Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications.

摘要: Color selection is one of the key elements building a strong brand development and product identity in pharmaceutical industry, besides to prevent counterfeiting. Moreover, colored dosage forms may increase patient compliance therapy enhancement. Although most synthetic dyes are classified as safe, their regulations stricter than other classes excipients. Safety concerns have increased during last years but efforts change natural seem be not promising. Their instability problems "non-toxic" still challenge. This review focuses specifically on issues related dye summarizes current regulatory status. A deep awareness toxicological data based public domain, making sure standards for regulation safety successful provided. In addition, strategies provided covalently bind polymers possibly overcome toxicity issues.