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Last Updated: October 31, 2020

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Claims for Patent: 9,486,530

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Summary for Patent: 9,486,530
Title:Ganciclovir compositions and related methods
Abstract: Gancyclovir formulations that are ready-to-use, substantially particulate free, and stable upon storage are disclosed. Methods of manufacture and administration of such compositions are also provided.
Inventor(s): Mallipeddi; Sreerama Murthy (Hickory, NC), Sterling; Jonathan E. (Morganton, NC), Koneru; Phanesh B. (Ashburn, VA)
Assignee: Exela Pharma Sciences, LLC (Ashburn, VA)
Application Number:14/475,206
Patent Claims: 1. A stable, injectable, ready to administer, sterile, particulate-matter-free, aqueous ganciclovir composition consisting essentially of: a ganciclovir base at a concentration of from 1 mg/ml to 3 mg/ml; a tonicity agent; and optionally a pH adjuster, wherein the composition has a pH of from 5 to 9 and the composition has an osmotic pressure of 250-350 mOsmol/Kg.

2. The composition of claim 1, wherein the ganciclovir is present in an amount of from 1.5 mg/ml to 2.5 mg/ml.

3. The composition of claim 2, wherein the ganciclovir is present in an amount of 2 mg/ml.

4. The composition of claim 1, wherein the tonicity agent is a member selected from the group consisting of: sodium chloride, mannitol, sorbitol, dextrose, ethanol, glycerin, sorbitol, propylene glycol, and combinations thereof.

5. The composition of claim 4, wherein the tonicity agent is sodium chloride.

6. The composition of claim 1, wherein the pH of the composition is 7.5.

7. The composition of claim 1, wherein the pH adjuster is selected from the group consisting of: sodium hydroxide, potassium hydroxide, hydrochloric acid, sulfuric acid, cysteine, lysine, acetic acid, citric acid, ascorbic acid, salicylic acid, and combinations thereof.

8. The composition of claim 1, wherein the pH adjuster is sodium hydroxide.

9. The composition of claim 1, wherein the composition does not include a pH adjuster and the composition has a pH of from 5.5 to 5.8.

10. A stable, injectable, ready to administer, sterile, particulate-matter-free, aqueous ganciclovir composition, consisting essentially of: a ganciclovir base at a concentration of 2.0 mg/ml; sodium chloride or dextrose as a tonicity agent; and a pH adjuster to adjust the pH of the composition to from 5.5 to 8, wherein the composition is terminally sterilized and the composition has an osmotic pressure of 250-350 mOsmol/Kg.

11. The composition of claim 10, wherein the tonicity agent is sodium chloride.

12. The composition of claim 10, wherein the tonicity agent is dextrose.

13. The composition of claim 10, wherein the pH is 7.5.

14. The composition of claim 10, wherein the pH adjuster is selected from the group consisting of: sodium hydroxide, potassium hydroxide, hydrochloric acid, sulfuric acid, cysteine, lysine, acetic acid, citric acid, ascorbic acid, salicylic acid, and combinations thereof.

15. A container comprising a stable ready to administer ganciclovir injectable composition consisting essentially of: a ganciclovir base, at a concentration of 2.0 mg/ml; sodium chloride or dextrose as a tonicity agent; and a pH adjuster to adjust the pH of the composition to from 5.5 to 8, wherein the composition has an osmotic pressure of 250-350 mOsmol/Kg and the container size ranges from 50 ml to 1000 ml.

16. The container of claim 15, wherein the composition is terminally sterilized.

17. The container of claim 15, wherein the container is made from a material comprising polyethylene or polypropylene or a combination thereof.

18. A method of manufacturing an aqueous, stable, injectable, ready to administer, ganciclovir composition consisting essentially of a ganciclovir base, at a concentration of from 1 mg/ml to 3 mg/ml, a tonicity agent, and optionally a pH adjuster, wherein the composition has a pH from 5 to 9, wherein the composition is free of particulate matter and the composition has an osmotic pressure of 250-350 mOsmol/Kg, comprising: dissolving the ganciclovir base in water; adding a tonicity agent; optionally adjusting the pH of the composition; filling the composition into a container; and sterilizing said container.

19. The method of claim 18, wherein the tonicity agent is added to water either prior to or simultaneously with the ganciclovir base.

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