Granted Patent B2

US 10,959,947 · App. 16/892,421 · Granted Mar 30, 2021

Abstract

Claims (28)

1. A non-sterile stable liquid formulation formulated for oral administration, consisting of:

(a) citric acid,

(b) water,

(c) a sweetener,

(d) sodium benzoate,

(e) 20-60 mg/ml vancomycin hydrochloride, and

(f) flavoring agent,

wherein the non-sterile stable liquid formulation is homogenous and stable for at least 1 week at ambient and refrigerated temperature and has a pH of 2.5-4.5.

2. The liquid formulation of claim 1 , wherein the citric acid is 0.12% w/v.

3. The liquid formulation of claim 1 , wherein the sweetener is 0.1-0.3% w/v.

4. The liquid formulation of claim 1 , wherein the flavoring agent is a berry flavor.

5. The liquid formulation of claim 1 , wherein the flavoring agent is 0.05% w/v.

6. The liquid formulation of claim 1 , wherein the flavoring agent is 0.01-0.1% w/v.

7. The liquid formulation of claim 1 , wherein the sodium benzoate is 0.02-0.08% w/v.

8. A method of treating Clostridium difficile pseudomembranous colitis or Staphylococcal enterocolitis in a subject comprising administering a vancomycin oral liquid composition to the subject in a therapeutically effective amount, wherein the vancomycin oral liquid composition consists of:

(a) citric acid,

(b) water,

(c) a sweetener,

(d) sodium benzoate,

(e) 20-60 mg/ml vancomycin hydrochloride, and

(f) flavoring agent,

wherein the vancomycin oral liquid composition has a pH of 2.5-4.5.

9. The method of claim 8 , wherein the citric acid is 0.1-0.4% w/v.

10. The method of claim 8 , wherein the sweetener is 0.1-0.3% w/v.

11. The method of claim 8 , wherein the flavoring agent is a berry flavor.

12. The method of claim 8 , wherein the flavoring agent is 0.05% w/v.

13. The method of claim 8 , wherein the flavoring agent is 0.01-0.1% w/v.

14. The method of claim 8 , wherein the sodium benzoate is 0.02% w/v.

Assignments (7)