IP Library Granted Patent US 11,129,817
Granted Patent B2
US 11,129,817 · App. 17/174,829 · Granted Sep 28, 2021

Solid dispersion forms of rifaximin

Inventors: Pam Golden (Durham, NC); Mohammed A. Kabir (Cary, NC)
Assignee: Salix Pharmaceuticals, Inc.
A61K31/437A61K9/00A61K9/10A61K9/2853A61K9/2866A61K47/02A61K47/10A61K47/12A61K47/38A61P1/16
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Quick Facts
Patent No.
US 11,129,817
App. No.
17/174,829
Granted
Sep 28, 2021
Kind
B2
Abstract

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

Claims (19)

1. A method of preventing complications of liver disease in a subject having liver cirrhosis, comprising administering to the subject a pharmaceutical composition comprising

from about 16 wt % to about 18 wt % rifaximin;

from about 16 wt % to about 18 wt % HPMC-AS;

from about 1 wt % to about 2 wt % poloxamer 407;

from about 8 wt % to about 10 wt % croscarmellose sodium;

from about 49 wt % to about 51 wt % microcrystalline cellulose;

from about 0.15 wt % to about 0.25 wt % colloidal silicon dioxide; and

from about 0.45 wt % to about 0.55 wt % magnesium stearate, wherein the total amount of rifaximin is 40 mg and 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).

2. The method of claim 1 , wherein the composition is an immediate release composition.

3. The method of claim 1 , wherein the composition is in the form of a tablet.

4. The method of claim 2 , wherein the composition is in the form of a tablet.

5. The method of claim 1 , wherein the complication of liver disease is hepatic encephalopathy (HE).

6. The method of claim 1 , wherein the complication of liver disease is esophageal variceal bleeding (EVB).

7. The method of claim 1 , wherein the complication of liver disease is spontaneous bacterial peritonitis (SBP).

8. The method of claim 1 , wherein the complication of liver disease is hepatorenal syndrome (HRS).

9. The method of claim 2 , wherein the complication of liver disease is hepatic encephalopathy (HE).

10. The method of claim 2 , wherein the complication of liver disease is esophageal variceal bleeding (EVB).

11. The method of claim 2 , wherein the complication of liver disease is spontaneous bacterial peritonitis (SBP).

12. The method of claim 2 , wherein the complication of liver disease is hepatorenal syndrome (HRS).

Assignments (8)
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
Reel/Frame 073654/0242 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Oct 5, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061606/0468 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Oct 4, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061595/0066 →
SECURITY AGREEMENT Recorded Feb 10, 2022
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 059121/0001 →
SECURITY INTEREST Recorded Jun 21, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SOLTA MEDICAL, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 056603/0237 →
SECURITY INTEREST Recorded Jun 21, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 056603/0227 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2021
From: GOLDEN, PAM; KABIR, MOHAMMED A.
To: SALIX PHARMACEUTICALS, LTD.
Reel/Frame 056196/0869 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2021
From: SALIX PHARMACEUTICALS, LTD.
To: SALIX PHARMACEUTICALS, INC.
Reel/Frame 056196/0961 →
Continuity (5)
Continuation 17101609 · Nov 23, 2020
Continuation 16369509 · Mar 29, 2019
Continuation PCTUS2017054288 · Sep 29, 2017
Provisional Application 62402119 · Sep 30, 2016
Related Publication 20210205279A1 · Jul 8, 2021
Cited By (2)
US 12,611,378 US 12,714,699