Stable aqueous solution of 3-(1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2-6-dione
AssigneeGruenenthal GmbH
InventorsTieno Germann, Heinrich Kugelmann
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Abstract
An aqueous solution 3-(1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione (EM 12) is described which is suitable for parenteral administration, particularly for intravenous administration of EM 12 for treating immunological and haematological-oncological diseases, and a method of producing the corresponding solution of EM 12 is also described.
Claims4
A stable aqueous solution containing 3-(1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione (EM 12) for parenteral administration, said solution comprising EM 12 dissolved in an isotonic glucose solution, and said stable aqueous solution having a pH less than or equal to 5.5.
A method of producing a stable aqueous solution containing 3-(1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione (EM 12), said method comprising:
- adding EM 12 to an isotonic glucose solution with a pH of 4 to 5;
- shaking the resulting mixture until the added EM 12 is substantially completely dissolved, and
- filtering the resulting solution under aseptic conditions.
Dependencies are inferred from the claim text.