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(12) United States Patent (10) Patent N0.: US 6,750,331 B1 Takaichi Et Al

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(12) United States Patent (10) Patent N0.: US 6,750,331 B1 Takaichi Et Al US006750331B1 (12) United States Patent (10) Patent N0.: US 6,750,331 B1 Takaichi et al. (45) Date of Patent: Jun. 15, 2004 (54) OLIGOSACCHARIDE-SUPPLYING (52) US. Cl. .................. .. 536/1.11; 536/1231; 536/41; COMPOSITIONS 424/464; 424/465; 424/466 (58) Field of Search ............................... .. 536/111; 41, (75) Inventors: Akihisa Takaichi; Naruto (JP); 536/1231; 424/464, 465, 466 Toshihiko Okamoto; Tokushima (JP); Toshiaki Matsumoto; Tokushima (JP); Takuya Kishimoto; Tokushima (JP) (56) References Cited (73) Assignee: Otsuka Pharmaceutical Co., Ltd.; U.S. PATENT DOCUMENTS Tokyo (JP) 5,164,192 A * 11/1992 Louwes 5,707,654 A * 1/1998 Beres et al. ( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 * cited by examiner U.S.C. 154(b) by 844 days. (21) Appl. No.: 10/019,197 Primary Examiner—Samuel Barts Assistant Examiner—Michael C. Henry (22) PCT Filed: Jun. 20, 2000 (74) Attorney, Agent, or Firm—Sughrue Mion; PLLC (86) PCT No.: PCT/JP00/03998 (57) ABSTRACT § 371 (6X1), (2); (4) Date: Dec. 31, 2001 The present invention provides an oligosaccharide supplying composition Which contains 10 to 80% by Weight (87) PCT Pub. No.: WO01/00883 of oligosaccharide; 0.3 to 10% by Weight of a foaming component and 0.9 to 30% by Weight of a neutralizing PCT Pub. Date: Jan. 4, 2001 component and is in the form of foaming cheWable tablets. (30) Foreign Application Priority Data The composition is highly useful in practice; has a uniform composition; excellent texture and high stability and can be Jun. 30, 1999 (JP) ......................................... .. 11-184814 easily taken. (51) Int. Cl.7 .......................... .. C07H 3/00; A61K 9/20; A61K 9/46; A61K 3/715; A61K 9/36 13 Claims, No Drawings US 6,750,331 B1 1 2 OLIGOSACCHARIDE-SUPPLYING oligosaccharide, 0.3 to 10% by Weight of a foaming com COMPOSITIONS ponent and 0.9 to 30% by Weight of a neutraliZing component, and being in the form of foaming cheWable This application the National Phase of PCT/JP00/03998 tablets. ?led Jun. 20, 2000. The present invention provides the above oligosaccharide-supplying composition further comprising DESCRIPTION 0.1 to 5 Wt. % of potassium carbonate as stabiliZer; the above 1. Technical Field composition further comprising 5 to 20 Wt. % of Water The present invention relates to an oligosaccharide insoluble dietary ?ber; the above composition Wherein the supplying composition, more speci?cally to an 10 oligosaccharide is lactosucrose; the above composition hav oligosaccharide-supplying composition With a high oli ing an oligosaccharide content of 30 to 75 Wt. %; the above gosaccharide content, Which has improved textureand high composition Wherein the oligosaccharide is at least one stability and is in the form of foaming cheWable tablets. member selected from the group consisting of lactosucrose; 2. Background Art palatinose oligosaccharide, isomaltooligosaccharide, 15 Oligosaccharides are knoWn to have loW digestability, xylooligosaccharide, fructooligosaccharide, lactulose, usually reaching the large intestine in an undigested state galactooligosaccharide, gentiooligosaccharide, chitin and are utiliZed by enterobacteria. It is also knoWn that oligosaccharide, soybean oligosaccharide, panose, oligosaccharides balance the intestinal environment and are cellooligosaccharide, pectin oligosaccharide, especially effective in increasing Lactobacillus bi?a'us lev inulooligosaccharide, levanoligosaccharide , els. The minimum required intake of oligosaccharides to 20 mannooligosaccharide, chitooligosaccharide and coupling achieve these effects is usually about 0.7 to 10 g per day, sugar; the above composition Wherein the oligosaccharide is although it may slightly vary depending on the type of at least one member selected from the group consisting of oligosaccharide. lactosucrose; palatinose oligosaccharide, isomaltooligosaccharide, xylooligosaccharide, Most oligosaccharides are amorphous and are mixtures of 25 fructooligosaccharide, lactulose, galactooligosaccharide and a plurality of carbohydrates. Therefore, the moisture absorp soybean oligosaccharide; the above composition Wherein tion of oligosaccharides is about several times higher than the oligosaccharide is lactosucrose; the above composition that of sugar. Thus it is also knoWn that compositions With Wherein the foaming component is at least one member higher oligosaccharide content have poor texture and loWer selected from the group consisting of sodium stability. 30 hydrogencarbonate, sodium carbonate and calcium carbon Commercially available oligosaccharides are generally in ate; the above composition Wherein the neutraliZing com the form of poWders of syrups. Oligosaccharides are rarely ponent is at least one member selected from the group taken in these commercially available forms and usually consisting of citric acid, L-tartaric acid, L-ascorbic acid and made into suitable preparations such as poWders, tablets DL-malic acid; the above composition Wherein the neutral (cheWables), etc. Such preparations of oligosaccharides, 35 iZing component is at least one member selected from the hoWever, have the draWback of sticking to teeth during group consisting of L-ascorbic acid and anhydrous citric ingestion. Another disadvantage is that such preparations of acid; the above composition Wherein the Water-insoluble oligosaccharides form a solid lump comparatively rapidly dietary ?ber is at least one member selected from the group because of their high hygroscopicity. In vieW of texture and consisting of crystalline cellulose, Wheat bran, oat bran, stability, most preparations containing oligosaccharides 40 cone ?ber, soy ?ber and beet ?ber; and the above compo have been formed into beverages free of the above problems. sition Wherein the Water-insoluble dietary ?ber is crystalline Thus, knoWn oligosaccharide-containing preparations are cellulose. usually unsuitable for ingestion or administration in an Foaming cheWable tablets of the composition of the amount suf?cient to produce their intrinsic effect of balanc present invention disintegrate and dissolve at a moderate ing the intestinal environment. Further improvement is still 45 rate in the mouth to thereby prevent binding due to the needed With respect to the form of preparation, texture, hygroscopic property intrinsic to oligosaccharides, i.e., stability and ease of ingestion and administration. sticking to teeth in the mouth, thus alloWing one to enjoy its DISCLOSURE INVENTION taste by licking or cheWing it Without Water and concurrently An object of the present invention is to provide an realiZing suf?cient supply and absorption of oligosaccha improved oligosaccharide-supplying preparation that can rides in the body through the ingestion. replace conventional oligosaccharide-containing The composition of the invention further containing the preparations, is highly advantageous in use, has a uniform speci?ed amount of potassium carbonate as a stabiliZer can dispersion of components in preparation, excellent texture prevent an unnecessary reaction betWeen the neutraliZer and and high stability and can be easily taken. 55 the foaming agent (caused by the presence of Water) before The inventors carried out intensive research to achieve the ingestion of the composition and can ensure a suf?cient above object and found the folloWing: foaming cheWable foaming reaction during ingestion. That is, potassium car tablets of the preparation easily disintegrate and is highly bonate acts as a desiccant. soluble in the mouth during ingestion or administration, so The composition of the invention further containing the that sticking to teeth during cheWing of the preparation can 60 speci?ed amount of Water-insoluble dietary ?ber has the be prevented, thus providing an improved oligosaccharide advantage that even a considerable increase of oligosaccha supplying preparation free of reduced texture and alloWing ride content does not adversely affect its texture and stability one to enjoy its taste by licking or cheWing it Without in a signi?cant manner. needing Water. The present invention Was accomplished The composition of the invention additionally containing based on this ?nding. 65 a sucrose fatty acid ester, poWder sugar, fruit juice poWder The present invention provides an oligosaccharide and ?avoring material achieves further improved shape supplying composition comprising 10 to 80% by Weight of retention of tablets and better taste. US 6,750,331 B1 3 4 It is essential to use oligosaccharide in the present inven The galactooligosaccharide-containing mixture can be tion. Preferably used are oligosaccharides that increase obtained by an enZymatic treatment of lactose. The mixture bi?dobacteria levels. Usable oligosaccharides, however, are contains 55 to 70 Wt. % or more of galactooligosaccharide not limited thereto and all oligosaccharides can be used that as a main component and further contains lactose, etc. are hygroscopic and have the problem that preparations The soybean oligosaccharide-containing mixture can be containing them stick to teeth, etc. The term “oligosaccha obtained by separation of sugar containing-component from rides that increase bi?dobacteria levels” herein used is de?ned as those that are essential and important nutrient soybeans and re?ning. The mixture contains over 10 Wt. % (sugar source) for intestinal groWth of Lactobacillus bi?dus of stachyose and raf?nose. and consist of 2 to 10 monosaccharides Which are substan Preferably, the proportion of oligosaccharide in
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