CYCLOSPORIN-CONTAINING SOFT GELATIN CAPSULE AND PRODUCTION THEREOF

摘要

PURPOSE: A method of making the titled soft gelatin capsule by using various surfactants, oil components and in particular non-volatile cosurfactants is provided. It permits the formation of a gelatin capsule film without glycerine, thereby producing a very stable preparation having almost no change over time. CONSTITUTION: The soft gelatin capsule containing self-emulsifying cyclosporin has a final HLB value of 6 to 10 and comprises: cyclosporin as an active component; polyethylene glycol and propylene glycol having a molecular weight of 200 to 600 as a main solvent; fatty acid, esterified compounds of a monohydric alkanol and a mixture of medium-chain fatty acid triglyceride and fatty acid monoglyceride as an oil component; and one or more surfactants having an HLB value of 10 to 17. It contains cyclosporin, polyethylene glycol, propylene glycol, oil components and surfactants in a ratio of 1:1 to 10:1 to 10:0.1 to 1:0.1 to 10.