Patent classifications
A61K31/568
Pharmaceutical compositions of testosterone
The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, as well as methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.
Pharmaceutical compositions of testosterone
The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, as well as methods of using such pharmaceutical compositions for hormone replacement therapy, e.g., in a male patient having a condition associated with symptoms of deficiency or absence of endogenous testosterone.
METHODS AND MEDICAL USES
There is provided a method of treatment of hypersomnolence comprising administering the steroidal compound 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment.
METHODS AND MEDICAL USES
There is provided a method of treatment of hypersomnolence comprising administering the steroidal compound 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment.
Gonadotropin-releasing hormones for use as adjuvant immunotherapeutics
The present invention relates to the use of a gonadotropin-releasing hormone (including GnRH I, a GnRH I analogue, GnRH II, or a GnRH II analogue) as adjuvant immunotherapeutic.
Gonadotropin-releasing hormones for use as adjuvant immunotherapeutics
The present invention relates to the use of a gonadotropin-releasing hormone (including GnRH I, a GnRH I analogue, GnRH II, or a GnRH II analogue) as adjuvant immunotherapeutic.
Gonadotropin-releasing hormones for use as adjuvant immunotherapeutics
The present invention relates to the use of a gonadotropin-releasing hormone (including GnRH I, a GnRH I analogue, GnRH II, or a GnRH II analogue) as adjuvant immunotherapeutic.
Oral testosterone non-undecanoate therapy
Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a non-undecanoate testosterone ester while avoiding unacceptably high testosterone levels.
Oral testosterone non-undecanoate therapy
Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a non-undecanoate testosterone ester while avoiding unacceptably high testosterone levels.
Applicator system for applying a viscous liquid to the human skin
The application relates to an applicator system (1) for applying a viscous liquid, in particular a transdermal pharmaceutical formulation, to the human skin comprising a metering dispenser (2) in turn comprising a container holding the viscous liquid and a pump (5) for metering the liquid and an applicator (3) detachably connected to the dispenser (2) and comprising an application surface (6) for receiving a metered amount of the liquid from the dispenser (2). The application surface (6) is convex.