The Whey of Things
New guidance outlines the safety of animal-derived excipients
Maryam Mahdi | | Quick Read
Responding to regulators’ calls for clearer guidance on the risks of excipients to patient health, the International Pharmaceutical Excipient Council (IPEC) Federation has published a position paper outlining the safety of the lactose-derived excipient whey (1). A natural polymer, whey is used in various oral dosage forms for its drug-binding capabilities – but some regulatory authorities consider ingredients from human or animal sources to have high chemical and biological risks when incorporated into oral preparations.
IPEC argues that the risk profile of pharmaceutical-grade whey is low because it is sourced from lactose manufactured to GMP standards. Historically, the excipient has also proven to be nontoxic with a good safety profile. The council now hopes that this classification will “result in fewer dossier requirements for lactose when applying for marketing authorizations” – making medicines that contain it more readily available.
Subscribe to The Medicine Maker Newsletters
- IPEC Federation (2021). Available at https://bit.ly/3d3H6nA.