AAPS PharmSciTech

, Volume 19, Issue 1, pp 176–183 | Cite as

Sucrose Octaacetate Chemical Kinetics and Shelf Lives at Various Formulation pHs

  • Shalini Gaddam
  • William C. StagnerEmail author
Research Article


Developing pediatric friendly dosage forms is a high priority worldwide. Sucrose octaacetate (SOA) has been recommended for use as a surrogate for bitter tasting active pharmaceutical ingredients. Even though SOA has found a number of human use applications and has been employed for decades, there are no rigorous chemical kinetic studies reported. A recently reported SOA stability-indicating method was used to perform SOA chemical kinetic and stability studies. As part of the chemical kinetic study, reaction order, activation energies, extrapolated rate constants, pH–rate profiles at 4 and 25°C, and estimated shelf lives at 4 and 25°C at different buffer pHs are provided. The estimated SOA shelf lives at 25°C and pHs 4.00, 5.20, and 6.00 were 25.3, 114, and 27.4 days, respectively. At 4°C, SOA’s estimated shelf lives were 0.478, 5.26, and 1.47 years at pHs 4.00, 5.20, and 6.00, respectively. SOA can be formulated at pHs 4 to 6 and stored at 25°C for short-duration (less than 25 days) uses such as a bitter tasting surrogate for fundamental taste mechanism studies or brief taste masking assessment clinical studies. For longer term solution studies, like being used as a bitter tasting control for blinded clinical trials, SOA should be formulated at the optimum pH of 5.40 and refrigerated at 4°C for maximum stability. The reported data can be used as a starting point for developing stable SOA formulations and estimating shelf life.


sucrose octaacetate (SOA) chemical kinetics pH–rate profile shelf life bitter-tasting surrogate low-wavelength ultraviolet diode array detection (UV-DAD) SOA stability-indicating method 


  1. 1.
    Best Pharmaceuticals for Children. Food and Drug Administration and the National Institutes of Health. Accessed on 2/11/2017.
  2. 2.
    US Food and Drug Administration. Intra-agency agreement between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the U.S. Food and Drug Administration (FDA) oral formulations platform—report 1. Accessed on 2/11/2017.
  3. 3.
    US Food and Drug Administration. Inter-agency agreement between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the U.S. Food and Drug Administration (FDA) final report. Accessed on 2/11/2017.
  4. 4.
    Better medicines for children. European Medicines Agency. Accessed on 2/11/2017.
  5. 5.
    Reflection paper: formulations of choice for the paediatric population. European Medicines Agency. Accessed on 2/11/2017.
  6. 6.
    Essential medicines list for children (EMLc); palliative care. World Health Organization. Accessed 2/11/2017.
  7. 7.
    Zajicek A, Fossler MJ, Barrett JS, Worthington JH, Ternik R, Charkoftaki G, et al. A report from the pediatric formulations task force: perspectives on the state of child-friendly oral dosage forms. AAPS J. 2013;15(4):1071–81. doi: 10.1208/s12248-013-9511-5.CrossRefGoogle Scholar
  8. 8.
    Sucrose octaacetate. United States Pharmacopoeia, USP-NF online <11> USP37-NF32, pp 6233–6234. Accessed on 12/02/2016.Google Scholar
  9. 9.
    Smith DS, Helzner EC, Nuttall CE Jr, Collins M, Rofman BA, Ginsberg D, et al. Failure of zinc gluconate in treatment of acute upper respiratory tract infections. Antimicrob Agents Chemother. 1989;33(5):646–8.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Zhao X, Xia H, Liu P, Wu A, Jiang H, Li S. Method for preparing placebo of traditional Chinese medicine preparation for treating gonarthromeningitis. Luoyang: Henan Luozheng Pharmaceutical Factory; 2012. Patent 6pp.Google Scholar
  11. 11.
    Schiffman SS, Gatlin LA, Sattely-Miller EA, Graham BG, Heiman SA, Stagner WC, et al. The effect of sweeteners on bitter taste in young and elderly subjects. Brain Res Bull. 1994;35(3):189–204.CrossRefPubMedGoogle Scholar
  12. 12.
    Schiffman SS, Gatlin LA, Frey AE, Heiman SA, Stagner WC, Cooper DC. Taste perception of bitter compounds in young and elderly persons: relation to lipophilicity of bitter compounds. Neurobio Aging. 1994;15(6):743–50.CrossRefGoogle Scholar
  13. 13.
    Schiffman SS, Gatlin LA, Suggs MS, Heiman SA, Stagner WC, Erickson RP. Modulators of the adenylate cyclase system can alter electrophysiological taste responses in gerbil. Pharmacol Biochem Behav. 1994;48(4):983–90.CrossRefPubMedGoogle Scholar
  14. 14.
    Schiffman SS, Suggs MS, Losee ML, Gatlin LA, Stagner WC, Bell RM. Effect of lipid-derived second messengers on electrophysiological taste responses in the gerbil. Pharmacol Biochem Behav. 1995;52(1):49–58.CrossRefPubMedGoogle Scholar
  15. 15.
    Code of Federal Regulations. 21 CFR 310.536. Nailbiting and thumbsucking deterrent drug products for over-the-counter human use. Accessed 2/11/2017.
  16. 16.
    Code of Federal Regulations. 21 CFR 172.515. Synthetic flavoring substances and adjuvants. Accessed 2/11/2017.
  17. 17.
    Winter R. A Consumer’s dictionary of food additives. New York: Three Rivers Press; 2009. p. 505–6.Google Scholar
  18. 18.
    Code of Federal Redulations. 21 CFR 175.300. Indirect food additives: adhesives and components of coatings. Accessed 6/15/2017.
  19. 19.
    Code of Federal Regulations. 27 CFR 21.151. List of denaturants authorized for denatured spirits. Accessed 5/15/2017.
  20. 20.
    Chung H, Seib PA, Finney KF, Magoffin CD. Sucrose monoesters and diesters in breadmaking. Cereal Chem. 1981;58(3):164–70.Google Scholar
  21. 21.
    Parmar R, Ghanta A, Haware RV, Johnson PR, Stagner WC. Statistical optimization of ELSD for molten sucrose octaacetate and comparison with UV-DAD validation parameters using tandem HPLC UV-DAD/ELSD specific stability-indicating method. J Pharm Sci. 2016;105:3603–10. doi: 10.1016/j.xphs.2016.08.030.CrossRefPubMedGoogle Scholar
  22. 22.
    Rathbone EB, Lee CK, Birch GG. Stability of sugar acetates in citric acid solution. Food Chem. 1980;5:1939–46.CrossRefGoogle Scholar
  23. 23.
    Stuve EM. Estimating and plotting logarithmic error bars. Copyright 2004–12. Accessed on 1/24/17.

Copyright information

© American Association of Pharmaceutical Scientists 2017

Authors and Affiliations

  1. 1.Department of Pharmaceutical SciencesCampbell University College of Pharmacy & Health SciencesBuies CreekUSA
  2. 2.Eurofins Lancaster LaboratoriesFoster CityUSA

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