# US 12,766,171 B2 · Long-term stable live fecal microbiota composition

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- Number: US 12,766,171 B2
- Document ID: US12766171B2
- Status: Granted
- Kind: B2
- Application number: 17/602,134
- Filed: 2020-04-14
- Published: 2022-05-12
- Granted: 2026-10-20
- Earliest claimed: 2019-04-15
- Assignees: Fundació De Recerca ClíNic Barcelona-Institut D'Investigacions BiomèDiques August Pi I Sunyer; Hospital Clinic De Barcelona; Universitat De Barcelona
- Applicants: Fundació De Recerca ClíNic Barcelona-Institut D'Investigacions BiomèDiques August Pi I Sunyer; Hospital ClíNic De Barcelona; Universitat De Barcelona
- Inventors: Josep M. Suñé Negre; Alex Soriano Viladomiu; Andrea Aira Gomez; Csaba Feher
- Web page: https://patentgrep.com/patent/US12766171B2

## CPC

- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- 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 9/485: {Inorganic compounds}
- A61K 9/4866: {Organic macromolecular compounds}
- 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)

## Abstract

The present invention provides a solid oral pharmaceutical composition comprising a pharmaceutically effective amount of living microorganisms and one or more pharmaceutically acceptable water absorbing excipient(s), wherein the composition has a water content, determined according to European Pharmacopoeia 9.4, section 2.5.12., from 0.5 to 30% with respect the total weight of the composition. The invention also provides processes for its preparation as well as it use in therapy. The live-cell based composition of the invention is stable at mild conditions.

## Claims

### Claim 1

A method for treating dysbiosis in a subject in need thereof, the method comprising: administering a solid oral pharmaceutical composition to a subject in need thereof, wherein the solid oral pharmaceutical composition comprises a pharmaceutically effective amount of non-lyophilized living fecal microbiota extract in admixture with one or more pharmaceutically acceptable water absorbing excipients comprising microcrystalline cellulose (MCC), wherein the ratio between the amount of living microorganisms expressed in volume units and the amount of water absorbing excipient(s), expressed in weight units, is from 0.1:1 to 0.99:1, wherein the composition has a water content, determined according to European Pharmacopoeia 9.4, section 2.5.12, from 0.5% to 30% with respect to the total weight of the composition, wherein alpha diversity of the non-lyophilized living microorganisms in the solid oral pharmaceutical composition is not significantly different than the alpha diversity of the non-lyophilized living microorganisms before admixture with the one or more water-absorbing excipients, and wherein the solid oral pharmaceutical composition is stable at 4° C. for 3 months.

### Claim 2 (depends on 1)

The method of claim 1, wherein the solid oral pharmaceutical composition further comprises one or more additional pharmaceutically acceptable excipients.

### Claim 3 (depends on 1)

The method of claim 1, wherein the solid oral pharmaceutical composition further comprises one or more of a cryoprotectant, a lubricant, a stearate salt, and glycerol.

### Claim 4 (depends on 1)

The method of claim 1, wherein the alpha diversity of the non-lyophilized living microorganisms is substantially maintained for at least 6 months of storage at 4° C.

### Claim 5 (depends on 1)

The method of claim 1, wherein alpha diversity comprises Faith Diversity Index.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject has irritable bowel syndrome (IBS).

### Claim 7 (depends on 1)

The method of claim 1, wherein the subject has hepatic encephalopathy.

### Claim 8 (depends on 1)

The method of claim 1, wherein the solid oral pharmaceutical composition is a single capsule.

### Claim 9 (depends on 2)

The method of claim 2, wherein the one or more additional water absorbing excipients is selected from: a cellulose-based excipient or a pharmaceutically acceptable salt thereof; kaolinite; talc; palygorskite; sepiolite; and smectites.

### Claim 10 (depends on 2)

The method of claim 2, wherein the one or more additional water absorbing excipients is a cellulose ether derivative, a cellulose ester derivative, or a combination thereof.

### Claim 11 (depends on 1)

The method of claim 1, wherein the solid oral pharmaceutical composition further comprises a lubricant, the weight ratio of water absorbing agent(s):lubricant being comprised from 30:1 to 70:1.