Claims for Patent: 10,688,046

Summary for Patent: 10,688,046

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:	CutisPharma, Inc. (Woburn, MA)
Application Number:	16/676,325
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 that is sucralose, (d) 0.02-0.08% w/v 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 2 weeks 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 0.12% w/v. 3. The liquid formulation of claim 1, wherein the sucralose 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% 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) 0.1-0.4% w/v citric acid, (b) water, (c) a sweetener that is sucralose, (d) 0.02-0.08% w/v sodium benzoate, (e) 20-60 mg/ml vancomycin hydrochloride, and (f) flavoring agent, wherein the vancomycin oral liquid composition is homogenous and stable for at least 2 weeks at ambient and refrigerated temperature and has a pH of 2.5-4.5. 9. The method of claim 8, wherein the citric acid is 0.12% w/v. 10. The method of claim 8, wherein the sucralose 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.