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Claims for Patent: 8,485,180

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Claims for Patent: 8,485,180

Title:Dry powder drug delivery system
Abstract: A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, and a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of endocrine disease, for example, diabetes and/or obesity.
Inventor(s): Smutney; Chad C. (Watertown, CT), Adamo; Benoit (Mount Kisco, NY), Polidoro; John M. (Coventry, CT), Kinsey; P. Spencer (Sandy Hook, CT), Overfield; Dennis (Fairfield, CT), Sahi; Carl R. (Coventry, CT), Billings; Christine (Danbury, CT), Marino; Mark T. (Danbury, CT)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:12/717,884
Patent Claims: 1. An inhalation system, comprising: a dry powder formulation comprising a plurality of powder particles of a diketopiperazine; and a dry powder inhaler configured to deliver the powder particles to the pulmonary circulation of a subject in a single inhalation and having a container including a cup-like chamber with two relatively flat and parallel sides and a relatively rounded bottom having an internal volume containing the powder particles and a mouthpiece; portions of the inhaler defining a first flow path for 20-70% of the volume of air through the inhaler, said first flow path leading from an inlet to the chamber through the chamber and through at least one outlet from the chamber to the mouthpiece, the inlet and the at least one outlet being configured so that an air flow entering the chamber re-circulates within the internal volume of the chamber tumbling the particles and entraining them in the air flow; the inlet and the at least one outlet further being configured so that the air flow from the inlet is directed across the at least one outlet and controls exit from the chamber of powder particles entrained within the air flow; portions of the inhaler defining a second flow path for 30-80% of the volume of air through the inhaler, said second flow path by-passing the inlet into the chamber and merging with the first path as the first path leaves the at least one outlet; the first flow path changing in direction where it merges with the second flow path, fluidized powder particles exiting the at least one outlet being sheared on contact with the air flow in the second flow path; wherein the inhalation system is configured to deliver the diketopiperazine to the pulmonary circulation of a subject, and said diketopiperazine is measured in a subject's plasma having an AUC.sub.0-.infin. greater than 2,300 ng*min/mL per mg of diketopiperazine content in the dry powder formulation.

2. The inhalation system of claim 1, further comprising a cartridge configured to adapt to said dry powder inhaler.

3. The inhalation system of claim 1, wherein the dry powder inhaler is a breath powered inhaler.

4. The inhalation system of claim 3, wherein the diketopiperazine is bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine.

5. The inhalation system of claim 4, wherein the bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine has a T.sub.max of less than 1 hour.

6. The inhalation system of claim 1, wherein the dry powder formulation comprises an active ingredient.

7. The inhalation system of claim 6, wherein the active ingredient is a protein, a peptide, a polypeptide or fragments thereof.

8. The inhalation system of claim 6, wherein the active ingredient is insulin.

9. The inhalation system of claim 1, wherein the cup-like chamber containing the dry powder formulation is reconfigurable in the inhaler from a containment configuration to a dosing configuration.

10. An inhalation system, comprising: a dry powder formulation comprising a plurality of diketopiperazine powder particles; and a dry powder inhaler configured to deliver the powder particles to the pulmonary circulation of a subject in a single inhalation and having a container including a cup-like chamber with two relatively flat and parallel sides and a relatively rounded bottom having an internal volume containing the powder particles and a mouthpiece; portions of the inhaler defining a first flow path for 20-70% of the volume of air through the inhaler, said first flow path leading from an inlet to the chamber through the chamber and through at least one outlet from the chamber to the mouthpiece, the inlet and the at least one outlet being configured so that an air flow entering the chamber re-circulates within the internal volume of the chamber tumbling the particles and entraining them in the air flow; the inlet and the at least one outlet further being configured so that the air flow from the inlet is directed across the at least one outlet and controls exit from the chamber of powder particles entrained within the air flow; portions of the inhaler defining a second flow path for 30-80% of the volume of air through the inhaler, said second flow path by-passing the inlet into the chamber and merging with the first path as the first path leaves the at least one outlet; the first flow path changing in direction where it merges with the second flow path, fluidized powder particles exiting the at least one outlet being sheared on contact with the air flow in the second flow path; wherein the inhalation system is operably configured to emit a powder plume comprising the diketopiperazine microparticles having a volumetric median geometric diameter ranging from 2 .mu.m to 8 .mu.m and a geometric standard deviation of less than 4 .mu.m.

11. The inhalation system of claim 10, further comprising a cartridge for adapting to said dry powder inhaler.

12. The inhalation system of claim 10, wherein the dry powder inhaler is a breath powered inhaler.

13. The inhalation system of claim 10, wherein the diketopiperazine is bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine.

14. The inhalation system of claim 10, wherein the dry powder formulation comprises an active ingredient.

15. The inhalation system of claim 14, wherein the active ingredient is a protein, a peptide, a polypeptide or fragments thereof.

16. The inhalation system of claim 14, wherein the active ingredient is insulin.

17. An inhalation system for pulmonary delivery of a drug, comprising: a dry powder formulation comprising a plurality of diketopiperazine powder particles; and a dry powder inhaler configured to deliver the powder particles to the pulmonary circulation of a subject in a single inhalation and having a container including a cup-like chamber with two relatively flat and parallel sides and a relatively rounded bottom having an internal volume containing the powder particles and a mouthpiece; portions of the inhaler defining a first flow path for 20-70% of the volume of air through the inhaler, said first flow path leading from an inlet to the chamber through the chamber and through at least one outlet from the chamber to the mouthpiece, the inlet and the at least one outlet being configured so that an air flow entering the chamber re-circulates within the internal volume of the chamber tumbling the particles and entraining them in the air flow; the inlet and the at least one outlet further being configured so that the air flow from the inlet is directed across the at least one outlet and controls exit from the chamber of powder particles entrained within the air flow; portions of the inhaler defining a second flow path for 30-80% of the volume of air through the inhaler, said second flow path by-passing the inlet into the chamber and merging with the first path as the first path leaves the at least one outlet; the first flow path changing in direction where it merges with the second flow path, fluidized powder particles exiting the at least one outlet being sheared on contact with the air flow in the second flow path; wherein the inhalation system is operably configured to emit more than 90% of the dry powder formulation and the diketopiperazine particles that dissolve and are absorbed into the blood in less than 30 minutes yield a peak concentration of the diketopiperazine after the single inhalation.

18. An inhalation system, comprising: a dry powder formulation comprising a plurality of dry powder particles comprising insulin; and a dry powder inhaler configured to deliver the powder particles to the pulmonary circulation of a subject in a single inhalation and having a container including a cup-like chamber with two relatively flat and parallel sides and a relatively rounded bottom having an internal volume containing the powder particles and a mouthpiece; portions of the inhaler defining a first flow path for 20-70% of the volume of air through the inhaler, said first flow path leading from an inlet to the chamber through the chamber and through at least one outlet from the chamber to the mouthpiece, the inlet and the at least one outlet being configured so that an air flow entering the chamber re-circulates within the internal volume of the chamber tumbling the particles and entraining them in the air flow; the inlet and the at least one outlet further being configured so that the air flow from the inlet is directed across the at least one outlet and controls exit from the chamber of powder particles entrained within the air flow; portions of the inhaler defining a second flow path for 30-80% of the volume of air through the inhaler, said second flow path by-passing the inlet into the chamber and merging with the first path as the first path leaves the at least one outlet; the first flow path changing in direction where it merges with the second flow path, fluidized powder particles exiting the at least one outlet being sheared on contact with the air flow in the second flow path; wherein the inhalation system is configured to deliver the insulin to the pulmonary circulation of a subject, and said insulin can be measured in a subject's plasma at an exposure having a AUC.sub.0-2 hr greater than 160 .mu.U*min/mL per unit of insulin emitted in the dry powder formulation.

19. The inhalation system of claim 18, wherein a C.sub.max for insulin is measured in less than 30 minutes after administration to a patient by oral inhalation.

20. The inhalation system of claim 18, wherein the powder formulation comprises a diketopiperazine.

21. The inhalation system of claim 20, wherein the diketopiperazine is bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine.
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