The safety of pharmaceutical excipients.
Excipients are essential ingredients of medicinal products. Approximately 1000 excipients are today in use in marketed pharmaceuticals. The safety issues regarding excipients can be classified into three categories: quality, toxicology and improper use. An overview of the current status, regulatory requirements and improvements is given.
de Jong
H J
HJ
Servier International Research Institute, Courbevoie, France.
D005060:Europe; D005079:Excipients / Q000009:adverse effects / Q000592:standards*; D005602:France; D006801:Humans; D007880:Legislation, Drug; D011785:Quality Assurance, Health Care; D012449:Safety
D005079:Excipients