Innovative (novel) excipients can improve drug product quality and are the basis for development of new drug delivery systems. In recent years mainly modified excipients or co-processed excipients have been introduced to the market. These two categories aim at improving the performance in existing applications or manufacturing processes.
A novel excipient is an excipient which is being used for the first time in a drug product, or by a new route of administration.
Novel materials are desired to overcome formulation challenges that cannot be addressed with standard excipients, but the development of a novel excipient has similarity to a new drug development and presents a real challenge.
Excipients bring specific and essential functionalities to medicines. Described as substances other than the active ingredient (API) which have been appropriately evaluated for safety, they are intentionally included in a drug delivery system.
The functionality of excipients is very diverse. They can be used as fillers, lubricants, coloring matters, antioxidants, preservatives, adjuvants, stabilizers, etc.
What is a novel excipient?
ICH, EMA: A novel excipient is an excipient which is being used for the first time in a drug product, or by a new route of administration. It may be a new chemical entity or a well-established one which has not yet been used for human administration and /or for a particular human administration pathway.
FDA: New excipients are any inactive ingredients that are intentionally added to the therapeutic and diagnostic products, but that:
1) are not intended to exert therapeutic effects at the intended dosage, although they may act to improve product delivery (e.g. enhance absorption or control release of the drug substance),
2) are not fully qualified by the existing safety data with respect to the currently proposed level of exposure, duration of exposure, or route of administration.
Under the current regulatory framework novel excipients are not evaluated independently, but as part of a submitted IND/IMPD. The absence of an independent regulatory pathway delays time-to-market and innovator companies may choose not to use novel excipients to formulate active substances (APIs).
Today, novel excipients are only approved together with the API for a specific medicine.
Advanced treatments and therapeutics, particularly in the area of biologics, for example m-RNA vaccines, increase the need to use novel excipients. Avoiding their use is no longer a viable strategy and Europe cannot fall behind if the future needs of EU patients are to be met without delay.
The lack of a workable system for novel excipients in the EU has a negative impact on Europe’s innovative medicines development compared with other countries.
Innovative Medicine Examples
- Advanced oncology drugs
- Next Generation of mRNA Vaccines
- Breakthrough Treatment for Postpartum Depression
- PSMA-Targeted Therapy in Prostate Cancer
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Resource Person: Barbara Pirola
