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Claims for Patent: 6,737,045

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Claims for Patent: 6,737,045

Title: Methods and compositions for the pulmonary delivery insulin
Abstract:Systemic delivery of insulin to a mammalian host is accomplished by inhalation of a dry powder of insulin. It has been found that dry insulin powders are rapidly absorbed through the alveolar regions of the lungs.
Inventor(s): Patton; John S. (Portola Valley, CA), Foster; Linda (Sunnyvale, CA), Platz; Robert M. (Half Moon Bay, CA)
Assignee: Nektar Therapeutics (San Carlos, CA)
Application Number:10/141,028
Patent Claims: 1. A method of delivering insulin to the lungs of a human patient, the method comprising: providing an individual dosage comprising from 0.5 mg to 10 mg of insulin in dry powder form; and delivering the individual dosage to the human patient in aerosolized form so that the insulin is delivered to the alveolar region of the lungs of the human patient; wherein the total dosage of insulin delivered during a single respiratory administration is in the range of from 0.5 mg to 15 mg.

2. A method according to claim 1 wherein the individual dosage comprises insulin selected from the group consisting of amorphous insulin, crystalline insulin, and mixtures thereof.

3. A method according to claim 1 wherein the individual dosage comprises amorphous insulin.

4. A method according to claim 1 wherein the individual dosage further comprises a pharmaceutical carrier.

5. A method according to claim 1 further comprising aerosolizing the individual dosage.

6. A method according to claim 5 wherein the individual dosage is aerosolized by an air or gas stream.

7. A method according to claim 6 wherein the aerosolized individual dosage is captured in a chamber before being delivered to the human patient.

8. A method of delivering insulin to a human patient, the method comprising: providing an individual dosage comprising from 0.5 mg to 10 mg of insulin in dry powder form; and delivering the individual dosage to the alveolar region of the lungs of the human patient; wherein the total dosage of insulin delivered during a single respiratory administration is in the range of from 0.5 mg to 15 mg.

9. A method according to claim 8 wherein the individual dosage comprises insulin selected from the group consisting of amorphous insulin, crystalline insulin, and mixtures thereof.

10. A method according to claim 8 wherein the individual dosage comprises amorphous insulin.

11. A method according to claim 8 wherein the individual dosage further comprises a pharmaceutical carrier.

12. A method of delivering insulin to a human patient, the method comprising: providing an individual dosage comprising at least 0.5 mg of amorphous insulin in dry powder form; and delivering the individual dosage to the alveolar region of the lungs of the human patient in aerosolized form.

13. A method according to claim 12 wherein the total dosage of amorphous insulin delivered during a single respiratory administration is in the range of from 0.5 mg to 15 mg.

14. A method according to claim 12 wherein the individual dosage further comprises crystalline insulin.

15. A method according to claim 12 wherein the individual dosage further comprises a pharmaceutical carrier.

16. A method according to claim 12 wherein the individual dosage consists essentially of amorphous insulin.

17. A method of delivering insulin to a human patient, the method comprising: providing an individual dosage comprising insulin particulates in dry powder form, the insulin particulates having a diameter of less than 10 .mu.m; aerosolizing the individual dosage in an air or gas stream, and delivering the individual dosage to the alveolar region of the lungs of the human patient.

18. A method according to claim 17 wherein the air or gas stream is of sufficiently high velocity to aerosolize the individual dosage.

19. A method according to claim 17 wherein the aerosolized individual dosage is captured in a chamber before being delivered to the human patient.
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