Ganciclovir compositions and related methods
View Patent ↗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.
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.