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US 2025/0051288 A1Published application
Method for solubilizing 5-amino-2,3-dihydro-1,4-phthalazinedione
AssigneeMetrioPharm AG
InventorsIngo SAAR, Wolfgang BRYSCH, Jörg VON WEGERER
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Abstract
The present invention relates to a method for solubilizing 5-amino-2,3-dihydro-1,4-phthalazinedione or salts thereof, to the solubilisate produced by this method and respective uses in pharmaceutical dosage forms. A phosphatidylcholine-based solubilization method is disclosed.
Claims19
1-15. (canceled)
A solubilisate of 5-amino-2,3-dihydro-1,4-phthalazinedione, comprising 5-amino-2,3-dihydro-1,4-phthalazinedione provided in the overall range of 0.1% to 25% per weight at room temperature and a pressure of 0.2 bar to 1 bar,
- at least one phosphatidylcholine in the overall range of 20% to 80% per weight,
- at least one medium-chained triglyceride in the overall range of 10% to 70% per weight,
- at least one lysophosphatidylcholine in the overall range of 1% to 15% per weight,
- at least one C2 to C4 alcohol in the overall range of 1% to 20% per weight, and
- at least one of glyceryl stearate and/or a saturated or unsaturated C14 to C20 fatty acid in the overall range of 0.5% to 10% per weight, respectively,
- wherein the relative weight percentages of all ingredients add up to 100% and all solubilization agents are independently from one another a food additive and/or a pharmaceutically acceptable excipient, and
- the solubilisate is devoid of polysorbate.
4 more elements
Dependencies are inferred from the claim text.