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Stability and compatibility study on enalapril maleate using thermoanalytical techniques

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Abstract

This paper demonstrates the application of thermal analysis in compatibility and stability studies between an ACE inhibitor (enalapril maleate) and excipients. The results have helped to elucidate the reason of a stability problem observed during the storage of enalapril maleate tablets. Incompatibility between enalapril maleate and colloidal silicon dioxide was detected. Besides, it was confirmed that the reaction between enalapril maleate and NaHCO3 increases the thermal stability of the drug. This study supports the importance of using thermoanalytical methods in the development of pharmaceuticals.

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References

  1. J. L. Ford and P. Timmins, Pharmaceutical Thermal Analysis: Techniques and Applications, Halsted Press, New York 1989, p. 238.

    Google Scholar 

  2. M. L. Cotton, D. W. Wu and E. B. Vadas, Int. J. Pharm., 40 (1987) 129.

    Article  CAS  Google Scholar 

  3. R. O. Macêdo, T. G. do Nascimento and J. W. E. Veras, J. Therm. Anal. Cal., 67 (2002) 483.

    Article  Google Scholar 

  4. A. Marini, V. Berbenni, S. Moioli, G. Bruni, P. Cofrancesco, C. Margheritis and M. Villa, J. Therm. Anal. Cal., 73 (2003) 529.

    Article  CAS  Google Scholar 

  5. A. Marini, V. Berbenni, M. Pegoretti, G. Bruni, P. Cofrancesco, C. Sinistri and M. Villa, J. Therm. Anal. Cal., 73 (2003) 547.

    Article  CAS  Google Scholar 

  6. G. G. G. Oliveira, H. G. Ferraz and J. S. R. Matos, J. Therm. Anal. Cal., 79 (2005) 267.

    Article  CAS  Google Scholar 

  7. L. C. S. Cides, A. A. S. Araújo, M. Santos-Filho and J. R. Matos, J. Therm. Anal. Cal., 84 (2006) 441.

    Article  CAS  Google Scholar 

  8. D. Kiss, R. Zelkó, Cs. Novák and Zs. Éhen, J. Therm. Anal. Cal., 84 (2006) 447.

    Article  CAS  Google Scholar 

  9. J. G. Hardman, L. E. Limbird, P. B. Molinoff, R. W. Ruddon and A. G. Gilman, As Bases Farmacológicas da Terapêutica, McGraw-Hill Interamericana Editores, México-DF 1996, p. 544.

    Google Scholar 

  10. M. M. Al-Omari, M. K. Abdelah, A. A. Badwan and A. M. Y. Jaber, J. Pharm. Biomed. Anal., 25 (2001) 893.

    Article  CAS  Google Scholar 

  11. B. C. Sherman, Stable Solid Pharmaceutical Compositions Containing Enalapril Maleate, US Pat. 5,562,921, 08 oct. 1996, 4p.

  12. S. Ungboriboonpisal and C. Wongpinairat, Mahidol Univ. J. Pharm. Sci., 24 (1997) 16.

    CAS  Google Scholar 

  13. World Health Organization. Fact Sheet N° 275. 2003. Aviable in: http://www.who.int/mediacentre/factsheets/2003/fs275/en. Last access: 02/22/2008.

  14. D. P. Ip, G. S. Brenner, J. M. Stevenson, S. Lindenbaum, A. W. Douglas, S. D. Klein and J. A. McCauley, Int. J. Pharm., 28 (1986) 183.

    Article  CAS  Google Scholar 

  15. R. Eyjolfsson, Pharmazie, 57 (2002) 347.

    CAS  Google Scholar 

  16. B. C. Sherman, Stable Solid Formulation of Enalapril Salt and Process for Preparation Thereof, WO Pat. 97/05881, 20 fev. 1997, p. 17.

  17. J. E. Daniel, M. R. Harris, G. C. Hokanson and J. Weiss, Stabilization of Formulations Containing ACE Inhibitors by Magnesium Oxide, WO Pat. 9962560, 09 dez. 1999, p. 27.

  18. D. P. Ip, G. S. Brenner, J. M. Stevenson, S. Lindenbaum, A. W. Douglas, S. D. Klein and J. A. McCauley, Int. J. Pharm., 28 (1986) 183.

    Article  CAS  Google Scholar 

  19. S.-L. Wang, S.-Y. Lin and T.-F. Chen, Chem. Pharm. Bull., 49 (2001) 402.

    Article  CAS  Google Scholar 

  20. S.-Y. Lin, S.-L. Wang, T.-F. Chen and T.-C. Hu, Eur. J. Pharm. Biopharm., 54 (2002) 249.

    Article  CAS  Google Scholar 

  21. B. Stanisz, J. Pharm. Biomed. Anal., 31 (2003) 375.

    Article  CAS  Google Scholar 

  22. E. A. G. Pineda, A. D. M. Ferrarezi, J. G. Ferrarezi and A. A. W. Hechenleitner, J. Therm. Anal. Cal., 79 (2005) 259.

    Article  CAS  Google Scholar 

  23. M. V. Devi and P. S. S. K. Babu, Int. J. Pharm. Excipients, 2 (2000) 153.

    CAS  Google Scholar 

  24. R. C. Rowe, P. J. Sheskey and P. J. Weller, Pharmaceutical Excipients 2003, Single-User Version, For Windows, Pharmaceutical Press, London 2003, CD-ROM.

    Google Scholar 

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Correspondence to J. R. Matos.

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Rezende, R.L.O., Santoro, M.I.R.M. & Matos, J.R. Stability and compatibility study on enalapril maleate using thermoanalytical techniques. J Therm Anal Calorim 93, 881–886 (2008). https://doi.org/10.1007/s10973-007-8187-4

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  • DOI: https://doi.org/10.1007/s10973-007-8187-4

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