Exela Pharma Sciences, LLC

Exela Sterile Medicines LLC

Aruna Koganti

Phanesh B Koneru

John Maloney

The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace Othat is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.

Stable, highly pure L-cysteine compositions for injection and methods of use

Stable, highly pure l-cysteine compositions for injection and methods of use

The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cysteine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace Othat is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.

The present disclosure provides compositions comprising phosphate salts having low levels of aluminum, as well as other elemental impurities. In general, phosphate salts compositions disclosed herein are liquid compositions (e.g., admixtures, solutions) comprising in situ formed phosphate salts, a pharmaceutically acceptable carrier, and less than about 250 &#x3bc;g/L of aluminum. Phosphate salts solutions disclosed herein are stable over time (e.g., the amount of total phosphorus and/or the ratio of phosphate salts and/or the level of aluminum does not substantially vary, and the compositions remain free of visible particulate matter). The compositions do not require storage at less than ambient (room) temperature, i.e., no refrigeration is needed. Also provided herein are methods and systems for preparing in situ phosphate salts compositions, and methods of using phosphate salt compositions to provide phosphorous to individuals in need thereof.

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Lenoir, NC, United States of America

Aruna Koganti