Cysteine composition and injection
AssigneeAvadel Legacy Pharmaceuticals, LLC
InventorsAngela Sutterer, Jill Simpson, Gauthier Pouliquen, Alain Constancis, Pierre Danner
Life of this patent
Estimating the term…
Abstract
Cysteine compositions comprising less than about 400 μg/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 μg/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.
Claims30
A cysteine hydrochloride solution comprising about 40 mg/mL to about 60 mg/mL of cysteine hydrochloride and a pH from about 1.0 to about 1.5, wherein preparation of the cysteine hydrochloride solution comprises:
- acidifying water to a pH from about 1.0 to about 1.5 to form acidified water;
- dissolving about 40 mg to about 60 mg of cysteine hydrochloride per 1 mL of acidified water to form a solution;
- and
- filling and sealing a container in which the solution is disposed under flow of an inert gas.
Dependencies are inferred from the claim text.