Ready-to-use sodium bicarbonate formulations and products
AssigneeInforlife SA
InventorsSergio Dusci, Abramo Civera
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Abstract
The invention includes a sodium bicarbonate product that is sterile and ready-to-use and can be stored at room temperature for a period of six months or more, including an aqueous sodium bicarbonate solution at a concentration suitable for administration to a patient, which does not contain a preservative or antimicrobial, in an infusion container. The invention includes methods of making and using the sodium bicarbonate product.
Claims32
A sodium bicarbonate product comprising an aqueous sodium bicarbonate solution comprising sodium bicarbonate at a concentration of about 0.1 mEq/mL to about 0.2 mEq/mL, a tonicity agent, and water;
- wherein the sodium bicarbonate product is sterile and ready-to-use;
- wherein the sodium bicarbonate solution is contained in an infusion bag comprising a flexible, multilayer film with at least one layer comprising maleic anhydride grafted polyethylene and at least one layer comprising poly(ethylene-co-1-octene);
- and wherein the pH of the aqueous sodium bicarbonate solution is maintained within a range of about 7.0 to 8.5 following storage for 6 months at a controlled room temperature of 25° C.±2° C. with relative humidity (RH) at 40%±5%.
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A sodium bicarbonate product comprising:
- (a) an aqueous sodium bicarbonate solution comprising about 0.1 to 0.2 mEq/mL sodium bicarbonate, a tonicity agent, and water for injection, and
- (b) an infusion container comprising a flexible, multilayer film comprising an outer layer and at least one inner layer, wherein at least one inner layer comprises a polymer selected from the group consisting of poly(ethylene-co-1-octene) and maleic anhydride grafted polyethylene, and wherein the outer layer of the multilayer film does not comprise maleic anhydride grafted polyethylene;
- wherein less than 5% of the total fill volume of the infusion container of (b) comprises headspace and the remainder of the fill volume comprises the aqueous sodium bicarbonate solution of (a);
- and
- wherein the sodium bicarbonate product is sterile, ready-to-use and has a shelf life of the pH of the aqueous sodium bicarbonate solution is maintained within a range of about 7.0 to 8.5 for at least 6 months when the sodium bicarbonate product is stored at a controlled room temperature of 25° C.±2° C. with relative humidity (RH) at 40%±5%.
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Dependencies are inferred from the claim text.