The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
May. 09, 2017

Filed:

Apr. 30, 2014
Applicant:

Aprofol Ag, Appenzell Steinegg, CH;

Inventor:

Martin Ulmann, Dachsen, CH;

Assignee:

APROFOL AG, Appenzell, Steinegg, CH;

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 31/519 (2006.01); A61K 9/00 (2006.01); A61K 47/12 (2006.01); A61K 47/24 (2006.01); A61K 9/08 (2006.01);
U.S. Cl.
CPC ...
A61K 31/519 (2013.01); A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/12 (2013.01); A61K 47/24 (2013.01);
Abstract

The administration of leucovorin as well as other active, reduced folates is useful as an antidote to drugs which act as folic acid antagonists and in combination chemotherapy with 5-FU. The most often used calcium salts of the folates have a low solubility in water and form almost insoluble degradation products. Therefore, aqueous solutions are unstable and precipitates result. Precipitates in injectable products present an unacceptable safety risk to patients. Stable high strength pharmaceutical aqueous compositions are formed containing calcium salts, magnesium or zinc salts of the reduced folates leucovorin, (6R,S)-tetrahydrofolic acid, (6S)-tetrahydrofolic acid, 5,10-methylene-(6R,S)-tetrahydrofolate, 5,10-methylene-(6R)-tetrahydrofolate, 5-methyl-(6R,S)-tetrahydrofolate or 5-methyl-(6S)-tetrahydrofolate and one or more of the compounds sodium gluconate, potassium gluconate, glycerophosphate disodium salt or glycerophosphate dipotassium salt.


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