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Organic Colouring Agents in the Pharmaceutical Industry Cover

Organic Colouring Agents in the Pharmaceutical Industry

Open Access
|Oct 2017

References

  1. 1. Alghamdi, A. H., Alshammery, H. M., Abdalla, M. A., Alghamdi, A. F., 2009: Determination of Carmine Food Dye (E120) in foodstuffs by stripping voltammetry. J. AOAC Int., 92, 1454—1459.10.1093/jaoac/92.5.1454
  2. 2. Allam, K. V., Kumar, G., 2011: Colorants – the cosmetics for the pharmaceutical dosage forms. Int. J. Pharm. Pharm. Sci., 3, 13—21.
  3. 3. Amchova, P., Kotolova, H., Ruda-Kucerova, J., 2015: Health safety issues of synthetic food colorants. Regul. Toxicol. Pharmacol., 73, 914—922.10.1016/j.yrtph.2015.09.026
  4. 4. American Academy of Pediatrics, Committee on Drugs, 1997: Inactive ingredients in pharmaceutical products: Update. Pediatrics, 99, 268–278.10.1542/peds.99.2.268
  5. 5. Ashkenazi, P., Yarnitzky, Ch., Cais, M., 1991: Determination of synthetic food colours by means of a novel sample preparations system. Anal. Chim. Acta, 248, 289—299.10.1016/S0003-2670(00)80898-3
  6. 6. Attokaran, M., 2011:Natural Food Flavours and Colorants. Wiley-Blackwell, 39.10.1002/9780470959152
  7. 7. Bagirova, V. L., Miťkina, L. I., 2003: Determination of Tartrazine in drugs. Pharm. Chem. J., 37, 558—559.10.1023/B:PHAC.0000014865.38792.52
  8. 8. Chanlon, S., Joly-Pottuz, L., Chatelut, M., Vittori, O., Cretier, J. L., 2005: Determination of Carmoisine, Allura red and Ponceau 4R in sweets and soft drinks by differential pulse polarography. J. Food Compos. Anal., 18, 503—515.10.1016/j.jfca.2004.05.005
  9. 9. Chen, Q. Ch., Mou, S. F., Hou, X. P., Riviello, J. M., Ni, Z. M., 1998: Determination of eight synthetic food dyes in drinks by high-performance ion chromatography. J. Chromatogr., A, 827, 73—81.10.1016/S0021-9673(98)00759-6
  10. 10. Choi, C. K., Dong, M. W., 2005: Chapter 5 — Sample preparation for HPLC analysis of drug products. In Ahuja, S., Dong, M. W.:Handbook of Pharmaceutical Analysis by HPLC. Elsevier, United Kingdom, 123—144.10.1016/S0149-6395(05)80049-2
  11. 11. Codex Alimentarius, 1962:http://www.fao.org/fao-who-codexalimentarius/about-codex/en/ (accessed 05.04.16).
  12. 12. Combeau, S., Chatelut, M., Vittori, O., 2002: Identification and simultaneous determination of Azorubin, Allura red and Ponceau 4R by differential pulse polarography: application to soft drinks. Talanta, 56, 115—122.10.1016/S0039-9140(01)00540-9
  13. 13. Commission Directive 95/45/EC, 1995: Laying down specific purity criteriaconcerning colours for use in foodstuffs, OJEC L226, 1.
  14. 14. Commission Regulation 1333/2008, 2008: On food additives, OJEC L354, 16.
  15. 15. Commission Regulation 257/2010, 2010: Setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additives, OJEC L80, 19.
  16. 16. Commission Regulation 232/2012, 2012: Amending Annex II to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council as regards the conditions of use and the use levels for Quinoline Yellow (E 104), Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124), OJEC L78, 1.
  17. 17. Council Directive 2645/62, 1962: On the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption, OJEC 2645/62, 279.
  18. 18. Council Directive 78/25/EEC, 1978: On the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products, OJEC L11, 18.
  19. 19. Council Directive 94/36/EC, 1994: On colours for use in foodstuffs, OJEC L237, 13.
  20. 20. Council Directive 2009/35/EC, 2009: On the colouring matters which may be added to medicinal products, OJEC L109, 10.
  21. 21. Council Regulation 178/2002, 2002: Laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJEC L31, 1.
  22. 22. de Boer, L., 2014: Biotechnological production of colorants. Adv. Biochem. Eng. Biotechnol., 143, 51–89.10.1007/10_2013_241
  23. 23. Dipalma, J. R., 1990: Tartrazine sensitivity. Am. Fam. Physician., 42, 1347—1350.
  24. 24. Downham, A., Collins, P., 2000: Colouring our foods in the last and next millennium. Int. J. Food Sci. Tech., 35, 5—22.10.1046/j.1365-2621.2000.00373.x
  25. 25. Dóka, O., Bicanic, D., Ajtony, Z., Koehorst, R., 2005: Determination of sunset yellow in multi-vitamin tablets byphotoacoustic spectroscopy and a comparison with alternative methods. Food Addit. Contam., 22, 503—507.10.1080/0265203050013279416019823
  26. 26. EFSA, 2009a: Scientific opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive. EFSA J., 7, 1329.10.2903/j.efsa.2009.1329
  27. 27. EFSA, 2009b: Panel on food additives and nutrient sources added to food, scientific opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive. EFSA J., 7, 1330.10.2903/j.efsa.2009.1330
  28. 28. EFSA, 2009c: Scientific opinion on the re-evaluation of Azorubine/Carmoisine (E 122) as a food additive. EFSA J., 7, 1332.10.2903/j.efsa.2009.1332
  29. 29. EFSA, 2010a: Scientific opinion on the appropriateness of the food azo-colours Tartrazine (E 102), Sunset Yellow FCF (E 110), Carmoisine (E 122), Amaranth (E 123), Ponceau 4R (E 124), Allura Red AC (E 129), Brilliant Black BN (E 151), Brown FK (E 154), Brown HT (E 155) and Litholrubine BK (E 180) for inclusion in the list of food ingredients set up in Annex IIIa of Directive 2000/13/EC. EFSA J., 8, 1778.10.2903/j.efsa.2010.1778
  30. 30. EFSA, 2010b: Scientific opinion on the reevaluation of Brilliant Blue FCF (E 133) as a food additive. EFSA J., 8, 36.10.2903/j.efsa.2010.1853
  31. 31. European Medicines Agency, 2007: Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003382.pdf (accessed 05.04.16).
  32. 32. Fallico, B., Chiappara, E., Arena, G., Ballistreri, E., 2011: Assessment of the exposure to Allura red colour from the consumption of red juice-based and red soft drinks in Italy. Food Addit. Contam., 28, 1501—1515.10.1080/19440049.2011.59616621854298
  33. 33. Gosetti, F., Frascarolo, P., Mazzucco, E., Gianotti, V., Bottaro, M., Gennaro, M.C., 2008: Photodegradation of E110 and E122 dyes in a commercial aperitif: A high performance liquid chromatography-diode array-tandem mass spectrometry study. J. Chromatogr., A, 1202, 58—63.10.1016/j.chroma.2008.06.04418635191
  34. 34. Grzelewska-Rzymowska, I., Szmidt, M., Kowalski, M. L., Roźniecki, J., 1986: Sensitivity and tolerance to tartrazine in aspirin-sensitive asthmatics. Allergol. Immunopathol., 14, 31—36.
  35. 35.http://www.codexalimentarius.net/gsfaonline/docs/CXS_192e.pdf (accessed 05.04.16).
  36. 36. Ishikawa, F., Shigeoka. S., Nagashima, M., Takahashi, M., Kamimura, H., 2003: Simultaneous determination of eleven dyes and their aluminum lakes in drugs. J. AOAC Int., 86, 215—221.10.1093/jaoac/86.2.215
  37. 37. Jaworska, M., Szulinska, Z., Wilk, M., Anuszewska, E., 2005: Separation of synthetic food colourants in the mixed micellar system application to pharmaceutical analysis. J. Chromatogr., A, 1081, 42—47.10.1016/j.chroma.2005.03.045
  38. 38. Kanarek, R. B., 2011: Artificial food dyes and attention deficit hyperactivity disorder. Nutr. Rev., 69, 385—391.10.1111/j.1753-4887.2011.00385.x
  39. 39. Kaur, A., Gupta, U., 2014: Identification and determination of binary mixtures of synthetic dyes with Cr (III) complexation in food stuffs and pharmaceutical samples by high performance liquid chromatography. Indian Journal of Pharmaceutical Science and Research, 4, 49—52.
  40. 40. Khanavi, M., Hajimahmoodi, M., Ranjbar, A. M., Oveisi, M. R., Ardekani, M. R. S., Mogaddam, G., 2012: Development of a green chromatographic method for simultaneous determination of food colorants. Food Analytical Methods, 5, 408—415.10.1007/s12161-011-9259-4
  41. 41. Khehra, M. S., Saini, H. S., Sharma, D. K., Chadha, B. S., Chimni, S. S., 2006: Biodegradation of azo dye CI Acid Red 88 by an anoxic–aerobic sequential bioreactor. Dyes Pigm., 70, 1—7.10.1016/j.dyepig.2004.12.021
  42. 42. Kim, S. H., Suk, E. H., Kil, S. H., Hahm, K. D., Hwang, J. H., 2011: Hypotension in patients administered indigo carmine containing impurities — A case report. Korean J. Anesthesiol., 61, 435—438.10.4097/kjae.2011.61.5.435
  43. 43. Kirschbaum, J., Krause, C., Pfalzgraf, S., Brückner, H., 2003: Development and Evaluation of an HPLC-DAD. Method for determination of synthetic food dyes. Chromatographia, 57, 115—119.10.1007/BF02492092
  44. 44. Kučerová, J., Kotolová, H., 2013: Toxicity of dyes used in medical preparations (In Czech). Prakt. Lekáren., 9, 83—89.
  45. 45. Kucharska, M., Grabka, J., 2010: A review of chromatographic methods for determination of synthetic food dyes. Talanta, 80, 1045—1051.10.1016/j.talanta.2009.09.032
  46. 46. Lim, H. S., Choi, J. Ch., Song, S. B., Kim, M., 2014: Quntitative determination of carmine in foods by high-performance liquid chromatography. Food Chem., 158, 521—526.10.1016/j.foodchem.2014.02.122
  47. 47. Liu, Y. M., Yu, Q., Sun, L., Wang, S., 2006: Determination of synthetic colorant contents in officinal capsule. Chin. Pharm. J., 41, 303—305.
  48. 48. Macioszek, V. K., Kononowicz, A. K., 2004: The evaluation of the genotoxicity of two commonly used food colours: Quinoline Yellow (E 104) and Brilliant Black BN (E 151). Cell Mol. Biol. Lett., 9, 107—122.
  49. 49. Materiienko, A. S., Grudko, V. A., Georgiyants, V. A., 2014: Development of methods for determining Tartrazine and Carmoisine as part of shell of tablets “NITROXOLINE” (In Russian). Management, Economy and Quality Assurance in the Pharmacy, 1, 10—14.
  50. 50. McCann, D., Barrett, A., Cooper, A., Crumpler, D., Dalen, L., Grimshaw, K., et al., 2007: 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, 370, 1560—1567.10.1016/S0140-6736(07)61306-3
  51. 51. Minioti, K. S., Sakellariou, Ch. F. Thomaidis, N. S., 2007: Determination of 13 synthetic food dyes in water-soluble foods by reversed-phase high-performance liuid chromatography coupled with diode-array detector. Anal. Chim. Acta, 583, 103—110.10.1016/j.aca.2006.10.00217386533
  52. 52. Moldoveanu, S. C., David, V., 2015: Chapter 2 — The role of sample preparation. In Moldoveanu, S. C., David, V.:Modern Sample Preparation for Chromatography. Elsevier, United Kingdom, 33—49.10.1016/B978-0-444-54319-6.00002-5
  53. 53. Mpountoukas, P., Pantazaki, A., Kostareli, E., Christodoulou, P., Kareli, D., Poliliou, S., 2010: Cytogenetic evaluation and DNA interaction studies of the food colorants amaranth, erythrosine and tartrazine. Food Chem. Toxicol., 48, 2934—2944.10.1016/j.fct.2010.07.030
  54. 54. Nagaraja, T. N., Desiraju, T., 1993: Effects of chronic consumption of metanil yellow by developing and adult rats on brain regional levels of noradrenaline, dopamine and serotonin, on acetylcholine esterase activity and on operant conditioning. Food Chem. Toxicol., 31, 41—44.10.1016/0278-6915(93)90177-Z
  55. 55. National Toxicology Program, U. S., 1997: Toxicology and Carcinogenesis Studies of D & C Yellow No. 11 (CAS no. 8003-22-3) in F344/N rats (feed studies). Natl. Toxicol. Program Tech. Rep. Ser., 463, 1—190.
  56. 56. Newsome, A. G., Culver, C. A., van Breemen, R. B., 2014: Nature's palette: the search for natural blue colorants. J. Agric. Food Chem., 62, 6498—6511.10.1021/jf501419q
  57. 57. Ni, Y., Gong, X., 1997: Simultaneous spectrophotometric determination of mixtures of food colorants. Anal. Chim. Acta, 354, 163—171.10.1016/S0003-2670(97)00297-3
  58. 58. Nickerson, B., 2011: Chapter 1—Properties that impact sample preparation and extraction of pharmaceutical dosage forms. In Nickerson, B.:Sample Preparation of Pharmaceutical Dosage Forms (Challenges and Strategies for Sample Preparation and Extraction). Springer, USA, 3—20.10.1007/978-1-4419-9631-2_1
  59. 59. Podczeck, F., Jones, B. E., 2004:Pharmaceutical Capsules, 2nd edn., Pharmaceutical Press, 66—67.
  60. 60. Ronald, A., Simon, M. D., 2003: Adverse reactions to food additives. Curr. Allergy Asthma Rep., 3, 62—66.10.1007/s11882-003-0014-9
  61. 61. Rowe, R. C., Sheskey, P. J., Quinn, M. E., 2009: Chapter — Coloring agents. In Rowe, R. C., Sheskey, P. J., Quinn, M. E.:Handbook of Pharmaceutical Excipients, 6th edn., Pharmaceutical Press and American Pharmacists Association, USA, 189—196.
  62. 62. Sayar, S., Őzdemir, Y., 1997: Determination of Ponceau 4R and Tartrazine in various samples by derivative spectrophotometric methods. Turk. J. Chem., 2, 182—187.
  63. 63. Sayar, S., Őzdemir, Y., 1998: First-derivative spectrophotometric determination of ponceau 4R, Sunset Yellow and Tartrazine in confectionery products. Food Chem., 61, 367—372.10.1016/S0308-8146(97)00073-3
  64. 64. Sindhu, P. R., Bagya, L. J., Surya, P. R., 2011: Estimation of synthetic colorant Tartrazine in food stuff and formulations and effect of colorant on the protein binding of drugs. Int. J. Pharm. Ind. Res., 1, 141–152.
  65. 65. Tabar, A. I., Acero, S., Arregui, C., Urdánoz, M., Quirce, S., 2003: Asthma and allergy due to carmine dye. An. Sist. Sanit. Navar., 26, 65—73.10.4321/S1137-66272003000400009
  66. 66. Timberlake, C. F., Bridle, P., 1980: In Walford, J. (Ed.): Developments in Food Colours-1. London, Applied Science Publishers Ltd., 115—149.
  67. 67. Tsuda, S., Murakami, M., Matsusaka, N., Kano, K., Taniguchi, K., Sasaki, Y. F., 2001: DNA damage induced by red food dyes orally administered to pregnant and male mice. Toxicol. Sci., 61, 92—99.10.1093/toxsci/61.1.9211294979
  68. 68. Üstün Özgür, M., Koyuncu, İ., 2002: The simultaneous determination of Quinoline Yellow (E-104) and Sunset Yellow (E-110) in syrups and tablets by second derivative spectrophotometry. Turk. J. Chem., 26, 501—508.
  69. 69. Vidotti, E. C., Costa, W. F., Oliveira, C. C., 2006: Development of a green chromatographic method for determination of colorants in food samples. Talanta, 68, 516—521.10.1016/j.talanta.2005.01.05918970351
  70. 70. Vlase, L., Muntean, D., Cobzac, S. C., Filip, L., 2014: Development and validation of an HPLC-UV method for determination of synthetic food dyes. Re. Roum. Chim., 59, 719—725.
  71. 71. Wu, T. T., Chang, Y. Ch., Lee, J. M., Hung, M. H., 2015: Anaphylactic reaction to patent blue V used in preoperative computed tomography-guided dye localization of small lung nodules. JFMA, 1—2.
  72. 72. Yamjala, K., Nainar, M. S., Ramisetti, N. R., 2016: Methods for the analysis of azo dyes employed in food industry — A review. Food Chem., 192, 813—824.10.1016/j.foodchem.2015.07.08526304415
  73. 73. Yilmaz, U. T., Ergun, F., Yilmaz, H., 2014: Determination of the food dye carmine in milk and candy products by differential pulse polarography. J. Food Drug Anal., 22, 329—335.10.1016/j.jfda.2013.12.00228911422
  74. 74. Yoshioka, N., Ichihashi, K., 2008: Determination of 40 synthetic food colours in drinks and candies by high-performance liquid chromatography using a short column with photodiode array detection. Talanta, 74, 1408—1413.10.1016/j.talanta.2007.09.01518371797
DOI: https://doi.org/10.1515/fv-2017-0025 | Journal eISSN: 2453-7837 | Journal ISSN: 0015-5748
Language: English
Page range: 32 - 46
Submitted on: Mar 21, 2017
Accepted on: Jul 13, 2017
Published on: Oct 11, 2017
Published by: The University of Veterinary Medicine and Pharmacy in Košice
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2017 M. Šuleková, M. Smrčová, A. Hudák, M. Heželová, M. Fedorová, published by The University of Veterinary Medicine and Pharmacy in Košice
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