Pharmaceutical compositions for parenteral administration comprising ibuprofen and a phosphate buffer
Inventors
PREISSEGGER, Patricia • TROTSCHA, Eva
Assignees
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Publication Number
US-11883532-B2
Publication Date
2024-01-30
Expiration Date
Abstract
The invention relates to pharmaceutical compositions for parenteral administration comprising a) Ibuprofen or a pharmaceutically acceptable salt thereof, and b) a phosphate buffer.
Core Innovation
The invention provides a ready-to-use pharmaceutical composition for parenteral administration comprising ibuprofen or a pharmaceutically acceptable salt thereof and a phosphate buffer. The composition contains 15-25 mmol/L ibuprofen or a pharmaceutically acceptable salt thereof, or alternatively 2-6 g/L ibuprofen or a pharmaceutically acceptable salt thereof, together with a phosphate buffer in a phosphate buffer to ibuprofen molar ratio of 0.3:1 to 0.4:1.
The composition has a pH of 6.5 to 8.2 and is sterile with a storage stability of at least 12 months at 25°C. The invention further provides the ready-to-use sterile composition for parenteral administration in a plastic container, including specific dependent refinements directed to heat sterilization and packaging-related limitations.
Claims Coverage
The independent claims are directed to a ready-to-use sterile parenteral ibuprofen/phosphate-buffer formulation with defined phosphate buffer:ibuprofen molar ratio (0.3:1 to 0.4:1), defined pH (6.5 to 8.2), and storage stability (at least 12 months at 25°C), with alternative ibuprofen concentration ranges and an additional packaging limitation in a plastic container. In total, the independent claim set covers three independent claim directions.
Ready-to-use parenteral ibuprofen/phosphate-buffer composition (mmol/L)
A ready-to-use pharmaceutical composition for parenteral administration comprising 15-25 mmol/L of Ibuprofen or a pharmaceutically acceptable salt thereof, and a phosphate buffer, wherein the phosphate buffer and Ibuprofen are present in a molar ratio of 0.3:1 to 0.4:1, the composition has a pH of 6.5 to 8.2, and the composition is sterile and has a storage stability of at least 12 months at 25°C.
Ready-to-use parenteral ibuprofen/phosphate-buffer composition (g/L)
A ready-to-use pharmaceutical composition for parenteral administration comprising 2-6 g/L of Ibuprofen or a pharmaceutically acceptable salt thereof, and a phosphate buffer, wherein the phosphate buffer and Ibuprofen are present in a molar ratio of 0.3:1 to 0.4:1, the composition has a pH of 6.5 to 8.2, and the composition is sterile and has a storage stability of at least 12 months at 25°C.
Ready-to-use parenteral ibuprofen/phosphate-buffer composition in a plastic container
A ready-to-use pharmaceutical composition for parenteral administration in a plastic container comprising 15-25 mmol/L of Ibuprofen or a pharmaceutically acceptable salt thereof, and a phosphate buffer, wherein the phosphate buffer and Ibuprofen are present in a molar ratio of 0.3:1 to 0.4:1, the composition has a pH of 6.5 to 8.2, and the composition is sterile and has a storage stability of at least 12 months at 25°C.
Across the independent claims, the core coverage is the combination of specific ibuprofen concentration, a phosphate buffer present at a defined phosphate buffer:ibuprofen molar ratio, a defined pH range, and a sterile composition with storage stability of at least 12 months at 25°C, including an additional independent coverage pathway requiring administration in a plastic container.
Stated Advantages
Improved stability and convenience versus higher-buffer/ratio formulations.
Reduced adsorption issues.
Ability to store in plastic containers, including plastic compatibility supported by ion leakage comparisons.
Documented Applications
Ready-to-use sterile parenteral (including parenteral administration/IV administration) ibuprofen compositions formulated with a phosphate buffer for storage stability.
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