Oral sustained-release combined formulation comprising NSAIDs and a proton pump inhibitor

摘要

a core containing non-steroidal anti-inflammatory drugs (NSAIDs) and pharmaceutically acceptable excipients; a sustained-release coating layer formed on the core and containing a sustained-release coating base; and As an oral sustained-release complex formulation formed on the sustained-release coating layer and comprising a proton pump inhibitor layer containing a proton pump inhibitor and a basic additive, The sustained-release coating layer is According to the second method paddle method according to the United States Pharmacopoeia (USP), after dissolution test at 50 rpm for 120 minutes in an aqueous buffer of 37±0.5 ℃, pH 1.2, 900 mL, 37±0.5 ℃ continuously, When dissolution test at 50 rpm for 60 minutes in aqueous buffer of pH 6.8, exhibiting a dissolution rate of less than 5% by weight of the non-steroidal anti-inflammatory agent for 120 minutes in said pH 1.2 aqueous buffer, It provides an oral sustained-release combination formulation that exhibits a dissolution rate of 80% or more of the non-steroidal anti-inflammatory agent within 60 minutes in the pH 6.8, aqueous buffer, and a method for preparing the same.