Respiratory drug condensation aerosols and methods of making and using them

A method for forming a respiratory drug condensation aerosol comprising the steps of:

• providing a respiratory drug composition in a unit dose form;
• and
• vaporizing the respiratory drug composition, wherein the step of vaporizing the respiratory drug composition comprises the step of heating the composition to form a vapor.

A respiratory drug condensation aerosol comprising:

• respiratory drug condensation aerosol particles, wherein the respiratory drug aerosol particles comprise a respiratory drug selected from the group consisting of β-adrenergics, methylxanthines, anticholinergics, corticosteroids, mediator-release inhibitors, anti-leukotriene drugs, asthma inhibitors, asthma antagonists, anti-endothelin drugs, prostacyclin drugs, ion channel or pump inhibitors, enhancers, or modulators, and pharmaceutically acceptable analogs, derivatives, and mixtures thereof, and wherein the respiratory drug condensation aerosol has a MMAD in the range of about 2-4 μm.

A kit for delivering a respiratory drug condensation aerosol comprising:

• a composition comprising a respiratory drug in a unit dose form;
• and
• a device for forming a respiratory drug aerosol, wherein the device for forming the respiratory drug aerosol comprises an element configured to heat the composition to form a vapor, an element allowing the vapor to condense to form a condensation aerosol, and an element permitting a user to inhale the condensation aerosol.

A method for treating a respiratory ailment comprising the step of:

• administering a therapeutically effective amount of a respiratory drug condensation aerosol to a person with the respiratory ailment, wherein the respiratory drug aerosol comprises a respiratory drug and has a MMAD in the range of about 1.5-4 μm and a purity of at least 90%, and
• wherein the step of administering comprises the step of administering an orally inhalable respiratory drug aerosol to the person with the respiratory ailment.

A composition for delivery of a drug comprising a respiratory drug condensation aerosol

• a) formed by volatilizing a heat stable drug composition comprising a respiratory drug selected from the group consisting of β-adrenergics, methylxanthines, anticholinergics, corticosteroids, mediator-release inhibitors, anti-leukotriene drugs, asthma inhibitors, asthma antagonists, anti-endothelin drugs, prostacyclin drugs, ion channel or pump inhibitors, enhancers, or modulators under conditions effective to produce a heated vapor of said drug composition and condensing the heated vapor of the drug composition to form condensation aerosol particles and wherein the respiratory drug condensation aerosol has a MMAD in the range of about 2-4 μm.

A method for treating a respiratory ailment comprising the step of:

• administering a therapeutically effective amount of a respiratory drug condensation aerosol comprising a heat stable respiratory drug to a person with the respiratory ailment, wherein the step of administering comprises administering an orally inhalable respiratory drug condensation aerosol to the person with the respiratory ailment, and wherein the aerosol comprises at least 50% by weight of a respiratory drug.

A method of producing a heat stable respiratory drug in an aerosol form comprising:

• a) volatilizing a heat stable respiratory drug under conditions effective to produce a heated vapor of the drug and
• b) during said volatilizing, passing through the heated vapor to produce aerosol particles of the drug and an aerosol having an MMAD in the range of 1.5-4.