The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of a new position paper, Pharmaceutical Lactose used in oral preparations is a low-risk excipient. This paper describes IPEC Federation’s position on the risk classification of lactose in all oral preparations.
Regulatory authorities worldwide increasingly seek to classify pharmaceutical excipients according to the risk they may present to patients when used in dosage forms.
Although lactose is derived from an animal derived material (whey), this position paper seeks to support pharmaceutical grade lactose as a low-risk excipient in oral dosage forms.
IPEC Federation considers that pharmaceutical grade lactose has a low risk profile with respect to chemical and biological risks when used in oral pharmaceutical preparations.
Therefore, this paper could help to advocate this classification status with regulatory authorities and consequently result in fewer dossier requirements for lactose when applying for marketing authorisations, thus facilitating the availability of medicines.
The position paper is available for download immediately via the website www.ipec-federation.org and on the regional IPEC websites.
For further information contact the IPEC Federation Secretariat at +32 2 213 74 40 or write to info@ipec-federation.org.