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Journal of Pharmaceutical Investigation

, Volume 43, Issue 4, pp 343–351 | Cite as

Quick dissolving films of nebivolol hydrochloride: formulation and optimization by a simplex lattice design

  • Punit B. Parejiya
  • Rakshit C. Patel
  • Dharmik M. Mehta
  • Pragna K. Shelat
  • Bhavesh S. BarotEmail author
Research Article

Abstract

Present study aims at formulation and development of quick dissolving film of nebivolol hydrochloride applying simple lattice experimental design using three hetero polymers hydroxypropyl methylcellulose, pullulan and polyvinyl pyrrolidone. Films were prepared using solvent casting technique and optimized formulation was derived by desirability function. Regression equations and contour plots were executed to narrate dependent variables, i.e. percentage drug release in 30 s (Y30), tensile strength, elastic modulus, percentage elongation and load at yield, to independent variables. Results of the experimental design revealed that the independent factors hydroxypropyl methylcellulose and pullulan significantly influenced the mechanical properties and percentage drug release from the film which was ultimately reflect in the formulation of optimized batch. The high % drug release of the film in simulated saliva and simulated gastric fluid indicated that it can be successfully used in drug delivery systems for drugs with high first-pass metabolism.

Keywords

Desirability function Nebivolol hydrochloride Quick dissolving films Similarity factor Simplex lattice design 

Notes

Conflict of interest

None.

References

  1. Arya A, Chandra A, Sharma V, Pathak K (2010) Fast dissolving oral films: an innovative drug delivery system and dosage form. Int J ChemTech Res 2(1):576–583Google Scholar
  2. Bushetti SS, Mane PP, Kardame SS (2011) Development and evaluation of mucoadhesive buccal films of nebivolol. RGUHS J Pharm Sci 1(2):157–162Google Scholar
  3. Dabhi MR et al (2009) Application of simplex lattice design and desirability function for the formulation development of mouth dissolving film of salbutamol sulphate. Curr Drug Deliv 6:486–494PubMedCrossRefGoogle Scholar
  4. Derringer G, Suich R (1980) Simultaneous optimization of several responses variables. J Qual Technol 12(4):214–219Google Scholar
  5. Kulkarni AS, Deokule HA, Mane MS, Ghadge DM (2010) Exploration of different polymers for use in the formulation of oral fast dissolving strips. J Curr Pharm Res 2(1):33–35Google Scholar
  6. Kumar GV, Krishna RV, William GJ, Konde A (2005) Formulation and evaluation of buccal films of salbutamol sulphate. Indian J Pharm Sci 67:160–164Google Scholar
  7. Lachman L, Lieberman H, Kanig J (1970) The theory and practice of industrial pharmacy. Lei & Feiberger, PhiladelphiaGoogle Scholar
  8. Mashru R, Sutariya V, Sankalia M, Parikh P (2005) Development and evaluation of quick dissolving film of salbutamol sulphate. Drug Dev Ind Pharm 31:25–34PubMedGoogle Scholar
  9. Moen MD, Wagstaff AJ (2006) Nebivolol a review of its use in the management of hypertension and chronic heart failure. Drugs 66(10):1389–1409PubMedCrossRefGoogle Scholar
  10. Nagai T, Machida Y (1993) Buccal delivery systems using hydrogels. Adv Drug Deliv Rev 11:179–191CrossRefGoogle Scholar
  11. Padula C, Colombo G et al (2003) Bioadhesive film for the transdermal delivery of lidocaine: in vitro and in vivo behaviour. J Control Release 88:277–285PubMedCrossRefGoogle Scholar
  12. Parejiya PB, Barot BS, Patel HK, Shelat PK, Shukla A (2012) Innovation of novel ‘Tab in Tab’ system for release modulation of milnacipran HCl: optimization, formulation and in vitro investigations. Drug Dev Ind Pharm. doi: 10.3109/03639045.2012.738686 PubMedGoogle Scholar
  13. Peh KK, Wong CF (1999) Polymeric films as vehicles for buccal delivery: swelling, mechanical and bioadhesive properties. J Pharm Pharm Sci 2:53–61PubMedGoogle Scholar
  14. Prabhu P et al (2011) Formulation and evaluation of fast dissolving films of levocitrizine dihydrochloride. Int J Pharm Invest 1(2):99–104CrossRefGoogle Scholar
  15. Rathbone MJ, Hadgraft J (1991) Absorption of drugs from the human oral cavity. Int J Pharm 74:9–24CrossRefGoogle Scholar
  16. Rosei EA, Rizzoni D (2007) Metabolic profile of nebivolol, a β-adrenoceptor antagonist with unique characteristics. Drugs 67(8):1097–1107CrossRefGoogle Scholar
  17. Senel S, Ikinci G, Kas S, Yousefi-Rad A, Sargon MF, Hincal AA (2000) Chitosan films and hydrogels of chlorhexidine gluconate for oral mucosal delivery. Int J Pharm 193:197–203PubMedCrossRefGoogle Scholar
  18. Tao W, Weisan P, Jimin C, Ruhua Z (2000) Studies of the drug permeability and mechanical properties of free films prepared by cellulose acetate pseudolatex coating system. Drug Dev Ind Pharm 26(1):95–102CrossRefGoogle Scholar
  19. Veverka A, Nuzum DS, Jolly JL (2006) Nebivolol: a third-generation b-adrenergic blocker. Ann Pharmacother 40:1353–1360PubMedCrossRefGoogle Scholar
  20. Woolfson AD, McCafferty DF, McCarron PA, Price JH (1995) A bioadhesive patch cervical drug delivery system for the administration of 5-fluorouracil to cervical tissue. J Control Release 35:49–58CrossRefGoogle Scholar
  21. Yoo JW, Dharmala K, Lee CH (2006) The physicodynamic properties of mucoadhesive polymeric films developed as female controlled drug delivery system. Int J Pharm 309:139–145PubMedCrossRefGoogle Scholar

Copyright information

© The Korean Society of Pharmaceutical Sciences and Technology 2013

Authors and Affiliations

  • Punit B. Parejiya
    • 1
  • Rakshit C. Patel
    • 1
  • Dharmik M. Mehta
    • 1
  • Pragna K. Shelat
    • 1
  • Bhavesh S. Barot
    • 1
    Email author
  1. 1.Department of PharmaceuticsK. B. Institute of Pharmaceutical Education and ResearchGandhinagarIndia

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