Enteric coated microgranules for stabilizing lactic acid bacteria

• US 6,365,148 B1
• Filed: 04/14/2000
• Issued: 04/02/2002
• Est. Priority Date: 10/17/1997
• Status: Expired due to Fees

• Current Assignee: Il-Yang Pharm. Co., Ltd.
• Original Assignee: Il-Yang Pharm. Co., Ltd.
• Inventors: Jeon, Hong Ryeol, Park, Dong Woo, Kim, Dong Yeun
• Primary Examiner(s): Weber, Jon P.
• Assistant Examiner(s): LEITH, PATRICIA A
• Application Number:
  US09/529,534
• Time in Patent Office: 718 Days
• Field of Search: 426/42, 426/61, 426/317, 426/565, 424/271, 424/93.45, 424/93.1, 424/489, 424/490, 435/244, 435/252.1, 435/252.9
• US Class Current: 424/93.1
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5036 Polysaccharides, e.g. gums, alginate; Cyclodextrin
• CPC Class Codes: A61K 9/5042 Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5052 Proteins, e.g. albumin
• CPC Class Codes: A61K 9/5073 having two or more different coatings optionally including drug-containing subcoatings
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents

Abstract

The present invention relates to an enteric coated granule prepared by coating lactic acid bacteria-containing seed with a water-miscilble coating material and then, if desired, subjecting the first coated product to the second coating with a controlled-release coating material.

Claims

1. An enteric coated granule consisting of a seed obtained from spray-coating lactic acid bacteria powder with a water-miscible coating material while suspending the powder in a chamber, wherein the water-miscible coating material is one or more selected from the group consisting of sodium alginate, polymethylmethacrylate, wheat protein, soybean protein, methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinylacetate phthalate, guar gum, locust bean gum, xanthan gum, gellan gum and arabic gum.

2. The coated granule according to claim 1, wherein lactic acid bacteria is one or more selected from the group consisting of the strains belonging to Streptococcus genus, Lactococcus genus, Leuconostoc genus, Pediococcus genus, Enterococcus genus, Lactobacillus genus and Bifidobacterium genus.

3. The coated granule according to claim 1, wherein the water-miscible coating material is sodium alginate.

4. The coated granule according to claim 1 or 3, wherein the water-miscible coating material is used in an amount of 1 to 80% by weight with respect to the powder.

5. The coated granule according to claim 1, wherein after coating with a water-miscible coating material, the seed is further coated with a controlled-release coating material.

6. The coated granule according to claim 5, wherein the controlled-release coating material is one or more selected from the group consisting of corn protein extract and processed materials thereof, sodium alginate, alginic acid, polymethylmethacrylate, shellac, hydroxypropylmethylcellulosephthalate, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose acetate succinate, carboxymethylcellulose, hydroxypropylcellulose, celluloseacetatephthalate, polyvinylacetatephthalate, ethylcellulose, methylcellulose, soybean protein, wheat protein, chitin, chitinic acid, agar, carrageenan, pectin, carbopol, guar gum, locust bean gum, xanthan gum, gellan gum and arabic gum.

7. The coated granule according to claim 6, wherein the controlled-release coating material is one or more selected from the group consisting of corn protein extract, hydroxypropylmethylcellulosephthalate and shellac.

8. The coated granule according to claim 6 or 7, wherein the controlled-release coating material is used in an amount of 1 to 95% by weight with respect to the seed.

9. The coated granule according to claim 5, wherein one or more solvents selected from the group consisting of water, alcohol, acetone, acetonitrile, methylene chloride, ether, hexane, chloroform, 1,4-dioxane, tetrahydrofuran, dimethylsulfoxide, ethyl acetate and methyl acetate are used for coating with a controlled-release coating material.

10. The coated granule according to claim 1 or 5, wherein one or more plasticizers selected from the group consisting of polyethyleneglycols, myvacet, propyleneglycol, glycerine, triethyl citrate, triacetin, cetyl alcohol and stearyl alcohol are mixed with the coating material.

11. The coated granule according to claim 10, wherein the plasticizer is used in an amount of 1 to 50% by weight with respect to the coating material.

12. The coated granule according to claim 1 or 5, wherein the coating procedure is carried out at the temperature ranging from 20 to 55°

C.

13. The coated granule of claim 1, wherein the seed further comprises a carrier.

14. The coated granule of claim 13 wherein the carrier is one or more substances selected from the group consisting of starch, lactose, oligosaccharides, glycoalcohols, calcium gluconate, calcium lactate and gluconic acid.

15. The coated granule of claim 1 wherein the water-miscible coating is applied with a solvent of water and substantially in the absence of an organic solvent.