FORMULATION AND IN VITRO EVALUATION OF BILAYER FLOATING TABLETS OF ACECLOFENAC AND RANITIDINE HCL

Abstract

The objective of the present investigation was to develop bilayer floating tablets of Aceclofenac and Ranitidine
HCL. OTC analgesics like NSAID are widely used, are frequently taken inappropriately and potentially dangerously, and users
are generally unaware of the potential for adverse side effects. Approximately 10-20% of patients taking NSAID’S suffer from
Gastric ulcers. This bilayer floating tablets of Aceclofenac and Ranitidine HCL is ideal to treat pain and inflammation and also to
control NSAID’S induced ulcer. It consists of an immediate release layer of Ranitidine hcl and a floating sustained release layer of
Aceclofenac formulated using direct compression technique. Nine formulations of immediate release layer containing Ranitidine
hcl (FR1 – FR9) were prepared by using three different superdisintegrants (Crospovidone, Croscarmellose sodium, Sodium starch
glycolate) at three different concentrations. Nine formulations of Floating sustained release layer containing Aceclofenac (FA1 –
FA9) were prepared by using 3 different release retarding polymers (Chitosan, Xanthangum, HPMC E15) at three different
concentrations along with other additives. The immediate release layer formula (FR3) was found to be optimum and released
98.45% of Ranitidine HCL in 10min. The floating sustained release formulation (FA9) released 98.44% of Aceclofenac in 12hrs
while thebuoyancy lag time was 29 sec and the tablet remained floatable throughout the studies. The drug release was inversely
proportional to the polymer concentration. FTIR study revealed the absence of any chemical interaction between drug and
polymers used.