Insulin formulations

摘要

A stable pharmaceutical formulation containing an insulin derivative can conveniently be prepared by adding glycerol, phenol, m-cresol and zinc ions to it.

主权项

1. A pharmaceutical formulation comprising an insulin derivative selected from the group consisting of A14E, B16H, B25H, B29K((Nεeicosanedioyl-γGlu-[2-(2-{2-[2-(2-aminoethoxy)-ethoxy]acetylamino}ethoxy)ethoxy]acetyl)), desB30 human insulin; A14E, B16H, B25H, B29K-(Nεhexadecandioyl-γGlu), desB30 human insulin; A14E, B16H, B25H, B29K(Nεeicosanedioyl-γGlu), desB30 human insulin; and A14E, B25H, desB27, B29K(Nε-(octadecandioyl-γGlu), desB30 human insulin, and from about 1 to about 2% (weight/weight) of glycerol, from about 16 to about 35 mM of phenol, from about 16 to about 35 mM of m-cresol, from about 3.5 to about 5.5 mole of zinc ions per six mole of said insulin derivative and not more than about 75 mM of sodium chloride.