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Details for Patent: 5,780,014

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Details for Patent: 5,780,014

Title: Method and apparatus for pulmonary administration of dry powder alpha 1-antitrypsin
Abstract:Methods are provided for administering .alpha.1-antitrypsin dry powder pulmonarily to a patient. In these methods, .alpha.1-antitrypsin is provided in a dry powder form which is aerosolized and administered to the patient. Apparatus are also provided for carrying out these methods. These methods and apparatus are may generally be used in the treatment of patients suffering from .alpha.1-antitrypsin deficiency and the functional derangements of emphysema.
Inventor(s): Eljamal; Mohammed (San Jose, CA), Patton; John S. (San Carlos, CA)
Assignee: Inhale Therapeutic Systems (San Carlos, CA)
Filing Date:Mar 13, 1996
Application Number:08/617,512
Claims:1. A method of administering .alpha.1-antitrypsin to a patient, comprising:

providing said .alpha.1-antitrypsin as a dry powder, having a mean particle size in the range from 1 .mu.m to 5 .mu.m and an .alpha.1-antitrypsin concentration of greater than or equal to 30% by weight;

aerosolizing said dry powder composition; and

administering said aerosolized dry powder composition pulmonarily to said patient.

2. The method as recited in claim 1, comprising:

dispersing an amount of the .alpha.1-antitrypsin dry powder in a gas stream to form an aerosol; and

capturing the aerosol in a chamber suitable for subsequent inhalation by the patient.

3. The method as recited in claim 1, wherein said .alpha.1-antitrypsin dry powder is greater than about 50% pure.

4. The method as recited in claim 1, wherein said .alpha.1-antitrypsin dry powder is greater than about 90% pure.

5. The method as recited in claim 1, wherein said .alpha.1-antitrypsin dry powder is greater than about 95% pure.

6. The method as recited in claim 1, wherein said .alpha.1-antitrypsin dry powder is greater than about 99% pure.

7. The method of claim 1, wherein said .alpha.1-antitrypsin dry powder comprises aggregates of particles, wherein said particles have a mean particle size of from about 1 .mu.m to about 5 .mu.m and said aggregates have a mean size of from about 50 .mu.m to about 600 .mu.m, and wherein said aggregates have a friability index of from about 10 to about 60.

8. The method of claim 7, wherein said aggregates are spherical in shape.

9. The method of claim 7, wherein said aggregates are formed with a nonaqueous solvent binding liquid.

10. The method of claim 9, wherein said nonaqueous solvent binding liquid comprises a fluorocarbon liquid.

11. The method of claim 10, wherein said fluorocarbon liquid is selected from the group consisting of perfluorodecalin and perfluorooctyl bromide.

12. The method as recited in claim 7, wherein said dispersible dry powder composition of a1-antitrypsin is from about 70% to about 90% pure.

13. A method of treating a patient deficient in .alpha.1-antitrypsin, comprising administering pulmonarily to said patient, a therapeutically effective amount of a .alpha.1-antitrypsin dry powder wherein the powder has a mean particle size in the range from 1 .mu.m to 5 .mu.m, the .alpha.1-antitrypsin is present as treater than or equal to 30% of dry powder by weight, and a daily dosage of from 1 mg to 80 mg.

14. The method of claim 13, wherein said therapeutically effective amount comprises from about 1 to about 50 mg of .alpha.1-antitrypsin daily.

15. The method as recited in claim 13, wherein said therapeutically effective amount comprises from about 5 to about 25 mg of .alpha.1-antitrypsin daily.

16. The method as recited in claim 13, wherein said therapeutically effective amount comprises from about 10 to about 15 mg of .alpha.1-antitrypsin daily.

17. A method of treating a patient suffering from emphysema, comprising administering pulmonarily to said patient a therapeutically effective amount of aerosolized dry powder .alpha.1-antitrypsin, wherein .alpha.1-antitrypsin is present in the powder at 30% by weight or greater.

18. An apparatus for administering .alpha.1-antitrypsin to a patient, the apparatus comprising:

a housing having a chamber disposed therein, said chamber containing an amount of an .alpha.1-antitrypsin dry powder composition;

a gas pressure source connected to said chamber, for delivering a gas stream to said chamber to aerosolize said dry powder composition; and

a means for delivering said aerosolized dry powder composition for inhalation by said patient, said means for delivering being connected to said chamber, whereby said aerosolized powder may be delivered for inhalation by said patient, wherein the powder has a mean Particle size in the range from 1 .mu.m to 5 .mu.m, the .alpha.1-antitrypsin is present as greater than or equal to 30% of dry powder by weight.
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