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- Nachgewiesen in: USPTO Patent Applications
- Sprachen: English
- Document Number: 20220378077
- Publication Date: December 1, 2022
- Appl. No: 17/330076
- Application Filed: May 25, 2021
- Claim: 1. A terminally heat-sterilized multi-chamber container (MCB) comprising at least: (a) a first chamber comprising a carbohydrate formulation and vitamins, (b) a second chamber comprising an amino acid formulation and vitamins, (c) a third chamber comprising a lipid formulation, (d) a fourth chamber comprising a trace element formulation, and (e) a fifth chamber comprising a vitamin formulation, wherein the vitamin formulation comprises at least vitamin B12, and wherein the trace element formulation comprises at least selenium (Se).
- Claim: 2. The terminally heat-sterilized multi-chamber container of claim 1, wherein the trace element formulation further comprises zinc (Zn), copper (Cu) and manganese (Mn).
- Claim: 3. The terminally heat-sterilized multi-chamber container of claim 1, wherein the vitamin formulation further comprises vitamin B2 and/or vitamin B5.
- Claim: 4. The terminally heat-sterilized multi-chamber container of claim 1, wherein the vitamin formulation or the lipid formulation further comprises vitamin A and optionally further comprises vitamin D, vitamin E, and/or vitamin K.
- Claim: 5. The terminally heat-sterilized multi-chamber container of claim 1, wherein the multi-chamber container further comprises at least one electrolyte selected from the group consisting of sodium (Na+), chloride (Cl−), potassium (K+), magnesium (Mg2+), calcium (Ca2+), hydrogen phosphate (HPO4−), glycerophosphate (C3H7O6P2−), acetate (CH3COO−) and hydrogen carbonate (HCO3−).
- Claim: 6. The terminally heat-sterilized multi-chamber container of claim 5, wherein the at least one electrolyte is provided in the amino acid formulation.
- Claim: 7. The terminally heat-sterilized multi-chamber container of claim 1, wherein the carbohydrate formulation or the trace element formulation comprises calcium.
- Claim: 8. The terminally heat-sterilized multi-chamber container of claim 1, wherein the carbohydrate formulation comprises glucose and at least one vitamin selected from the group of vitamins consisting of vitamin B1, vitamin B3 and vitamin B6.
- Claim: 9. The terminally heat-sterilized multi-chamber container of claim 1, wherein the carbohydrate formulation is an aqueous solution having a pH of from about 3.2 to about 5.5 and comprises: (a) from about 24 g to about 411 g glucose, (b) from about 0.1 g to about 1.5 g calcium, (c) from about 1.1 mg to about 10.0 mg vitamin B1, (d) from about 16 mg to about 115 mg vitamin B3, and (e) from about 0.5 mg to about 10.5 mg vitamin B6.
- Claim: 10. The terminally heat-sterilized multi-chamber container of claim 1, wherein the amino acid formulation comprises at least one vitamin selected from the group of vitamins consisting of vitamin B8, vitamin B9 and vitamin C.
- Claim: 11. The terminally heat-sterilized multi-chamber container of claim 1, wherein the amino acid formulation is an aqueous solution having a pH of from about 4.5 to about 7.0, preferably of from about 6.0 to about 7.0, and comprises: (a) from about 8 g to about 223 g amino acids, (b) from about 17 μg to about 125 μg vitamin B8, (c) from about 120 μg to about 1000 μg vitamin B9, (d) from about 60 mg to about 340 mg vitamin C, and (e) optionally one or more electrolytes selected from the group of electrolytes comprising sodium, potassium, glycerophosphate, magnesium, calcium, acetate, and chloride.
- Claim: 12. The terminally heat-sterilized multi-chamber container of claim 1, wherein the trace element formulation is an aqueous solution having a pH of from about 2.0 to about 4.0 and comprises: (a) from about 580 μg to about 7000 μg zinc, (b) from about 10 μg to about 120 μg selenium, (c) from about 80 μg to about 800 μg copper, (d) from about 1 μg to about 350 μg manganese, and optionally (e) from about 0 μg to about 3000 μg iron, (f) from about 0 μg to about 25 μg chromium, (g) from about 5 μg to about 200 μg iodine, (h) from about 0 μg to about 1500 μg fluorine, and/or (i) from about 1 μg to about 30 μg molybdenum.
- Claim: 13. The terminally heat-sterilized multi-chamber container of claim 1, wherein the trace element formulation further comprises an organic acid selected from the group of organic acids consisting of malic acid, tartaric acid, citric acid, maleic acid, and fumaric acid in a concentration of from 50 mM to 400 mM.
- Claim: 14. The terminally heat-sterilized multi-chamber container of claim 1, wherein the vitamin formulation comprises vitamin B2, vitamin B5 and vitamin B12.
- Claim: 15. The terminally heat-sterilized multi-chamber container of claim 1, wherein the vitamin formulation comprises: (a) from about 0.5 mg to about 6.0 mg vitamin B2, (b) from about 4.3 mg to about 45.0 mg vitamin B5, and (c) from about 0.7 μg to about 35.0 μg vitamin B12.
- Claim: 16. The terminally heat-sterilized multi-chamber container of claim 1, wherein the vitamin formulation further comprises vitamin B2, vitamin B5, vitamin B12, vitamin A, vitamin D, vitamin K and vitamin E.
- Claim: 17. The terminally heat-sterilized multi-chamber container of claim 1, wherein the vitamin formulation is a lipid emulsion having a pH of from about 5.0 to about 7.0 and comprises an aqueous phase, and about 1% to about 20% by weight of an oil phase based on the total weight of the lipid emulsion.
- Claim: 18. The terminally heat-sterilized multi-chamber container of claim 1, wherein the vitamin formulation contains no more than 1.5 ppm of dissolved oxygen.
- Claim: 19. The terminally heat-sterilized multi-chamber container of claim 1, wherein the multi-chamber container comprises a sixth chamber comprising: (a) a lipid emulsion having a pH of from about 5.0 to about 9.0 which comprises an aqueous phase and about 1% to about 20% by weight of an oil phase based on the total weight of the lipid emulsion, and contains less than 1.5 ppm of dissolved oxygen, (b) vitamin A, and (c) optionally at least one of the vitamins selected from the group of vitamins consisting of vitamin D, vitamin K and vitamin E.
- Claim: 20. The terminally heat-sterilized multi-chamber container of claim 19, wherein the vitamin formulation of the fifth chamber is an aqueous solution having a pH of from about 5.0 to about 7.0, and comprises vitamin B12 and optionally at least one vitamin selected from the group consisting of vitamin B2 and vitamin B5, and further comprises less than 1.5 ppm dissolved oxygen.
- Claim: 21. The terminally heat-sterilized multi-chamber container of claim 1, wherein the lipid formulation comprises an aqueous phase and about 5% to about 35% by weight of an oil phase.
- Claim: 22. The terminally heat-sterilized multi-chamber container of claim 1, wherein the lipid formulation comprises vitamin A and optionally at least one vitamin selected from the group consisting of vitamin D, vitamin K and vitamin E.
- Claim: 23. The terminally heat-sterilized multi-chamber container of claim 1, wherein the fat-soluble vitamins are present in an amount of (a) from about 215 IU to about 6600 IU vitamin A, (b) from about 400 IU to about 1700 IU vitamin D, (c) from about 8 IU to about 40 IU vitamin E, and (d) from about 30 μg to about 650 μg vitamin K, respectively.
- Claim: 24. The terminally heat-sterilized multi-chamber container of claim 1, wherein the multi-chamber container is terminally heat-sterilized by moist heat.
- Claim: 25. The terminally heat-sterilized multi-chamber container of claim 1, wherein the chambers of the multi-chamber container are separated from each other by nonpermanent seals.
- Claim: 26. The terminally heat-sterilized multi-chamber container of claim 1, wherein the fourth and fifth and optionally sixth chamber each have a volume of from about 2.5 mL to about 50 mL.
- Claim: 27. The terminally heat-sterilized multi-chamber container of claim 1, wherein the formulations of the at least five chambers can be reconstituted by breaking the nonpermanent seals separating the chambers from each other.
- Claim: 28. A parenteral nutrition formulation reconstituted from a multi-chamber container according to claim 1.
- Claim: 29. A reconstituted terminally heat-sterilized parenteral nutrition formulation having a pH of from about 4.5 to about 7.2, preferably of from about 5.0 to about 7.0, comprising lipids, amino acids, carbohydrates and further comprising: (a) from about 10 μg to about 120 μg selenium, (b) from about 10 μg to about 120 μg vitamin A, and (c) from about 0.7 μg to about 35.0 μg vitamin B12.
- Claim: 30. The parenteral nutrition formulation of claim 29, further comprising: (a) from about 580 μg to about 7000 μg zinc, (b) from about 80 μg to about 800 μg copper, and (c) from about 1 μg to about 350 μg manganese.
- Claim: 31. The parenteral nutrition formulation of claim 29, further comprising: (a) from about 400 IU to about 1700 IU vitamin D, (b) from about 8 IU to about 40 IU vitamin E, (c) from about 30 μg to about 650 μg vitamin K, (d) from about 1.1 mg to about 10.0 mg vitamin B1, (e) from about 0.5 mg to about 6.0 mg vitamin B2 (f) from about 16 mg to about 115 mg vitamin B3, (g) from about 4.3 mg to about 45.0 mg vitamin B5, (h) from about 0.5 mg to about 10.5 mg vitamin B6, (i) from about 17 μg to about 125 μg vitamin B8, (j) from about 120 μg to about 1000 μg vitamin B9, and/or (k) from about 60 mg to about 340 mg vitamin C.
- Claim: 32. The parenteral nutrition formulation of claim 28, further comprising: (a) from about 0 μg to about 3000 μg iron, (b) from about 0 μg to about 25 μg chromium, (c) from about 5 μg to about 200 μg iodine, (d) from about 0 μg to about 1500 μg fluorine, and/or (e) from about 1 μg to about 30 μg molybdenum.
- Claim: 33. The parenteral nutrition formulation according to claim 29, wherein the parenteral nutrition formulation comprises from about 20 g/L to about 40 g/L of lipids, from about 60 g/L to about 160 g/L of glucose, and from about 20 g/L to about 80 g/L of amino acids.
- Claim: 34. The parenteral nutrition formulation according to claim 28, wherein the parenteral nutrition formulation comprises from about 0.3 g to about 4.5 g of sodium acetate trihydrate, from about 0.4 g to about 6.8 g potassium chloride, from about 0.1 g to about 3.0 g of magnesium chloride hexahydrate, from about 0.5 to about 11.0 g of sodium glycerophosphate, hydrated, and from about 0.08 g to about 1.6 g of calcium chloride dihydrate.
- Claim: 35. The terminally heat-sterilized multi-chamber container of claim 1 for providing parenteral nutrition to a patient when oral or enteral nutrition is impossible, insufficient, or contraindicated.
- Claim: 36. The terminally heat-sterilized multi-chamber container according to claim 35, wherein the patient is an adult patient.
- Claim: 37. The terminally heat-sterilized multi-chamber container according to claim 1 for providing total parenteral nutrition (TPN) or partial parenteral nutrition (PPN).
- Claim: 38. The terminally heat-sterilized multi-chamber container according to claim 1 for providing total parenteral nutrition (TPN), partial parenteral nutrition (PPN) to home parenteral nutrition (HPN) patients.
- Current International Class: 23; 23; 23; 23; 23; 23; 23
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