Jelly composition

摘要

A composition in which a preparation of the composition itself has an excellent disintegratability in the right place and excellent active ingredient releasability within the digestive tract, the active ingredient and the preparation itself have long-term stability, excellent ease of operation such as manufacturability and filling into containers, an amount sufficient for achieving physiological effects can be easily taken and swallowed, and can be absorbed rapidly from the digestive tract, thus the physiological effect can be expected. The composition is an easy-release jelly composition containing an emulsified polyvalent unsaturated fatty acid or derivative thereof in an amount exceedingly 10 mass % and further containing an emulsifying agent and a gallant. The easy-release jelly composition includes an emulsified polyunsaturated fatty acid or derivative thereof in an amount greater than 10 wt %, an emulsifying agent, and a gelling agent.

主权项

1. An easy-release jelly pharmaceutical composition comprising:
at least one emulsified pharmaceutical component selected from the group consisting of eicosapentaenoic acid, docosahexaenoic acid and ethyl esters thereof, wherein said at least one pharmaceutical component is in an amount greater than 10 wt %; an emulsifying agent which is at least one selected from the group consisting of polyoxyethylene polyoxypropylene glycols, sucrose fatty acid esters, lecithin, polyglycerol fatty acid esters, glycerol fatty acid esters, sorbitan fatty acid esters, propylene glycol fatty acid esters and C12-22 saturated fatty acids, the emulsifying agent being in an amount of 0.01-10 wt %; a gelling agent which is at least one selected from the group consisting of 0.1-2 wt % of carrageenan and 0.05-1 wt % of locust bean gum; a syneresis inhibitor in an amount of 0.05-5 wt % which is at least one selected from the group consisting carmellose sodium and pullulan; and a flavoring agent in an amount of 3-20 wt % selected from the group consisting of erythritol, xylitol, and trehalose; wherein the easy-release jelly pharmaceutical composition is capable of being orally ingested, and when filled into a cylindrical container having an inside diameter of 20 mm, has a jelly strength (breaking strength) of at least 50 gf/cm2, but not more than 250 gf/cm2, obtained by testing with a rheometer using a 10-mm diameter cylindrical plunger at an insertion rate of 30 cm/min, an insertion distance of 10 mm and room temperature, and wherein said easy-release jelly pharmaceutical composition has a release ratio of at least 50% of the pharmaceutical component into a test solution containing 2000 nylon beads having a diameter of 6.4 mm, 30 minutes after mixing the easy-release jelly pharmaceutical composition into the test solution and stirring at a temperature of 37° C. with a paddle rotation at 25 rpm, said test solution being composed of 160 mL of an artificial gastric fluid 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.