| 摘要 |
A liquid oromucosal composition comprises testosterone for use in treating testosterone deficiency. Preferably, the composition is an aqueous formulation which is administered buccally or sublingually in the form of a spray and comprises about 0.1-5% w/v testosterone or a pharmaceutically acceptable ester thereof in an aqueous vehicle comprising a complexing agent for testosterone, wherein the complexing agent is preferably a cyclodextrin in particular, 0.1-1.5% w/v beta-cyclodextrin or 1-10% w/v randomly methylated-beta-cyclodextrin. The composition may further comprise up to 15% v/v C2-5 alcohol. A non-aqueous pharmaceutical composition for oromucosal administration comprising 0.1-5% w/v testosterone or a pharmaceutically acceptable ester thereof, a non-aqueous vehicle comprising about 4-35% v/v C2-5 alcohol and a pharmaceutically acceptable non-aqueous solvent preferably isopropyl myristate or dimethyl isosorbide is also outlined. A device for administering the testosterone liquid composition to a patient dose-wise, each dose having a volume of about 10-500µL and an alarm for emitting a detectable signal at predetermined times or intervals to remind the patient to administer a dose of the composition is also provided. |
