Non-aqueous surfactant-containing formulations for extended release of somatotropin
AssigneeMonsanto Technology LLC
InventorsYunhua N. Jeng, Kanaiyalal R. Patel
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Abstract
The present invention provides compositions comprising biologically-active somatotropin formulated for extended release and methods of preparing and methods of using the same. These compositions comprise somatotropin, at least a first bioavailability-enhancing constituent (BEC), and a substantially non-aqueous, hydrophobic excipient, and optionally a second BEC. The first BEC is typically a surfactant (preferably a non-ionic surfactant) or a cyclodextrin compound. The optional second BEC may comprise (i) amino acids or amino acid derivatives; (ii) hydroxamate derivatives; (iii) non-reducing carbohydrates; (iv) oxo-acid salts; or (v) a mixture of two or more compounds from within the foregoing classes (i)-(iv).
Claims19
A composition of matter, comprising:
- a) somatotropin;
- b) a first bioavailability enhancing constituent (BEC);
- and,
- c) optionally, a second BEC;
- wherein the first BEC is a non-ionic surfactant;
- wherein the second BEC is selected from one or a mixture of two or more of the following:
- one or more non-reducing carbohydrate(s) and one or more oxo-acid salt(s);
- wherein the somatotropin and BEC 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 first (BEC) is present at from about 0.1% to about 10% by weight of the composition;
- and,
- wherein the composition is fluidly injectable at 25° C.
A composition of matter, comprising:
- a) somatotropin,
- b) a first bioavailability enhancing constituent (BEC), and,
- c) optionally, a second BEC;
- wherein the first BEC comprises one or a mixture of two or more of the following:
- polyoxyethylene 4 stearate, polyoxyethylene 8 stearate, polyoxyethylene(20) sorbitan monooleate;
- wherein the second BEC is selected from one or a mixture of two or more of the following:
- one or more non-reducing carbohydrate(s) and one or more oxo-acid salt(s);
- wherein the somatotropin and BEC 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 first (BEC) is present at from about 0.1% to about 10% by weight of the composition;
- and,
- wherein the composition is fluidly injectable at 25° C.
A method of administering somatotropin to a susceptible animal comprising:
- parenterally administering to the animal a biocompatible composition of matter comprising:
- a) a somatotropin, biologically-active in the animal;
- b) a first bioavailability enhancing constituent (BEC);
- and,
- c) optionally, a second BEC;
- wherein the first BEC is selected from a non-ionic surfactant;
- wherein the second BEC is selected from one or a mixture of two or more of the following:
- one or more non-reducing carbohydrate(s) and one or more oxo-acid salt(s);
- wherein the somatotropin and BEC 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 first (BEC) is present at from about 0.1% to about 10% by weight of the composition;
- and,
- wherein the composition is fluidly injectable at 25° C.
The method of 16, wherein the first BEC is selected from one or a mixture of two or more of the following:
- polyoxyethylene 4 stearate, polyoxyethylene 8 stearate, and polyoxyethylene(20) sorbitan monooleate.
Dependencies are inferred from the claim text.