Claims for Patent: 10,493,028

Summary for Patent: 10,493,028

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:	US15/791,717
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,493,028
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, (f) 0.0001-0.0003% w/v of a dye, and (g) vancomycin hydrochloride, wherein the non-sterile stable liquid formulation is homogenous and stable for at least 30 days at ambient and refrigerated temperature conditions and has a pH of 2.5-4.5, and wherein the concentration of vancomycin in the solution is 25-50 mg/ml. 2. The liquid formulation of claim 1, wherein the non-sterile stable liquid formulation is stable for up to 3 months at accelerated conditions. 3. The liquid formulation of claim 1, wherein the non-sterile stable liquid formulation is stable for up to 24 months at ambient conditions. 4. The liquid formulation of claim 1, wherein the non-sterile stable liquid formulation has 0.12% w/v anhydrous citric acid. 5. The liquid formulation of claim 1, wherein the no-sterile stable liquid formulation has 0.2% w/v sucralose. 6. The liquid formulation of claim 1, wherein the flavoring agent is 0.05% w/v artificial grape flavor. 7. The liquid formulation of claim 1, wherein the non-sterile stable liquid formulation has 0.1% w/v sodium benzoate. 8. The liquid formulation of claim 1, wherein the dye consists of 0.0002% w/v D&C Yellow No. 10 and 0.000038% w/v FD&C Red No. 40. 9. The liquid formulation of claim 1, wherein the non-sterile stable liquid formulation is formulated for use in the treatment of C. difficile pseudomembranous colitis and Staphylococcal enterocolitis. 10. The liquid formulation of claim 1, wherein the non-sterile stable liquid formulation is formulated to inhibit the growth of bacteria, mold and yeast for at least 30 days at ambient and refrigerated temperature conditions. 11. The liquid formulation of claim 1, wherein the non-sterile stable liquid formulation is formulated to inhibit the growth of mold and yeast for greater than 30 days at room temperature conditions. 12. The liquid formulation of claim 1, wherein the anhydrous citric acid in the formulation is 0.12% w/v, the sucralose in the formulation is 0.2% w/v, the flavoring agent in the formulation is 0.05% w/v, the sodium benzoate in the formulation is 0.1% w/v, and the dye in the formulation is 0.0002% w/v. 13. The liquid formulation of claim 12, wherein the dye is 0.0002% w/v D&C Yellow No. 10 and 0.000038% w/v FD&C Red No. 40. 14. The liquid formulation of claim 12, wherein the non-sterile stable liquid formulation is formulated for use in the treatment of C. difficile pseudomembranous colitis and Staphylococcal enterocolitis. 15. The liquid formulation of claim 12, wherein the non-sterile stable liquid formulation is formulated to inhibit the growth of bacteria, mold and yeast for at least 30 days at ambient and refrigerated temperature conditions. 16. The liquid formulation of claim 12, wherein the non-sterile stable liquid formulation is formulated to inhibit the growth of mold and yeast for greater than 30 days at room temperature conditions. 17. The liquid formulation of claim 12, wherein the non-sterile stable liquid formulation is stable for up to 3 months at accelerated conditions. 18. The liquid formulation of claim 12, wherein the non-sterile stable liquid formulation is stable for up to 24 months at ambient conditions.