A61K31/568

Microemulsion Delivery Systems for Alcohol-Soluble Species Including DHEA, Pregnenolone, and Chrysin for Reducing Menopausal Symptoms

Microemulsions are described where hydrophobic liquid droplets are distributed in a continuous hydrophilic liquid phase. In relation to conventional oil-in-water (OIW) microemulsions, the described microemulsions may be thought of as modified oil-in-water (MOIW) microemulsions, where both the “oil” and “water” phases of the microemulsion are modified. The oil phase droplets of the MOIW microemulsion are modified with alcohol and can solubilize alcohol-soluble species, including nonderivatized hormones. More preferably, the modified oil phase droplets of the MOIW microemulsion directly solubilize nonderivatized hormones. The oil phase droplets of the MOIW microemulsion include DHEA, pregnenolone, and a polyphenol, where a ratio of DHEA to polyphenol is from 1:1 to 12:1 by weight. Methods of supporting and/or increasing bloodstream hormone levels in perimenopausal and postmenopausal females and improving menopausal symptoms also are disclosed.

DEUTERATED FORMS OF TESTOSTERONE AND METHODS OF USE

Provided herein are compositions (e.g., pharmaceutical compositions) comprising deuterated testosterone, deuterated methyltestosterone, or derivatives thereof. The provided compositions and related methods may be useful for treating and/or preventing various diseases and conditions, such as hypogonadism, delay of growth and puberty, weight loss associated with HIV-associated wasting, vulvar dystrophies, micropenis, breast cancer, and sexual disorders.

DEUTERATED FORMS OF TESTOSTERONE AND METHODS OF USE

Provided herein are compositions (e.g., pharmaceutical compositions) comprising deuterated testosterone, deuterated methyltestosterone, or derivatives thereof. The provided compositions and related methods may be useful for treating and/or preventing various diseases and conditions, such as hypogonadism, delay of growth and puberty, weight loss associated with HIV-associated wasting, vulvar dystrophies, micropenis, breast cancer, and sexual disorders.

TESTOSTERONE CONTAINING PHARMACEUTICAL COMPOSITION

We disclose a pharmaceutical composition adapted for oral delivery comprising native testosterone; a treatment regimen comprising administration of the composition(s); and methods and uses for the treatment of hormone related conditions such as hypogonadism in human male, female and transgender subjects.

TESTOSTERONE CONTAINING PHARMACEUTICAL COMPOSITION

We disclose a pharmaceutical composition adapted for oral delivery comprising native testosterone; a treatment regimen comprising administration of the composition(s); and methods and uses for the treatment of hormone related conditions such as hypogonadism in human male, female and transgender subjects.

Steroidal compositions and method of making and use

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.

Steroidal compositions and method of making and use

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.

HORMONAL MANIPULATION OF FIBROBLAST THERAPEUTIC ACTIVITY
20230158080 · 2023-05-25 ·

Disclosed are means of enhancing therapeutic activities of fibroblasts through manipulation of nuclear receptor activation accomplished by, intra alia, alteration in hormone levels. In some embodiments angiogenic, and/or neurogenic, and/or immunomodulatory activities of fibroblasts are increased by normalization or augmentation of sex-specific hormones. In one embodiment a candidate for fibroblast therapy is administered hormones, pro-hormones, or growth factors to augment therapeutic activities of fibroblasts. In some embodiments fibroblasts are treated in vitro prior to administration with various hormones and/or growth factors in order to augment therapeutic activities of said cells.

HORMONAL MANIPULATION OF FIBROBLAST THERAPEUTIC ACTIVITY
20230158080 · 2023-05-25 ·

Disclosed are means of enhancing therapeutic activities of fibroblasts through manipulation of nuclear receptor activation accomplished by, intra alia, alteration in hormone levels. In some embodiments angiogenic, and/or neurogenic, and/or immunomodulatory activities of fibroblasts are increased by normalization or augmentation of sex-specific hormones. In one embodiment a candidate for fibroblast therapy is administered hormones, pro-hormones, or growth factors to augment therapeutic activities of fibroblasts. In some embodiments fibroblasts are treated in vitro prior to administration with various hormones and/or growth factors in order to augment therapeutic activities of said cells.

Oral (17-ß)-3-Oxoandrost-4-EN-17-YL Tridecanoate Therapy

Disclosed are pharmaceutical compositions and oral dosage forms including capsules containing (17-β)-3-oxoandrost-4-en-17-yl tridecanoate, and related methods. The capsule fill can include an additive and about 14 wt % to about 42 wt % for androst-4-en-17β-ol-3-one esters that comprise (17-β)-3-oxoandrost-4-en-17-yl tridecanoate or a combination of (17-β)-3-oxoandrost-4-en-17-yl undecanoate, (17-β)-3-oxoandrost-4-en-dodecanoate, and (17-β)-3-oxoandrost-4-en-17-yl tridecanoate. A single oral administration to a male subject of one or more dosage forms with a total androst-4-en-17β-ol-3-one equivalent dose of about 150 mg to about 895 mg is provided. In another embodiment, a method for providing a serum concentration of androst-4-en-17β-ol-3-one within a target PK performance for a male subject is provided. In a further embodiment, the pharmaceutical compositions and methods comprising androst-4-en-17β-ol-3-one ester loading of 14 wt % to 42 wt % achieve androst-4-en-17β-ol-3-one PK performance targets and require titration(s) to show therapeutic effectiveness for treatment of hypogonadism.