# US 11,028,422 B2 · Process for the production of ultrapure galacto-oligosaccharides

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- Number: US 11,028,422 B2
- Document ID: US11028422B2
- Status: Granted
- Kind: B2
- Application number: 16/153,544
- Filed: 2018-10-05
- Published: 2019-05-09
- Granted: 2021-06-08
- Earliest claimed: 2009-08-07
- Assignees: Ritter Pharmaceuticals, Inc.
- Applicants: Ritter Pharmaceuticals, Inc.
- Inventors: Silvia Giacomelli; Marco Manoni; Giovanni Cipolletti; Silvia Biagiolini; Luana Vagnoli; Jacopo Chini
- Web page: https://patentgrep.com/patent/US11028422B2

## CPC

- C12P 19/04: Polysaccharides, i.e. compounds containing more than five saccharide radicals attached to each other by glycosidic bonds
- A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres
- A61K 31/7016: Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032)
- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- 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
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- C12P: FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE {(brewing of beer C12C; producing vinegar C12J; producing specific peptides or proteins C07K; producing enzymes C12N9/00; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification C12N15/00; measuring or testing processes involving enzymes or microorganisms C12Q; measuring or testing processes involving nucleic acid amplification reactions C12Q1/6844; fermentation processes to form a food composition, A21 or A23; compounds in general, see the relevant compound class, e.g. C01, C07)}
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention describes a process for preparing ultrapure (≥95%) galacto-oligosaccharides (GOS), starting from GOS at lower purities by using sequential microbiological purifications involving Saccharomyces cerevisiae and Streptococcus thermophilus.

## Claims

### Claim 1

A method of purifying a galactooligosaccharides (GOS) composition with a purity ≥95% in which an overall percentage of the digestible sugars lactose, glucose and galactose is ≤5%, comprising providing a GOS mixture of a lower purity and subjecting the GOS mixture to at least one fermentation step with Streptococcus thermophilus and at least one fermentation step with Saccharomyces cerevisiae, where said purity is calculated by any analytical method able to distinguish and quantify GOS and said digestible sugars.

### Claim 2 (depends on 1)

The method of claim 1, wherein said method comprises a fermentation step with S. thermophilus followed by a fermentation step with S. cerevisiae.

### Claim 3 (depends on 1)

The method of claim 1, wherein said method comprises a fermentation step with S. thermophilus followed by a fermentation step with S. cerevisiae when a starting GOS mixture has a glucose ≤5% by HPLC area percent.

### Claim 4 (depends on 2)

The method of claim 2, wherein the fermentation step with S. thermophilus is preceded by a fermentation step with S. cerevisiae comprises when the starting GOS mixture has a glucose content >5% by HPLC area percent.

### Claim 5 (depends on 4)

The method of claim 4, wherein the fermentations with S. cerevisiae are conducted at pH 6.5±0.5 at a temperature of 35±5° C. for at least 12 hours using 15-40 g of dehydrated S. cerevisiae per kg of dry weight of starting GOS.

### Claim 6 (depends on 5)

The method of claim 5 wherein the fermentation with S. thermophilus is conducted at a temperature of 40±5° C. maintaining the pH at 6.0-6.5 by adding a base, for at least 15 hours and using 1-0.4 g of dehydrated S. thermophiles per kg of dry weight of starting GOS.

### Claim 7 (depends on 6)

The method prepared of claim 6 wherein after the fermentation steps the mixture is subjected to further processing by means of ceramic ultrafiltration, nanofiltration, decolorization with carbon and ion-exchange resin deionization.

### Claim 8 (depends on 1)

The method of claim 1, wherein said fermentation steps are preceded by pasteurization undertaken at 75±5° C. for at least 5 minutes.