STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
First Claim
1. A solution of L-cysteine comprising,a pharmaceutically acceptable carrier,about 50 mg/mL of L-cysteine hydrochloride monohydrate, or equivalent amount of a pharmaceutically acceptable L-cysteine or a salt or hydrate thereof,a pharmaceutically acceptable amount of cystine for at least about 12 months from the time of manufacture of the solution,less than about 150 ppb of aluminum for at least about 12 months from the time of manufacture of the solution,a pH from about 1.0 to about 2.5, andwherein the solution is enclosed in a single-use vial.
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0 Petitions
Accused Products
Abstract
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 02 that 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.
2 Citations
27 Claims
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1. A solution of L-cysteine comprising,
a pharmaceutically acceptable carrier, about 50 mg/mL of L-cysteine hydrochloride monohydrate, or equivalent amount of a pharmaceutically acceptable L-cysteine or a salt or hydrate thereof, a pharmaceutically acceptable amount of cystine for at least about 12 months from the time of manufacture of the solution, less than about 150 ppb of aluminum for at least about 12 months from the time of manufacture of the solution, a pH from about 1.0 to about 2.5, and wherein the solution is enclosed in a single-use vial.
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18. A method of preparing an L-cysteine solution comprising,
preparing a mixture of a pharmaceutically acceptable carrier comprising less than about 1 ppm dissolved oxygen and L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof; -
adjusting the pH of said mixture to from about 1.0 to about 2.5; transferring an amount of the pH-adjusted mixture into a single-use container; reducing the headspace oxygen in the container; and sealing the container. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27)
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Specification