Claims for Patent: 12,150,956

Summary for Patent: 12,150,956

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:	US18/653,608
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,150,956
Patent Claims:	1. A method of supplementing trace elements to an adult or pediatric human patient in need thereof, the method comprising administering an injectable trace element composition to the patient, the injectable trace element composition comprising water, about 3,000 μg of zinc, about 300 μg of copper, about 60 μg of selenium, and about 55 μg of manganese per 1 mL of the injectable trace element composition, wherein the injectable trace element composition contains no iron or iron in an amount not to exceed 10 μg, no chromium or chromium in an amount not to exceed 1 μg and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the injectable trace element composition. 2. The method of claim 1, wherein the injectable trace element composition comprises 3,000 μg of zinc, 300 μg of copper, 60 μg of selenium, and 55 μg of manganese per 1 mL of the injectable trace element composition. 3. The method of claim 1, wherein the injectable trace element composition consists essentially of water, about 3,000 μg of zinc, about 300 μg of copper, about 60 μg of selenium, about 55 μg of manganese and optionally sulfuric acid per 1 mL of the injectable trace element composition. 4. The method of claim 1, wherein the injectable trace element composition consists of water, about 3,000 μg of zinc, about 300 μg of copper, about 60 μg of selenium, about 55 μg of manganese and optionally sulfuric acid per 1 mL of the injectable trace element composition. 5. The method of claim 1, wherein the zinc, copper, selenium, and manganese are active ingredients in the injectable trace element composition. 6. The method of claim 1, wherein the zinc is elemental zinc from zinc sulfate or zinc sulfate heptahydrate, the copper is elemental copper from cupric sulfate or cupric sulfate pentahydrate, the manganese is elemental manganese from manganese sulfate or manganese sulfate monohydrate and the selenium is elemental selenium from selenious acid. 7. The method of claim 1, wherein the injectable trace element composition contains from 0 μg to 0.5 μg of chromium per 1 mL of the injectable trace element composition. 8. The method of claim 1, wherein the injectable trace element composition is administered to the adult or pediatric human patient and is a source of zinc, copper, manganese, and selenium when added to parenteral nutrition. 9. The method of claim 7, wherein the injectable trace element composition contains impurities of aluminum in an amount not to exceed 6 μg per 1 mL of the injectable trace element composition. 10. The method of claim 1, wherein the injectable trace element composition further comprises (i) at least one of silicon from about 0.0001 μg to about 100 μg, magnesium from about 0.0001 μg to about 50 μg, calcium from about 0.0001 μg to about 50 μg, or from about 0.0001 μg to about 50 μg per 1 mL of the injectable trace element composition; or (ii) at least one of silicon from about 0 μg to about 100 μg, magnesium from about 0 μg to about 50 μg, calcium from about 0 μg to about 50 μg, or boron from about 0 μg to about 50 μg per 1 mL of the injectable trace element composition. 11. The method of claim 1, wherein the injectable trace element composition has a pH of about 1.0 to about 5.0. 12. A method of supplementing trace elements to an adult or pediatric human patient in need thereof, the method comprising administering to the patient a trace element composition, the trace element composition comprising water, about 7.41 mg of zinc sulfate or zinc sulfate heptahydrate, about 0.75 mg of cupric sulfate or cupric sulfate pentahydrate, about 151 μg of manganese sulfate or manganese sulfate monohydrate and about 98 μg of selenious acid per 1 mL of the trace element composition, wherein the trace element composition contains no iron or iron in an amount not to exceed 10 μg, no chromium or chromium in an amount not to exceed 1 μg and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the trace element composition. 13. The method of claim 12, wherein the trace element composition contains less than about 0.5 μg ug/mL of chromium per 1 mL of the trace element composition. 14. The method of claim 12, wherein the trace element composition consists essentially of water, about 7.41 mg of zinc sulfate or zinc sulfate heptahydrate, about 0.75 mg of cupric sulfate or cupric sulfate pentahydrate, about 151 μg of manganese sulfate or manganese sulfate monohydrate, about 98 μg of selenious acid and optionally sulfuric acid per 1 mL of the trace element composition. 15. The method of claim 12, wherein the trace element composition consists of water, about 7.41 mg of zinc sulfate or zinc sulfate heptahydrate, about 0.75 mg of cupric sulfate or cupric sulfate pentahydrate, about 151 ug of manganese sulfate or manganese sulfate monohydrate, about 98 μg of selenious acid and optionally sulfuric acid per 1 mL of the trace element composition. 16. The method of claim 12, wherein the trace element composition is injectable and has a pH of about 1.0 to about 5.0. 17. The method of claim 12, wherein the trace element composition contains from 0 μg to 0.5 μg of chromium per 1 mL of the trace element composition. 18. The method of claim 17, wherein the trace element composition contains impurities of aluminum in an amount not to exceed 6 μg per 1 mL of the trace element composition. 19. A method of supplementing trace elements to a pediatric or neonatal human patient in need thereof, the method comprising administering a trace element composition to the patient, the trace element composition comprising water, about 1,000 μg of zinc, about 60 μg of copper, about 6 μg of selenium, and about 3 μg of manganese per 1 mL of the trace element composition, wherein the trace element composition contains no iron or iron in an amount not to exceed 10 μg, no chromium or chromium in an amount not to exceed 1 μg and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the trace element composition. 20. The method of claim 19, wherein the trace element composition consists essentially of water, about 1,000 μg of zinc, about 60 μg of copper, about 6 μg of selenium, about 3 μg of manganese and optionally sulfuric acid per 1 mL of the trace element composition. 21. The method of claim 19, wherein the trace element composition consists of water, about 1,000 μg of zinc, about 60 μg of copper, about 6 μg of selenium, about 3 μg of manganese and optionally sulfuric acid per 1 mL of the trace element composition. 22. The method of claim 19, wherein the zinc, copper, manganese, and selenium are active ingredients in the trace element composition. 23. The method of claim 19, wherein the trace element composition is injectable and contains from 0 μg to 0.5 μg of chromium per 1 mL of the trace element composition. 24. The method of claim 19, wherein the trace element composition is administered to a pediatric or neonatal human patient and is a source of zinc, copper, manganese, and selenium when added to parenteral nutrition. 25. The method of claim 19, wherein the trace element composition contains impurities of aluminum in an amount not to exceed 6 μg per 1 mL of the trace element composition. 26. A method of supplementing trace elements to a pediatric or neonatal human patient in need thereof, the method comprising administering to the patient an injectable trace element composition comprising water, about 2,470 μg of zinc sulfate or zinc sulfate heptahydrate, about 150 μg of cupric sulfate or cupric sulfate pentahydrate, about 8.22 μg of manganese sulfate or manganese sulfate monohydrate, and about 9.8 μg of selenious acid per 1 mL of the injectable trace element composition, wherein the injectable trace element composition contains no iron or iron in an amount not to exceed 10 82 g, no chromium or chromium in an amount not to exceed 1 μg and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the injectable trace element composition. 27. The method of claim 26, wherein the injectable trace element composition consists essentially of water, about 2,470 μg of zinc sulfate or zinc sulfate heptahydrate, about 150 μg of cupric sulfate or cupric sulfate pentahydrate, about 8.22 μg of manganese sulfate or manganese sulfate monohydrate, about 9.8 μg of selenious acid and optionally sulfuric acid per 1 mL of the injectable trace element composition. 28. The method of claim 26, wherein the injectable trace element composition consists of water, about 2,470 μg of zinc sulfate or zinc sulfate heptahydrate, about 150 μg of cupric sulfate or cupric sulfate pentahydrate, about 8.22 μg of manganese sulfate or manganese sulfate monohydrate, about 9.8 μg of selenious acid and optionally sulfuric acid per 1 mL of the injectable trace element composition. 29. The method of claim 26, wherein the zinc sulfate or zinc sulfate heptahydrate, cupric sulfate or cupric sulfate pentahydrate, manganese sulfate or manganese sulfate monohydrate, and selenious acid are active ingredients in the injectable trace element composition. 30. The method of claim 19, wherein the trace element composition further comprises (i) at least one of silicon from about 0.0001 μg to about 100 μg, magnesium from about 0.0001 μg to about 50 μg, calcium from about 0.0001 μg to about 50 μg, boron from about 0.0001 μg to about 50 μg per 1 mL of the trace element composition; or (ii) at least one of silicon from about 0 μg to about 100 μg, magnesium from about 0 μg to about 50 μg, calcium from about 0 μg to about 50 μg, or boron from about 0 μg to about 50 μg per 1 mL of the trace element composition.