Process for the preparation of hardcapsule formulation containing lansoprazole

摘要

PURPOSE: A method of making hard gelatin capsules by emulsification of lansoprazole, oils or fatty acids, emulsifiers and alkalizing agents, spraying of the emulsion on a calcium chloride aqueous solution, protective and enteric coating of the pellet containing lansoprazole and then filling of enteric-coated pellets into a hard gelatin capsule is provided. The hard gelatin capsules have and convenient to take. CONSTITUTION: The hard gelatin capsules are prepared by the steps of: preparing an emulsion by solubilizing or dispersing lansoprazole in a mixture containing oils or fatty acid in ratio of 0.5 to 5:1, adding the emulsion to polymer liquid containing an emulsifier and an alkalizing agent, agitating and then adding with an additive; preparing a pellet having a size of 100 to 1,500m by spraying the mixed solution on a calcium chloride aqueous solution, followed by washing to remove calcium ions and then freeze drying; preparing a pellet containing lansoprazole by performing film coating and enteric coating; and then filling the pellet into a hard gelatin capsule. The alkalinizing agent is methylglucamine. The additive is selected from starch, pregelatinized starch, lactose, mannitol, sorbitol, sucrose, dextrin, calcium carbonate, calcium phosphate dibasic, calcium phosphate tribasic, calcium sulfate or talc.