IP Library Granted Patent US 12,611,378
Granted Patent B2
US 12,611,378 · App. 18/012,362 · Granted Apr 28, 2026

Targeted release rifaximin compositions

Inventors: Jacob Cole (Fairport, NY); Brian R. Rohrs (Fairport, NY); Daniel J. Stein (Rochester, NY); Robert J. Israel (Suffern, NY); Ezra R. Lowe (Bridgewater, NJ)
Assignee: Bausch Health Ireland Limited
A61K9/0056A61K31/137A61K31/437A61K31/4468A61K31/485A61K45/06A61K47/10A61K47/14A61K47/32A61K47/38A61P7/00A61P7/04
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Quick Facts
Patent No.
US 12,611,378
App. No.
18/012,362
Granted
Apr 28, 2026
Kind
B2
Abstract

Provided herein are GI specific rifaximin release compositions which can be formulated for targeted delivery of rifaximin to one or more portions of the GI tract. Methods of treating diseases and disorders with the disclosed compositions are also provided.

Claims (9)

1 . A rifaximin bead composition comprising a plurality of sugar spheres coated with rifaximin and a combination of hydroxypropyl methylcellulose (HPMC) and polyvinylpyrrolidone (PVP);

wherein:

HPMC is present in an amount of from about 5% to about 15% by weight based on the total weight of rifaximin in the composition or from about 0.1% to about 2.5% by weight based on the total weight of the composition, and

PVP is present in an amount of from about 15% to about 35% by weight based on the total weight of rifaximin in the composition, or from about 0.5% to about 4.0%, or from about 3.0% to about 8.0% by weight based on the total weight of the composition.

2 . The rifaximin bead composition of claim 1 , wherein HPMC is present in an amount of from about 5% to about 15% by weight based on the total weight of rifaximin in the composition.

3 . The rifaximin bead composition of claim 1 , wherein PVP is present in an amount of from about 15% to about 35% by weight based on the total weight of rifaximin in the composition.

4 . The rifaximin bead composition of claim 1 , further comprising a surfactant.

5 . The rifaximin bead composition of claim 1 , wherein the rifaximin is present in an amount of from about 1% to about 30% by weight based on the total weight of the composition.

6 . A method of treating one or more disorders in a subject in need thereof, comprising the step of administering to said subject a therapeutically effective amount of the composition of claim 1 , wherein the one or more disorders are selected from irritable bowel syndrome (IBS), diarrhea, microbe associated diarrhea, infectious diarrhea, Clostridium difficile infections and symptoms, travelers' diarrhea, small intestinal bacterial overgrowth (SIBO), Crohn's disease, sickle-cell disease, diverticular disease, pancreatitis, pancreatic insufficiency, enteritis, colitis, antibiotic associated colitis, hepatic encephalopathy, gastric dyspepsia, cirrhosis, polycystic liver disease, pouchitis, peritonitis, short bowel syndrome, inflammatory bowel disease, rosacea, and H. pylori infection.

Assignments (7)
U.S. PATENT SECURITY AGREEMENT Recorded Nov 25, 2025
From: BAUSCH HEALTH IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 073715/0375 →
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 30, 2023
From: COLE, JACOB; ROHRS, BRIAN R.; STEIN, DANIEL J.
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 063797/0185 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 30, 2023
From: COLE, JACOB; ROHRS, BRIAN R.; STEIN, DANIEL J.; ISRAEL, ROBERT J.; LOWE, EZRA R.
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 063797/0236 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062853/0695 →
SECOND LIEN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062853/0729 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 062853/0655 →
Continuity (4)
Provisional Application 63190349 · May 19, 2021
Provisional Application 63107400 · Oct 29, 2020
Provisional Application 63044450 · Jun 26, 2020
Related Publication 20230277447A1 · Sep 7, 2023
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