Non-aqueous injectable formulations for extended release of somatotropin

A method of making a composition of matter, comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent is selected from the group consisting of one or a mixture of both of the following:
• a) one or more non-reducing carbohydrate(s) and
• b) one or more oxo-acid salt(s);
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier, wherein the somatotropin is present at from about 10 to about 50% by weight of the composition, wherein the bioavailability enhancing constituent is present at from about 1% to about 20% by weight of the composition, and
• wherein the composition is fluidly injectable at 25° C.;
• the method comprising:
• providing the somatotropin as a lyophilized dry solid, the bioavailability enhancing constituent, as a dry solid, and the hydrophobic carrier;
• mixing the bioavailability enhancing constituent with the hydrophobic carrier, to produce a first suspension;
• and,
• mixing the somatotropin with the first suspension to produce a second suspension.

A composition of matter, comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or more non-reducing carbohydrates;
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier, wherein the somatotropin is present at from about 10 to about 50% by weight of the composition, wherein the bioavailability enhancing constituent is present at from about 1% to about 20% by weight of the composition, and
• wherein the composition is fluidly injectable at 25° C.

A composition of matter, comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or more oxo-acid salts;
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier, wherein the somatotropin is present at from about 10 to about 50% by weight of the composition, wherein the bioavailability enhancing constituent is present at from about 1% to about 20% by weight of the composition, and
• wherein the composition is fluidly injectable at 25° C.