Jelly composition

摘要

It is intended to provide a composition having at least one effect among the following effects; a plurality of medicinal ingredients can be taken as one preparation and the convenience for patients is excellent; the drug compliance is excellent; the amount of jelly composition to be taken at a time is small; the release of an active ingredient in the digestive tract is excellent; the absorption of an active ingredient to the body is excellent; the storage stability of an active ingredient is excellent; the dispersibility of an active ingredient in the composition is excellent; the storage stability of the composition is excellent; the syneresis of the composition is less, it has an appropriate jelly strength to a degree that does not disintegrate during carrying and before taking and easily disintegrates after taking; the handleability during preparation of the composition is excellent; the portability of the composition is excellent; the feeling of taking the composition is excellent; it has an effect on reducing side effects; and the like. The jelly composition contains a polyvalent unsaturated fatty acid, a second medicinal ingredient, an emulsifying agent and a gelling agent.

主权项

1. A pharmaceutical jelly composition formulated for oral administration, said pharmaceutical jelly composition comprising:
a first pharmaceutical component comprising icosapentaenoic acid or an ethyl ester thereof; a second pharmaceutical component comprising an antihyperlipidemic agent selected from the group consisting of statin drugs (HMG-CoA reductase inhibitors), fibrates, squalene synthase inhibitor, and cholesterol absorption inhibitor; from 0.05 to 10% by weight, based upon the total weight of the jelly composition, of an emulsifying agent which is at least one member selected from the group consisting of polyoxyethylene polyoxypropylene glycol, sucrose fatty acid ester, lecithin, polyglycerin fatty acid ester, glycerin fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, and a saturated fatty acid containing 12 to 22 carbon atoms; a gelling agent which is at least one member selected from the group consisting of carrageenan and locust bean gum; and from 0.5 to 5% by weight, based upon the total weight of the jelly composition, of a syneresis inhibitor selected from the group consisting of carmellose sodium, pullulan, hydroxypropyl methylcellulose, hydroxypropyl cellulose, and crystalline cellulose, wherein said pharmaceutical jelly composition has a jelly strength of 50 to 250gf/cm2 and wherein said pharmaceutical jelly composition has a release ratio of higher than 50% of icosapentaenoic acid or an ethyl ester thereof, into a test solution in a beaker containing 2000nylon beads having a diameter of 6.4 mm, 30 minutes after mixing the jelly composition into the test solution and stirring at a temperature of 37° C. with a paddle rotation rate of 25, said test solution being composed of 160 mL of an artificial gastric juice comprising an aqueous solution containing 115 mmol/L of sodium chloride and 35 mmol/L of potassium chloride adjusted with hydrochloric acid to a pH of 2.5.