Composition, vessel, dry powder inhalation system, and related methods for transpulmonary administration

A dry powder inhalation system for transpulmonary administration comprising:

• an inlet flow path;
• a vessel containing a non-powder-form freeze-dried composition, formed by freeze-drying without further processing, comprising an active ingredient;
• and
• an outlet flow path;
• wherein a positive pressure in the inlet flow path causes air from the inlet flow path to impact the non-powder-form freeze-dried composition in the vessel and discharge at least part of the freeze-dried composition through the outlet flow path in the form of fine particles,
• wherein the non-powder-form freeze-dried composition has a disintegration index greater than or equal to 0.015,
• wherein the non-powder-form freeze-dried composition becomes the fine particles upon receiving air impact at an air speed greater than or equal to 1 meter/second and an air flow rate greater than or equal to 17 milliliters/second, and
• wherein the fine particles have:
• a mean particle diameter less than or equal to 1×10−5 meters;
• or
• a fine particle fraction greater than or equal to 10%;
• or
• a mean particle diameter less than or equal to 1×10−5 meters and a fine particle fraction greater than or equal to 10%.

A dry powder inhalation system for transpulmonary administration comprising:

• an inlet flow path;
• a vessel containing a non-powder-form freeze-dried composition, formed by freeze-drying without further processing, comprising an active ingredient;
• and
• an outlet flow path in communication with an inhalation port;
• wherein a negative pressure in the outlet flow path causes air from the inlet flow path to impact the non-powder-form freeze-dried composition in the vessel and discharge at least part of the freeze-dried composition through the outlet flow path in the form of fine particles,
• wherein the non-powder-form freeze-dried composition has a disintegration index greater than or equal to 0.015,
• wherein the non-powder-form freeze-dried composition becomes the fine particles upon receiving air impact at an air speed greater than or equal to 1 meter/second and an air flow rate greater than or equal to 17 milliliters/second, and
• wherein the fine particles have:
• a mean particle diameter less than or equal to 1×10−5 meters;
• or
• a fine particle fraction greater than or equal to 10%;
• or
• a mean particle diameter less than or equal to 1×1031 5 meters and a fine particle fraction greater than or equal to 10%.

A dry powder inhalation system for transpulmonary administration comprising:

• a source of pressurized air;
• a first needle part comprising a first flow path;
• a second needle part comprising a second flow path;
• a vessel containing a freeze-dried cake, formed by freeze-drying without further processing, comprising at least one active ingredient;
• and
• an inhalation port;
• wherein the source of pressurized air communicates with the vessel via the first flow path, and
• wherein the vessel communicates with the inhalation port via the second flow path,
• wherein the freeze-dried cake has at least the following properties:
• a disintegration index greater than or equal to 0.015;
• and
• the freeze-dried cake becomes fine particles upon receiving air impact at an air speed greater than or equal to 1 meter/second and an air flow rate greater than or equal to 17 milliliters/second;
• and
• wherein the fine particles have:
• a mean particle diameter less than or equal to 1×10−5 meters;
• or
• a fine particle fraction greater than or equal to 10%;
• or
• a mean particle diameter less than or equal to 1×10−5 meters and a fine particle fraction greater than or equal to 10%.

A dry powder inhalation system for transpulmonary administration comprising:

• a first needle part comprising a first flow path;
• a second needle part comprising a second flow path;
• an inhalation port;
• and
• a vessel containing a freeze-dried cake, formed by freeze-drying without further processing, comprising at least one active ingredient;
• wherein the inhalation port communicates with the vessel via the first flow path, and
• wherein the vessel communicates with an external environment via the second flow path,
• wherein the freeze-dried cake has at least the following properties:
• a disintegration index greater than or equal to 0.015;
• and
• the freeze-dried cake becomes fine particles upon receiving air impact at an air speed greater than or equal to 1 meter/second and an air flow rate greater than or equal to 17 milliliters/second;
• and
• wherein the fine particles have:
• a mean particle diameter less than or equal to 1×10−5 meters;
• or
• a fine particle fraction greater than or equal to 10%;
• or
• a mean particle diameter less than or equal to 1×10−5 meters and a fine particle fraction greater than or equal to 10%.

A dry powder inhalation system for transpulmonary administration comprising:

• a needle part;
• an inhalation port;
• and
• a vessel containing a non-powder-form freeze-dried composition, formed by freeze-drying without further processing, comprising at least one active ingredient;
• wherein the needle part comprises:
• a first flow path;
• and
• a second flow path;
• wherein the inhalation port communicates with the vessel via the first flow path,
• wherein the vessel communicates with an external environment via the second flow path,
• wherein air from the second flow path impacts the non-powder-form freeze-dried composition in the vessel, and
• wherein the non-powder-form freeze-dried composition has a disintegration index greater than or equal to 0.015.

A dry powder inhalation system for transpulmonary administration comprising:

• a source of pressurized air;
• a needle part;
• an inhalation port;
• and
• a vessel containing a non-powder-form freeze-dried composition, formed by freeze-drying without further nrocessing, comprising at least one active ingredient;
• wherein the needle part comprises:
• a first flow path;
• and
• a second flow path;
• wherein the source of pressurized air communicates with the vessel via the first flow path,
• wherein the vessel communicates with the inhalation port via the second flow path,
• wherein air from the first flow path impacts the non-powder-form freeze-dried composition in the vessel, and
• wherein the non-powder-form freeze-dried composition has a disintegration index greater than or equal to 0.015.

A non-powder-form freeze-dried composition, formed by freeze-drying without further processing, for transpulmonary administration having a disintegration index greater than or equal to 0.015 and containing at least one active ingredient;

• wherein the composition becomes fine particles upon receiving air impact at an air speed greater than or equal to 1 meter/second and an air flow rate greater than or equal to 17 milliliters/second, and
• wherein the fine particles have:
• a mean particle diameter less than or equal to 1×10−5 meters;
• or
• a fine particle fraction greater than or equal to 10%;
• or
• a mean particle diameter less than or equal to 1×10−5 meters and a fine particle fraction greater than or equal to 10%.

A composition comprising a freeze-dried cake in non-powder form, formed by freeze-drying without further processing, having at least the following properties:

• a disintegration index greater than or equal to 0.015;
• and
• the freeze-dried cake becomes fine particles upon receiving air impact at an air speed in a range of 1 meter/second to 300 meters/second and an air flow rate in a range of 17 milliliters/second to 15 liters/second;
• wherein the fine particles have:
• a mean particle diameter less than or equal to 1×10−5 meters;
• and/or
• a fine particle fraction greater than or equal to 10%.