Abstract

FORMULATION AND EVALUATION OF FLOATING BILAYERED TABLETS OF NAPROXEN AND SUMATRIPTAN

Amreen Sultana* and R. Balaji Reddy

Abstract

Floating drug delivery systems (FDDS) have a bulk density less than gastric fluids and so remain buoyant in the stomach without affecting the gastric emptying rate for a prolonged period of time. Usual treatment for migraine includes “double therapy” consisting of an NSAID (Naproxen) and 5HT- agonist (Sumatriptan). The aim of the present investigation was to develop a bilayer floating tablets of Naproxen and Sumatriptan for effective treatment of Migraine. Naproxen is newly developed NSAID having analgesic and antiinflammatory activity,Sumatriptan is the most effective vasoconstrictor among the Triptans for treatment of migraine. Bilayer floating tablets were formulated using direct compression method, it consist of two layers i.e IR layer containing Naproxen and floating SR layer containing Sumatriptan. The IR layer comprises ofpolysplasdone XL as super disintegrant and the SR layer contains Methocel as release retarding polymers. Sodium bicarbonate was used as gas generating agent in the floating layer. In order to optimize, the best formulation among the six formulations from IR and SR was selected on the basis of their dissolution profiles. IR layer tablets IR5 containing 15mg of polypasdone was found to be optimum and released 98.24% of Naproxen in 300mins. The optimized floating SR layer tablet of Sumatriptan SR3 containing Methocel containing 50mg showed 99.3% of drug release at the end of 12 hours. The optimized IR 6 and SR 3 fomulation was combined and made into bilayer floating tablet. The optimized bilayer tablet of Naproxen and Sumatriptan was evaluated for various evaluation parameters i.e Hardness 2.5kg/cm2, Friability 0.56%, floating lag time 2mins 20sec and floating time of 24 hours. All the results of evaluations was found to be within limits and the final optimized bilayer formulation released 98.24% of Naproxen in 30mins and 98.67% of Sumatriptan in 12 hours. The optmised formulation was fitted in the Kinetic models and it follows korsmeyerpeppas kinetics and the release mechanism was Case II Non- fickian refers to a combination of both diffusion controlled and erosion controlled-drug delivery.

Keywords: Naproxen, Sumatriptan, SR floating layer,Floating bilayer tablets, polyplasdone, methocel, floating lag time and floating time.