# US 11,896,720 B2 · Orally available articles containing at least one stabilized supplement therein

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- Number: US 11,896,720 B2
- Document ID: US11896720B2
- Status: Granted
- Kind: B2
- Application number: 16/141,070
- Filed: 2018-09-25
- Published: 2019-03-28
- Granted: 2024-02-13
- Earliest claimed: 2017-09-26
- Assignees: Captek Softgel International, Inc.
- Applicants: Captek Softgel International
- Inventors: Timothy Brian Chiprich; Argelia Sinay Melendez; Bibu Philip George; David Wood; Jangsoon Park; Jung Ku Cho; Lilyan Hong Tran; Paul Hwang; Ronnie Bayless
- Web page: https://patentgrep.com/patent/US11896720B2

## CPC

- A61K 9/5057: {Gelatin}
- A23G 1/00: Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor (preservation thereof A23B80/00)
- A23K 10/18: of live microorganisms
- A23K 20/10: Organic substances
- A23K 20/174: Vitamins
- A23K 50/20: for horses
- A23K 50/30: for swines
- A23K 50/40: for carnivorous animals, e.g. cats or dogs
- A23K 50/50: for rodents
- A23K 50/70: for birds
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23P 10/30: Encapsulation of particles, e.g. foodstuff additives
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K 9/4833: {Encapsulating processes; Filling of capsules (mechanical aspects A61J3/07)}
- A61K 9/4858: {Organic compounds}
- A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)}
- A23L 29/206: of vegetable origin
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23G: COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23K: FODDER
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A23P: SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS

## Abstract

The present disclosure relates to orally available stabilized supplement-containing articles (e.g., softgels). The stabilized supplement may be a probiotic, and may contain a stabilizing component derived from chocolate. The present disclosure also relates to methods of making such stabilized articles.

## Claims

### Claim 1

An orally available softgel comprising:
a liquid fill material comprising:
a pre-wetted probiotic comprising a probiotic and an edible oil, wherein the edible oil is present in a range of 25% to 75% by weight of a total weight of the probiotic and edible oil; and
a stabilizing component derived from cacao seeds selected from the group consisting of chocolate liquor, milk chocolate, white chocolate, dark chocolate, cocoa nib paste, cocoa solid, cocoa flavanol, and combinations thereof as a balance of the fill material;
wherein the edible oil is present in an amount sufficient to reduce a melting point temperature of the stabilizing component and edible oil mixture to below 40° C., and
a softgel capsule shell surrounding the fill material, the softgel capsule shell comprising a plasticizer and 7% to 15% by weight water;
wherein upon cooling the liquid fill material becomes a solid and the stabilizing component protects the probiotic from the deleterious effects of the water in the softgel capsule shell.

### Claim 2 (depends on 1)

The orally available softgel of claim 1, wherein the softgel capsule is a chewable gel capsule, a swallow-able capsule, a sublingual capsule, or a buccal capsule.

### Claim 3 (depends on 1)

The orally available softgel of claim 1, wherein the edible oil is selected from coconut oil, palm oil, jojoba oil, avocado oil or any other edible oil that has melting point less than 35° C.

### Claim 4 (depends on 1)

An article comprising the orally available softgel of claim 1 and a protective package.

### Claim 5 (depends on 4)

The article of claim 4, wherein the orally available softgel is a chewable softgel capsule and the protective package includes a relative humidity controlling salt blend therein to retain desired chew-ability characteristics.

### Claim 6 (depends on 4)

The article of claim 4, wherein the protective package comprises thermal insulation configured to maintain a temperature below 40° C. therein.

### Claim 7 (depends on 1)

The orally available softgel of claim 1, wherein the probiotic comprises a non-spore-forming probiotic powder.

### Claim 8 (depends on 7)

The orally available softgel of claim 7, wherein the non-spore-forming probiotic powder is freeze-dried.

### Claim 9 (depends on 7)

The orally available softgel of claim 7, wherein the non-spore-forming probiotic powder is Lactobacillus acidophilus powder and/or Bifidobacterium lactis powder.

### Claim 10 (depends on 7)

The orally available softgel of claim 7, wherein the non-spore-forming probiotic powder has at least 200 Billion Colony Forming Units per gram.

### Claim 11 (depends on 1)

The orally available softgel of claim 1, wherein the liquid fill material further comprises a secondary supplement.

### Claim 12 (depends on 1)

The orally available softgel of claim 1, wherein the one or more components derived from cacao seeds comprises dark chocolate.

### Claim 13 (depends on 1)

The orally available softgel of claim 1, wherein the edible oil and the probiotic are present in a ratio of 1:3 to 3:1 oil to probiotic.

### Claim 14 (depends on 11)

The orally available softgel of claim 11, wherein the secondary supplement is selected from the group consisting of CoQ10, fish oil, krill oil, a vegetable oil comprising omega 3, omega 6, omega 7, omega 9 fatty acids or combinations thereof, a water-soluble vitamin, an oil-soluble vitamin, a mineral, an herb, an herbal extract, and a combination of any two or more thereof.

### Claim 15 (depends on 1)

The orally available softgel of claim 1, wherein the edible oil and the probiotic are present in a ratio of 1:2 and the stabilizing component and edible oil are present in a ratio of 9:1.

### Claim 16

An orally available softgel comprising:
a softgel capsule shell surrounding a fill material, wherein the softgel capsule shell comprises 5% to 15% by weight water and the fill material is a solid at room temperature and comprises:
a non-spore-forming probiotic pre-wetted with an edible oil, wherein the edible oil is present in a range of 25% to 75% by weight of a total weight of the non-spore-forming probiotic and edible oil and is a concentration enabling the non-spore-forming probiotic to melt below 40° C.; and
a chocolate component as a balance of the fill material, the chocolate component being selected from the group consisting of chocolate liquor, milk chocolate, white chocolate, dark chocolate, cocoa butter, cocoa nib paste, cocoa solid, cocoa flavanol, and mixtures thereof;
wherein the non-spore-forming probiotic and edible oil are warmed together to a temperature in a range of 35° C. to 40° C. for mixing with the chocolate component while molten and is encapsulated in the softgel capsule shell while liquid; and
wherein the chocolate component protects the non-spore-forming probiotic from the deleterious effect of the water of the softgel capsule shell.

### Claim 17 (depends on 16)

The orally available softgel of claim 16, wherein the non-spore-forming probiotic powder is Lactobacillus acidophilus powder and/or Bifidobacterium lactis powder.

### Claim 18 (depends on 16)

The orally available softgel of claim 16, wherein the edible oil is selected from the group consisting of coconut oil, palm oil, jojoba oil, avocado oil, and combination thereof.

### Claim 19 (depends on 1)

The orally available softgel of claim 1, wherein the edible oil and the probiotic are present in a ratio of 1:2 and the stabilizing component and edible oil are present in a ratio of 9:1.