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 comprises one or more of the following:
• a) non-reducing carbohydrate,
• b) amino acid, amino acid derivative, amino acid polymer, polyhistidine,
• c) hydroxamate or hydroxamate derivative, or
• d) oxo-acid salt;
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier;
• 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 method which comprises injecting into a mammal a composition of matter comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or more of the following:
• a) non-reducing carbohydrate,
• b) amino acid, amino acid derivative, amino acid polymer, polyhistidine,
• c) hydroxamate or hydroxamate derivative, or
• d) oxo-acid salt;
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier.

A composition of matter, comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or more non-reducing carbohydrates;
• and
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier.

A composition of matter, comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or more compounds selected from the group consisting of amino acids, amino acid derivatives, amino acid polymers, and polyhistidine;
• and
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier.

A composition of matter, comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or more compounds selected from the group consisting of hydroxamates and hydroxamate derivatives;
• and
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier.

A composition of matter, comprising:

• somatotropin and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or more oxo-acid salts;
• and
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier.

A method for sustaining elevated milk production response in a lactating mammal comprising:

• injecting into the mammal a biocompatible composition of matter, comprising:
• a somatotropin, active in the mammal, and a bioavailability enhancing constituent;
• wherein the bioavailability enhancing constituent comprises one or a mixture of two or more of the following:
• a) non-reducing carbohydrate,
• b) amino acid, amino acid derivative, amino acid polymer, polyhistidine,
• c) hydroxamate or hydroxamate derivative, or
• d) oxo-acid salt;
• and
• wherein the somatotropin and the bioavailability enhancing constituent are suspended in a substantially non-aqueous hydrophobic carrier.