Preparation and Characterization of Montelukast Sodium ( SMLT ) as a Dual Sustained Release Buccal Strips

Abstract

An oral bi layer  sustained release (SR) strips of Sodium  Montelukast SMLT , which is selective  leukotriene  antagonist  , used  for  patients  suffered from mid-night asthma , were prepared successfully ,using different polymers, like guar  gum , carrageenan , and xanthan gum , by solvent casting method .

The results obtained by this study revealed  ,that best  fast  dissolving  film of  SMLT was  loaded  in carrageenan   polymer 57%  w\w (30mg.) ,  with  acceptable  physical properties, like film thickness , elastic endurance and  surface pH  .

Besides  to that , the  disintegration  time , and  cumulative  80%   drug  release  were estimated  22 seconds and 3.7 minutes , respectively .On the other hand , the sustained release film ( FSR6-7 )  as a second layer , appear to be the most promised  layer of SMLT loaded in 50 % w\w  (15mg.) PVP K17 , with respect to its film thickness, elastic endurance and , surface pH .

Moreover the , the disintegration time of the second layer film was 21seconds , and the time for 50% drug release  was 15 minutes  extended  for 4hours of 100% drug release .

Meanwhile , the  investigation of possible  interference  between the  drug , and, polymers used  revealed  no evidence of this effect ,using FTIR  , and SEM  technique . In an attempt to evaluate the extended release effect of the selected formula , Singulair® plain tablet  as a marketed product was used , the result gave  more  than 4 hours  of  selected formula , compared with  30 minutes to marketed product Singulair® .

The overall results candidates  the selected  FSR6-7  formula  as a promised  bi layer buccal fast , as compliance  and  extended therapy for asthmatic mid- night patients.

Keywords: Montelukast sodium, Dual buccal  strips, Guar gum, Xanthan gum, Carrageenan.