IPEC-Americas and IPEC Europe Publish Co-Processed Excipient Guide
IPEC-Americas and IPEC Europe have jointly published the Co-processed Excipient Guide for excipient makers and users. The new guide offers best practices toward co-processed excipient development, manufacture and use, and provides support to both co-processed excipient manufacturers and users.

A co-processed excipient is a combination of two or more compendial or non-compendial excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change.

Co-processed excipient users are responsible for assuring fitness for purpose and that the co-processed excipient and its components are manufactured to acceptable good manufacturing practice (GMP) standards. The guide facilitates communication between excipient users and suppliers regarding the safety information required for regulatory filing for a product containing a novel co-processed excipient.

The Guide is available for download at no charge to IPEC-Americas members and non-members (after registering) by visiting www.ipecamericas.org and at the IPEC Europe website at www.ipec-europe.org.

About IPEC-Americas
IPEC-Americas is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with its counterparts in Europe, China, Japan, and India serves as a primary international resource on excipients for its members, governments, and public audiences.