Method for administration of active substances to the olfactory region

A method for treatment or prophylaxis of conditions or disorders in the brain or in the central nervous system, the method comprising administering an effective amount of an active substance to the olfactory region of a human, in a pharmaceutical preparation comprising said substance, by ejection from a nozzle of a spray device through a nostril of the human, the device being positioned so that a nozzle orifice of the nozzle is positioned approximately at the orifice of the nostril or in the vestibulum nasi, the device and the pharmaceutical preparation being adapted so that when the nasal spray device comprising the pharmaceutical preparation is subjected to the test “In vitro Delivery Test” which comprises

• a) placing said spray device comprising said nozzle orifice and the pharmaceutical preparation to be delivered, so that said nozzle orifice of the device points straight up,
• b) placing a water absorbent surface which is adapted to receive and substantially immediately absorb a spray or droplets 3 cm above, and perpendicular to, said nozzle orifice of the device, and
• c) ejecting a unit dose of the pharmaceutical preparation from the device and thereby applying it to the water absorbent surface by normal actuation of the device,
• d) determining the diameter of a region within which substantially all of the unit dose is delivered by measuring the diameter of the smallest circle which encompasses the area of the water absorbent surface which has been wetted by the pharmaceutical preparation, and
• e) assessing the delivery of at least a particular percentage of the unit dose within a region of the deposited unit dose, excising the circle from the surface, extracting the active substance from the excised area and measuring it quantitatively by spectrophotometry,
• the result of said test is utilized to deposit, substantially the total amount of the unit dose in a region having a diameter of at most 2 cm.

A nasal spray device containing an amount of a pharmaceutical preparation which contains an odorant and being adapted for ejecting a unit dose of the pharmaceutical preparation from a nozzle of the spray device through a nostril of a human on actuation of the device, the device having audiameter of a nozzle orifice of the nozzle in the range of 0.1-1.0 mm and the pharmaceutical preparation comprising a viscosity enhancing agent and having a dynamic viscosity in the range of 5-300 cP at 25° C., the device and the pharmaceutical preparation being adapted so that, when the nasal spray device comprising the pharmaceutical preparation is subjected to an In vitro Delivery Test which comprises:

• a) placing said spray device comprising said nozzle orifice and the pharmaceutical preparation to be delivered, so that said nozzle orifice of the device points straight up,
• b) placing a water absorbent surface which is adapted to receive and substantially immediately absorb a spray or droplets 3 cm above, and perpendicular to, said nozzle orifice of the device, and
• c) ejecting a unit dose of the pharmaceutical preparation from the device and thereby applying it to the water absorbent surface by normal actuation of the device,
• d) determining the diameter of a region within which substantially all of the unit dose is delivered by measuring the diameter of the smallest circle which encompasses the area of the water absorbent surface which has been wetted by the pharmaceutical preparation, and
• e) assessing the delivery of at least a particular percentage of the unit dose within a region of the deposited unit dose, excising the circle from the surface, extracting the active substance from the excised area and measuring it quantitatively by spectrophotometry,
• substantially the total amount of the unit dose is deposited in a region having a diameter of at the most 2 cm.