Use of antistatic materials in the airway for thermal aerosol condensation process
Inventors
Myers, Daniel J. • Kubel, Khe • Cassella, James
Assignees
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Publication Number
US-11511054-B2
Publication Date
2022-11-29
Expiration Date
Abstract
The disclosure teaches the use of antistatic materials in the airway for thermal aerosol generation devices. The present disclosure teaches the use of antistatic materials for drug delivery in any drug that may be susceptible to charging during aerosol generation.
Core Innovation
A device is provided for delivering a thermal condensation aerosol using a solid support with a thin layer of a drug composition coated on the solid support. The drug composition is alprazolam, and a housing defines an airway in which the housing cools a drug vapor generated by heating the alprazolam to form the condensation aerosol. Heating is via breath actuation, and a heat source supplies heat to the solid support at a rate that achieves a support temperature of at least 300°C and produces substantially complete vaporization of alprazolam within 2 seconds.
The resulting condensation aerosol is completely devoid of organic solvents, propellants, and any excipients. The method forms the condensation aerosol by heating a thin layer containing alprazolam on a solid support to produce alprazolam vapor, followed by condensing the vapor to form a condensation aerosol characterized by less than 10% drug degradation products by weight and an MMAD of less than 5 microns.
The airway housing includes an antistatic material. The claims refine how the antistatic material is provided in the airway housing, including antistatic material coated on an inner wall, metallized airways formed by coating the inner wall with conductive metals, conductive metals formed as a four-layer stack of stainless steel, copper, copper, and stainless steel, metallic tape applied to both the inner and outer walls of the airway housing, and antistatic plastics that are anti-static polycarbonate.
Claims Coverage
The document contains two independent claims. Across the independent claim set, the main inventive features are centered on a breath-actuated thermal condensation aerosol device/method for alprazolam using a thin layer on a solid support with specific vaporization and aerosol composition constraints, and an airway housing incorporating an antistatic material to enable vapor condensation through cooling in the airway.
Antistatic airway housing for thermal condensation aerosol delivery
A housing defining an airway in which the airway housing comprises an antistatic material, wherein the housing cools a drug vapor generated by heating the alprazolam to form the condensation aerosol; heating is via breath actuation.
Breath-actuated thin-layer thermal vaporization to form solvent/propellant-free condensation aerosol
A device comprising a solid support with a thin layer of a drug composition coated on the solid support, wherein the drug composition is alprazolam and the condensation aerosol is completely devoid of organic solvents, propellants, and any excipients, with heating via breath actuation to achieve a support temperature of at least 300°C and produce substantially complete vaporization of the alprazolam within 2 seconds.
Condensation aerosol characterized by low degradation and fine MMAD while condensing through an antistatic airway
A method producing drug condensation aerosol for inhalation by heating a thin layer containing alprazolam on a solid support via breath actuation to achieve a support temperature of at least 300°C and substantially complete vaporization within 2 seconds, condensing the vapor to form a condensation aerosol characterized by less than 10% drug degradation products by weight and an MMAD of less than 5 microns, and wherein an airway housing comprises an antistatic material and the vapor is condensed through cooling in an airway; the condensation aerosol is completely devoid of organic solvents, propellants, and any excipients.
The claim coverage is directed to a breath-actuated thermal condensation aerosol delivery approach for alprazolam using a thin layer on a solid support with specified vaporization/time and solvent/propellant/excipient-free condensation aerosol constraints, combined with an antistatic airway housing in which the vapor is condensed through airway cooling. Dependent claims further narrow the antistatic implementation to specified forms including coated inner walls, metallized/conductive-metal layered constructions, metallic tape on inner and outer walls, and anti-static polycarbonate.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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