Self-emulsifying composition of omega3 fatty acid

Abstract

A self-emulsifying composition contains: 70 to 90% by weight in total of one or more compounds selected from the group consisting of ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters; 1 to 29% by weight of an emulsifying agent selected from among a polyoxyethylene sorbitan fatty acid ester, a sorbitan fatty acid ester, a glycerin fatty acid ester and a polyoxyl castor oil; and 0.5 to 6% by weight of water when the composition is defined to be 100% by weight as a whole. The self-emulsifying composition is excellent in self-emulsifying property, composition dispersibility, emulsion stability, and absorbability, is free from ethanol and polyhydric alcohols or only has such an alcohol added thereto at a reduced concentration, and is useful for foods and pharmaceuticals.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation of copending application Ser. No. 14 / 905,520, filed on Jan. 15, 2016, which is the National Phase under 35 U.S.C. §371 of International Application No. PCT / JP2014 / 069115, filed on Jul. 17, 2014, which claims the benefit under 35 U.S.C. §119(a) to Patent Application No. 2013-149645, filed in Japan on Jul. 18, 2013, all of which are hereby expressly incorporated by reference into the present application.TECHNICAL FIELD[0002]This invention provides a self-emulsifying composition containing at least one member selected from the group consisting of ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters. This invention also provides a pharmaceutical product using such a composition, and production and application methods thereof.BACKGROUND ART[0003]Known ω3 polyunsaturated fatty acids (hereinafter abbreviated as ω3 PUFA) include α-linolenic acid, eicosapentaenoic acid (hereinafte...

AI Technical Summary

Benefits of technology

The present invention is a self-emulsifying composition that improves compatibility, reduces the amount of emulsifier needed, and increases the amount of ω3 PUFA. The composition contains a small amount of water instead of ethanol and polyhydric alcohols, which improves safety for animals and humans. It prevents capsule film deformation and is rapidly absorbed even when taken before or after meals. The composition is stable and free from separation and cloudiness. It is advantageous in at least one aspect such as appearance, self-emulsifying property, and absorbability.

Problems solved by technology

However, dosage method or drug compliance has become a problem for those people not taking breakfast with the recent change in the life style, patients who can only take meals at a reduced amount, patients who can only take a fluid diet (milk, rice broth, starch gruel, egg, soup, juice, or oral nutritional supplement), patients with reduced absorption ability of the intestinal tract (for example, elderly, patients of intestinal disease, patients after intestinal surgery, terminal cancer patients, and patients taking a lipase inhibitor), or patients who are unable to take meals such as those after the cerebral infarction.

However, volatilization of the ethanol is associated with the risk of capsule deformation and bubble inclusion in the capsule, damages in the quality such as capsule deformation and cracks, as well as denaturing of the content in the capsule such as cloudiness and separation.

In addition, use of a preparation containing such composition should be difficult if not impossible for patients intolerable for the alcohol (ethanol).