Formulation and evaluation of floating bilayer tablet of Aceclofenac and Esomeprazole

Abstract

The development of bilayer floating tablets containing esomeprazole and aceclofenac was the objective of this study. OTC analgesics, like NSAIDs, are extensively used, but they are frequently abused and may be harmful, and users are often unaware of the possibility of adverse effects. It consists of an instant release aceclofenac layer and a floating sustained release esomeprazole layer manufactured using the wet granulation method. Aceclofenac was included into five immediate release layer formulations (F1–F5) made with sodium starch glycolate super disintegrants. To create five formulations of sustained release layer containing Esomeprazole (F1-F5), synthetic release retarding polymers (HPMC E15) were combined with other ingredients. The immediate release formulation (F3) released 97 % of the Aceclofenac in 1 hours, and the sustained release formulation (F5) released 96 % of the esomeprazole in 10 hours. There was an inverse relationship between the amount of polymer present and the amount of drug released. There were no chemical interactions between the drug and the polymers used, according to an FTIR analysis. 10% to 20 percent of patients who take nonsteroidal anti-inflammatory medicines (NSAIDs) develop stomach ulcers. This bilayer floating tablet containing aceclofenac and esomeprazole is useful for managing pain and inflammation in addition to NSAID-induced ulcer.