Ingredient & Excipient safety assessment
Excipients may be defined as the constituents of a pharmaceutical form that are not the active substance. Excipients are used in all drug products and in substance based medical devices (correctly named co-formulants) as well as in most food products. They include colouring matters, antioxidants, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, solubilisers, permeation enhancers, flavouring and aromatic substances as well the constituents of the outer covering of the medicinal products, e.g. gelatine capsules.
Excipients must present the characteristics required by their technological function but, as with any substance administered to man, they must also correspond to suitable safety requirements.
Toxicity evaluation of excipients to be used in pharmaceutical formulations is a difficult and extremely diversified task in particular for drugs to be administered in the pediatric population.
ToxHub safety experts have extensive experience on pharmacology, drug metabolism and pharmacokinetics, and toxicology matters, including the safety evaluation for excipient for specific age target groups and site of applications.
We can support our customers providing expert consulting services to support the safety of their pharmaceutical formulations.
Our services include:
- Safety evaluation of both known and novel excipients
- Identification of compounds of regulatory concern
- Assessment of the inherent risk of the excipient based on its source (animal derived etc.) and its quantity and function within the medicinal product formulation
- Identification of toxic effects for the whole population or for specific populations
- Calculation of safe and allowable levels for excipients for different route of exposures and different target population including pediatrics
- Excipient Risk Assessment
- Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
- Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use (Text with EEA relevance)
- Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) Excipients and information for the package leaflet EMA/CHMP/302620/2017 Rev. 1*
- Guideline on pharmaceutical development of medicines for paediatric use EMA/CHMP/QWP/805880/2012 Rev. 2.