IP Library › Granted Patent US 9,486,460
Granted Patent B2
US 9,486,460 · App. 14/698,934 · Granted Nov 8, 2016

Bismuth containing liquid pharmaceutical suspensions

Inventors: Daniel Jerome White, Jr. (West Chester, OH); Michael Selden Godlewski (Loveland, OH); Timothy Charles Gulbin (Maineville, OH); Graham John Myatt (Manakin Sabot, VA)
Assignee: The Procter & Gamble Company
A61K31/60A61K9/0053A61K9/0095A61K9/08A61K31/29A61K47/02A61K47/12A61K47/36A61K47/38
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Quick Facts
Patent No.
US 9,486,460
App. No.
14/698,934
Granted
Nov 8, 2016
Kind
B2
Abstract

A liquid pharmaceutical suspension for oral administration containing a bismuth-containing pharmaceutical agent, a suspension system, and water. The suspension system can contain from about 0.001% to about 0.2% gellan gum and from about 0.001% to about 0.75% magnesium aluminum silicate.

Claims (30)

1. A liquid pharmaceutical suspension for oral administration comprising:

a. a bismuth-containing pharmaceutical agent;

b. a suspension system comprising from about 0.01% to about 0.2% gellan gum and from about 0.01% to about 0.75% magnesium aluminum silicate; and

c. water.

2. The liquid pharmaceutical suspension of claim 1 wherein the suspension system comprises from about 0.05% to about 0.6% magnesium aluminum silicate.

3. The liquid pharmaceutical suspension of claim 1 further comprising a preservative comprising benzoic acid.

4. The liquid pharmaceutical suspension of claim 3 wherein the preservative further comprises sorbic acid.

5. The liquid pharmaceutical suspension of claim 1 further comprising from about 0.01% to about 0.5% salicylic acid.

6. The liquid pharmaceutical suspension of claim 1 comprising from about 0.1% to about 0.6% magnesium aluminum silicate; and

wherein the pH change over 36 days is from about 0.02 to about 0.5.

7. The liquid pharmaceutical suspension of claim 1 comprising from about 0.1% to about 0.6% magnesium aluminum silicate; and wherein the initial viscosity at 0.1 s −1 shear rate is greater than about 3,000 cps.

8. The liquid pharmaceutical suspension of claim 1 comprising from about 0.01% to about 0.05% gellan gum; and wherein the liquid suspension has no more than slight sedimentation that is visually perceptible after 30 days at 40° C.

9. A liquid pharmaceutical suspension for oral administration comprising:

a. from about 1% to about 6% of a bismuth-containing pharmaceutical agent;

b. a suspension system comprising from about 0.005% to about 0.06% gellan gum; and

c. water.

10. The liquid pharmaceutical suspension of claim 9 wherein the suspension system further comprises methyl cellulose.

11. The liquid pharmaceutical suspension of claim 10 wherein the suspension system further comprises magnesium aluminum silicate.

12. The liquid pharmaceutical suspension of claim 9 further comprising benzoic acid.

13. A liquid pharmaceutical suspension for oral administration comprising:

a. a bismuth-containing pharmaceutical agent;

b. a suspension system comprising from about 0.01% to about 0.2% gellan gum and from about 0.01% to about 0.8% magnesium aluminum silicate; and

c. water;

wherein the formulation comprises less than about 0.2 ppm lead and wherein the liquid formulation has no more than slight sedimentation that is visually perceptible after 30 days at 40° C.

14. The liquid pharmaceutical suspension of claim 13 wherein the suspension system comprises from about 0.02% to about 0.04% gellan gum.

15. The liquid pharmaceutical suspension of claim 14 wherein the suspension system further comprises from about 0.05% to about 0.6% magnesium aluminum silicate.

16. The liquid pharmaceutical suspension of claim 14 wherein the suspension system further comprises from about 0.5% to about 1.5% methyl cellulose.

17. The liquid pharmaceutical suspension of claim 13 further comprising methyl cellulose wherein the pH change over 36 days is from about 0.1 to about 0.3.

18. The liquid pharmaceutical suspension of claim 1 wherein the gellan gum is high acyl gellan gum.

19. The liquid pharmaceutical suspension of claim 1 further comprising methyl cellulose.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 29, 2015
From: WHITE, DANIEL JEROME, JR.; GODLEWSKI, MICHAEL SELDEN; GUILBIN, TIMOTHY CHARLES; MYATT, GRAHAM JOHN
To: THE PROCTER & GAMBLE COMPANY
Reel/Frame 035525/0616 →
Continuity (2)
Provisional Application 61985650 · Apr 29, 2014
Related Publication 20150306113A1 · Oct 29, 2015