US 12,186,338 B1
Stable, highly pure L-cysteine compositions for injection and methods of use
John Maloney, Salisbury, NC (US); Aruna Koganti, Lenoir, NC (US); and Phanesh Koneru, Waxhaw, NC (US)
Assigned to EXELA PHARMA SCIENCES, LLC, Lenoir, NC (US)
Filed by EXELA PHARMA SCIENCES, LLC, Lenoir, NC (US)
Filed on Apr. 30, 2024, as Appl. No. 18/651,036.
Application 18/651,036 is a continuation of application No. 18/520,172, filed on Nov. 27, 2023, granted, now 11,969,439.
Application 18/520,172 is a continuation of application No. 18/332,677, filed on Jun. 9, 2023, granted, now 11,826,383, issued on Nov. 28, 2023.
Application 18/332,677 is a continuation of application No. 18/067,605, filed on Dec. 16, 2022, granted, now 11,679,125, issued on Jun. 20, 2023.
Application 18/067,605 is a continuation of application No. 17/950,964, filed on Sep. 22, 2022, granted, now 11,672,824, issued on Jun. 13, 2023.
Application 17/950,964 is a continuation of application No. 17/188,922, filed on Mar. 1, 2021, granted, now 11,510,942, issued on Nov. 29, 2022.
Application 17/188,922 is a continuation of application No. 16/746,028, filed on Jan. 17, 2020, granted, now 10,933,089, issued on Mar. 2, 2021.
Application 16/746,028 is a continuation of application No. 16/665,702, filed on Oct. 28, 2019, granted, now 10,583,155, issued on Mar. 10, 2020.
Application 16/665,702 is a continuation of application No. 16/248,460, filed on Jan. 15, 2019, granted, now 10,478,453, issued on Nov. 19, 2019.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 33/06 (2006.01); A23L 33/16 (2016.01); A23L 33/175 (2016.01); A61K 9/00 (2006.01); A61K 31/095 (2006.01); A61K 31/191 (2006.01); A61K 31/198 (2006.01); A61K 31/401 (2006.01); A61K 31/405 (2006.01); A61K 31/4172 (2006.01); A61K 33/00 (2006.01); A61K 33/241 (2019.01); A61K 33/28 (2006.01); A61K 33/36 (2006.01); A61K 47/02 (2006.01); A61J 1/14 (2023.01)
CPC A61K 33/06 (2013.01) [A23L 33/16 (2016.08); A23L 33/175 (2016.08); A61K 9/0029 (2013.01); A61K 31/095 (2013.01); A61K 31/191 (2013.01); A61K 31/198 (2013.01); A61K 31/401 (2013.01); A61K 31/405 (2013.01); A61K 31/4172 (2013.01); A61K 33/00 (2013.01); A61K 33/241 (2019.01); A61K 33/28 (2013.01); A61K 33/36 (2013.01); A61K 47/02 (2013.01); A23V 2002/00 (2013.01); A61J 1/1412 (2013.01)] 21 Claims
OG exemplary drawing
 
1. A composition for injection comprising a mixture of:
one or more amino acids selected from the group consisting of: leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, and tyrosine;
a L-cysteine composition, wherein the L-cysteine composition contributes to the composition for injection, 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; and,
an intravenous fluid;
wherein, the one or more amino acids contribute no more than about 1 mcg/kg/day of Al as dosed as part of a parenteral nutrition regimen containing a therapeutically effective dose of L-cystine, and all components of the composition for injection combined contribute no more than about 4 mcg/kg/day of Al as dosed as part of a parenteral nutrition regimen.