If it is so difficult to qualify a new excipient for pharmaceutical use, doesn’t that have a chilling effect on the ability of finished drug manufacturers to develop better delivery systems for new, improved drug therapy for heart disease, cancer, and other serious conditions?
Yes. This is why far-sighted makers and users of excipients used in finished drug dosage forms joined together in 1991 to form the International Pharmaceutical Excipients Council (IPEC).