Claims for Patent: 10,959,948

Summary for Patent: 10,959,948

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):	Indu Muni, Peter Mione, Anisa Gandhi, Cristina LeChiara
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US16/941,400
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,959,948
Patent Claims:	1. A non-sterile stable liquid formulation formulated for oral administration, consisting of: (a) a buffering agent, wherein the buffering agent is selected from the group consisting of citric acid, sodium citrate, sodium tartarate, sodium acetate, sodium carbonate, sodium polyphosphate, potassium polyphosphate, sodium pyrophosphate, potassium pyrophosphate, disodium hydrogen phosphate, trisodium phosphate, tripotassium phosphate, sodium acetate, potassium metaphosphate, magnesium oxide, magnesium carbonate, magnesium silicate, calcium acetate, calcium glycerophosphate, calcium chloride, calcium hydroxide, calcium lactate, calcium carbonate, calcium bicarbonate, and calcium salts, (b) water, (c) a sweetener, (d) sodium benzoate, (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. 2. The liquid formulation of claim 1, wherein the sodium benzoate is 0.02-0.08% w/v. 3. The liquid formulation of claim 1, wherein the buffer is citric acid 0.12% w/v. 4. The liquid formulation of claim 1, wherein the sweetener is 0.1-0.3% w/v. 5. A non-sterile stable liquid formulation formulated for oral administration, consisting of: (a) a buffering agent, wherein the buffering agent is selected from the group consisting of citric acid, sodium citrate, sodium tartarate, sodium acetate, sodium carbonate, sodium polyphosphate, potassium polyphosphate, sodium pyrophosphate, potassium pyrophosphate, disodium hydrogen phosphate, trisodium phosphate, tripotassium phosphate, sodium acetate, potassium metaphosphate, magnesium oxide, magnesium carbonate, magnesium silicate, calcium acetate, calcium glycerophosphate, calcium chloride, calcium hydroxide, calcium lactate, calcium carbonate, calcium bicarbonate, and calcium salts, (b) water, (c) a sweetener, (d) a preservative, wherein the preservative is selected from the group consisting of sodium benzoate, parabens, benzoic acid, potassium sorbate, benzyl alcohol or salts thereof, (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. 6. The liquid formulation of claim 5, wherein the buffer is citric acid 0.12% 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) a buffering agent, wherein the buffering agent is selected from the group consisting of citric acid, sodium citrate, sodium tartarate, sodium acetate, sodium carbonate, sodium polyphosphate, potassium polyphosphate, sodium pyrophosphate, potassium pyrophosphate, disodium hydrogen phosphate, trisodium phosphate, tripotassium phosphate, sodium acetate, potassium metaphosphate, magnesium oxide, magnesium carbonate, magnesium silicate, calcium acetate, calcium glycerophosphate, calcium chloride, calcium hydroxide, calcium lactate, calcium carbonate, calcium bicarbonate, and calcium salts, (b) water, (c) a sweetener, (d) a preservative, wherein the preservative is selected from the group consisting of sodium benzoate, parabens, benzoic acid, potassium sorbate, benzyl alcohol, or salts thereof, (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 buffering agent is citric acid. 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. 11. The method of claim 7, wherein the preservative is sodium benzoate.