Application of Box-Behnken design to formulate and optimize multipolymeric fast dissolving film of rizatriptan benzoate

Main Article Content

Dharmik M. Mehta
Divyang J. Dave
Dhaval V. Dadhaniya
Pragna K. Shelat
Punit B. Parejiya
Bhavesh S. Barot

Abstract

The present investigation aims at formulation and optimization of multipolymeric fast dissolving film of rizatriptan benzoate.
Three film forming polymers namely hydroxypropyl methylcellulose (HPMC), maltodextrin and polyvinylalcohol were
explored using Box-Behnken experimental design to derive optimized fast dissolving film formulation using desirability function.
Analysis of variance (ANOVA) was performed for five dependent variables tensile strength, folding endurance, load at yield,
percentage elongation and percentage drug release in 30 s (Q30). Mathematical regression equations were derived by applying
ANOVA and validated using checkpoint batches. Results of the experimental design exposed that the effect of independent
factors HPMC and maltodextrin significantly influenced the mechanical properties and percentage drug release from the
film. Optimized batch was derived based on set criteria using desirability function. Reponses of the optimized formulation
were tensile strength (500 N/m2), folding endurance (203), load at yield (15.06 N/m2), percentage elongation (4.56%) and
Q30 (60.03%) falling under acceptable limits. High percentage drug release from the film in simulated saliva and simulated
gastric fluid reveal fast dissolving characteristics. Fast dissolving dosage form can help patients with diseases like migraine

Downloads

Download data is not yet available.

Article Details

How to Cite
Mehta, D. M., J. Dave, D., Dadhaniya, D. V., Shelat, P. K., Parejiya, P. B., & S. Barot, B. (2014). Application of Box-Behnken design to formulate and optimize multipolymeric fast dissolving film of rizatriptan benzoate. Asian Journal of Pharmaceutics (AJP), 8(1). https://doi.org/10.22377/ajp.v8i1.320
Section
Articles

References

Sastry SV, Nyshadham JR, Fix JA. Recent technological advances in oral

drug delivery: A review. Pharm Sci Technolo Today 2000;3:138-45.

Rathbone MJ, Hadgraft J. Absorption of drugs from the human oral

cavity. Int J Pharm 1991;74:9-24.

Malke S, Shidhaye S, Kadam VJ. Formulation and evaluation of

oxcarbazepine fast dissolve tablets. Indian J Pharm Sci 2003;69:211-4.

Nagai T, Machida Y. Buccal delivery systems using hydrogels. Adv Drug

Deliv Rev 1993;11:179-91.

Siddiqui MD, Garg G, Sharma PK. A short review on “A novel approach

in oral fast dissolving drug delivery system and their patentsâ€. Adv

Biol Res 2011;5:291-303.

Heer D, Aggarwal G, Kumar SL. Recent trends of fast dissolving

drug delivery system: An overview of formulation technology.

Pharmacophore 2013;4:1-9.

Gohel MC, Parikh RK, Aghara PY, Nagori SA, Delvadia RR, Dabhi MR.

Application of simplex lattice design and desirability function for

the formulation development of mouth dissolving film of salbutamol

sulphate. Curr Drug Deliv 2009;6:486-94.

Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: An

innovative drug delivery system and dosage form. Int J ChemTech Res

;2:576-83.

Hardman JG, Limbird L. Goodman and Gilman’s the Pharmacological

Basis of Therapeutics. 10th ed. New York: McGraw-Hill; 2004. p. 278-81.

Arulmozhi DK, Veeranjaneyulu A, Bodhankar SL. Migraine: Current

concepts and emerging therapies. Vascul Pharmacol 2005;43:176-87.

Goadsby PJ. Recent advances in understanding migraine mechanisms,

molecules and therapeutics. Trends Mol Med 2007;13:39-44.

Gladstone JP, Gawel M. Newer formulations of the triptans: Advances

in migraine management. Drugs 2003;63:2285-305.

Keny RV, Desouza C, Lourenco CF. Formulation and evaluation of

rizatriptan benzoate mouth disintegrating tablets. Indian J Pharm Sci

;72:79-85.

Kulkarni AP, Khedkar AB, Lahotib SR, Dehghanb MH. Development of

oral disintegrating tablet of rizatriptan benzoate with inhibited bitter

taste. Am Eurasian J Sci Res 2012;7:47-57.

Rapolu K, Sanka K, Vemula PK, Aatipamula V, Mohd AB, Diwan PV.

Optimization and characterization of gastroretentive floating drug delivery

system using Box-Behnken design. Drug Dev Ind Pharm 2013;39:1928-35.

Hao J, Fang X, Zhou Y, Wang J, Guo F, Li F, et al. Development and

optimization of solid lipid nanoparticle formulation for ophthalmic

delivery of chloramphenicol using a Box-Behnken design. Int J

Nanomedicine 2011;6:683-92.

Bushetti SS, Mane PP, Kardame SS. Development and evaluation of

mucoadhesive buccal films of nebivolol. RGUHS J Pharm Sci 2011;1:157-62.

Prabhu P, Malli R, Koland M, Vijaynarayana K, D’Souza U, Harish N, et al.

Formulation and evaluation of fast dissolving films of levocitirizine di

hydrochloride. Int J Pharm Investig 2011;1:99-104.

Bhyan B, Jangra S. Formulation and evaluation of fast dissolving sublingual

films of rizatriptan benzoate. Int J Drug Dev Res 2012;4:133-43.

Kumar GV, Krishna RV, William GJ, Konde A. Formulation and evaluation

of buccal films of salbutamol sulphate. Indian J Pharm Sci 2005;67:160-4.

Mashru RC, Sutariya VB, Sankalia MG, Parikh PP. Development and

evaluation of fast-dissolving film of salbutamol sulphate. Drug Dev

Ind Pharm 2005;31:25-34.

Wu T, Pan W, Chen J, Zhang R. Studies of the drug permeability and

mechanical properties of free films prepared by cellulose acetate

pseudolatex coating system. Drug Dev Ind Pharm 2000;26:95-102.

Parejiya PB, Barot BS, Patel HK, Shelat PK, Shukla A. Innovation of

novel ‘Tab in Tab’ system for release modulation of milnacipran HCl:

Optimization, formulation and in vitro investigations. Drug Dev Ind

Pharm 2013;39:1851-63.

Bolton S, Bon C. Pharmaceutical Statistics: Practical and Clinical

Applications. Vol. ed. 4th New York: Marcel Dekker; 2004. p. 265-88.

Barot BS, Parejiya PB, Patel TM, Parikh RK, Gohel MC. Compactibility

improvement of metformin hydrochloride by crystallization technique.

Adv Powder Technol 2012;23:814-23.