AU2020267162B2 — Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration

USPTO Abstract

An intranasal testosterone gel for topical administration into a nasal cavity to control release of testosterone over a period of at least about 6 hours following the nasal cavity administration to provide replacement or supplemental testosterone in a male or female for treating male or female testosterone deficiency, without causing an unacceptable spike in testosterone blood level over dose life, said intranasal testosterone gel comprising: (a) testosterone in an amount effective to treat male/female testosterone deficiency; (b) at least one lipophilic or partly lipophilic carrier; (c) a super solvent for increasing testosterone solubility in said intranasal testosterone gel; and (d) a viscosity regulating agent in an amount effective to control the release of said testosterone from said intranasal testosterone gel, wherein said intranasal testosterone gel does not need a surfactant. An applicator system for perinasal administration testosterone gel (a) a chamber pre-filled with the plurality of doses of the testosterone gel; (b) an actuator nozzle, said actuator nozzle comprising an outlet channel and a tip and having a shape that conforms to the interior surface within the nasal cavity. WO 2012/156822 PCT/IB2012/001127 1/29 134 130 102 132 100 144 128 150 126 122 120 .124 FIG. 1