US 12,239,780 B2
Bi-dose nasal spray
Johannes Malte Fröhlich, Zollikon (CH); Matthias Gergely Zadory, Dietikon (CH); and Stefan Pascal Biendl, Basel (CH)
Assigned to AKROSWISS AG, Zug (CH)
Appl. No. 17/053,284
Filed by AKROSWISS AG, Zug (CH)
PCT Filed May 8, 2019, PCT No. PCT/EP2019/061827
§ 371(c)(1), (2) Date Nov. 5, 2020,
PCT Pub. No. WO2019/215235, PCT Pub. Date Nov. 14, 2019.
Claims priority of application No. 00575/18 (CH), filed on May 8, 2018; and application No. 18209897 (EP), filed on Dec. 3, 2018.
Prior Publication US 2021/0361884 A1, Nov. 25, 2021
Int. Cl. A61M 15/08 (2006.01); A61K 31/5517 (2006.01); A61M 11/00 (2006.01)
CPC A61M 11/007 (2014.02) [A61K 31/5517 (2013.01); A61M 15/08 (2013.01); A61M 2209/02 (2013.01)] 9 Claims
OG exemplary drawing
 
1. A ready-to-use bi-dose nasal spray device for sedation, premedication, or treatment of patients with claustrophobia, anxiety disorders, panic attacks; or for the treatment of convulsions in CNS diseases consisting of four components:
a) a drive element (A) including an actuator, including a spring and a hollow needle;
b) a vial holder (B);
c) an active agent container (C); and
d) an air-tight sealing plug (D),
whereby triggering of the nasal spray device is independent from air pressure by direct shift of the active agent container (C) against the air-tight sealing plug (D) by pressure to the drive element (A) whereby the hollow needle perforates the air-tight sealing plug (D);
characterized in that
i) the nasal spray device has a blocking system consisting of two blocking points (BP) in the vial holder (B) whereby a spraying mechanism is blocked at a first spray blocking point (BP1) and then again blocked at a second spray blocking point (BP2);
ii) the active agent container (C) contains an aqueous solution or a liquid of midazolam or a salt thereof;
iii) the active agent container (C) containing the aqueous solution or the liquid of the midazolam or the salt thereof is hermetically sealed with the air-tight sealing plug (D) so that as little as possible or no residual air is left in the active agent container (C);
iv) the nasal spray device is configured to allow the administration of two doses consisting of a first spray-dose and a second spray-dose with each an equivalent, defined volume of the aqueous solution or the liquid of the midazolam or the salt thereof, and the aqueous solution or the liquid of the midazolam or the salt thereof is depleted after delivery of the second spray-dose so that no further spray of the ready-to-use bi-dose nasal spray device is possible; and
(v) wherein the nasal spray device is configured to allow for an equal administration of the two doses, independent of a spatial orientation of the nasal spray device.