Archives of Pharmacal Research

, Volume 28, Issue 1, pp 120–126 | Cite as

Surfactant effects upon dissolution patterns of carbamazepine immediate release tablet

  • Hyeontae Lee
  • Sang-Ae Park
  • Hongkee Sah
Article Drug efficacy


The objective of this study was to investigate the effects of sodium lauryl sulfate upon the saturation solubility of carbamazepine, its dissolution kinetics, and T50% defined as the time required for dissolving 50% of carbamazepine. Water, 0.1N-HCI, and phosphate buffers at pH 4.0 and 6.8 containing 0.1, 0.5, 1, and 2% sodium lauryl sulfate were used as dissolution media. The dissolution study was conducted by using the USP dissolution apparatus II with an agitation rate of 75 rpm. Samples of the dissolution media were taken in 7, 15, 30, 45, 60, 75, and 90 min, and the amounts of carbamazepine were determined spectrophotometrically at 285 nm. All dissolution data were fitted well into a four-parameter exponential equation:Q = a(1 — e-bxt)+c(1 — e-dxt). In this equation Q represented % carbamazepine dissolved at a time t, anda, b, c, andd were constants. This equation led to the calculation of dissolution rates at various time points and T50%. It was found that the dissolution rate of carbamazepine was directly proportional to the aqueous concentration of sodium lauryl sulfate. In addition, under our experimental conditions T50% values ranged from 37.8 to 4.9 min. It was interesting to note that T50% declined rapidly as the surfactant concentration increased from 0.1 to 0.5%, whereas it declined more slowly at concentrations greater than 1 %. These results clearly demonstrated that the dissolution rate of carbamazepine and duration of its dissolution test could be tailored by optimizing the amount of sodium lauryl sulfate in a dissolution medium.

Key words

Dissolution test Dissolution kinetics Carbamazepine Sodium lauryl sulfate 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Abrahamsson, B., Johansson, D., Torstensson, A., and Wingstrand, K., Evaluation of solubilizers in the drug release testing of hydrophilic matrix extended-release tablets of felodipine.Pharm. Res., 11, 1093–1097 (1994).PubMedCrossRefGoogle Scholar
  2. Aunins, J. G., Southard, M., Meyers, R. A., Hemmelstein, K. J., and Stella, V. J., Dissolution of carboxylic acids III. The effect of polyionizable buffers.J. Pharm. Sci., 74, 1305–1316 (1985).PubMedCrossRefGoogle Scholar
  3. Castillo, J. A., Palomo-Canales, J., Garcia, J. J., Lastres, J. L., Bolas, F., and Torrado, J. J., Preparation and characterization of albendazole β-cyclodextrin complexes.Drug Dev. Ind. Pharm., 25, 1241–1248 (1999).PubMedCrossRefGoogle Scholar
  4. Chen, L. R., Wesley, J. A., Bhattachar, S., Ruiz, B., Bahash, K., and Babu, S. R., Dissolution behavior of a poorly water soluble compound in the presence of Tween 80.Pharm. Res., 20, 797–801 (2003).PubMedCrossRefGoogle Scholar
  5. Costa, P., and Lobo, J. M. S., Influence of dissolution medium agitation on release profiles of sustained-release tablets.Drug Dev. Ind. Pharm., 27, 811 -817 (2001).CrossRefGoogle Scholar
  6. Crison, J. R., Weiner, N. D., and Amidon, G. L., Dissolution media for in vitro testing of water-insoluble drugs: effect of surfactant purity and electrolyte onin vitro dissolution of carbamazepine in aqueous solutions of sodium lauryl sulfate.J. Pharm. Sci., 86, 384–388 (1997).PubMedCrossRefGoogle Scholar
  7. Dawoodbhai, al., Optimization of tablet formulation talc.Drug Dev. Ind. Pharm., 17, 1343–1371 (1991).CrossRefGoogle Scholar
  8. FDA, Center for Drug Evaluation and Research. Guidance for Industry - Extended release oral dosage forms: development, evaluation and application ofin vitro/in vivo correlation, September 1997b.Google Scholar
  9. FDA, Center for Drug Evaluation and Research. Guidance for Industry - Immediate release solid dosage forms: Scale-up and postapproval changes (SUPAC-IR): Chemistry, manufacturing, and controls,in vitro dissolution testing andin vivo bioequivalence test documentation, November, 1995.Google Scholar
  10. FDA, Center for Drug Evaluation and Research. Guidance for Industry - SUPAC-MR: Modified release solid oral dosage forms: Scale-up and postapproval changes: Chemistry, manufacturing, and controls;in vitro dissolution testing andin vivo bioequivalence documentation, September 1997a.Google Scholar
  11. Jain, A. C. and Adeyeye, M. C., Hygroscopicity, phase solubility and dissolution of various substituted sulfobutylether β-cyclodextrins (SBE) and danazol-SBE inclusion complexes.Int. J. Pharm., 212, 177–186 (2001).PubMedCrossRefGoogle Scholar
  12. Kervinen, L. and Yliruusi, J., Modelling S-shaped dissolution curves.Int. J. Pharm., 92, 115–122 (1993).CrossRefGoogle Scholar
  13. Langernbucher, F., Linearization of dissolution rate curves by the Weibull distribution.J. Pharm. Pharmacol., 24, 979–981 (1972).Google Scholar
  14. Pena Romero, al., Water uptake and force development in an optimized prolonged release formulation.Int. J. Pharm., 73, 239–248 (1991).CrossRefGoogle Scholar
  15. Qazi, S., Peter Samuel, N. K., Venkatachalam, T. K., and Uckun, F. M., Evaluating dissolution profiles of an anti-HIV agent using ANOVA and non-linear regression models in JMP software.Int. J. Pharm., 252, 27–39 (2003).PubMedCrossRefGoogle Scholar
  16. Riegelman, S., and Collier, P., The application of statistical moment theory to the evaluation of the in vivo dissolution time and absorption time.J. Pharmacokient. Biopharm., 8, 509–534 (1980).CrossRefGoogle Scholar
  17. Serajuddin, A. T., and Rosoff, M., pH-solubility profile of papaverine hydrochloride and its relationship to the dissolution rate of sustained-release pellets.J. Pharm. Sci., 73, 1203–1208 (1984).PubMedCrossRefGoogle Scholar
  18. Shah, V. P., Konecny, J. J., Everett, R. L., McCullough, B., Noorizadeh, A. C., and Skelly, J. P.,In vitro dissolution profile of water-insoluble drug dosage forms in the presence of surfactants.Pharm. Res., 6, 612–618 (1989).PubMedCrossRefGoogle Scholar
  19. Sun, W., Larive, C. K., and Southard, M. Z., A mechanistic study of danazol dissolution in ionic surfactant solutions.J. Pharm. Sci., 92, 424–435 (2003).PubMedCrossRefGoogle Scholar
  20. Velasco-De-Paola, M. V. R., Santoro, M. I. R. M., and Gai, M. N., Dissolution kinetics evaluation of controlled-release tablets containing propranolol hydrochloride.Drug Dev. Ind. Pharm., 25, 535–541 (1999).PubMedCrossRefGoogle Scholar

Copyright information

© The Pharmaceutical Society of Korea 2005

Authors and Affiliations

  • Hyeontae Lee
    • 1
  • Sang-Ae Park
    • 2
    • 1
  • Hongkee Sah
    • 1
  1. 1.Dept. of Pharmaceutical Sciences, College of PharmacyCatholic University of DaeguGyeongbukKorea
  2. 2.Korea Food & Drug AdministrationSeoulKorea

Personalised recommendations