Process for the preparation of an aqueous insulin...

A - Human Necessities – 61 – K

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167/103.41

A61K 38/28 (2006.01) A61K 47/10 (2006.01) A61K 47/36 (2006.01) A61K 47/42 (2006.01)

Patent

CA 1258427

Abstract of the disclosure: The invention relates to a process for the prepara- tion of an aqueous insulin formulation which is stabilized towards mechanical stresses, has an insulin concentration of more than 1 I.U./ml and has a viscosity of at least 1.75 mPa.s at 4°C, which comprises adding a physiologic- ally acceptable thickener, by itself or additionally with a physiologically acceptable surface-active substance, to an aqueous insulin formulation. The invention furthermore relates to the use of such an agent as a medicine in the treatment of diabetes mellitus, in particular for use in devices for continuous release of insulin or as a medicine with a delayed action, the use of a physiologically acceptable thickener, by itself or together with a physio- logically acceptable surface-active substance, for stabilizing the abovementioned aqueous insulin formula- tions, and the use of a thickener as a depot auxiliary in aqueous insulin formulations.

483496

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