ORAL SUSTAINED-RELEASE COMBINED FORMULATION COMPRISING NON-STEROIDAL ANTI-INFLAMMATORY DRUG AND PROTON PUMP INHIBITOR

摘要

The present invention relates to an oral sustained-release combined formulation comprising: a core containing a non-steroidal anti-inflammatory drug (NSAID) and pharmaceutically acceptable additives; a sustained-release coating layer formed on the core and containing a sustained-release coating base; and a proton pump inhibitor layer formed on the sustained-release coating layer and containing a proton pump inhibitor and a basic additive. In the formulation, the sustained-release coating layer shows a dissolution ratio less than 5 wt% of the non-steroidal anti-inflammatory drug in an aqueous buffer solution having a pH of 1.2 for 120 minutes, when the combined formulation is subjected to a dissolution test in 900 mL of an aqueous buffer solution at 37 ± 0.5°C and pH 1.2 for 120 minutes under 50 rpm and continuously to a dissolution test in 900 mL of an aqueous buffer solution at 37 ± 0.5°C and pH 6.8 for 60 minutes under 50 rpm, according to the second paddle method as defined in USP. The present invention also relates to a method for preparing the oral sustained-release combined formulation.;COPYRIGHT KIPO 2016