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US 2026/0090983 A1Published application
Parenteral nutrition formulation
AssigneesBaxter International Inc., Baxter Healthcare S.A.
InventorsJean-Luc TROUILLY, Mary HISE BROWN, Laurent JEANNIN, Julien HECQ, Julie FAHIER
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Abstract
Parenteral nutrition formulations for pediatric patients are disclosed. The nutritional formulations include a lipid for mulation that comprises an aqueous phase and an oil phase, wherein the lipid formulation is in the form of an oil-in-water emulsion. Multi-chamber containers for parenteral nutrition administration comprising a carbohydrate formulation present in a first chamber, an amino acid formulation present in a second chamber, and the lipid formulation present in a third chamber also are disclosed.
Claims20
1:
- A multi-chamber container for parenteral administration comprising:
- (i) a carbohydrate formulation present in a first chamber;
- (ii) an amino acid formulation present in a second chamber;
- and
- (iii) a lipid formulation present in a third chamber;
- wherein:
- the lipid formulation comprises an aqueous phase and about 5% to about 35% by weight of an oil phase based on the total weight of the lipid formulation;
- the lipid formulation is present in the form of an oil-in-water emulsion;
- the oil phase comprises docosahexaenoic acid (DHA) obtained from a single cell source, wherein the single cell source is an extract of microalgae and wherein the DHA is present in a concentration of from 0.1 g to 5.0 g per 100 g of oil phase;
- the oil phase comprises arachidonic acid (ARA);
- the lipid formulation includes about 70 mg phytosterols or less per 100 g of oil phase;
- and
- the lipid formulation is essentially free of water soluble forms of choline,
- wherein the carbohydrate formulation comprises glycerophosphocholine (GPC).
11 more elements
2:
- The multi-chamber container of claim 1, wherein the DHA is present in a concentration of from 0.25 g to 3.0 g per 100 g of oil phase.
3:
- The multi-chamber container of claim 1, wherein the DHA is present in a concentration of from 1.5 g to 2.5 g per 100 g of oil phase.
4:
- The multi-chamber container of claim 1, wherein the DHA is present in triglyceride form or ethyl ester form.
5:
- The multi-chamber container of claim 1, wherein the lipid formulation further comprises eicosapentaenoic acid (EPA) and the ratio of the DHA to the EPA in the lipid formulation is 10:1 to 1000:1 (w/w).
6:
- The multi-chamber container of claim 1, wherein the lipid formulation further comprises EPA and the ratio of the DHA to the EPA in the lipid formulation is 10:1 to 200:1.
7:
- The multi-chamber container of claim 1, wherein the lipid formulation further comprises EPA and the ratio of the DHA to the EPA in the lipid formulation is 20:1 to 150:1.
8:
- The multi-chamber container of claim 5, wherein the DHA and/or the EPA are present in triglyceride form or ethyl ester form.
9:
- The multi-chamber container of claim 1, wherein the lipid formulation is essentially free of EPA.
10:
- The multi-chamber container of claim 1, wherein the microalgae is Crypthecodinium cohnii or Schizochytrium sp.
11:
- The multi-chamber container of claim 1, wherein the lipid formulation includes about 15 mg to about 35 mg phytosterols per 100 g of oil phase.
12:
- The multi-chamber container of claim 1, wherein the lipid formulation further comprises one or more pharmaceutically acceptable surfactants selected from the group consisting of phospholipids, oleate salts, and combinations thereof.
13:
- The multi-chamber container of claim 12, wherein the phospholipid is selected from the group consisting of egg phosphatide and soy lecithin.
14:
- The multi-chamber container of claim 1, wherein the lipid formulation further comprises one or more pharmaceutically acceptable isotonic agents.
15:
- The multi-chamber container of claim 14, wherein the one or more pharmaceutically acceptable isotonic agents is glycerol.
16:
- The multi-chamber container of claim 1, wherein the lipid formulation further comprises one or more pharmaceutically acceptable antioxidants selected from the group consisting of tocopherols, ascorbyl palmitate, and combinations thereof.
17:
- The multi-chamber container of claim 1, wherein the lipid formulation has a pH in the range of about 6 to about 9.
18:
- The multi-chamber container of claim 1, wherein the GPC is present in a concentration of from 20 mg to 2000 mg choline equivalent per liter of a reconstituted multi-chamber container.
19:
- A multi-chamber container for parenteral administration comprising:
- (i) a carbohydrate formulation present in a first chamber;
- (ii) an amino acid formulation present in a second chamber;
- and
- (iii) a lipid formulation present in a third chamber;
- wherein:
- the lipid formulation comprises an aqueous phase and about 5% to about 35% by weight of an oil phase based on the total weight of the lipid formulation;
- the lipid formulation is present in the form of an oil-in-water emulsion;
- the oil phase comprises docosahexaenoic acid (DHA) obtained from a single cell source, wherein the single cell source is an extract of microalgae and wherein the DHA is present in a concentration of from 0.1 g to 5.0 g per 100 g of oil phase;
- the oil phase comprises arachidonic acid (ARA);
- the lipid formulation includes about 70 mg phytosterols or less per 100 g of oil phase;
- and
- the lipid formulation is essentially free of water soluble forms of choline,
- wherein the carbohydrate formulation comprises glycerophosphocholine (GPC),
- wherein the multi-chamber container comprises openable seals among the first chamber, the second chamber and the third chamber, and wherein the carbohydrate formulation, the amino acid formulation and the lipid formulation are admixed into a whole liquid solution after the openable seals are open for the parenteral administration.
12 more elements
20:
- The multi-chamber container of claim 1, wherein the carbohydrate formulation comprises the GPC in a concentration of from 30 mg to 1000 mg choline equivalent per liter of a reconstituted multi-chamber container.