Preparation of Omeprazole Enteric Capsules by Encapsulating Enteric-coated Pellets

Objective To develop omeprazole enteric-coated pellet capsules.Methods Omeprazole enteric-coated pellets were prepared with air-flow coating apparatus by coating blank pellets with the medicine layer,insulation layer and enteric layer.The formulation composition and process factors were optimized.Omeprazole enteric capsules were conformed by encapsulating enteric-coated pellets into hard gelatin capsules.Results The medicine layer coating solution was made by mixing omeprazole,HPMC(5 mPa·s),anhydrous sodium carbonate,Tween-80 and methylsilicone oil with water.Anhydrous sodium carbonate was used as the alkaline adjustment agent of the insulation layer.EUDRAGIT L30D-55 was used as the enteric coating material.The cumulative release of three batches of omeprazole enteric-coated pellet capsules in artificial intestinal solution within 45 min was(98.0±1.2)%,(95.3±4.0)% and(94.3±1.8)%,respectively.Conclusion This method is feasible for preparation of omeprazole enteric capsules by encapsulating enteric-coated pellets,able to obtain good repeatability and stable quality.