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Publication Number
US-12403173-B2
Publication Date
2025-09-02
Expiration Date
Abstract
An aqueous pharmaceutical composition suitable for parenteral administration and having enhanced storage stability includes between about 0.1 mg/mL and about 40 mg/mL micafungin; (ii) between about 0.1 mM and 400 mM buffering agent; and (iii) between about 0 mg/mL and about 500 mg/mL tonicity adjusting agent, wherein the pH of the composition is between about 3.0 and 7.0, for example, between about 3.5 and 7.0.
Core Innovation
The invention concerns aqueous micafungin sodium pharmaceutical compositions suitable for parenteral administration, provided in a packaged sealed container as sterile, ready to use without further compounding or processing. The composition consists of micafungin sodium, a citrate buffering agent, sodium chloride, and water, with the pH between 4.0 and 5.5.
A core aspect is the formulation design using micafungin sodium within specified concentration limits together with citrate buffering agent and sodium chloride within defined ranges, combined with a pH window. The packaged sealed container provides a formulation that remains stable during formulation and storage as determined by HPLC analysis, including less than 1.5% area total impurities after formulation and storage at room temperature for three weeks.
The document further emphasizes that the ready-to-use sterile formulations are provided in sealed containers that can be frozen yet remain stable. Stability is supported by determination of stable pH within a cited range and by showing buffer and tonicity effects on impurities and assay results, including observations that citrate or acetate buffering improves stability relative to ascorbic-acid buffers that perform poorly.
Claims Coverage
The independent claim is directed to a packaged sealed container containing a sterile, ready-to-use aqueous pharmaceutical composition for parenteral administration, with defined micafungin sodium, citrate buffer, sodium chloride, water composition and pH constraints, plus an HPLC impurity performance condition after room-temperature storage for three weeks. This coverage is refined by dependent claims that further limit impurity after long storage at cold temperature, specify frozen composition state, and define alternative packaged sealed container formats.
Packaged sealed container with sterile ready-to-use aqueous micafungin sodium composition
A packaged sealed container comprising an aqueous pharmaceutical composition suitable for parenteral administration, wherein the aqueous pharmaceutical composition is sterile and ready to use without further compounding or processing.
Citrate-buffered micafungin sodium/sodium chloride formulation with defined pH
An aqueous pharmaceutical composition consisting of between 0.5 mg/ml and 2.5 mg/ml micafungin sodium, between 1 mM and 20 mM citrate buffering agent, between 4 mg/ml and 10 mg/ml sodium chloride, and water, wherein the pH is between 4.0 and 5.5.
HPLC impurity performance after room-temperature storage
The aqueous pharmaceutical composition has less than 1.5% area total impurities after formulation and storage at room temperature for three weeks, as determined by HPLC analysis.
Across the independent claim and its refinements, the inventive coverage centers on a packaged sealed container for parenteral administration containing a sterile, ready-to-use aqueous micafungin sodium formulation. The key limitations are the citrate buffering agent and sodium chloride formulation with a defined pH range, and measured impurity control by HPLC after specified storage conditions, including additional constraints in dependent claims such as long storage at cold temperature, frozen composition, and container format.
Stated Advantages
Provides less than 1.5% area total impurities after formulation and storage at room temperature for three weeks as determined by HPLC analysis.
Maintains stability of the ready-to-use sterile formulations in sealed containers that can be frozen yet remain stable.
Documented Applications
Parenteral administration using a sterile, ready-to-use aqueous pharmaceutical composition provided in a packaged sealed container.
Use of ready-to-use formulations in sealed container formats including vials, syringes, plastic bags, bottles, and other sealed container types.
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