Preservative free insulin formulations and systems and methods for aerosolizing
Inventors
Patton, John S. • Patton, Ryan S. • Kuo, Mei-chang • Ivri, Yehuda
Assignees
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Publication Number
US-9180261-B2
Publication Date
2015-11-10
Expiration Date
Abstract
One embodiment describes an insulin formulation that is specifically adapted for aerosolization. The formulation includes a major amount of water and a minor amount of insulin. Further, the formulation is preservative free, without meta-cresol, cresol or phenol, to permit the formulation to be aerosolized using a vibrating aperture plate without substantial foaming of the insulin formulation.
Core Innovation
The invention relates to a preservative free insulin formulation that comprises a major amount of water and minor amounts of insulin, HCl and NaOH. The formulation is preservative free such that the formulation may be aerosolized using a vibrating aperture plate without substantial foaming of the formulation.
A dome shaped aperture plate having a plurality of apertures is used to aerosolize the preservative free insulin formulation. An amount of the insulin formulation is supplied to a rear side of the aperture plate where the amount is stored while resting on the rear side by force of gravity. The aperture plate is vibrated by an annular piezoelectric element circumscribing the apertures, and vibration causes the supplied insulin to be ejected from a front side of the aperture plate beneath the rear side as an aerosolized spray.
An aerosolization system is disclosed in which an inhaler includes a housing defining a mouthpiece and an aerosol generator. The aerosol generator comprises a vibratable membrane having a front face and a rear face vertically above the front face, with the rear face exposed to the atmosphere, and the membrane being dome shaped in geometry with apertures. A container positioned vertically above the rear face gravity feeds a metered amount of the preservative free insulin formulation to be held on the rear face until aerosolized solely by vibration of the aperture plate/membrane, and the system is configured for dispensing a metered amount in a specified volume range.
Claims Coverage
The independent claims are clm-00001 and clm-00010. Across these claims, the main coverage is directed to a preservative free insulin formulation and its gravity-fed, dome-shaped, vibration-based aerosolization using an annular piezoelectric element, including system-level structure that holds a metered amount on a rear face until aerosolization, with limitations against substantial foaming.
Gravity-fed dome shaped aperture plate aerosolization of preservative free insulin
A method for aerosolizing an insulin formulation comprising a major amount of water and minor amounts of insulin, HCl and NaOH that is preservative free, supplying a metered amount to a rear side of a dome shaped aperture plate having a plurality of apertures where the amount is stored by force of gravity, and vibrating the dome shaped aperture plate with an annular piezoelectric element circumscribing the apertures to eject the insulin from a front side beneath the rear side as an aerosolized spray without substantial foaming.
A vibrating dome shaped membrane inhaler with a gravity-fed metered preservative free insulin container
An aerosolization system with an inhaler housing having a mouthpiece and an aerosol generator comprising a vibratable dome shaped membrane with a plurality of apertures and a vibratable annular element circumscribing the apertures, together with a container containing a preservative free insulin formulation with a major amount of water and minor amounts of insulin, HCl and NaOH, positioned vertically above the rear face such that insulin is gravity fed to the rear face and held by gravity until aerosolized solely by vibration of the aperture plate, the container being configured to dispense a metered amount of insulin formulation in a specified volume range, with the membrane diameter sized such that the metered amount may be held on the rear face until aerosolized.
The claim set covers both (i) a method in which a gravity-held metered amount of a preservative free insulin formulation on a dome shaped, aperture plate is ejected by vibration with an annular piezoelectric element as an aerosolized spray without substantial foaming, and (ii) an aerosolization system that implements this architecture using a vibratable dome shaped membrane and a gravity-fed metered container positioned above a vertically separated rear face.
Stated Advantages
Aerosolized spray without substantial foaming of the preservative free insulin formulation.
Documented Applications
An inhaler system that aerosolizes insulin using a vibrating dome shaped aperture plate/membrane with gravity-fed, metered dosing from a preservative free insulin formulation container.
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