IP Library Granted Patent US 8,540,980
Granted Patent B2
US 8,540,980 · App. 13/686,147 · Granted Sep 24, 2013

Delivery system for biological component

Inventors: Christopher London (Redmond, WA); Stephen J. Turner (Snoqualmie, WA); Tanya Borek (Bellevue, WA); Catherine Federici (Seattle, WA); Michael P. Hite (Normandy Park, WA)
Assignee: TNTGamble, Inc.
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Quick Facts
Patent No.
US 8,540,980
App. No.
13/686,147
Granted
Sep 24, 2013
Kind
B2
Abstract

A controlled release delivery system composition and method applied to humans and animals, for oral, anal or vaginal administration of a biological component is disclosed. Preferably, a bacterium is delivered, and more preferably the bacterium is probiotic in nature, however, the biological component is not limited to the bacterium.

Claims (60)

1. A controlled release formulation for oral delivery to an intestinal system, the formulation comprising:

about 5% to 40% by total weight of hydroxypropyl methylcellulose;

about 5% to 40% by total weight of pectin;

about 1% to 40% by total weight of at least one electrolytic agent selected from the group consisting of sodium carbonate and sodium bicarbonate; and

a probiotic.

2. The controlled release formulation of claim 1 wherein the hydroxypropyl methylcellulose and the pectin are present in a ratio of about 1:1.

3. The controlled release formulation of claim 1 having a total weight of approximately 343 mg and consisting of the following components, each in the approximate amount of:

50 mg of hydroxypropyl methylcellulose;

50 mg of pectin;

50 mg of sodium bicarbonate;

100 mg of microcrystalline cellulose;

8 mg of stearic acid;

8 mg of silica;

2 mg of a turmeric; and

75 mg of a lactic acid bacteria pre-blend comprising a lyophilized powder including the probiotic and starch.

4. The controlled release formulation of claim 1 wherein the probiotic is non-viable.

5. The controlled release formulation of claim 1 having a total weight of approximately 532 mg and consisting of the following components, each in the approximate amount of:

150 mg of hydroxypropyl methylcellulose;

100 mg of pectin;

100 mg of sodium bicarbonate;

16 mg of stearic acid;

16 mg of silica; and

150 mg of a bifidobacterium bacteria pre-blend comprising a lyophilized powder including the probiotic and starch.

6. The formulation of claim 1 wherein the probiotic is a lactic acid bacteria.

7. The formulation of claim 1 wherein the probiotic comprises one or more of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus plantarum, Streptococcus thermophilus, Bifidobacterium infantis, Bifidobacterium bifidum , or Bifidobacterium longum.

8. The formulation of claim 1 wherein the electrolytic agent is sodium bicarbonate.

9. The formulation of claim 1 wherein said formulation is a directly compressed monolithic tablet.

10. A controlled release formulation for oral delivery to an intestinal system, the formulation comprising:

about 5% to 40% by total weight of hydroxypropyl methylcellulose;

about 5% to 40% by total weight of pectin;

about 1% to 40% by total weight of sodium bicarbonate; and

a probiotic;

wherein said formulation is a monolithic tablet without an enteric coating.

11. The controlled release formulation of claim 10 wherein the hydroxypropyl methylcellulose and the pectin are present in a ratio of about 1:1.

12. The controlled release formulation of claim 10 having a total weight of approximately 343 mg and consisting of the following components, each in the approximate amount of:

50 mg of hydroxypropyl methylcellulose;

50 mg of pectin;

50 mg of sodium bicarbonate;

100 mg of microcrystalline cellulose;

8 mg of stearic acid;

8 mg of silica;

2 mg of a turmeric; and

75 mg of a lactic acid bacteria pre-blend comprising a lyophilized powder including the probiotic and starch.

13. The controlled release formulation of claim 10 wherein the probiotic is non-viable.

14. The controlled release formulation of claim 10 having a total weight of approximately 532 mg and consisting of the following components, each in the approximate amount of:

150 mg of hydroxypropyl methylcellulose;

100 mg of pectin;

100 mg of sodium carbonate bicarbonate;

16 mg of stearic acid;

16 mg of silica; and

150 mg of a bifidobacterium bacteria pre-blend comprising a lyophilized powder including the probiotic and starch.

15. The formulation of claim 10 wherein the probiotic is a lactic acid bacteria.

16. The formulation of claim 10 wherein the probiotic comprises one or more of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus plantarum, Streptococcus thermophilus, Bifidobacterium infantis, Bifidobacterium bifidum , or Bifidobacterium longum.

17. The formulation of claim 10 wherein said formulation is a directly compressed monolithic tablet.

18. A controlled release formulation for oral delivery to an intestinal system, the formulation comprising:

about 5% to 40% by total weight of hydroxypropyl methylcellulose;

about 5% to 40% by total weight of pectin;

about 1% to 40% by total weight of sodium carbonate; and

a probiotic;

wherein said formulation is a monolithic tablet without an enteric coating.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 19, 2017
From: TNTGAMBLE,INC. D/B/A NUTRACEUTIX
To: PROBI USA, INC.
Reel/Frame 043627/0928 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2017
From: TNTGAMBLE, INC.
To: PROBI USA, INC.
Reel/Frame 041009/0919 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 7, 2013
From: NUTRACEUTIX, INC.
To: TNTGAMBLE, INC.
Reel/Frame 030364/0705 →
Continuity (4)
Continuation 11634397 · Dec 5, 2006
Continuation In Part 10261639 · Sep 30, 2002
Provisional Application 60325937 · Sep 28, 2001
Related Publication 20130084265A1 · Apr 4, 2013