GANCICLOVIR COMPOSITIONS AND RELATED METHODS
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 parenteral dosage form for parenteral administration to a subject, consisting essentially of:
ganciclovir 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.
2 . The parenteral dosage form of claim 1 , wherein the ganciclovir is present in an amount of from 1.5 mg/ml to 2.5 mg/ml.
3 . The parenteral dosage form of claim 1 , wherein the ganciclovir is present in an amount of 2 mg/ml.
4 . The parenteral dosage form of claim 1 , wherein the tonicity agent is a member selected from the group consisting of: sodium chloride, mannitol, sorbitol, dextrose, ethanol, glycerin, propylene glycol, and combinations thereof.
5 . The parenteral dosage form of claim 1 , wherein the tonicity agent is sodium chloride.
6 . The parenteral dosage form of claim 1 , wherein parenteral dosage form has a tonicity of from 250-350 mOsmol/Kg.
7 . The parenteral dosage form of claim 1 , wherein the pH of the parenteral dosage form is 7.5.
8 . The parenteral dosage form 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.
9 . The parenteral dosage form of claim 1 , wherein the pH adjuster is sodium hydroxide.
10 . The parenteral dosage form of claim 1 , wherein the parenteral dosage form does not include a pH adjuster and the parenteral dosage form has a pH of from 5.5 to 5.8.
11 . A container comprising a stable, ready to administer, sterile ganciclovir injectable composition consisting essentially of:
ganciclovir at a concentration of 1 mg/ml to 3 mg/ml;
a tonicity agent; and
optionally a pH adjuster
wherein the composition has pH of from 5 to 9 and the composition has an osmotic pressure of 250-350 mOsmol/Kg.
12 . The container of claim 11 , wherein the composition is terminally sterilized.
13 . The container of claim 11 , wherein the container is made from a material comprising polyethylene, polypropylene, or a combination thereof.
14 . The container of claim 11 , wherein the container size ranges from 50 ml to 1000 ml.
15 . The container of claim 11 , wherein the container size ranges from 10 ml to 500 ml.
16 . The container of claim 11 , wherein the container size is 100 ml.
17 . The container of claim 11 , wherein the container size is 200 ml.
18 . The container of claim 11 , wherein the container size is 250 ml.