title: Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications.
abstract: Color selection is one of the key elements of building a strong brand development and product identity in the pharmaceutical industry, besides to prevent counterfeiting. Moreover, colored pharmaceutical dosage forms may increase patient compliance and therapy enhancement. Although most synthetic dyes are classified as safe, their regulations are stricter than other classes of excipients. Safety concerns have increased during the last years but the efforts to change to natural dyes seem to be not promising. Their instability problems and the development of "non-toxic" dyes is still a challenge. This review focuses specifically on the issues related to dye selection and summarizes the current regulatory status. A deep awareness of toxicological data based on the public domain, making sure the compliance of standards for regulation and safety for successful product development is provided. In addition, synthetic strategies are provided to covalently bind dyes on polymers to possibly overcome toxicity issues.
authors.affiliation: Evonik Nutrition & Care GmbH, Kirschenallee, 64293 Darmstadt, Germany.
authors.forename: Leire
authors.initials: L
authors.lastname: Pérez-Ibarbia
authors.affiliation: Laboratory of Organic and Macromolecular Chemistry (IOMC), Friedrich Schiller University Jena, Humboldtstrasse 10, 07743 Jena, Germany; Jena Center for Soft Matter (JCSM), Friedrich Schiller University Jena, Philosophenweg 7, 07743 Jena, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Majdanski
authors.affiliation: Jena Center for Soft Matter (JCSM), Friedrich Schiller University Jena, Philosophenweg 7, 07743 Jena, Germany; Institute of Pharmacy, Friedrich Schiller University Jena, Otto-Schott-Straße 41, 07743 Jena, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Schubert
authors.affiliation: Evonik Nutrition & Care GmbH, Kirschenallee, 64293 Darmstadt, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Windhab
authors.affiliation: Laboratory of Organic and Macromolecular Chemistry (IOMC), Friedrich Schiller University Jena, Humboldtstrasse 10, 07743 Jena, Germany; Jena Center for Soft Matter (JCSM), Friedrich Schiller University Jena, Philosophenweg 7, 07743 Jena, Germany. Electronic address: ulrich.schubert@uni-jena.de.
authors.forename: Ulrich S
authors.initials: US
authors.lastname: Schubert
mesh_terms: D003116:Color; D004396:Coloring Agents / Q000737:chemistry / Q000633:toxicity*; D019587:Dietary Supplements; D005079:Excipients / Q000737:chemistry / Q000633:toxicity*; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations; D011108:Polymers / Q000737:chemistry / Q000633:toxicity
chemical_list: D004396:Coloring Agents; D005079:Excipients; D004364:Pharmaceutical Preparations; D011108:Polymers
keywords: Coloring agents; Dye; Excipients; Nutraceutical; Pharmaceutical; Regulation; Safety; Toxicology