Claims for Patent: 11,998,565

Summary for Patent: 11,998,565

Title:	Trace element compositions, methods of making and use
Abstract:	Injectable compositions that can be added to parenteral nutrition are provided. In particular, a stable injectable composition is provided which includes water, and at least one of about 800 μg to about 4,000 μg of zinc, about 40 μg to about 400 μg of copper, from about 4 μg to about 90 μg of selenium, or from about 1 μg to about 80 μg of manganese per 1 mL of the injectable composition. Methods of preparing and using of the stable injectable composition are also provided.
Inventor(s):	Gopal Anyarambhatla, Richard Lawrence, Jasmina Marinkovic
Assignee:	American Regent Inc
Application Number:	US18/124,391
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,998,565
Patent Claims:	1. An injectable composition comprising water, 6 μg or 60 μg of selenium, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg per 1 mL of the injectable composition. 2. The injectable composition of claim 1, wherein the injectable composition comprises 60 μg of selenium per 1 mL of the injectable composition. 3. The injectable composition of claim 1, wherein the injectable composition comprises 6 μg of selenium per 1 mL of the injectable composition. 4. The injectable composition of claim 1, wherein the injectable composition contains 0.0001 μg to 0.6 μg of aluminum per 1 mL of the injectable composition. 5. The injectable composition of claim 1, wherein the injectable composition contains 0.0001 μg to 10 μg of iron per 1 mL of the injectable composition. 6. The injectable composition of claim 1, wherein the injectable composition is suitable for administration to an adult or pediatric patient when added to parenteral nutrition. 7. The injectable composition of claim 1, wherein the injectable composition contains iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition. 8. The injectable composition of claim 1, wherein the injectable composition has a pH of 1.8 to 2.4. 9. The injectable composition of claim 1, wherein the injectable composition further comprises nitric acid. 10. The injectable composition of claim 1, wherein the selenium is elemental selenium from selenious acid. 11. The injectable composition of claim 2, wherein the selenium is elemental selenium from selenious acid. 12. The injectable composition of claim 3, wherein the selenium is elemental selenium from selenious acid. 13. The injectable composition of claim 1, wherein the injectable composition contains 0.0001 μg/mL to 0.25 μg/mL of chromium. 14. The injectable composition of claim 1, wherein the injectable composition contains 1 ppm to 6 μg/mL of aluminum. 15. An injectable composition comprising water, 6 μg or 60 μg of selenium, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition. 16. The injectable composition of claim 1, wherein the injectable composition comprises 0.0001 μg to 0.25 μg of chromium; 0.0001 μg to 0.6 μg of aluminum; 0.0001 μg to 10 μg of iron; 0.0001 μg to 0.2 μg of iodine; and 0.0001 μg to 100 μg of silicon per mL of the injectable composition. 17. The injectable composition of claim 15, wherein the injectable composition is suitable for administration to an adult or pediatric patient. 18. The injectable composition of claim 3, wherein the injectable composition is suitable for administration to a pediatric or neonatal patient when added to parenteral nutrition. 19. The injectable composition of claim 15, wherein the selenium is elemental selenium from selenious acid. 20. The injectable composition of claim 15, wherein the injectable composition comprises 60 μg of selenium per 1 mL of the injectable composition. 21. The injectable composition of claim 15, wherein the injectable composition comprises 6 μg of selenium per 1 mL of the injectable composition. 22. The injectable composition of claim 1, wherein the injectable composition is in a volume that fills a 1 mL, 2 mL, 3 mL, 5 mL or 10 mL vial. 23. The injectable composition of claim 15, wherein the injectable composition comprises 0.0001 μg to 0.25 μg of chromium; 0.0001 μg to 0.6 μg of aluminum; 0.0001 μg to 10 μg of iron; 0.0001 μg to 2.7 μg of fluoride; and 0.0001 μg to 100 μg of silicon per mL of the injectable composition. 24. The injectable composition of claim 1, wherein the injectable composition contains less than 0.25 μg/mL of chromium. 25. The injectable composition of claim 1, wherein permitted daily limits (PDL) of the injectable composition do not exceed 0.4 μg/day of cadmium, 0.5 μg/day of lead, 1.5 μg/day of arsenic, 0.4 μg/day of mercury, 1 μg/day of cobalt, about 2 μg/day of vanadium, 4 μg/day of nickel, 1.6 μg/day of thallium, 20 μg/day of gold, 2 μg/day of palladium, 2 μg/day of iridium, 2 μg/day of osmium, 2 μg/day of rhodium, 2 μg/day of ruthenium, 2 μg/day of silver, 2 μg/day of platinum, 50 μg/day of lithium, 18 μg/day of antimony, 140 μg/day of barium, 300 μg/day of molybdenum, 120 μg/day of tin, 1 μg/day of chromium, 6 μg/day of aluminum, 50 μg/day of boron, 50 μg/day of calcium, 10 μg/day of iron, 94,000 μg/day of potassium, 50 μg/day of magnesium, 24,000 μg/day of sodium, 1 μg/day of tungsten, and/or 100 μg/day of silicon. 26. An injectable composition consisting essentially of water, nitric acid, selenious acid 98 μg, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg or iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition. 27. An injectable composition consisting essentially of water, nitric acid, selenious acid 9.8 μg, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg or iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition. 28. The injectable composition of claim 1, wherein the injectable composition is in a glass vial or ampule and has a silicon impurity in an amount of not more than 100 μg/mL. 29. The injectable composition of claim 15, wherein the injectable composition further comprises nitric acid and has a pH of 1.8 to 2.4.