Have a personal or library account? Click to login
Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design Cover

Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design

Acta Pharmaceutica
Volume 66 (2016): Issue 2 (June 2016)
By: Zoltán-István Szabó,  Blanka Székely-Szentmiklósi,  Boglárka Deák,  István Székely-Szentmiklósi,  Béla Kovács,  Katalin Zöldi and  Emese Sipos  
Open Access
|May 2016

References

  1. 1. B. Gil-Extremera and P. Cía-Gómez, Hypertension in the elderly, Int. J. Hypertens.2012 (2012) 859176; DOI: 10.1155/2012/859176.10.1155/2012/859176315775821876789
    Search in Google Scholar
  2. 2. P. W. de Leeuw, Combination perindopril/indapamide for the treatment of hypertension: a review, Expert Opin. Pharmacother.12 (2011) 1827–1833; DOI: 10.1517/14656566.2011.585638.10.1517/14656566.2011.58563821651456
    Search in Google Scholar
  3. 3. S.-S. Huang, T.-C. Wu, S.-J. Lin and J.-W. Chen, Combination of an ACE inhibitor and indapamide improves blood pressure control, but attenuates the beneficial effects of ACE inhibition on plasma adiponectin in patients with essential hypertension, Circ. J.73 (2009) 2282–2287.10.1253/circj.CJ-09-038719789415
    Search in Google Scholar
  4. 4. S. Kalra, B. Kalra and N. Agrawal, Combination therapy in hypertension: An update, Diabetol. Metab. Syndr.2 (2010) 44; DOI: 10.1186/1758-5996-2-44.10.1186/1758-5996-2-44290124620576135
    Search in Google Scholar
  5. 5. C. L. Brown, C. I. Backhouse, J. C. Grippat and J. P. Santoni, The effect of perindopril and hydrochlorothiazide alone and in combination on blood pressure and on the renin-angiotensin system in hypertensive subjects, Eur. J. Clin. Pharmacol.39 (1990) 327–332.10.1007/BF003154042076713
    Search in Google Scholar
  6. 6. S. G. Mallat, H. S. Itani and B. Y. Tanios, Current perspectives on combination therapy in the management of hypertension, Integr. Blood Press. Control6 (2013) 69–78; DOI: 10.2147/IBPC.S33985.10.2147/IBPC.S33985369929323837009
    Search in Google Scholar
  7. 7. L. Cavalieri and G. Cremonesi, Delapril plus indapamide: a review of the combination in the treatment of hypertension, Clin. Drug Investig.27 (2007) 367–380.10.2165/00044011-200727060-0000117506588
    Search in Google Scholar
  8. 8. I. N. Belenkov, F. T. Ageev, I. A. Orolova, O. I. Abrosimova, E. G. Volkova, L. I. Gapon, L. I. Katel’nitskaia, A. O. Kondari, I. F. Patrusheva, I. V Fomin and R. A. Khokhlov, Clinical and vascular effects of ACE inhibitor enalapril in combination with thiaside-like diuretic indapamide in hypertensive outpatients. Results of the multicenter trial POEMA, Ter. Arkh.79 (2007) 33–38.
    Search in Google Scholar
  9. 9. S. C. Sweetman, Martindale: The Complete Drug Reference, 37th ed., Pharmaceutical Press, London 2011.
    Search in Google Scholar
  10. 10. D. C. Montgomerey, Design and Analysis of Experiments, 7th ed., John Wiley & Sons, Hoboken, New York 2009.
    Search in Google Scholar
  11. 11. L. Erikkson, E. Johansson, N. Kettaneh-Wold, C. Wilkström and S. Wold, Design of Experiments: Principles and Applications (Third revised and enlarged edition), MKS Umetrics AB, Umea 2008.
    Search in Google Scholar
  12. 12. A. Curić, R. Reul, J. Möschwitzer and G. Fricker, Formulation optimization of itraconazole loaded PEGylated liposomes for parenteral administration by using design of experiments, Int. J. Pharm.448 (2013) 189–197; DOI: 10.1016/j.ijpharm.2013.03.029.10.1016/j.ijpharm.2013.03.02923524086
    Search in Google Scholar
  13. 13. European Pharmacopoeia, 7th ed., Council of Europe, Strasburg 2010.
    Search in Google Scholar
  14. 14. United States Pharmacopoeia, 35th ed., United States Pharmacopeial Convention, Rockville MD 2011.
    Search in Google Scholar
  15. 15. I. Popovici and D. Lupuleasa, Tehnologie Farmaceutica, Vol. 3, Editura Polirom, București 2009.
    Search in Google Scholar
  16. 16. R. C. Rowe, P. J. Sheskey and M. E. Quinn (editors), Handbook of Pharmaceutical Excipients, 6th ed., Pharmaceutical Press, London 2009.
    Search in Google Scholar
  17. 17. L. X. Liu, I. Marziano, A. C. Bentham, J. D. Litster, E. T. White and T. Howes, Effect of particle properties on the flowability of ibuprofen powders, Int. J. Pharm.362 (2008) 109–117; DOI: 10.1016/j.ijpharm.2008.06.023.10.1016/j.ijpharm.2008.06.02318652883
    Search in Google Scholar
  18. 18. M. Leturia, M. Benali, S. Lagarde, I. Ronga and K. Saleh, Characterization of flow properties of cohesive powders: A comparative study of traditional and new testing methods, Powder Technol.253 (2014) 406–423; DOI: 10.1016/j.powtec.2013.11.045.10.1016/j.powtec.2013.11.045
    Search in Google Scholar
  19. 19. C. T.-Y. Pourcelot, Preformulation of five commercial celluloses in drug development: Rheological and mechanical behaviour, Drug Dev. Ind. Pharm.19 (1993) 1947–1964; DOI: 10.3109/03639049309073901.10.3109/03639049309073901
    Search in Google Scholar
  20. 20. P. Kleinebudde, M. Jumaa and F. El Saleh, Influence of the degree of polymerization on the behavior of cellulose during homogenization and extrusion/spheronization, AAPS PharmSci2 (2000) E21.10.1208/ps020321
    Search in Google Scholar
  21. 21. T. Suzuki and H. Nakagami, Effect of crystallinity of microcrystalline cellulose on the compactability and dissolution of tablets, Eur. J. Pharm. Biopharm.47 (1999) 225–230.10.1016/S0939-6411(98)00102-7
    Search in Google Scholar
  22. 22. G. Thoorens, F. Krier, B. Leclercq, B. Carlin and B. Evrard, Microcrystalline cellulose, a direct compression binder in a quality by design environment-A review, Int. J. Pharm.473 (2014) 64–72; DOI: 10.1016/j.ijpharm.2014.06.055.10.1016/j.ijpharm.2014.06.055
    Search in Google Scholar
  23. 23. J. Muzíková and P. Sináglová, Comparison of properties of tablets and energy profile of compaction of two spray-dried lactoses, Acta Pol. Pharm.70 (2013) 129–135.
    Search in Google Scholar
  24. 24. F. Podczeck and Y. Mia, The influence of particle size and shape on the angle of internal friction and the flow factor of unlubricated and lubricated powders, Int. J. Pharm.144 (1996) 187–194; DOI: 10.1016/S0378-5173(96)04755-2.10.1016/S0378-5173(96)04755-2
    Search in Google Scholar
  25. 25. A. Mehrotra, M. Llusa, A. Faqih, M. Levin and F. J. Muzzio, Influence of shear intensity and total shear on properties of blends and tablets of lactose and cellulose lubricated with magnesium stearate, Int. J. Pharm.336 (2007) 284–291; DOI: 10.1016/j.ijpharm.2006.12.013.10.1016/j.ijpharm.2006.12.01317236729
    Search in Google Scholar
  26. 26. L. X. Liu, I. Marziano, A. C. Bentham, J. D. Litster, E. T. White and T. Howes, Effect of particle properties on the flowability of ibuprofen powders, Int. J. Pharm.362 (2008) 109–117; DOI: 10.1016/j.ijpharm.2008.06.023.10.1016/j.ijpharm.2008.06.02318652883
    Search in Google Scholar
  27. 27. G. Gold, R. N. Duvall, B. T. Palermo and J. G. Slater, Powder flow studies III. Factors affecting the flow of lactose granules, J. Pharm. Sci.57 (1968) 667–671; DOI: 10.1002/jps.2600570429.10.1002/jps.26005704295652162
    Search in Google Scholar
  28. 28. A. M. N. Faqih, A. Mehrotra, S. V Hammond and F. J. Muzzio, Effect of moisture and magnesium stearate concentration on flow properties of cohesive granular materials, Int. J. Pharm.336 (2007) 338–345; DOI: 10.1016/j.ijpharm.2006.12.024.10.1016/j.ijpharm.2006.12.02417289312
    Search in Google Scholar
  29. 29. A. C. Shah and A. R. Mlodozeniec, Mechanism of surface lubrication: Influence of duration of lubricant-excipient mixing on processing characteristics of powders and properties of compressed tablets, J. Pharm. Sci.66 (1977) 1377–1382; DOI: 10.1002/jps.2600661006.10.1002/jps.2600661006925889
    Search in Google Scholar
  30. 30. M. E. Johansson and M. Nicklasson, Investigation of the film formation of magnesium stearate by applying a flow-through dissolution technique, J. Pharm. Pharmacol.38 (1986) 51–54; DOI: 10.1111/j.2042-7158.1986.tb04466.x.10.1111/j.2042-7158.1986.tb04466.x
    Search in Google Scholar
  31. 31. C. F. Lerk, G. K. Bolhuis and S. S. Smedema, Interaction of lubricants and colloidal silica during mixing with excipients. I. Its effect on tabletting, Pharm. Acta Helv.52 (1977) 33–39.
    Search in Google Scholar
  32. 32. V. Nicolas, O. Chambin, C. Andrès, M. H. Rochat-Gonthier and Y. Pourcelot, Preformulation: effect of moisture content on microcrystalline cellulose (Avicel PH-302) and its consequences on packing performances, Drug Dev. Ind. Pharm.25 (1999) 1137–1142; DOI: 10.1081/DDC-100102280.10.1081/DDC-100102280
    Search in Google Scholar
  33. 33. G. E. Amidon and M. E. Houghton, The effect of moisture on the mechanical and powder flow properties of microcrystalline cellulose, Pharm. Res.12 (1995) 923–929; DOI: 10.1023/A:1016233725612.10.1023/A:1016233725612
    Search in Google Scholar
  34. 34. A. Mihranyan, A. P. Llagostera, R. Karmhag, M. Strømme and R. Ek, Moisture sorption by cellulose powders of varying crystallinity, Int. J. Pharm.269 (2004) 433–442; DOI: 10.1016/j.ijpharm.2003.09.030.10.1016/j.ijpharm.2003.09.030
    Search in Google Scholar
  35. 35. C. C. Sun, Mechanism of moisture induced variations in true density and compaction properties of microcrystalline cellulose, Int. J. Pharm.346 (2008) 93–101; DOI: 10.1016/j.ijpharm.2007.06.017.10.1016/j.ijpharm.2007.06.017
    Search in Google Scholar
  36. 36. I. Jivraj, L. Martini and C. Thomson, An overview of the different excipients useful for the direct compression of tablets, Pharm. Sci. Technolo. Today3 (2000) 58–63; DOI: 10.1016/S1461-5347(99)00237-0.10.1016/S1461-5347(99)00237-0
    Search in Google Scholar
  37. 37. C. Ferrero, N. Muñoz, M. V. Velasco, A. Muñoz-Ruiz and R. Jiménez-Castellanos, Disintegrating efficiency of croscarmellose sodium in a direct compression formulation, Int. J. Pharm.147 (1997) 11–21; DOI: 10.1016/S0378-5173(96)04784-9.10.1016/S0378-5173(96)04784-9
    Search in Google Scholar
  38. 38. N. O. Lindberg, Evaluation of some tablet lubricants, Acta Pharm. Suec.9 (1972) 207–214.
    Search in Google Scholar
  39. 39. A. F. Marais, M. Song and M. M. D. V. Φ, Effect of compression force, humidity and disintegrant concentration on the disintegration and dissolution of directly compressed furosemide tablets using croscarmellose sodium as disintegrant, Trop. J. Pharm. Res.2 (2003) 125–135.
    Search in Google Scholar
DOI: https://doi.org/10.1515/acph-2016-0019 | Journal eISSN: 1846-9558 | Journal ISSN: 1330-0075
Journal RSS Feed
Language: English
Page range: 191 - 206
Accepted on: Oct 11, 2016
|
Published on: May 28, 2016
Published by: Croatian Pharmaceutical Society
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
Keywords:
design of experiments,
optimization,
factorial design,
placebo formulation
Related subjects:
Pharmacy,
Pharmacy, other

© 2016 Zoltán-István Szabó, Blanka Székely-Szentmiklósi, Boglárka Deák, István Székely-Szentmiklósi, Béla Kovács, Katalin Zöldi, Emese Sipos, published by Croatian Pharmaceutical Society
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Previous articleVolume 66 (2016): Issue 2 (June 2016)Next article