Genentech, Inc.

John E Battersby

William S Hancock

Ross G Clark

Virgil B Lawlis

The present document discloses the formation of imine adducts, preferably between a primary amine of a biologically active polypeptide and a reactive aldehyde group of a physiologically acceptable carrier. The imine adduct of human growth hormone and dextran is specifically described. These adducts serve to release the biologically active polypeptide via the reversible reaction in the formation of the imine adduct bond. These adducts have a surprising degree of stability that permits the use of the complex as a sustained release preparation. A key advantage of this technology is that after hydrolysis the complex releases the unmodified pharmaceutical. Thus, these adducts can be used as pharmaceutical compositions useful for the sustained release of the biologically active polypeptide over a predetermined, desired period of time.

Sustained release pharmaceutical composition

Container systems for stable storage of pharmaceutical compounds are disclosed. The container systems prevent the formation of adducts between pharmaceutical compounds and aldehydes during storage of these compounds in containers sealed with elastomeric stoppers that leach aldehydes. Methods for determining the presence of these adducts are also disclosed.

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Hillsborough, CA, United States of America

John E Battersby