SODIUM BICARBONATE INJECTABLE FORMULATION AND METHODS THEREOF
The present disclosure is directed to ready-to-use, injectable formulations of a liquid pharmaceutical composition comprising sodium bicarbonate, and methods of treatment using said formulations.
1 - 82 . (canceled)
83 . A sterile, ready-to-use liquid pharmaceutical composition comprising:
sodium bicarbonate at a concentration of from about 0.05 mEq/mL to about 5 mEq/mL; and
carbon dioxide,
wherein the composition has an initial pH of 7.0 to 8.5,
wherein the composition is packaged in a container for intravenous use,
wherein the container is packaged in an overwrap, and
wherein the initial pH of the composition increases by less than 0.5 after storage for at least 6 months at 25° C.
84 . The composition of claim 83 , wherein the sodium bicarbonate is present at a concentration of from about 0.15 mEq/mL to about 1 mEq/mL.
85 . The composition of claim 83 , wherein the sodium bicarbonate is present at a concentration of about 0.1 mEq/mL.
86 . The composition of claim 83 , wherein the sodium bicarbonate is present at a concentration of about 0.25 mEq/mL.
87 . The composition of claim 83 , wherein the sodium bicarbonate is present at a concentration of about 0.5 mEq/mL.
88 . The composition of claim 83 , wherein the sodium bicarbonate is present at a concentration of about 0.75 mEq/mL.
89 . The composition of claim 83 , wherein the sodium bicarbonate is present at a concentration of about 0.8 mEq/mL.
90 . The composition of claim 83 , wherein the sodium bicarbonate is present at a concentration of about 1 mEq/mL.
91 . The composition of claim 83 , wherein the pH of the composition increases by less than 0.5 after storage for at least 12 months at 25° C.
92 . The composition of claim 83 , wherein the composition is preservative free.
93 . The composition of claim 83 , wherein the container comprises SiO x .
94 . The composition of claim 83 , wherein the container comprises an inner layer and an outer layer, and wherein the inner layer comprises SiO x .
95 . The composition of claim 83 , wherein a space between the container and the overwrap is evacuated.
96 . The composition of claim 83 , wherein the container is a single-dose container.
97 . A method for alleviating metabolic acidosis in a subject comprising administering to the subject the composition of claim 83 , wherein the subject has an arterial blood pH of less than 7.5.
98 . The method of claim 97 , wherein the metabolic acidosis is due to diabetic ketoacidosis, lactic acidosis, septic shock, intraoperative metabolic acidosis, or cardiac arrest.
99 . The method of claim 97 , wherein the composition is sterile and aseptic upon administration to the subject.
100 . A method of replacing sodium bicarbonate in a subject comprising administering to the subject the composition of claim 83 , wherein the subject suffers from sodium bicarbonate loss.
101 . The method of claim 100 , wherein the sodium bicarbonate loss is due to hyperchloremic acidosis resulting from diarrhea or renal proximal tubular acidosis.
102 . The method of claim 100 , wherein the composition is sterile and aseptic upon administration to the subject.
103 . A method of treating kidney dysfunction in a subject, the method comprising administering to the subject the composition of claim 83 .