The present study was an attempt to develop and evaluate mucoadhesive bilayered buccal patches to ensure satisfactory unidirectional release of montelukast sodium (MS). The patches were designed to release the drug for a prolonged period of time so as to reduce the frequency of administration of the available conventional dosage forms of MS. Experimental design was built to investigate the effect of two factors sodium carboxymethylcellulose (NaCMC) and Carbopol 974P (CP 974P), each at three levels, as independent variables on mucoadhesion strength and in-vitro residence time as dependent variables. The Design Expert software has given the optimized formulation as desired patches with mucoadhesion strength in the range 41–48 g and in-vitro residence time in the range 243–268 minutes could be obtained by using NaCMC amount in the range 2.1%w/v to 2.7% w/v and CP 974P amount in the range 0.6%w/v to 0.9% w/v. The patches were prepared by solvent casting method and also evaluated for key test parameter such as in vitro drug release. The impermeable backing layer prepared was of ethyl cellulose based to ensure unidirectional drug release. Efficiency of impermeable backing membrane found suitable for mucoadhesive dosage form was also evaluated. After 8 hours the drug lost from ethyl cellulose based backing membrane was <9% of the total amount. The drug release kinetics and mechanism was found to be function of suitable combination of polymers NaCMC and CP 974P. The drug release mechanism was found to follow non-fickian diffusion as release mechanism. Stability study was conducted at accelerated storage condition and prepared muco adhesive bilayered buccal patches were found to be suitable with respect to morphological characteristics and with in-vitro drug release mechanism unaffected after three months
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