Bi-dose nasal spray

Inventors

Fröhlich, Johannes Malte • ZADORY, MATTHIAS GERGELY • BIENDL, STEFAN PASCAL

Assignees

Akroswiss AG

Abstract

A nasal spray containing an aqueous solution or a fluid with an anxiolytic or anticonvulsant substance, wherein the nasal spray is characterized in that with the nasal spray, two sprays with each an equivalent, defined volume of the aqueous solution or liquid of the active agent, can be intranasally administered to a patient. The nasal spray allows for an administration, independent of the spatial orientation of the nasal spray in any position of the patient (standing upright, sitting, lying or in any intermediate position). The nasal spray can be used directly without prior activation. It is apparent from the nasal spray whether a spray or even a second spray has been made with the nasal spray. A spray can be administered one-handed by the patient or a third person. The active agent is midazolam or a salt thereof.

Core Innovation

The invention describes 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. The device contains four components: a drive element including an actuator, a spring, and a hollow needle, a vial holder, an active agent container, and an air-tight sealing plug. Triggering of the nasal spray device is independent from air pressure by direct shift of the active agent container against the air-tight sealing plug by pressure to the drive element, whereby the hollow needle perforates the air-tight sealing plug.

The invention is characterized by a blocking system consisting of two blocking points in the vial holder, whereby a spraying mechanism is blocked at a first spray blocking point and then again blocked at a second spray blocking point. The active agent container contains an aqueous solution or a liquid of midazolam or a salt thereof. The active agent container is hermetically sealed with the air-tight sealing plug so that as little as possible or no residual air is left in the active agent container.

The device is configured to allow administration of two doses 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 is depleted after delivery of the second spray-dose so that no further spray is possible. The device is configured to allow for equal administration of the two doses independent of a spatial orientation of the nasal spray device.

Claims Coverage

The independent claim covers a ready-to-use bi-dose nasal spray device with four component mechanical triggering and a two-point blocking system, delivering two equal, defined-volume doses of a hermetically sealed aqueous midazolam (or salt) formulation independent of device spatial orientation; the claim includes five inventive features.

Overall, the independent claim centers on a bi-dose nasal spray device whose activation is independent of air pressure via direct container shift and hollow-needle perforation of an air-tight sealing plug, coupled with a two-point blocking mechanism and hermetically sealed, aqueous midazolam (or salt) formulation that minimizes residual air. It further specifies two equal, defined-volume doses with depletion after the second spray and equal administration regardless of device spatial orientation.

Stated Advantages

Documented Applications