Abstract: Stable methocarbamol ready to use compositions for parenteral administration including parenteral infusion are provided. In certain embodiments, the compositions are sterile, isotonic, and particulate-matter-free. Further, the compositions reduce or avoid allergic reactions to latex, reduce or avoid extravasation, and permit administration of methocarbamol to subjects having renal pathology. Methods of manufacture and methods of administration are also provided.
Abstract: Stable methocarbamol ready to use compositions for parenteral administration including parenteral infusion are provided. In certain embodiments, the compositions are sterile, isotonic, and particulate-matter-free. Further, the compositions reduce or avoid allergic reactions to latex, reduce or avoid extravasation, and permit administration of methocarbamol to subjects having renal pathology. Methods of manufacture and methods of administration are also provided.
Abstract: 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 ?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.
Type:
Grant
Filed:
October 9, 2020
Date of Patent:
October 12, 2021
Assignee:
EXELA STERILE MEDICINES LLC
Inventors:
Phanesh Koneru, John Maloney, Aruna Koganti
Abstract: Cysteine compositions comprising less than about 400 ?g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 ?g/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.