Claims for Patent: 10,959,949

Summary for Patent: 10,959,949

Title:	Composition and method for vancomycin oral liquid
Abstract:	The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.
Inventor(s):	Muni; Indu (North Reading, MA), Mione; Peter (Malden, MA), Gandhi; Anisa (Medford, MA), LeChiara; Cristina (Saugus, MA)
Assignee:	Azurity Pharmaceuticals, Inc. (Woburn, MA)
Application Number:	16/941,414
Patent Claims:	1. A non-sterile stable liquid formulation formulated for oral administration, consisting of: (a) 0.1-0.4% w/v citric acid, (b) water, (c) a sweetener, (d) a preservative, wherein the preservative is selected from the group consisting of ascorbic acid, ascorbyl palmitate, benzyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, erythorbic acid, fumaric acid, malic acid, propyl gallate, sodium ascorbate, sodium benzoate, sodium bisulfate, sodium metabisulfite, sodium sulfite, parabens, benzoic acid, potassium sorbate, and vanillin, (e) 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 25-4.5. 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. A non-sterile stable liquid formulation formulated for oral administration, consisting of: (a) 0.1-0.4% w/v citric acid, (b) water, (c) a sweetener, (d) a preservative, wherein the preservative is selected from the group consisting of benzyl alcohol, sodium benzoate, parabens, benzoic acid, and potassium sorbate, (e) 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. 5. The liquid formulation of claim 4, wherein the citric acid is 0.12% w/v. 6. The liquid formulation of claim 4, wherein the sweetener is 0.1-0.3% w/v. 7. 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) 0.1-0.4% w/v citric acid, (b) water, (c) a sweetener, (d) a preservative, wherein the preservative is selected from the group consisting of benzyl alcohol, sodium benzoate, parabens, benzoic acid, and potassium sorbate, (e) vancomycin hydrochloride, and (f) flavoring agent, wherein the vancomycin oral liquid composition is homogenous and stable for at least 1 week at ambient and refrigerated temperature and has a pH of 2.5-4.5. 8. The method of claim 7, wherein the preservative is sodium benzoate. 9. The method of claim 7, wherein the sweetener is 0.1-0.3% w/v. 10. The method of claim 7, wherein the flavoring agent is a berry flavor.