Advertisement

AAPS PharmSciTech

, Volume 19, Issue 1, pp 36–47 | Cite as

Stability of Organoleptic Agents in Pharmaceuticals and Cosmetics

  • Akash Patil
  • Supriya Bhide
  • Mustafa Bookwala
  • Bhavik Soneta
  • Vijaykumar Shankar
  • Ahmed Almotairy
  • Mashan Almutairi
  • S. Narasimha MurthyEmail author
Mini-Review Theme: Stability of Pharmaceutical Excipients
Part of the following topical collections:
  1. Theme: Stability of Pharmaceutical Excipients

Abstract

Organoleptic agents constitute an important niche in the field of pharmaceutical excipients. These agents encompass a range of additives responsible for coloring, flavoring, sweetening, and texturing formulations. All these agents have come to play a significant role in pharmaceuticals and cosmetics due to their ability to increase patient compliance by elevating a formulation’s elegance and esthetics. However, it is essential to review their physical and chemical attributes before use, as organoleptic agents, similar to active pharmaceutical ingredients (APIs), are susceptible to physical and chemical instability leading to degradation. These instabilities can be triggered by API-organoleptic agent interaction, exposure to light, air and oxygen, and changes in pH and temperature. These organoleptic agent instabilities are of serious concern as they affect API and formulation stability, leading to API degradation or the potential for manifestation of toxicity. Hence, it is extremely critical to evaluate and review the physicochemical properties of organoleptic agents before their use in pharmaceuticals and cosmetics. This literature review discusses commonly used organoleptic agents in pharmaceutical and cosmeceutical formulations, their associated instabilities, and probable approaches to overcoming them.

KEY WORDS

colors flavors sweeteners textures stability interaction 

References

  1. 1.
    US Pharmacopeia [Internet]. US Pharmacopeia, Excipients. 2007 [cited 2016 Oct 20]. 1–11 p. Available from: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/chapter3.pdf
  2. 2.
    Jacobs MG, Klug DB, Moreton RC, Silverstein I. Qualification of excipients for use in pharmaceuticals. Chim Oggi. 2009;27(5 Suppl):11–3.Google Scholar
  3. 3.
    Loftsson T. Excipient pharmacokinetics and profiling. Int J Pharm [Internet]. 2015 Mar 1 [cited 2017 may 4];480(1–2):48–54. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25596414.
  4. 4.
    Mohanta G, Parimalakrishnan S, Manna P. An overview of organoleptic excipients [Internet]. Pharmabiz.com. 2011. p. 1–6. Available from: http://www.pharmabiz.com/NewsDetails.aspx?aid=65654&sid=21
  5. 5.
    Gennaro AR. Remington: the science and practice of pharmacy. 21st ed. Lippincott Williams and Wilkins:1060 p.Google Scholar
  6. 6.
    Weerawatanakorn M, Wu J, Pan M, Ho C. Reactivity and stability of selected flavor compounds. J Food Drug Anal. 2015. p. 176–90.Google Scholar
  7. 7.
    Lenik J, Wesoły M, Ciosek P, Wróblewski W. Evaluation of taste masking effect of diclofenac using sweeteners and cyclodextrin by a potentiometric electronic tongue. J Electroanal Chem [Internet]. 2016 [cited 2017 May 4];780:153–9 Available from: http://www.sciencedirect.com/science/article/pii/S1572665716304751
  8. 8.
    Allen L, Popovich N, Ansel H. Pharmaceutical dosage forms and drug delivery systems [internet]. 9th ed. Allen L, Popovich N, Ansel H, editors. Pharmaceutical dosage forms and drug delivery systems. MD and PA: Lippincott Williams & Wilkins; 2011. 130 p. Available from: http://pharmachitchat.com/wp-content/uploads/2015/05/ansel-drug-delivery-system.pdf
  9. 9.
    Classen C, Howes D, Synnott A. Aroma: the cultural history of smell [Internet]. 18th ed. London and New York: Routledge; 1994. 1–20 p. Available from: file:///C:/Users/akash/Downloads/1440494494.Constan Classen, David Howes, Anthony Synnott Aroma The Cultural History of Smell 1994.pdf.Google Scholar
  10. 10.
    US patent for odor-masking coating for a pharmaceutical preparation Patent (Patent # 6,667,059 issued December 23, 2003) - Justia Patents Search [Internet]. Available from: http://patents.justia.com/patent/6667059
  11. 11.
    US Pharmacopeia USP29-NF 24. 2006. 2994 p.Google Scholar
  12. 12.
    The IPEC Excipient stability program guide [Internet]. International Pharmaceutical Excipients Council 2010 p. 1–14. Available from: http://ipec-europe.org/UPLOADS/100311_IPECStabilityGuide-Final.pdf
  13. 13.
    Allam K, Kumar G. Colorants—the cosmetics for the pharmaceutical dosage forms. Int J Pharm Pharm Sci. 2011. p. 13–21.Google Scholar
  14. 14.
    Schoneker D. Coloring Agents for use in pharmaceuticals. In: Swarbrick J, editor. Encylopedia of Pharmaceutical Technology [Internet]. 3rd ed. New York: Informa Healthcare; 2007. p. 648. Available from: http://www.gmpua.com/Process/EncyclopediaPT.pdf
  15. 15.
    Peck B. Pharmaceutical dosage forms—tablets. 2nd ed. 116–117 p.Google Scholar
  16. 16.
    Rowe RC. The opacity of tablet film coatings. J Pharm Pharmacol [Internet]. 1984 Sep [cited 2016 Oct 20];36(9):569–72. Available from: http://www.ncbi.nlm.nih.gov/pubmed/6149277.
  17. 17.
    Kanekar H, Khale A. Coloring agents: current regulatory perspective for coloring agents intended for pharmaceutical and cosmetic use. Int J Pharm Phytopharm Res. 2014;3(5):365–73.Google Scholar
  18. 18.
    US Pharmacopeia USP39-NF 34. 2016.Google Scholar
  19. 19.
    US FDA. Summary of color additives for use in the United States in foods, drugs, cosmetics, and medical devices. [Internet]. Center for Food Safety and Applied Nutrition; [cited 2016 Oct 20] Available from: http://www.fda.gov/forindustry/coloradditiv https://www.fda.gov/forindustry/coloradditives/coloradditiveinventories/ucm115641.htm#table3A
  20. 20.
    Azeredo H. Betalains: properties, sources, applications, and stability—a review. Int J Food Sci Technol. 2009;44:2365–7.CrossRefGoogle Scholar
  21. 21.
    Stintzing F, Carle R. Betalains—emerging prospects for food scientists. Trends Food Sci Technol. 2007;18(10):514–25.CrossRefGoogle Scholar
  22. 22.
    Trouillas P, Sancho-García J, De Freitas V, Gierschner J, Otyepka M, Dangles O. Stabilizing and modulating color by copigmentation: insights from theory and experiment. Chem Rev. 2016;116(9):4937–82.CrossRefPubMedGoogle Scholar
  23. 23.
    Khan M. Stabilization of betalains: a review. Food Chemistry. 2016. p. 1280–5.Google Scholar
  24. 24.
    Menon V, Sudheer A. Antioxidant and anti-inflammatory properties of curcumin [Internet]. Advances in Experimental Medicine and Biology. Boston, MA: Springer US; 2007 [cited 2016 Nov 3]. p. 105–25. Available from:  http://link.springer.com/10.1007/978-0-387-46401-5_3
  25. 25.
    Maing I, Miller I. Curcumin-metal color complexes [Internet]. US; US 4263333 A, 1979 [cited 2016 Oct 20]. Available from: https://www.google.com/patents/US4263333
  26. 26.
    Lauro G, Francis J. Natural food colorants—science and technology. 1st ed. New York: Marcel Dekker; 2000. p. 205–23.Google Scholar
  27. 27.
    He J, Giusti MM. Anthocyanins: Natural colorants with health-promoting properties. Annu Rev Food Sci Technol [Internet]. 2010 Apr [cited 2016 Nov 3];1(1):163–87 Available from:  http://www.annualreviews.org/doi/10.1146/annurev.food.080708.100754
  28. 28.
    Francis F. Carotenoids as food colorants [Internet]. Cereal Foods World. 2000 [cited 2016 Nov 3]. p. 198–203. Available from:  http://www.tandfonline.com/doi/full/10.1080/10408398209527357
  29. 29.
    Frank J. Beta carotene: a work-horse colorant & pro-vitamin A [internet]. PRO 2015. Available from: http://knowledge.ulprospector.com/2838/fbn-beta-carotene-work-horse-colorant-pro-vitamin-a/
  30. 30.
    Peica N, Kiefer W. Characterization of indigo carmine with surface-enhanced resonance Raman spectroscopy (SERRS) using silver colloids and island films, and theoretical calculations. J Raman Spectrosc [Internet]. 2008 Jan [cited 2016 Nov 3];39(1):47–60 Available from:  http://doi.wiley.com/10.1002/jrs.1813
  31. 31.
    Thorngate J. Synthetic food colorants, food additives. In: Thorngate J, Salminen S, Branen L, Davidson M, editors. Food Additives. 2nd ed. Marcel Dekker; 2002. p. 477–500.Google Scholar
  32. 32.
    Anderson M, Opawale F, Rao D, Delmarre D, Anyarambhatla G. Excipients for oral liquid formulations. In: Katdare A, Chaubal M, editors. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems [Internet]. New York London: Informa Healthcare USA, Inc; 2006 [cited 2016 Oct 20]. p. 174. Available from:  http://www.crcnetbase.com/doi/book/10.1201/9781420004137
  33. 33.
    Abramsson-Zetterberg L, Ilbäck NG. The synthetic food colouring agent Allura Red AC (E129) is not genotoxic in a flow cytometry-based micronucleus assay in vivo. Food Chem Toxicol [Internet]. 2013 Sep [cited 2016 Nov 3];59:86–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23748052.
  34. 34.
    Knehr E. Maintaining color stability [internet]. Natura Products Insider, Informa Health. 2006. p. 1–4. Available from: http://www.naturalproductsinsider.com/articles/2006/08/maintaining-color-stability.aspx#
  35. 35.
    Humphrey AM. Chlorophyll. Food Chem Elsevier. 1980;5(1):57–67.CrossRefGoogle Scholar
  36. 36.
    Özkan G, Ersus Bilek S. Enzyme-assisted extraction of stabilized chlorophyll from spinach. Food Chem [Internet]. 2015 Jun 1 [cited 2016 Oct 20];176:152–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25624218.
  37. 37.
    Periasamy V, Athinarayanan J, Al-Hadi A, Juhaimi F, Mahmoud M, Alshatwi A. Identification of titanium dioxide nanoparticles in food products: induce intracellular oxidative stress mediated by TNF and CYP1A genes in human lung fibroblast cells. Environ Toxicol Pharmacol. 2015;39(1):176–86.CrossRefPubMedGoogle Scholar
  38. 38.
    Rowe R, Sheskey P, Quinn M. Handbook of pharmaceutical excipients [internet]. 6th ed. Rowe R, Sheskey P, Quinn M, editors. Pharmaceutical press. London Chicago: APhA/Pharmaceutical Press.; 2009. Available from: http://www.pharmpress.com/product/9780857110275/excipients
  39. 39.
    Cornell R, Schwertmann U. Introduction to the iron oxides. In: Cornell R, Schwertmann U, editors. The iron oxides: structure, properties, reactions, occurrences and uses. 2nd ed. Wiley VCH; 2004. p. 1–7.Google Scholar
  40. 40.
    Sengar G, Sharma H. Food caramels: a review [internet]. Journal of food science and technology. Springer; 2012 [cited 2016 Nov 3]. p. 1686–96. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25190825.
  41. 41.
    Hagiwara A, Imai N, Ichihara T, Sano M, Tamano S, Aoki H, et al. A thirteen-week oral toxicity study of annatto extract (norbixin), a natural food color extracted from the seed coat of annatto (Bixa orellana L.), in Sprague-Dawley rats. Food Chem Toxicol [Internet]. 2003 Aug [cited 2016 Nov 3];41(8):1157–64. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12842184.
  42. 42.
    Britton J. Carotenoids. In: Houghton J, Henry G, editors. Natural Food Colorants. 1996. p. 197–243.Google Scholar
  43. 43.
    Lyday P. Iodine and iodine compounds. Wiley VCH: Ullmann’s Encyclopedia of Industrial Chemistry; 2005.Google Scholar
  44. 44.
    Pawar S, Kumar A. Issues in the formulation of drugs for oral use in children: role of excipients. Paediatr Drugs [Internet]. 2002 [cited 2016 Oct 20];4(6):371–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12038873.
  45. 45.
    Basu D, Sen D. Organoleptic agents: adaptability, acceptability and palatability in formulations to make it lucrative. World J Pharm Pharm Sci. 2015;4(10):1573–86.Google Scholar
  46. 46.
    Graves D, Luo S. Decomposition of aspartame caused by heat in the acidified and dried state. J Agric Food Chem [Internet]. American Chemical Society; 1987 May [cited 2016 Oct 20];35(3):439–42 Available from:  http://pubs.acs.org/doi/abs/10.1021/jf00075a038
  47. 47.
    Klug C, Lipinski G. Sweeteners and sugar alternatives in food technology. 2nd ed. O’Donnell K, Kearsley M, editors. West Sussex, UK: Wiley Blackwell; 2012. 93–112 p.Google Scholar
  48. 48.
    Prakash I, DuBois G, Clos J, Wilkens K, Fosdick L. Development of rebiana, a natural, non-caloric sweetener. Food Chem Toxicol [Internet]. 2008 Jul [cited 2017 may 17];46(7):S75–82. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18554769.
  49. 49.
    Sharma V, Sharma P. Flavouring agents in pharmaceutical formulations. Anc Sci Life [Internet]. 1988 [cited 2016 Oct 20];8(1):38–40 Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3331350&tool=pmcentrez&rendertype=abstract
  50. 50.
    Sedrak M, Patel D. Drugs used in the treatment of common disorders of the gastrointestinal system. In: Tindall W, Sedrak M, Boltri J, editors. Patient-centered pharmacology: learning system for the conscientious prescribe. Philadelphia: FA Davis; 2013. p. 177–96.Google Scholar
  51. 51.
    Hoffman A, Salgado R, Dresler C, Faller R, Bartlett C. Flavour preferences in youth versus adults: a review. Tob Control. 2016;25:ii32–9.CrossRefPubMedPubMedCentralGoogle Scholar
  52. 52.
    Mennella J, Beauchamp G. Optimizing oral medications for children. Clin Ther [Internet]. NIH Public Access; 2008 Nov [cited 2017 may 17];30(11):2120–32. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19108800.
  53. 53.
    Burri J, Graf M, Lambelet P, Löliger J. Vanillin: more than a flavouring agent—a potent antioxidant. J Sci Food Agric. 1989;48:49–56.CrossRefGoogle Scholar
  54. 54.
    Schieberle P, Grosch W. Identification of potent flavor compounds formed in an aqueous lemon oil/citric acid emulsion. J Agric Food Chem [Internet]. American Chemical Society; 1988 Jul [cited 2016 Oct 20];36(4):797–800 Available from:  http://pubs.acs.org/doi/abs/10.1021/jf00082a031
  55. 55.
    Kimura K, Iwata I, Nishimura H. Relationship between acid-catalyzed cyclization of citral and deterioration of lemon flavor. Agric Biol Chem [Internet]. 1982 May 9 [cited 2016 Oct 20];46(5):1387–9 Available from:  http://www.tandfonline.com/doi/full/10.1080/00021369.1982.10865253
  56. 56.
    Iwanami Y, Tateba H, Kodama N, Kishino K. Changes of lemon flavor components in an aqueous solution during UV irradiation. J Agric Food Chem Am Chem Soc. 1997;8561(96):463–6.CrossRefGoogle Scholar
  57. 57.
    Rouseff R, Naim M. Citrus flavor stability. Flavor Chem [Internet]. 2000 Mar 23 [cited 2016 Oct 20];756(3):101–21 Available from:  http://pubs.acs.org/doi/abs/10.1021/bk-2000-0756.ch008
  58. 58.
    Freeburg E, Mistry B, Reineccius G. Stability of citral-containing and citralless lemon oils in flavor emulsions and beverages. Perfum Flavorist [Internet]. 1994;19:23–32. Available from: http://www.perfumerflavorist.com/flavor/application/citrus/Stability-of-Citral-Containing-and-Citralless-Lemon-Oils-in-Flavor-Emulsions-and-Beverages-370512591.html#sthash.BRCIOdHl.dpuf Google Scholar
  59. 59.
    Choi S, Decker E, Henson L, Popplewell L, McClements D. Influence of droplet charge on the chemical stability of citral in oil-in-water emulsions. J Food Sci [Internet]. Blackwell Publishing Inc; 2010 Aug [cited 2016 Oct 20];75(6):C536–40 Available from:  http://doi.wiley.com/10.1111/j.1750-3841.2010.01693.x
  60. 60.
    Mishra P. Kinetics and mechanisms of oxidation of 4-hydroxy -3-methoxy benzaldehyde (vanillin) by bi (V) in aqueous alkaline medium. Int J PharmTech Res. 2009;1(4):1234–40.Google Scholar
  61. 61.
    Mourtzinos I, Konteles S, Kalogeropoulos N, Karathanos V. Thermal oxidation of vanillin affects its antioxidant and antimicrobial properties. Food Chem. 2009;114(3):791–7.CrossRefGoogle Scholar
  62. 62.
    Li Z, Grun I, Fernando L. Interaction of vanillin with soy and dairy proteins in aqueous model systems: a thermodynamic study. J Food Sci [Internet]. Blackwell Publishing Ltd; 2000 Sep [cited 2016 Oct 20];65(6):997–1001 Available from:  http://doi.wiley.com/10.1111/j.1365-2621.2000.tb09406.x
  63. 63.
    Mcneill V, Schmidt K. Vanillin interaction with milk protein isolates in sweetened drinks. J Food Sci [Internet]. Blackwell Publishing Ltd; 1993 Sep [cited 2016 Oct 20];58(5):1142–7 Available from:  http://doi.wiley.com/10.1111/j.1365-2621.1993.tb06133.x
  64. 64.
    Kenya I, Takashi A. Vanillin acetals. US. 2012;8236970:B2.Google Scholar
  65. 65.
    Roscher R, Schwab W, Schreier P. Stability of naturally occurring 2,5-dimethyl-4-hydroxy-3[2H]-furanone derivatives. Food Res Technol [Internet]. Springer-Verlag; 1997 Jun 10 [cited 2016 Oct 20];204(6):438–41 Available from:  http://link.springer.com/10.1007/s002170050109
  66. 66.
    Chen C, Shu C, Ho C. Photosensitized oxidative reaction of 2,5-Dimethyl-4-hydroxy-3(2H)-furanone. J Agric Food Chem Am Chem Soc. 1996;44(8):2361–5.CrossRefGoogle Scholar
  67. 67.
    El Hadi M, Zhang F, Wu F, Zhou C, Tao J. Advances in fruit aroma volatile research [internet]. Molecules. 2013 [cited 2016 Oct 20]. p. 8200–29. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23852166.
  68. 68.
    Shu C, Mookherjee B, Ho C. Volatile components of the thermal degradation of 2,5-Dimethyl-4-hydroxy-3(2H)-furanone. J Agric Food Chem [Internet]. American Chemical Society; 1985 May [cited 2016 Oct 20];33(3):446 Available from:  http://pubs.acs.org/doi/abs/10.1021/jf00063a030
  69. 69.
    Antipova I, Mukha S, Medvedeva S. Determination of composition and instability constants of maltol complexes with iron(III) ions. Russ Chem Bull [Internet]. Kluwer Academic Publishers-Plenum Publishers; 2004 Apr [cited 2016 Oct 20];53(4):780–4 Available from:  http://link.springer.com/10.1023/B:RUCB.0000037841.67079.2b
  70. 70.
    Rovira D. Dictionary of flavors. 3rd ed. John Wiley & Sons; 2008. 113–114. p.Google Scholar
  71. 71.
    Gholivand M, Ahmadi F. Simultaneous determination of trans-cinnamaldehyde and benzaldehyde in different real samples by differential pulse polarography and study of heat stability of trans-cinnamaldehyde. Anal Lett [Internet]. Taylor & Francis Group; 2008 Dec 10 [cited 2016 Oct 20];41(18):3324–41 Available from:  http://www.tandfonline.com/doi/abs/10.1080/00032710802507893
  72. 72.
    Gilmore L. Process for preparing a caramel butterscotch flavor syrup. US 4753814 A, 1987.Google Scholar
  73. 73.
    Bäcktorp C, Wass J, Panas I, Sköld M, Börje A, Nyman G. Theoretical investigation of linalool oxidation. J Phys Chem A Am Chem Soc. 2006;110(44):12204–12.Google Scholar
  74. 74.
  75. 75.
    Reitsema R, Frederick J. Oxidation of peppermint oil. Ind Eng Chem. 1952;44:176–80.CrossRefGoogle Scholar
  76. 76.
    Marketsandmarkets.com. Food texture market by applications, functionalities & geography - 2018 [Internet]. 2013. Available from: http://www.marketsandmarkets.com/Market-Reports/texturizing-agents-market-1224.html
  77. 77.
    Diamante C. Cosmetic Ingredient Review 2008;1–31.Google Scholar
  78. 78.
    Becker K, Salar-Behzadi S, Zimmer A. Solvent-free melting techniques for the preparation of lipid-based solid oral formulations. Pharm Res [Internet]. 2015 May [cited 2016 Oct 20];32(5):1519–45. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25788447.
  79. 79.
  80. 80.
    Porter N, Wolf R, Weenen H. The free radical oxidation of polyunsaturated lecithins. Lipids [Internet]. Springer-Verlag; 1980 Mar [cited 2016 Oct 20];15(3):163–7 Available from:  http://link.springer.com/10.1007/BF02540963
  81. 81.
    Pichot R, Watson R, Norton I. Phospholipids at the interface: current trends and challenges. Int J Mol Sci [Internet]. Multidisciplinary Digital Publishing Institute; 2013 Jun 3 [cited 2016 Oct 20];14(6):11767–94 Available from: http://www.mdpi.com/1422-0067/14/6/11767/
  82. 82.
    Ghosh A, Bandyopadhyay P. Polysaccharide-protein interactions and their relevance in food colloids. In: Karunaratne D, editor. The Complex World of Polysaccharides [Internet]. 2012 [cited 2016 Oct 20]. Available from:  https://doi.org/10.5772/50561
  83. 83.
    Leal-Calderon F. Emulsified lipids: formulation and control of end-use properties. Oléagineux, Corps gras, Lipides [Internet]. John Libbey Eurotext; 2012 Mar 15 [cited 2016 Oct 20];19(2):111–9 Available from:  http://www.ocl-journal.org/10.1051/ocl.2012.0438
  84. 84.
    Votano J, Parham M, Hall L. PEG stability: a look at pH and conductivity changes over time in polyethylene glycols. Chem… [Internet]. 2004;577–82. Available from:  http://onlinelibrary.wiley.com/doi/10.1002/cbdv.200490137/abstract
  85. 85.
    Glastrup J. Degradation of polyethylene glycol. A study of the reaction mechanism in a model molecule: tetraethylene glycol. Polym Degrad Stab Elsevier. 1996;52(3):217–22.CrossRefGoogle Scholar
  86. 86.
    Propylene glycol stability and storage [Internet]. DowChemicals.com. 2016. Available from: http://dowac.custhelp.com/app/answers/detail/a_id/7485/~/propylene-glycols---stability-%26-storage
  87. 87.
    Neobee® Medium chain triglycerides brochure, Stepan Lipid Nutrition Pharmaceutical. 2012.Google Scholar
  88. 88.
  89. 89.
    Piccolo J, Tawashi R, Saad HY, Higuchi WI, Buckley HE, Ives MB, et al. Inhibited dissolution of drug crystals by a certified water-soluble dye. J Pharm Sci [Internet]. Elsevier; 1970 Jan [cited 2016 Nov 3];59(1):56–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/5411326.
  90. 90.
    Cooper J, Ansel H, Cadwallader D. Liquid and solid solution interactions of primary certified colorants with pharmaceutical gelatins. J Pharm Sci [Internet]. Wiley Subscription Services, Inc., A Wiley Company; 1973 Jul [cited 2016 Nov 3];62(7):1156–64 Available from: http://linkinghub.elsevier.com/retrieve/pii/S0022354915411359
  91. 91.
    Prillig E. Effect of colorants on the solubility of modified cellulose polymers. J Pharm Sci [Internet]. Wiley Subscription Services, Inc., A Wiley Company; 1969 Oct [cited 2016 Nov 3];58(10):1245–9 Available from: http://linkinghub.elsevier.com/retrieve/pii/S0022354915370271
  92. 92.
    Bharate S, Bharate S, Bajaj A. Incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review. J Excipients Food Chem. 2010;1(3):3–26.Google Scholar
  93. 93.
    Excipient guide [Internet]. Available from: http://www.excipientsguide.com/excipient_details.aspx?Id=151
  94. 94.
    US FDA. Guidance for industry Q1A(R2) stability testing of new drug substances and products. ICH [Internet]. 2003 [cited 2016 Oct 20];(November):1–22 Available from: http://www.fda.gov/cder/guidance/index.htm

Copyright information

© American Association of Pharmaceutical Scientists 2017

Authors and Affiliations

  • Akash Patil
    • 1
  • Supriya Bhide
    • 1
  • Mustafa Bookwala
    • 1
  • Bhavik Soneta
    • 1
  • Vijaykumar Shankar
    • 1
  • Ahmed Almotairy
    • 1
  • Mashan Almutairi
    • 1
  • S. Narasimha Murthy
    • 1
    • 2
    Email author
  1. 1.Department of Pharmaceutics and Drug DeliveryUniversity of MississippiUniversityUSA
  2. 2.Institute for Drug Delivery and Biomedical ResearchBangaloreIndia

Personalised recommendations