Klin Farmakol Farm. 2013;27(1):41-47

Dyes used in medicinal products

Jana Kučerová, 2, Hana Kotolová3
1 Masarykova univerzita, Lékařská fakulta, Farmakologický ústav, Brno

Nowadays, every medicinal product is a complex system of active substances and excipients. Dyes are excipients used to improve the

aesthetic appearance of a drug, help identify the product in the production and distribution stages, serve as a signalling tool in the case

of dispensing error, or help patients tell their medications apart. The permission to use dyes in the pharmaceutical industry is subject to

a number of health tests and legislative measures. The article deals with toxicological assessment of synthetic dyes used in medicinal

products permitted by a guideline of the State Institute for Drug Control. Given the multitude of available literature sources and clinical

trials performed, it is unlikely that these substances significantly affect the health of the population.

Keywords: excipient, dyes, legislative measures, toxicity markers

Published: May 15, 2013  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Kučerová J, Kotolová H. Dyes used in medicinal products. Klin Farmakol Farm. 2013;27(1):41-47.
Share...
Download citation
  • BibTeX (.bib)
  • Bookends (.ris)
  • EasyBib (.ris)
  • EndNote (.enw)
  • EndNote 8 (.xml)
  • ISI WoS (.isi)
  • Medlars (.medlars)
  • Mendeley (.ris)
  • MODS (.xml)
  • Papers (.ris)
  • RefWorks (.txt)
  • RefManager (.ris)
  • RIS (.ris)
  • MS Word (.xml)
  • Zotero (.ris)
    • Open full article

    References

    1. Allam KV, Kumar GP. Colorants - the cosmetics for the pharmaceutical dosage forms. Int J Pharm Pharm Sci, 2011; 3(Suppl 3): 9.
    2. Chalabala M. Technologie léků. Edtion ed.: Galén, 2001: 408.
    3. Dobrila-Dintinjana R, Nacinovic-Duletic A. Placebo in the treatment of pain. Coll Antropol, Sep 2011; 35(Suppl 2): 319-323.
    4. Herman E, Praško J, Seiertová D. Konziliární psychiatrie. Edtion ed. Praha: Medical Tribune CZ, s.r.o., 2007: 604.
    5. Meissner K, Bingel U, Colloca L, Wager TD, Watson A, Flaten MA. The placebo effect: advances from different methodological approaches. J Neurosci, 2011; 31(45) 16117-16124. Go to original source... Go to PubMed...
    6. Shenefelt PD. Psychodermatological disorders: recognition and treatment. Int J Dermatol, Nov 2011; 50(11) 1309-1322. Go to original source... Go to PubMed...
    7. Benedetti F, Carlino E, Pollo A. How placebos change the patient's brain. Neuropsychopharmacology, Jan 2011; 36(1): 339-354. Go to original source... Go to PubMed...
    8. Rowe RC. The opacity of tablet film coatings. J Pharm Pharmacol, Sep 1984; 36(9): 569-572. Go to original source... Go to PubMed...
    9. SÚKL. REG-40 Barviva povolená pro použití v léčivých přípravcích. Pokyn Státního ústavu pro kontrolu léčiv [Type of Work]. 2000, pp. 15. Available from Internet: <http://www.sukl.cz/leciva/reg-40>.
    10. Hallagan JB, Allen DC, Borzelleca JF. The safety and regulatory status of food, drug and cosmetics colour additives exempt from certification. Food Chem Toxicol, Jun 1995; 33(6): 515-528. Go to original source... Go to PubMed...
    11. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) on a request from the Commission on the results of the study by McCann et al. (2007) on the effect of some colours and sodium benzoate on children's behaviour. European Food Safety Authority (EFSA) Journal, 2008: 54.
    12. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive on request from the European Commission. European Food Safety Authority (EFSA) Journal, 2009a; 7(11): 39.
    13. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the re-evaluation of Azorubine/Carmoisine (E 122) as a food additive on request the European Commission. European Food Safety Authority (EFSA) Journal, 2009b; 7(11): 40.
    14. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive. European Food Safety Authority (EFSA) Journal, 2009c; 7(11): 40.
    15. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive on request from the European Commission. European Food Safety Authority (EFSA) Journal, 2009d; 7(11): 44.
    16. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the re-evaluation Tartrazine (E 102). European Food Safety Authority (EFSA) Journal, 2009e; 7(11): 52.
    17. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the reevaluation of Ponceau 4R (E 124) as a food additive on request from the European Commission. European Food Safety Authority (EFSA) Journal, 2009f; 7(11): 39.
    18. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the re-evaluation of Brown HT (E 155) as a food additive. European Food Safety Authority (EFSA) Journal, 2010a; 8(4): 32.
    19. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the reevaluation of Brilliant Black BN (E 151) as a food additive on request from the European Commission. European Food Safety Authority (EFSA) Journal, 2010b; 8(4): 30.
    20. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the reevaluation of Brilliant Blue FCF (E 133) as a food additive. European Food Safety Authority (EFSA) Journal, 2010c; 8(11): 36.
    21. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the reevaluation of Green S (E 142) as a food additive. European Food Safety Authority (EFSA) Journal, 2010d; 8(11): 32.
    22. Efsa panel on food additives and nutrient sources added to food, E. Revised exposure assessment for Sunset Yellow FCF based on the proposed revised maximum permitted levels of use as a food additive. European Food Safety Authority (EFSA) Journal, 2011a; 9(9): 10.
    23. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the reevaluation of Erythrosine (E 127) as a food additive. European Food Safety Authority (EFSA) Journal, 2011b; 9(1): 46.
    24. Efsa panel on food additives and nutrient sources added to food, E. Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive. European Food Safety Authority (EFSA) Journal, 2013; 3(11): 35.
    25. Sasaki YF, Kawaguchi S, Kamaya A, Ohshita M, Kabasawa K, Iwama K, Taniguchi K, Tsuda S. The comet assay with 8 mouse organs: results with 39 currently used food additives. Mutat Res, Aug 26 2002; 519(1-2): 103-119. Go to original source... Go to PubMed...
    26. Axon A, May FE, Gaughan LE, Williams FM, Blain PG, Wright MC. Tartrazine and sunset yellow are xenoestrogens in a new screening assay to identify modulators of human oestrogen receptor transcriptional activity. Toxicology, Aug 16 2012; 298(1-3): 40-51. Go to original source... Go to PubMed...
    27. Mpountoukas P, Pantazaki A, Kostareli E, Christodoulou P, Karel D, Poliliou S, Mourelatos C, Lambropoulou V, Lialiaris T. Cytogenetic evaluation and DNA interaction studies of the food colorants amaranth, erythrosine and tartrazine. Food Chem Toxicol, Oct 2010; 48(10): 2934-2944. Go to original source... Go to PubMed...
    28. Pan X, Qin P, Liu R, Wang J. Characterizing the Interaction between tartrazine and two serum albumins by a hybrid spectroscopic approach. J Agric Food Chem,2011; 59(12): 6650-6656. Go to original source... Go to PubMed...
    29. McCann D, Barrett A, Cooper A, Crumpler D, Dalen L, Grimshaw K, Kitchin E, Lok K, Porteous L, Prince E, Sonuga-Barke E, Warner JO, Stevenson J. Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial. Lancet, Nov 3 2007; 370(9598): 1560-1567. Go to original source... Go to PubMed...
    30. Macioszek VK, Kononowicz AK. The evaluation of the genotoxicity of two commonly used food colors: Quinoline Yellow (E 104) and Brilliant Black BN (E 151). Cell Mol Biol Lett, 2004; 9(1): 107-122.
    31. Osman MY, Sharaf IA, El-Rehim WM, El-Sharkawi AM. Synthetic organic hard capsule colouring agents: in vitro effect on human true and pseudo-cholinesterases. Br J Biomed Sci, 2002; 59(4): 212-217. Go to original source... Go to PubMed...
    32. Mathur N, CHaudhary V, Mehta M, Krishnatrey R. Effect of Sunset Yellow on testis in rats. J. Ecophysiol. Occup. Hlth., 2005b; 5: 1-3.
    33. Mathur N, Chaudhary V, Mehta M, Gupta S. Sunset Yellow Induced Changes in the Lipid Profile in Male Albino Rat Biochem. Cell. Arch., 2005a; 5(2): 3.
    34. Sardi M, Haldemann Y, Nordmann H, Bottex B, Safford B, Smith B, Tennant D, Howlett J, Jasti PR. Use of retailer fidelity card schemes in the assessment of food additive intake: Sunset Yellow a case study. Food Addit Contam Part A Chem Anal Control Expo Risk Assess, Nov 2010; 27(11): 1507-1515. Go to original source... Go to PubMed...
    35. Groten JP, Butler W, Feron VJ, Kozianowski G, Renwick AG, Walker R. An analysis of the possibility for health implications of joint actions and interactions between food additives. Regul Toxicol Pharmacol, Feb 2000; 31(1): 77-91. Go to original source... Go to PubMed...
    36. Zaharia D, Pavel A. The influence of certain food additives on mitosis. In 4-th European Cytogenesis Conference. Iaşi: Dept Bioactive Substances and Medical Biotechnology, Faculty of Medical Bioengineering of medicine and Pharmacy, 2003.
    37. Tanaka T. Reproductive and neurobehavioural toxicity study of Ponceau 4R administered to mice in the diet. Food Chem Toxicol, Oct 2006; 44(10): 1651-1658. Go to original source... Go to PubMed...
    38. Tsuda S, Murakami M, Matsusaka N, Kano K, Taniguchi K, Sasaki YF. DNA damage induced by red food dyes orally administered to pregnant and male mice. Toxicol Sci, May 2001; 61(1): 92-99. Go to original source... Go to PubMed...
    39. Jennings AS, Schwartz SL, Balter NJ, Gardner D, Witorsch RJ. Effects of oral erythrosine (2', 4', 5', 7'-tetraiodofluorescein) on the pituitary-thyroid axis in rats. Toxicol Appl Pharmacol, May 1990; 103(3): 549-556. Go to original source... Go to PubMed...
    40. Gardner DF, Utiger RD, Schwartz SL, Witorsch P, Meyers B, Braverman LE, Witorsch RJ. Effects of oral erythrosine (2', 4', 5', 7'-tetraiodofluorescein) on thyroid function in normal men. Toxicol Appl Pharmacol, Dec 1987; 91(3): 299-304. Go to original source... Go to PubMed...
    41. Fallico B, CHiappara E, Arena E, Ballistreri G. Assessment of the exposure to Allura Red colour from the consumption of red juice-based and red soft drinks in Italy. Food Addit Contam Part A Chem Anal Control Expo Risk Assess, Nov 2011; 28(11): 1501-1515. Go to original source... Go to PubMed...
    42. Borzelleca JF, Depukat K, Hallagan JB. Lifetime toxicity/carcinogenicity studies of FD & C Blue No. 1 (brilliant blue FCF) in rats and mice. Food Chem Toxicol, Apr 1990; 28(4): 221-234. Go to original source... Go to PubMed...
    43. Schab DW, Trinh NH. Do artificial food colors promote hyperactivity in children with hyperactive syndromes? A meta-analysis of double-blind placebo-controlled trials. J Dev Behav Pediatr, Dec 2004; 25(6) 423-434. Go to original source... Go to PubMed...
    44. Kleinman RE, Brown RT, Cutter GR, Dupaul GJ, Clydesdale FM. A research model for investigating the effects of artificial food colorings on children with ADHD. Pediatrics, Jun 2012; 127(6): e1575-1584. Go to original source... Go to PubMed...
    45. Nigg JT, Lewis K, Edinger T, Falk M. Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives. J Am Acad Child Adolesc Psychiatry, Jan 2012; 51(1): 86-97 e88. Go to original source... Go to PubMed...
    46. CHeeseman MA. Artificial food color additives and child behavior. Environ Health Perspect, Jan 2012; 120 (1): A15-16; author reply A17. Go to original source... Go to PubMed...
    47. Zaknun D, Schroecksnadel S, Kurz K, Fuchs D. Potential role of antioxidant food supplements, preservatives and colorants in the pathogenesis of allergy and asthma. Int Arch Allergy Immunol, 2011; 157(2): 113-124. Go to original source... Go to PubMed...

    Return to the content


    Clinical Pharmacology and Pharmacy

    Madam, Sir,
    please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
    Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

    I declare:

    1. that I have met the above instruction
    2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited

    No
    Yes

    If your statement is not true, please be aware
    that brings the risk of danger to their health or the health of others.