Steroidal compositions and method of making and use
Inventors
Boatman, Cody • DeNeui, Daniel • Graves, Justin
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11628138-B2
Publication Date
2023-04-18
Expiration Date
Abstract
Disclosed herein are compositions useful for treating hypogonadism in men and women. The disclosed compositions comprise an admixture of testosterone and triamcinolone which combination alleviates pellet injection site pain and/or discomfort, as well as pellet extrusion.
Core Innovation
The invention relates to an implantable pharmaceutical composition consisting of testosterone, triamcinolone, and stearic acid, ethylcellulose, or mixtures thereof, with specified weight ranges. The composition is configured as an implantable delivery format and is associated with pellet-form characteristics, including hardness of less than 75 N.
The described pharmaceutical composition includes from about 10 mg to about 250 mg by weight of testosterone and from about 1 µg to about 50 µg by weight of triamcinolone. The composition also includes from about 0.4 mg to about 12 mg of stearic acid, ethylcellulose or mixtures thereof.
A method is described for treating a subject in need of an increased testosterone level by contacting the subject with the defined implantable pharmaceutical composition. Clinical data are reported for male and female subjects, including initial and final total testosterone and initial and final free testosterone.
Claims Coverage
The document includes two independent claims. Across the claims, the core inventive structure is defined by specified weight ranges for testosterone and triamcinolone, together with specified amounts of stearic acid and ethylcellulose, expressed as a composition that consists of those components.
Implantable pharmaceutical composition with defined testosterone, triamcinolone, and stearic acid/ethylcellulose ranges
An implantable pharmaceutical composition consisting of from about 10 mg to about 250 mg by weight of testosterone; from about 1 µg to about 50 µg by weight of triamcinolone; and from about 0.4 mg to about 12 mg of stearic acid, ethylcellulose or mixtures thereof.
Treating a subject needing increased testosterone using a composition with defined testosterone, triamcinolone, stearic acid, and ethylcellulose ranges
A method for treating a subject in need of an increased testosterone level, comprising contacting the subject with a composition consisting of from about 10 mg to about 250 mg by weight of testosterone; from about 1 µg to about 50 µg by weight of triamcinolone; from about 0.5 mg to about 12.5 mg by weight of stearic acid; and from about 0.113 mg to about 1.8 mg by weight of ethylcellulose.
Claim coverage centers on an implantable pharmaceutical composition defined by fixed weight ranges for testosterone and triamcinolone combined with specified stearic acid and/or ethylcellulose amounts, and a treating method that contacts a subject needing increased testosterone using that defined composition.
Stated Advantages
Reduces injection site pain/discomfort.
Reduces pellet extrusion.
Documented Applications
Treatment of hypogonadism in men and women using implantable pharmaceutical compositions in pellet form.
Treating a subject in need of an increased testosterone level by contacting the subject with the defined implantable pharmaceutical composition.
Interested in licensing this patent?