Taste Masked Oral Fast Dissolving Sublingual Strips of Rizatriptan Benzoate for Migraine Therapy

Year 2017, Volume: 21 Issue: 2, 235 - 242, 01.04.2017

Kailas K. Mali Remeth J. Dias Vishwajeet S Ghorpade Vijay D Havaldar Bhimrao K. Rupnoor Nikhil S Dhane

https://doi.org/10.12991/marupj.300316

Abstract

The aim of present investigation was to develop a taste masked

fast dissolving sublingual strips of rizatriptan benzoate. The

fast dissolving strips (FDS) were prepared by solvent casting

method using polyox N-10 and polyethylene glycol 400 (PEG

400) as polymer and plasticizer respectively. The FDS were

evaluated for pH, folding endurance, tensile strength, moisture

absorption, disintegration time and in vitro dissolution. All

formulations were free from bubble and exhibited smooth

appearance. The pH of the films was acidic. It was observed

that increase in the concentration of polyox N-10 increased

the disintegration time but reduced the dissolution rate.

The formulation A2 showed all the evaluation parameters

within the acceptable range and was considered as optimized

formulation. The optimized formulation was subjected to the

taste masking and stability study. The results of taste masking

study indicated an efficient masking of the bitter taste of drug

by the flavouring agents in the film. The formulation A2 was

found to be stable for three months with an insignificant

change in the drug content and mean dissolution time (MDT).

The compatibility study performed using ATR-FTIR and

DSC analysis indicated absence of any unusual interaction

between drug and excipients used in formulation. Thus, the

FDS comprised of polyox N-10 and PEG 400 may be a better

alternative to the other available fast dissolving systems for

delivery of rizatriptan benzoate.

Keywords

Fast dissolving strips, Polyox N-10, PEG 400, Rizatriptan benzoate

References

• 1. Pandey P, Chauhan S. Fast dissolving sublingual films of Zolmitriptan: A novel treatment approach for migraine attacks. Indian J Pharm Educ Res 2014;48:67–72.
• 2. Galletti F, Cupini LM, Corbelli I, Calabresi P, Sarchielli P. Pathophysiological basis of migraine prophylaxis. Prog Neurobiol 2009;89:176–92.
• 3. Freitag FG, Schloemer F, Shumate D. Recent developments in the treatment of migraine in children and adolescents. J Headache Pain Manag 2016;1:1–8.
• 4. Láinez MJA. Rizatriptan in the treatment of migraine. Neuropsychiatr Dis Treat 2006;2:247–59.
• 5. Keny R V, Desouza C, Lourenco CF. Formulation and evaluation of rizatriptan benzoate mouth disintegrating tablets. Indian J Pharm Sci 2010;72:79–85.
• 6. Kulkarni AP, Khedkar AB, Lahotib SR. Development of oral disintegrating tablet of rizatriptan benzoate with ınhibited bitter taste. Am J Sci Res 2012;7:47–57.
• 7. Kunte S, Tandale P. Fast dissolving strips: A novel approach for the delivery of verapamil. J Pharm Bioallied Sci 2010;2:325–8.
• 8. Kate L, Pol A, Patravale V. Advantages of oral fast dissolving films [Internet]. Pharmabiz. 2010 [cited 2016 Oct 21]. p. 1. Available from: http://www.pharmabiz.com/NewsDetails. aspx?aid=58417&sid=9
• 9. Irfan M, Rabel S, Bukhtar Q, Qadir MI, Jabeen F, Khan A. Orally disintegrating films: A modern expansion in drug delivery system. Saudi Pharm J 2016; 24:537–46.
• 10. Dixit RP, Puthli SP. Oral strip technology: Overview and future potential. J Control Release 2009;139:94–107.
• 11. Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: An innovative drug delivery system and dosage form. Int J ChemTech Res 2010;2:576–83.
• 12. Sayed S, Ibrahim HK, Mohamed MI, El-Milligi MF. Fastdissolving sublingual films of terbutaline sulfate: Formulation and in vitro/in vivo evaluation. Mol Pharm 2013;10:2942–7.
• 13. Bhupinder B, Sarita J. Formulation and evaluation of fast dissolving sublingual films of Rizatriptan Benzoate. Int J Drug Dev Res 2012;4:133–43.
• 14. Hirpara F, Debnath SK, Saisivam S. Optimization & screening of different film forming polymers and plasticizers in fast dissolving sublingual film. Int J Pharm Pharm Sci 2014;6:41– 2.
• 15. Chaturvedi A, Srivastava P, Yadav S, Bansal M, Garg G, Sharma PK. Fast dissolving films: a review. Curr Drug Deliv 2011;8:373–80.
• 16. Shah KR, Chaudhary SA, Mehta TA. Polyox (Polyethylene Oxide) multifunctional polymer in novel drug delivery system. Int J Pharm Sci Drug Res 2014;6:95–101.
• 17. Dinge A, Nagarsenker M. Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity. AAPS PharmSciTech 2008;9:349–56.
• 18. Semalty M, Semalty A, Kumar G. Formulation and characterization of mucoadhesive buccal films of glipizide. Indian J Pharm Sci 2008;70:43–8.
• 19. Mehta DM, Dave DJ, Dadhaniya D V, Shelat PK, Parejiya PB, Barot BS. Application of Box-Behnken design to formulate and optimize multipolymeric fast dissolving film of rizatriptan benzoate. Asian J Pharm 2014;8:35–42.
• 20. Ma M, Lin R, Liu J. Statistical evaluations of dissolution similarity. Stat Sin 1999;9:1011–27.
• 21. Bhise K, Shaikh S, Bora D. Taste mask, design and evaluation of an oral formulation using ion exchange resin as drug carrier. AAPS PharmSciTech 2008;9:557–62.
• 22. Repka MA, Gerding TG, Repka SL, McGinity JW. Influence of plasticizers and drugs on the physical-mechanical properties of hydroxypropylcellulose films prepared by hot melt extrusion. Drug Dev Ind Pharm 1999;25:625–33.
• 23. Sapkal NP, Kilor VA, Daud AS, Bonde MN. Development of fast dissolving oral thin films of ambroxol hydrochloride: Effect of formulation variables. J Adv Pharm Res 2011;2:102–9.