Process for preparation of mesalamine composition and mesalamine composition thereof

摘要

PROCESS FOR PREPARATION OF MESALAMINE COMPOSITION AND MESALAMINE COMPOSITION THEREOF A process for preparation of a mesalamine composition, comprising: preparing a first drug layering suspension comprising mesalamine; performing a first drug layering in the fluid bed coater to form first drug layered pellets; preparing a seal coating suspension; performing the seal coating in the fluid bed coater on the first drug layered pellets to form seal coated pellets; preparing a second drug layering suspension comprising mesalamine; performing the second drug layering in the fluid bed coater on seal coated pellets to form second drug layered pellets; preparing an extended release coating suspension; performing the extended release coating in the fluid bed coater on the second drug layered pellets to form extended release pellets; preparing a color coating suspension; performing the color coating in the fluid bed coater on the extended release pellets to form color coated pellets; and lubricating the color coated pellets to form mesalamine pellets. FIG. 1