Ready-To-Use Liquid Parenteral Formulations Of Ribavirin
AssigneeNavinta III Inc
InventorSandipkumar Arvindbhai Patel
Life of this patent
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Abstract
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.
Claims27
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>.
The composition of claim 10, wherein the composition is suitable for administration via Inhalation route of administration.
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.
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.
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.
Dependencies are inferred from the claim text.