Abstract
FORMULATION AND OPTIMIZATION OF RIZATRIPTAN BENZOATE ORAL FAST DISINTEGRATING FILMS

Ch. Prasanna Lakshmi*, M. Venkata Ramana, N. Rama Rao and V. Ravi

ABSTRACT

The aim of present research work was to develop and optimize oral fast disintegrating film of rizatriptan benzoate to improve bioavailability and patient compliance. Rizatriptan benzoate is a serotonin 5-HT1 receptor agonist. It is a new generation anti-migraine drug which has oral bioavailability of 45% due to hepatic metabolism. Oral fast disintegrating films of rizatriptan benzoate were prepared by solvent casting method using HPMC E-5 as a film forming polymer, propylene glycol as a plasticizer, sodium starch glycolate as a superdisintegrant and aspartame was added as sweetener. The physical mixture of drug and polymer characterised by FTIR showed compatibility. A 23 factorial design was employed for the optimization of developed formulation considering concentration of polymer, plasticizer and superdisintegrant as independent variables with drug release, disintegration time, folding endurance as dependent variables. It was found that enhancing the polymer and plasticizer concentrations shows negative effect on disintegration time and drug release. But when the concentration of superdisintegrant was increased it had a positive effect on drug release and disintegration time. From the results obtained the optimized formulation was prepared with 4% HPMC E5,1.5% of propylene glycol and 4% of sodium starch glycolate showed disintegration time 8 sec, drug release 99.15% and folding endurance of 264 times. The stability study result reveals that there was no significant change in paraeters after three months. From the above research work it is concluded that oral fast disintegrating film of rizatriptan benzoate was successfully designed and developed by solvent casting method and it gives quick onset of action, patient compliance.

Keywords: Rizatriptan benzoate, hydroxyl propyl methyl cellulose, propylene glycol, sodium starch glycolate.


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