United States Patent:  6,011,011

Assignee:  Pharmacia & Upjohn Company (Kalamazoo, MI)

Filed:  March 20, 1995

The invention provides novel compositions useful for the sustained-release of bioactive proteins. More particularly, the present invention relates to novel suspensions of somatotropin and growth hormone releasing factor, in triacetin or polyethylene glycol. Also provided are methods of using these novel compositions as vehicles for the sustained or prolonged release of the bioactive protein or peptide.

SUMMARY OF THE INVENTION

The present invention relates to compositions of proteins in triacetin or polyethylene glycol (PEG). More particularly, the invention provides prolonged release of hormones, most particularly growth hormone or somatotropin and growth hormone releasing factor.

A particular embodiment of this aspect of the invention provides bovine somatotropin suspended in triacetin in a concentration of about five to about fifty percent (W/V).

An alternative embodiment of this aspect of the invention provides bovine somatotropin suspended in PEG 400 in a concentration of about five to about fifty percent (w/v).

An additional aspect of the invention provides the use of the compositions of the invention as sustained release vehicles, especially for subcutaneous and intramuscular injection.

More particularly, this aspect of the invention relates to the use of somatotropin suspended in triacetin or polyethylene glycol 400 to increase milk production in cows.

Most particularly, this aspect of the invention relates to the use of the somatotropin suspended in triacetin or in PEG, in a concentration of about ten to about thirty percent for injection into cows to increase milk production.

Claim 1 of 36 Claims

1. A nonaqueous composition consisting essentially of a therapeutically effective amount of a bioactive protein suspended in polyethylene glycol wherein said bioactive protein is selected from the group consisting of somatotropin and growth hormone releasing factor and said polyethylene glycol is selected from the group consisting of PEG 300 to PEG 600.

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