Claims for Patent: 11,975,022

Summary for Patent: 11,975,022

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:	US18/482,612
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,975,022
Patent Claims:	1. A method of providing trace elements to a patient in need thereof, the method comprising administering an injectable trace element composition to the patient, the injectable trace element composition comprising water, about 60 μg of selenium, about 3,000 μg of zinc, about 300 μg of copper, and about 55 μg of manganese per 1 mL of the injectable composition, wherein the injectable composition contains 0 μg per 1 mL to about 10 μg per 1 mL of iron, does not contain any vitamins, contains no added chromium and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the injectable 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 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. 4. The method of claim 1, wherein the injectable trace element composition consists of 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. 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 an adult or pediatric human patient to provide 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) silicon from about 0.0001 to about 100 μg/mL, magnesium from about 0.0001 to about 50 μg/mL, calcium from about 0.0001 to about 50 μg/mL, boron from about 0.0001 to about 50 μg/mL or a mixture thereof; or (ii) silicon from about 0 to about 100 μg/mL, magnesium from about 0 to about 50 μg/mL, calcium from about 0 to about 50 μg/mL, boron from about 0 to about 50 μg/mL or a mixture thereof. 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 providing trace elements to a patient in need thereof, the method comprising administering to the patient an injectable 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 mcg of manganese sulfate or manganese sulfate monohydrate and about 98 mcg of selenious acid per 1 mL of the injectable composition, wherein the injectable composition contains impurities of chromium, aluminum, and iron, wherein the impurities are chromium in an amount not to exceed 1 μg, aluminum in an amount not to exceed 6 μg, and 0 μg to about 10 μg of the iron per 1 mL of the injectable composition. 13. The method of claim 12, wherein the injectable trace element composition contains less than about 0.5 μg/mL of chromium. 14. The method of claim 12, wherein the injectable trace element composition consists essentially of about 7.41 mg of zinc sulfate or zinc sulfate heptahydrate, about 0.75 mg of cupric sulfate or cupric sulfate pentahydrate, about 151 mcg of manganese sulfate or manganese sulfate monohydrate, and about 98 mcg of selenious acid per 1 mL of the injectable trace element composition. 15. The method of claim 12, wherein the injectable trace element composition consists of about 7.41 mg of zinc sulfate or zinc sulfate heptahydrate, about 0.75 mg of cupric sulfate or cupric sulfate pentahydrate, about 151 mcg of manganese sulfate or manganese sulfate monohydrate, and about 98 mcg of selenious acid per 1 mL of the injectable trace element composition. 16. The method of claim 12, 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. 17. The method of claim 12, 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. 18. A method of providing trace elements to a patient in need thereof, the method comprising administering an injectable trace element composition to the patient, the injectable trace element composition comprising water, about 6 μg of selenium, about 1,000 μg of zinc, about 60 μg of copper, and about 3 μg of manganese per 1 mL of the injectable composition, wherein the injectable composition contains 0 μg per 1 mL to about 10 μg per 1 mL of iron, does not contain any vitamins, contains no added chromium and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the injectable composition. 19. The method of claim 18, wherein the injectable trace element composition consists essentially of 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 injectable trace element composition. 20. The method of claim 18, wherein the injectable trace element composition consists of 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 injectable trace element composition. 21. The method of claim 18, wherein the zinc, copper, manganese, and selenium are active ingredients in the injectable trace element composition. 22. The method of claim 18, 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. 23. The method of claim 18, wherein the injectable trace element composition is administered to a pediatric or neonatal human patient to provide a source of zinc, copper, manganese, and selenium when added to parenteral nutrition. 24. The method of claim 18, 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. 25. A method of providing trace elements to a patient in need thereof, the method comprising administering to the patient an injectable trace element composition comprising about 2,470 mcg of zinc sulfate or zinc sulfate heptahydrate, about 150 mcg of cupric sulfate or cupric sulfate pentahydrate, about 8.22 mcg of manganese sulfate or manganese sulfate monohydrate, and about 9.8 mcg of selenious acid per 1 mL of the injectable trace element composition, wherein the injectable trace element composition contains no chromium or chromium as an impurity in an amount less than 1 μg per 1 mL of the injectable trace element composition. 26. The method of claim 25, wherein the injectable trace element composition consists essentially of about 2,470 mcg of zinc sulfate or zinc sulfate heptahydrate, about 150 mcg of cupric sulfate or cupric sulfate pentahydrate, about 8.22 mcg of manganese sulfate or manganese sulfate monohydrate, and about 9.8 mcg of selenious acid per 1 mL of the injectable trace element composition. 27. The method of claim 25, wherein the injectable trace element composition consists of about 2,470 mcg of zinc sulfate or zinc sulfate heptahydrate, about 150 mcg of cupric sulfate or cupric sulfate pentahydrate, about 8.22 mcg of manganese sulfate or manganese sulfate monohydrate, and about 9.8 mcg of selenious acid per 1 mL of the injectable trace element composition. 28. The method of claim 25, 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. 29. The method of claim 25, 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.