Ready-To-Use Liquid Parenteral Formulations Of Ribavirin
Stable ready to use pharmaceutical compositions of Ribavirin including a primary packaging container containing a sterile aqueous Ribavirin solution having a concentration of 10 mg/mL to 40 mg/mL Ribavirin and a seal sealing the primary packaging container. The Ribavirin solution is free of viable microbial contamination in in accordance with the test methods in 40 USP <71> using Trypticase Soy Broth and Fluid Thioglycollate Medium. A method of manufacturing ready to use Ribavirin solutions by terminally sterilizing a Ribavirin solution. Methods of treating respiratory syncytial virus by administering ready to use 20 mg/mL Ribavirin solutions in a nebulizer.
1 . A sterile, ready to use pharmaceutical composition of Ribavirin comprising
a primary packaging container containing a sterile aqueous Ribavirin solution having a concentration of 10 mg/mL to 40 mg/mL Ribavirin; and
a seal sealing the primary packaging container;
wherein the Ribavirin solution is free of viable microbial contamination in in accordance with a Sterility test method in 40 USP <71>.
2 . The composition of claim 1 , wherein the concentration of Ribavirin is 20 mg/mL.
3 . The composition of claim 1 , wherein the primary packaging container is a plastic or glass container.
4 . The composition of claim 1 , wherein the Ribavirin solution consists essentially of Ribavirin and water.
5 . The composition of claim 4 , wherein the Ribavirin solution consists of Ribavirin and water.
6 . The composition of claim 1 , wherein the Ribavirin solution is sterilized by terminal sterilization.
7 . The composition of claim 6 , wherein the terminal sterilization is autoclaving at about 121° C. for about 10 to 15 min.
8 . The composition of claim 1 , wherein the composition is suitable for administration via a parenteral route of administration.
9 . The composition of claim 10 , wherein the composition is suitable for administration via Inhalation route of administration.
10 . A stable, liquid pharmaceutical composition of Ribavirin comprising
a primary packaging container containing a Ribavirin solution consisting essentially of 10 mg/mL to 40 mg/mL Ribavirin and water; and
a seal sealing the primary packaging container,
wherein the composition is sterilized by a sterilization process selected from terminal sterilization, gamma irradiation and sterile filtration.
11 . The composition of claim 10 , wherein the product is stable in the primary packaging for an extended period of time at normal storage conditions.
12 . The composition of claim 10 , wherein the product is stable in the secondary packaging for an extended period of time at normal storage conditions.
13 . A method of manufacturing a stable, sterile, aqueous pharmaceutical composition of Ribavirin comprising the steps of:
solubilizing Ribavirin active ingredient in water;
filling the Ribavirin solution into a primary packaging container; and
terminally sterilizing the Ribavirin solution in the primary packaging container.
14 . The method of claim 13 , wherein the concentration of Ribavirin in the Ribavirin solution is 10 mg/mL to 40 mg/mL.
15 . The method of claim 14 , wherein the concentration of Ribavirin in the Ribavirin solution is 20 mg/mL.
16 . The method of claim 13 , further comprising the step of filtering the Ribavirin solution through a filter prior to the step of filling the Ribavirin solution.
17 . The method of claim 16 , wherein the filter is a sterilizing filter.
18 . The method of claim 13 , further comprising the step of sealing the primary packaging container before the step of terminally sterilizing.
19 . The method of claim 13 wherein the primary packaging is a vial and the step of sealing comprises placing a stopper into the vial.
20 . The method of claim 19 , wherein the step of sealing further comprises placing a flip-off seal over the stopper.
21 . The method of claim 13 , where in the terminal sterilization method is autoclaving at about 121° C. for about 10 to 15 min.
22 . The method of claim 13 , wherein the primary packaging container is a bag, bottle or vial.
23 . The method of claim 13 , further comprising the step of packaging the terminally sterilized product into secondary packaging.
24 . The method of claim 23 , wherein the secondary packaging is selected from the group consisting of pouch, carton and bag.
25 . The method of claim 13 , wherein the Ribavirin solution is stable in the primary packaging for an extended period of time at normal storage conditions.
26 . The method of claim 1 , wherein the Ribavirin solution is stable in the secondary packing for an extended period of time at normal storage conditions.
27 . A method of treating respiratory syncytial virus in a patient in need thereof by pouring a 20 mg/mL ready to use Ribavirin solution into a SPAG-2 nebulizer reservoir and nebulizing the Ribavirin solution without further dilution thereof.