of the ICH.

It is therefore important to emphasize, that MEGGLE’s CPEs e.g.

• Cellactose 80
• MicroceLac 100
• StarLac
• RetaLac

are not novel excipients according to the ICH definition.

As MEGGLE continues to play a vital role in the manufacturing of co-processed excipients, newly developed products will fall into the category of novel excipients making it necessary to consider excipient´s pharmacological and toxicological profile. In this regard the IPEC’s co-processed Excipient Guide for Pharmaceutical Excipients gives advice and explains procedures how to evaluate pharmacology and toxicology. These procedures are acknowledged and embraced by MEGGLE.

Therefore a maximum of regulatory certainty to all parties involved is guaranteed.

MEGGLE´s commitment to co-processed Excipients:
How MEGGLE provides multi-level regulatory support.

Continue reading here on how Meegle provides multi-level regulatory support