Testosterone containing pharmaceutical composition
AssigneeNeurocrine UK Limited
InventorsMartin Whitaker, John Porter, Richard Ross, Stewart Jones, Elizabeth Cocks
Life of this patent
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Abstract
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.
Claims72
A pharmaceutical composition for adapted for oral administration comprising at least 10% w/w native testosterone, at least 36% w/w sesame oil, at least 28% w/w propylene glycol monolaurate, at least 9% w/w ethanol and at least 14% w/w benzyl alcohol.
A dosage regimen for use in a human subject in need of treatment that would benefit from administration of native testosterone comprising administering a pharmaceutical composition comprising:
- native testosterone, sesame oil, propylene glycol monolaurate, ethanol and benzyl alcohol wherein the composition is administered orally at least once in a 24-hour period to said human subject to normalise serum testosterone.
A dosage regimen for use in a human subject in need of treatment that would benefit from administration of native testosterone comprising administering at least a first and a second pharmaceutical compositions wherein,
- the first composition comprises between 2.5-7.5% w/w native testosterone, sesame oil, propylene glycol monolaurate, ethanol and benzyl alcohol;
- and
- the second composition comprises at least 9% w/w native testosterone, sesame oil, propylene glycol monolaurate, ethanol and benzyl alcohol;
- wherein said first and second compositions are administered orally at least once in a 24-hour period to said human subject to normalise serum testosterone.
A dosage regimen for a human female subject in need of treatment that would benefit from administration of native testosterone comprising administering a pharmaceutical composition comprising:
- native testosterone, sesame oil, propylene glycol monolaurate, ethanol and benzyl alcohol wherein the composition is administered orally at least once in a 24 hour period to said human subject to normalise serum testosterone.
A dosage regimen for use in a human subject suffering from frailty comprising administering a pharmaceutical composition comprising:
- native testosterone, sesame oil, propylene glycol monolaurate, ethanol and benzyl alcohol wherein the composition is administered orally to said human subject to increase serum testosterone.
A dosage regimen for use in a female human subject in the treatment of Turner's syndrome comprising administering a pharmaceutical composition comprising:
- native testosterone, sesame oil, propylene glycol monolaurate, ethanol and benzyl alcohol wherein the composition is administered orally to said human female subject to increase serum testosterone.
A process to produce a composition comprising native testosterone comprising
- i) forming a homogeneous preparation comprising sesame oil, propylene glycol monolaurate, benzyl alcohol and ethanol;
- ii) adding native testosterone at a concentration of about 13% w/w to said homogeneous preparation to form a combined testosterone preparation;
- and
- iii) mixing the combined preparation to dissolve testosterone to form a substantially clear preparation.
Dependencies are inferred from the claim text.