Prolonged release of biologically active somatotropins
AssigneeMonsanto Company
InventorJames W. Mitchell
Life of this patent
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Abstract
Prolonged parenteral release of a bioactive somatotropin at desirably effective levels can be achieved using novel compositions in which the somatotropin is present in a biocompatible oil in an unusually high proportion such as at least about 10% by weight. Also disclosed are certain metal-associated somatotropins that are useful for prolonged parenteral release of such somatotropins.
Claims35
An injectable prolonged release substantially nonaqueous suspension composition comprising:
- a biocompatible oil forming a continuous phase;
- an antihydration agent in the oil in an amount effective for retarding penetration of the oil by aqueous bodily fluids following administration of the composition by parenteral injection;
- a biologically active bovine somatotropin dispersed as a suspension in the composition and comprising from about 10% to about 50% by weight of the composition;
- the suspension composition being substantially free of water and other materials accelerating release of bovine somatotropin from the composition into aqueous fluids;
- and
- the suspension composition being effective for forming a parenteral depot following an administration by parenteral injection into an animal and having sufficient bovine somatotropin for providing release of the bovine somatotropin for at least seven days measurable as an increased bloodstream level of bovine somatotropin relative to the pre-bovine-somatotropin injected animal.
An injectable substantially nonaqueous suspension composition comprising:
- a biocompatible oil in an amount sufficient for forming a continuous phase;
- an antihydration agent in the oil in an amount effective for retarding penetration of the oil by aqueous bodily fluids following administration of the composition by parenteral injection;
- and
- a biologically active bovine somatotropin suspended in the composition and constituting from about 10 to about 50 weight percent of the composition;
- sufficient bovine somatotropin being present in the composition that an administration by parenteral injection into a bovine animal provides a prolonged release of the bovine somatotropin for at least seven days measurable as an increased bloodstream level of bovine somatotropin relative to the pre-bovine-somatotropin-injected animal;
- the composition being effective following parenteral injection for forming a parenteral depot providing said prolonged release, other materials optionally present in the composition not inhibiting said prolonged release.
An injectable prolonged-release substantially nonaqueous suspension composition comprising:
- a biocompatible oil forming a continuous phase and having therein (a) an antihydration agent retarding penetration of the oil by aqueous bodily fluids following administration by parenteral injection and (b) suspended biologically active bovine somatotropin constituting from at least 10 to about 50 percent of the composition by weight,
- the composition having sufficient bovine somatotropin that an administration by parenteral injection into a bovine animal is effective following injection for providing an increased bloodstream level of bovine somatotropin for at least seven days relative to the pre-bovine-somatotropin-injected animal.
Dependencies are inferred from the claim text.