Ready-to-use parenteral nutrition formulation
Inventors
Bourezg, Zouaoui • Desbrosses, Freddy • Dupont, Caroline Roselyn • Couthouis, Aurélie • Brossard, Gabriel • Padula, Pierpaolo • Trouilly, Jean-Luc
Assignees
Baxter R&D Europe SPRL • Baxter Healthcare SA • Baxter International Inc
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Publication Number
US-12507721-B2
Publication Date
2025-12-30
Expiration Date
Abstract
The present disclosure relates to a terminally heat-sterilized ready-to-use parenteral nutrition formulation comprising all macronutrients and micronutrients required to meet the clinical guidelines for parenteral nutrition, wherein all said micronutrients and macronutrients are provided in one multi-chamber bag (MCB). The disclosure is also directed to a parenteral nutrition formulation comprising all such macronutrients and micronutrients. More specifically, the present disclosure is directed to a MCB comprising at least five chambers containing a carbohydrate formulation in a first chamber, an amino acid formulation in a second chamber, a lipid formulation in a third chamber, a fourth chamber comprising a vitamin formulation and a fifth chamber comprising a trace element formulation, wherein the carbohydrate formulation, amino acid formulation and/or the lipid formulation may also contain certain vitamins and certain trace elements that can be stably accommodated therein.
Core Innovation
The invention is a terminally heat-sterilized multi-chamber container for ready-to-use parenteral nutrition. Separate chambers contain carbohydrate formulations with vitamins, amino acid formulations with vitamin B8 or B9, lipid formulations, trace element formulations containing selenium, and a vitamin formulation in the form of a lipid emulsion. The vitamin formulation includes vitamins B12, B2, B5, and A, and optionally includes vitamins D, E, or K.
The container addresses nutrient incompatibility and degradation during terminal sterilization and storage by segregating formulations across distinct chambers and controlling pH and dissolved oxygen. Vitamin A stability improves in pH-adjusted lipid emulsions with reduced heat exposure, while selenium stability associates with controlled oxygen. The vitamin lipid emulsion excludes glucose, vitamin B1, and vitamin C, enabling ready-to-use administration without requiring addition of micronutrients prior to use.
Claims Coverage
The claims identify one independent claim covering a terminally heat-sterilized multi-chamber container with four inventive features.
Multi-chamber formulation arrangement
The container comprises at least five chambers: a first chamber comprising a carbohydrate formulation and vitamins; a second chamber comprising an amino acid formulation and vitamins, including at least one of vitamin B8 or vitamin B9; a third chamber comprising a lipid formulation; a fourth chamber comprising a trace element formulation; and a fifth chamber comprising a vitamin formulation.
Vitamin formulation in a lipid emulsion
The fifth chamber contains a lipid emulsion having a pH of 5.0 to 7.0 and comprising vitamins B12, B2, B5, and A, with optional vitamin D, vitamin E, and/or vitamin K. The formulation does not comprise glucose, vitamin B1, or vitamin C.
Trace element formulation comprising selenium
The trace element formulation in the fourth chamber comprises at least selenium.
Terminal heat sterilization
The multi-chamber container is terminally heat-sterilized. [procedural detail omitted for safety]
The independent claim combines a specified multi-chamber arrangement of parenteral-nutrition formulations with a dedicated selenium-containing trace element formulation, a distinct vitamin-containing lipid emulsion, and terminal heat sterilization.
Stated Advantages
The summary reports improved vitamin A stability in pH-adjusted lipid emulsions with controlled oxygen and reduced heat exposure.
The summary reports improved vitamin B12 recovery in dedicated formulations compared with the listed glucose, standard amino-acid, lipid-emulsion, and micellar formulations.
The summary associates selenium stability with dissolved oxygen, oxygen-barrier packaging, and headspace.
The product is ready to use without adding micronutrients before administration.
Documented Applications
The container is described for providing total or partial parenteral nutrition when oral or enteral nutrition is impossible, insufficient, or contraindicated.
The summary describes ready-to-use parenteral-nutrition administration in hospital or home settings.
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