Therapeutic insulin preparation and a process for the production of a stable insulin preparation with protracted effect
AssigneeNordisk Insulinlaboratorium
InventorsBruno A. Hansen, Finn H. Andresen
Life of this patent
Estimating the term…
Abstract
Novel stable insulin preparations with protracted action and reduced or no antigenicity are obtained by reacting insulin free of antigenic impurities with an organic compound having basic amino groups, preferably a basic polypeptide or a cleavage product of a basic polypeptide, such as protamine, in a buffered protein dissociating or protein depolymerizing aqueous medium. Examples of preferred protein dissociating or protein depolymerizing media are aqueous solutions containing urea, a lower alkanol dialkylformamide, acetamide, N-alkyl-acetamide or acetonitrile.
Claims17
In a process for producing a stable insulin preparation with protracted action, wherein insulin is purified to a state of reduced or no antigenicity and then is reacted with an organic base containing amino groups in an aqueous medium maintained at a pH of about 6 to about 9, and the insulin preparation is isolated, the improvement comprising utilizing for said reaction with said organic base a medium containing a protein depolymerizing or protein dissociating stabilizer to maintain said purified insulin in a dissolved monomeric or loosely aggregated form during said reaction, thereby producing a stable insulin preparation with protracted action and reduced or no antigencity.
Dependencies are inferred from the claim text.