Patent ID: 6647980
Filing Date: 2003-11-18
Classification: A61M,B05B,Y10S

Abstract:
A method for administering a pharmaceutical preparation comprising at least one active substance to the olfactory region of a human, the method comprising administering a unit dose of the pharmaceutical preparation 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 â€œIn vitro Delivery Testâ€  which comprisesa) 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.