Alcohol free formulation of argatroban

A pharmaceutically acceptable formulation of the compound of formula I or a pharmaceutically acceptable salt thereof,

• which is solubilized in an aqueous solution at a concentration greater than that of the compound of formula I in water alone, with at least one of
• (a) an optional amino acid;
• (b) an optional a carboxylic acid selected from the group consisting of gluconic acid, glucuronic acid, gluconic acid ethers, glucuronic acid ethers, carbonic acid alkali metal salts, carbonic acid ammonium salts and mixtures thereof;
• (c) an optional buffer
• alkaline pH conditions
• wherein
• R1 represents an unsubstituted or substituted 2-carboxypiperidino group (where there may be up to 5 substituents independently selected from alkyl, carboxy, an amidated carboxy (the amidated carboxy nitrogen being further unsubstituted or having one or two alkyl substituents which may me joined so as to form a 5, 6, or 7 membered ring with the amidated carboxy nitrogen), an esterified carboxy, or a pharmaceutically acceptable salt of the carboxy group,
• R2 represents a phenyl group or a condensed polycyclic compound residue, which residue includes a benzene ring which binds to the sulfur atom of the sulfonyl group and is condensed with one or more other rings which may be heterocyclic and which further has 3 to 14 carbon atoms as the ring-constituent atoms exclusive of those contained in the benzene ring attached to the sulfonyl sulfur atom, the heteroatoms being selected from nitrogen, oxygen, and sulfur, and in which said nitrogen atoms may be unsubstituted or substituted with lower alkyl and said sulfur atoms my be unoxidized, mono-oxidized, or deoxidized, said heterorings having from 1 to 4 heteroatoms, which formulation is substantially free of ethanol and substantially free of a mono-, di-, or oligo-saccharide and substantially free of a sugar alcohol.