Claims for Patent: 10,959,946

Summary for Patent: 10,959,946

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:	15/126,059
Patent Claims:	1. A non-sterile stable liquid formulation formulated for oral administration, consisting of: (a) 0.1-0.4% w/v anhydrous citric acid, (b) water, (c) 0.1-0.3% w/v sucralose, (d) 0.01-0.1% w/v of a flavoring agent, (e) 0.08-0.2% w/v sodium benzoate, and (f) vancomycin hydrochloride, wherein the non-sterile stable liquid formulation is a compounded solution of vancomycin hydrochloride that is homogenous and stable for at least 30 days at ambient and refrigerated temperature, and wherein the compounded solution has a high solubility in water and a pH of 2.5-4.5. 2. A liquid solution consisting of: (a) 0.1-0.4% w/v anhydrous citric acid, (b) water, (c) 0.1-0.3% w/v sucralose, (d) 0.01-0.1% w/v of a flavoring agent, (e) 0.08-0.2% w/v sodium benzoate, and (f) vancomycin hydrochloride, and wherein the liquid solution is formulated for oral administration, homogenous, and stable for at least 30 days at ambient and refrigerated temperature. 3. The liquid solution of claim 2, wherein the anhydrous citric acid is 0.12% w/v of the liquid solution. 4. The liquid solution of claim 2, wherein the sucralose is 0.2% w/v of the liquid solution. 5. The liquid solution of claim 2, wherein the flavoring agent is artificial grape flavor and wherein the artificial grape flavor is 0.05% w/v of the liquid solution. 6. The liquid solution of claim 2, wherein the sodium benzoate is 0.1% w/v of the liquid solution. 7. The non-sterile stable liquid formulation of claim 1, wherein the anhydrous citric acid is 0.12% w/v of the liquid formulation. 8. The non-sterile stable liquid formulation of claim 1, wherein the sucralose is 0.2% w/v of the liquid formulation. 9. The non-sterile stable liquid formulation of claim 1, wherein the flavoring agent is artificial grape flavor and wherein the artificial grape flavor is 0.05% w/v of the liquid formulation. 10. The non-sterile stable liquid formulation of claim 1, wherein the sodium benzoate is 0.1% w/v of the liquid formulation.