SODIUM BICARBONATE INJECTABLE FORMULATION AND METHODS THEREOF
The disclosure is directed to an aseptic, ready-to-use, premixed liquid pharmaceutical composition having sodium bicarbonate in a concentration of from about 0.05 mEq/mL to about 5 mEq/mL, carbon dioxide, and optionally one or more pharmaceutically acceptable excipients, the liquid pharmaceutical composition being packaged in a container for intravenous use, and the container including polyethylene terephthalate and SiOx. Also disclosed are method of making the an aseptic, ready-to-use, premixed liquid pharmaceutical compositions described herein.
1 . An aseptic, ready-to-use, premixed liquid pharmaceutical composition comprising:
sodium bicarbonate in a concentration of from about 0.05 mEq/mL to about 5 mEq/mL,
carbon dioxide, and
optionally one or more pharmaceutically acceptable excipients,
wherein the liquid pharmaceutical composition is packaged in a container for intravenous use, and
wherein the container comprises polyethylene terephthalate and SiOx.
2 . The liquid pharmaceutical composition of claim 1 , wherein the container is provided in an overwrap.
3 . The liquid pharmaceutical composition of claim 2 , wherein the overwrap comprises aluminum, polyethylene terephthalate, and polyethylene.
4 . The liquid pharmaceutical composition of claim 1 , wherein the liquid pharmaceutical composition has a pH of from about 7.0 to about 9.0.
5 . The liquid pharmaceutical composition of claim 4 , wherein the liquid pharmaceutical composition has been sterilized via a terminal sterilization treatment.
6 . The liquid pharmaceutical composition of claim 5 , wherein the pH of the liquid pharmaceutical composition has increased by less than 0.5 from an initial pH of the liquid pharmaceutical composition prior to the terminal sterilization treatment.
7 . The liquid pharmaceutical composition of claim 1 , wherein the container is a bag.
8 . The liquid pharmaceutical composition of claim 1 , further comprising a diluent.
9 . The liquid pharmaceutical composition of claim 8 , wherein the diluent comprises water.
10 . The liquid pharmaceutical composition of claim 8 , wherein the liquid pharmaceutical composition is mixed in a total volume of about 500 mL or about 1000 mL of the diluent.
11 . A method for making a packaged aseptic, ready-to-use, premixed liquid pharmaceutical composition comprising:
combining sodium bicarbonate, carbon dioxide, and a diluent to provide a liquid pharmaceutical composition, wherein the sodium bicarbonate is provided at a concentration of from about 0.05 mEq/mL to about 5 mEq/mL, and
packaging the liquid pharmaceutical composition in a container for intravenous use, wherein the container comprises polyethylene terephthalate and SiOx.
12 . The method of claim 11 , further comprising providing the container in an overwrap.
13 . The method of claim 12 , wherein the overwrap comprises aluminum, polyethylene terephthalate, and polyethylene.
14 . The method of claim 11 , further comprising subjecting the liquid pharmaceutical composition contained in the container to a terminal sterilization process.
15 . The method of claim 14 , wherein the terminal sterilization process comprises autoclaving.
16 . The method of claim 14 , wherein the liquid pharmaceutical composition an initial pH prior to the terminal sterilization process and a final pH after the terminal sterilization process, wherein the final pH is no more than about 0.5 units more than the initial pH.
17 . The method according to claim 16 , wherein the final pH is from about 7.5 to about 7.9.
18 . The method of claim 11 , wherein the container is a bag.
19 . The method of claim 11 , wherein the liquid pharmaceutical composition is mixed in a total volume of about 500 mL or about 1000 mL of the diluent.
20 . The method of claim 11 , wherein the diluent comprises water.