Stable salt of 5,10-methylene-(6r)-tetrahydrofolic acid
AssigneeMerck & Cie
InventorsRudolf MOSER, Viola GROEHN, Thomas EGGER, Thomas AMMANN
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Abstract
The present invention is directed towards the hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid, preferably in substantially crystalline form, as well as pharmaceutical compositions and uses thereof in therapy, preferably chemotherapy.
Claims20
Hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid, which is resistant to chemical degradation and/or hydrolysis as it lacks an extremely high sensitivity to oxidation by air as well as instability in neutral and/or acidic environments thereby allowing the effective use of this compound in medicinal applications.
The effective use in medicinal applications of the hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid, which in addition is in substantially crystalline form, comprising administering as a pharmaceutical agent the hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid.
Hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid having one X-ray pattern peak position at an angle of diffraction 2theta of 4.7° expressed in 2θ±0.2° 2θ (CuKα radiation, reflection), which is sufficient for the recognition of this compound as the hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid.
A method for the recognition of the hemisulfate salt of 5,10-methylene-(6R)-tetrahydrofolic acid by finding a single X-ray pattern peak position at an angle of diffraction 2theta of 4.7° expressed in 2θ±0.2° 2θ (CuKα radiation, reflection).
Dependencies are inferred from the claim text.