Dexlansoprazole, weight variation, Disintegration, Dissolution
Abstract
Dexlansoprazole delayed release is a newly developed class of Proton Pump Inhibitor (PPI). The drug is effective in the treatment of erosive esophagitis, maintenance of eosinophilic esophagitis and relief of heartburn. Additionally, it is also beneficial in the treatment of heartburn with symptomatic gastroesophageal reflux disease. The drug offers the advantage of no dosage adjustment in patients with hepatic impairment. Dexlansoprazole inhibits the stomach acid secrection by specific inhibition of the hydrogen-potassium–ATPase in parietal cells of stomach. Dexlansoprazole inhibits the final step of acid production. The purpose of this study was to perform in-vitro evaluation of different randomly selected brands of dexlansoprazole available in the market. The in-vitro evaluation was performed by assessing the quality control testing parameters .i.e. weight variation, disintegration and dissolution test as specified in BP/USP. All the three brands were found to comply with the offcial pharmacopeial limits of weight variation, disintegration and dissolution. As the therapeutic response of a drug depends largely on its quality parameters, hence, it is concluded that the brands investigated in the study can be interchangeably used owing to their similar quality profile.