Current Advances in Technology of Proton Pump Inhibitor Formulations

Since the identification of gastro erosive reflux disease and peptic ulcer in the early 1900’s, the line of treatment of the disease has evolved reasonably. The antisecretory agents used in the treatment regime have developed, beginning with the introduction of cimetidine in the mid-1970s to proton pump inhibitor (PPI) omeprazole in 1989 and subsequently dexlansoprazole dual delayed release in 2009. This development was done to address the unmet needs of patients suffering from severe esophagitis and nocturnal acid breakthrough (NAB). The available PPI formulations which had short plasma elimination half life of less than 2 hours could not inhibit the proton pumps synthesized in the nighttime hours. The inadequacy in symptom control and high prevalence of NAB in patients with more severe gastro esophageal disease still prevailed after medication. This was identified as the unmet needs of PPI formulations. Although novel formulations, including immediate release omeprazole may offer some advantages over existing formulations, it does not address many of the potential unmet needs of patients with these disorders. However, these needs are addressed by dual delayed release technology which delivers dose in a pulsatile manner and provides acid suppression for prolonged period of time.