Kailas Krishnat MALI, Remeth J DIAS, Vishwajeet S. GHORPADE, Vijay D HAVALDAR, Bhimrao K. RUPNOOR, Nikhil S. DHANE

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

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.

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