# US 2025/0367175 A1 · Solid Dispersion Forms of Rifaximin

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- Number: US 2025/0367175 A1
- Document ID: US20250367175A1
- Status: Published application
- Kind: A1
- Application number: 19/299,563
- Filed: 2025-08-14
- Published: 2025-12-04
- Earliest claimed: 2016-09-30
- Assignees: Salix Pharmaceuticals, Inc.
- Applicants: Salix Pharmaceuticals, Inc.
- Inventors: Pam GOLDEN; Mohammed A. KABIR
- Web page: https://patentgrep.com/patent/US20250367175A1

## CPC

- A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K 9/10: Dispersions; Emulsions
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2853: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)}
- A61K 9/2866: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- 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

## Abstract

Provided herein are solid dispersions comprising rifaximin and pharmaceutical compositions and uses thereof.

## Claims

### Claim at position 1

1-35. (canceled)

### Claim 36

A method of preventing complications of liver disease in a subject having liver cirrhosis, the method comprising administering to the subject an immediate-release tablet comprising:
(a) an amorphous solid dispersion comprising 40 mg of rifaximin and an inert carrier matrix; and
(b) one or more ingredients selected from the group consisting of a dissolution enhancer, a filler, a glidant, and a lubricant;
wherein the complications of liver disease are selected from the group consisting of hepatic encephalopathy (HE), esophageal variceal bleeding (EVB), spontaneous bacterial peritonitis (SBP), and hepatorenal syndrome (HRS).

### Claim 37 (depends on 36)

The method of claim 36, wherein the dissolution enhancer comprises croscarmellose sodium.

### Claim 38 (depends on 36)

The method of claim 36, wherein the filler comprises microcrystalline cellulose.

### Claim 39 (depends on 36)

The method of claim 36, wherein the lubricant comprises magnesium stearate.

### Claim 40 (depends on 36)

The method of claim 36, wherein the inert carrier matrix is hydrophilic.

### Claim 41 (depends on 36)

The method of claim 36, wherein the inert carrier matrix comprises one or more polymers.

### Claim 42 (depends on 41)

The method of claim 41, wherein the solid dispersion is prepared by a spray drying process in which the rifaximin and the one or more polymers are mixed and then spray dried.