Alcohol free formulation of argatroban
AssigneeScidose LLC
InventorNageswara R. Palepu
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Abstract
An aqueous formulation of argatroban and of related compounds is disclosed along with a reconstitutable formulation, each of which is substantially, if not totally alcohol free. The formulations are also substantially free, if not totally free, of mono-, di-, and oligo-saccharides. An especially preferred embodiment is a ready-to-administer 1 mg/ml injectable dosage form having argatroban, lactobionic acid, and methionine.
Claims24
A pharmaceutically acceptable formulation of argatroban of formula I or a pharmaceutically acceptable salt thereof, which is solubilized in aqueous solution with (a) optionally an amino acid and (b) a buffer under alkaline pH conditions
- which formulation is (a) substantially free of ethanol and/or (b) substantially free of a mono-, di-, or oligo-saccharide and substantially free of a sugar alcohol.
The formulation of claim 4 wherein said amino acid is arginine, glycine, or methionine.
A reconstitutable formulation of argatroban comprising
- (a) said argatroban or a salt thereof or mixtures thereof,
- (b) optionally an amino acid or a salt thereof or mixtures thereof,
- (c) at least one of (1) a non-amino acid carboxylic acid or salt thereof or mixtures thereof and (2) an alkali metal salt or ammonium salt of carbonic acid or mixtures thereof.
Dependencies are inferred from the claim text.