Preservative-free single dose inhaler systems

Inventors

Patton, John S. • Patton, Ryan S. • Kuo, Mei-chang • Ivri, Yehuda

Assignees

Aerami Therapeutics Inc

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Publication Number

US-8950394-B2

Patent

Publication Date

2015-02-10

Expiration Date


Abstract

An aerosolization system includes a squeezable container having a resilient container body. The container is configured to deliver a unit dosage of a liquid when squeezed a single time. The system also includes an aerosolizer that is constructed of a housing defining a mouthpiece, and an aerosol generator disposed in the housing. The aerosol generator includes a vibratable membrane having a front face and a rear face, and a vibratable element used to vibrate the membrane. Further, the housing includes an opening that is adapted to receive a unit dosage of the liquid from the container. The opening provides a liquid path to the rear face of the vibratable membrane.

Core Innovation

The invention relates to an aerosolization system comprising a container configured to deliver a unit dosage of a liquid when actuated a single time, and an aerosolizer comprising a housing defining a mouthpiece and an aerosol generator disposed entirely within the housing. The aerosol generator includes a vibratable membrane having a front face and a rear face, and a vibratable element used to vibrate the membrane.

The housing includes an opening configured to receive a unit dosage of the liquid from the container while the container is generally external to the housing, so the container can be grasped by a human hand to manually actuate the container a single time while the container is outside the housing. The opening provides a liquid path configured to drain the entire unit dosage onto the rear face of the vibratable membrane, where the unit dosage is stored on the rear face until the vibratable element is energized to aerosolize the entire unit dosage stored on the rear face.

In various configurations, the housing provides a sloped well region draining into the opening, and the opening and liquid path are configured to drain the entire unit dosage onto the rear face upon dispensing onto the well region. The invention further provides a vibratable membrane and vibratable element arrangement, including a dome-shaped vibratable membrane with multiple apertures and an annular piezoelectric element.

Claims Coverage

The independent claims are clm-00001, clm-00009, and clm-00017. Across these claims, the inventive coverage centers on three inventive features: a single-time actuation unit-dose container, draining and storing the entire unit dosage on the rear face of a vibratable membrane, and energizing a vibratable element to aerosolize the entire stored unit dosage.

Single-actuation unit-dose container delivers liquid to an internal vibratable membrane rear face via housing opening

An aerosolization system including a container configured to deliver a unit dosage of a liquid when actuated a single time, and an aerosolizer housing with an aerosol generator disposed entirely within the housing, where the generator comprises a vibratable membrane with a front face and a rear face and a vibratable element used to vibrate the membrane; the housing includes an opening configured to receive the unit dosage from the container while the container is generally external so the container can be grasped by a human hand to manually actuate it once; the opening provides a liquid path configured to drain the entire unit dosage onto the rear face where the unit dosage is stored until the vibratable element is energized to aerosolize the entire unit dosage stored on the rear face.

Sloped well region liquid path drains entire unit dosage onto vibratable membrane rear face

An aerosolization system including a container configured to deliver a unit dosage of a liquid when actuated a single time and an aerosolizer with a housing defining a mouthpiece and an aerosol generator disposed entirely within the housing comprising a vibratable membrane with a front face and a rear face and a vibratable element; the housing includes a sloped well region that drains into an opening adapted to receive the unit dosage from the container while the container is generally external to the housing; the opening provides a liquid path configured to drain the entire unit dosage onto the rear face upon dispensing onto the well region, with the entire unit dosage stored on the rear face until the vibratable element is energized to aerosolize the entire stored unit dosage.

Spring-biased tip seal single-actuation unit-dose container draining onto membrane rear face

An aerosolization system comprising a container having a proximal end, a distal end, and a nozzle positioned at the distal end, configured to deliver a unit dosage of a liquid when actuated a single time; the container further comprises a tip seal and a spring that biases the tip seal in a normally closed position, where actuation creates a sufficient pressure to move the tip seal and deliver the unit dosage from the nozzle and wherein after dispensing the tip seal closes to prevent liquids from moving back into the container; and an aerosolizer with a housing defining a mouthpiece and an aerosol generator disposed entirely within the housing including a vibratable membrane with a front face and a rear face and a vibratable element; the housing includes an opening adapted to receive the unit dosage while the container is generally external, where the opening provides a liquid path configured to drain the entire unit dosage onto the rear face for storage until the vibratable element is energized to aerosolize the entire stored unit dosage.

Across clm-00001, clm-00009, and clm-00017, the claims consistently require a manually actuated single-time unit-dose liquid container delivering liquid through a housing opening and liquid path that drains and stores the entire unit dosage on the rear face of a vibratable membrane, followed by energizing a vibratable element to aerosolize the entire stored unit dosage. Dependent refinements additionally include a sloped well region configuration, a spring-biased tip seal arrangement, a dome-shaped membrane with multiple apertures, and an annular piezoelectric element.

Stated Advantages

Reduces ambient-air contact by dispensing the unit dosage onto and storing it on the rear face of the vibratable membrane until aerosolization.

Avoids preservatives and avoids evaporative losses.

Provides dose delivery efficiency by dispensing substantially all of the dose onto the membrane for aerosolizing.

Documented Applications

Inhalation/aerosol delivery of liquid formulations, with insulin formulations mentioned.

Treatment of type I/II diabetes.

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