Display options
Share it on

J Adv Res. 2020 May 01;24:281-290. doi: 10.1016/j.jare.2020.04.019. eCollection 2020 Jul.

Enhanced pharmacokinetic performance of dapoxetine hydrochloride via the formulation of instantly-dissolving buccal films with acidic pH modifier and hydrophilic cyclodextrin: Factorial analysis, .

Journal of advanced research

Hibah M Aldawsari, Shaimaa M Badr-Eldin

Affiliations

  1. Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
  2. Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

PMID: 32419956 PMCID: PMC7215178 DOI: 10.1016/j.jare.2020.04.019

Abstract

Instantly dissolving buccal films have gained attention owing to their easy administration and capability to surmount the hepatic first pass effect of drugs. Dapoxetine hydrochloride (DPX) has a low oral bioavailability due to significant hepatic first pass metabolism. In addition, DPX is a weakly basic drug with a pH dependent solubility that could limit its dissolution in the body neutral fluids. In order to surpass these challenges, this work aimed at enhancing DPX bioavailability via the formulation of instantly dissolving buccal films comprising a pH modifier and a hydrophilic cyclodextrin. Tartaric acid and hydroxypropyl beta-cyclodextrin were selected as dual solubilizing agents based on the screening study. 3

© 2020 THE AUTHORS. Published by Elsevier BV on behalf of Cairo University.

Keywords: Dapoxetine hydrochloride; Hydroxypropyl methyl cellulose E5; In vivo mouth dissolving time; Maltodextrin; Mechanical properties; Microenvironmental pH

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

  1. AAPS PharmSciTech. 2014 Dec;15(6):1603-10 - PubMed
  2. Int J Pharm. 2007 Feb 1;329(1-2):1-11 - PubMed
  3. Int J Pharm. 2012 Apr 15;426(1-2):61-66 - PubMed
  4. J Control Release. 2009 Oct 15;139(2):94-107 - PubMed
  5. Pharm Res. 2016 Jun;33(6):1456-71 - PubMed
  6. AAPS PharmSciTech. 2011 Dec;12(4):1401-6 - PubMed
  7. Int J Pharm. 2016 May 30;505(1-2):212-22 - PubMed
  8. Curr Drug Deliv. 2013 Dec;10(6):667-84 - PubMed
  9. Polymers (Basel). 2017 Jul 20;9(7): - PubMed
  10. Iran J Basic Med Sci. 2013 Dec;16(12):1223-31 - PubMed
  11. Arch Pharm Res. 2015 Jan 13;: - PubMed
  12. Drug Deliv. 2016;23(1):355-61 - PubMed
  13. Int J Pharm. 2014 Oct 1;473(1-2):398-406 - PubMed
  14. Expert Opin Pharmacother. 2018 Jul;19(10):1077-1085 - PubMed
  15. Int J Clin Pract. 2016 Sep;70(9):723-33 - PubMed
  16. Drug Dev Ind Pharm. 2018 Sep;44(9):1443-1450 - PubMed
  17. Pharm Dev Technol. 2014 Aug;19(5):521-30 - PubMed
  18. Int J Pharm. 2015 May 15;485(1-2):329-40 - PubMed
  19. BJU Int. 2006 Feb;97(2):311-5 - PubMed
  20. Eur J Pharm Biopharm. 2008 Nov;70(3):819-27 - PubMed
  21. Eur J Pharm Sci. 2001 May;13(2):123-33 - PubMed
  22. Pharm Res. 2013 Jun;30(6):1561-73 - PubMed
  23. Pharmaceutics. 2019 Mar 20;11(3): - PubMed
  24. Drug Dev Ind Pharm. 2014 Jan;40(1):110-9 - PubMed
  25. Drug Dev Ind Pharm. 2018 Jun;44(6):988-1000 - PubMed
  26. Int J Pharm. 2017 Feb 25;518(1-2):242-252 - PubMed
  27. Eur J Pharm Sci. 2008 Oct 2;35(3):183-92 - PubMed
  28. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 May 1;926:42-6 - PubMed
  29. AAPS PharmSciTech. 2011 Dec;12(4):1384-92 - PubMed
  30. Expert Opin Drug Deliv. 2010 Jul;7(7):845-57 - PubMed
  31. Drug Dev Ind Pharm. 2009 Oct;35(10):1210-8 - PubMed
  32. Chem Pharm Bull (Tokyo). 2017;65(5):426-431 - PubMed
  33. Drug Deliv. 2016;23(3):739-57 - PubMed
  34. Expert Opin Drug Deliv. 2014 Apr;11(4):505-16 - PubMed
  35. Pharmaceuticals (Basel). 2019 Feb 20;12(1): - PubMed
  36. Eur J Pharm Biopharm. 2009 Nov;73(3):361-5 - PubMed
  37. Int J Pharm. 2015 Apr 30;484(1-2):172-80 - PubMed
  38. Ther Adv Urol. 2012 Oct;4(5):233-51 - PubMed
  39. Eur J Pharm Sci. 2015 Aug 30;76:225-30 - PubMed
  40. Int J Pharm. 2017 Jun 30;526(1-2):77-87 - PubMed
  41. Eur J Pharm Biopharm. 2008 Nov;70(3):895-900 - PubMed
  42. Adv Pharm Bull. 2018 Nov;8(4):721-725 - PubMed

Publication Types