Method of treating diabetes mellitus in a patient

• US 20050274377A1
• Filed: 05/17/2005
• Published: 12/15/2005
• Est. Priority Date: 01/29/1993
• Status: Active Grant

• Current Assignee: Aradigm Corporation
• Original Assignee: Aradigm Corporation
• Inventors: Farr, Stephen J., Gonda, Igor, Rubsamen, Reid M.
• Granted Patent: US 7,448,375 B2
• Time in Patent Office: Days
• US Class Current: 128/200.140
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 15/0043 Non-destructive separation of the package, e.g. peeling
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers

Abstract

Dosages of inhaled insulin are controlled within a narrow range by controlling the total volume of air inhaled by a patient By repeatedly delivering aerosolized insulin with the same total inhaled volume of air, the amount of insulin delivered to the patient each time is consistent. A device for delivering insulin by inhalation is disclosed which device comprises a means for measuring inhaled volume and for halting inhalation at a pre-determined point. The device also comprises an adjustable means for applying various amounts of force to a container of formulation to expel different amounts of drug from the container based on the force applied.

Claims

1. A method of delivering insulin to the lungs of a human patient, the method comprising:

a. providing an individual dosage of insulin in dry powder form; and

b. 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.

2. A method of treating diabetes in a patient that is incapable of maintaining a normal blood glucose level because the patient is suffering from diabetes, the method comprising:

a. providing a dosage of dry insulin powder containing between 2 and 300 units of insulin;

b. delivering into the patient'"'"'s circulatory system between 1 and 30 units of insulin by pulmonary transport of the dry insulin powder across the alveolar region of the patient'"'"'s lungs;

thereby maintaining an acceptable blood glucose level in the patient.

3. A method of treating diabetes in a patient in need of such treatment, the method comprising the steps of:

a. providing a dose of dry insulin powder in the range of 2 to 300 units;

wherein the dry powder comprises particles of less than 10 microns in size;

b. aerosolizing the dry powder;

c. delivering the aerosolized dry powder to the alveolar region of the patient'"'"'s lungs for pulmonary transport into the patient'"'"'s circulatory system;

d. wherein the amount of insulin absorbed is sufficient for the patient to maintain an acceptable blood glucose level.

4. A method of delivering insulin to the lungs of a human patient, the method comprising the steps of:

b. delivering the individual dosage to the patient in aerosolized form so that the insulin is delivered to the lungs of the patient in a controlled amount, and is absorbed into the patient'"'"'s circulatory system.

5. The method of claim 4, wherein the dosage is about 1-300 insulin units.

6. The method of claim 4, wherein about 1-30 insulin units are absorbed into the patient'"'"'s circulatory system.

7. The method of claim 4, wherein the dry powder particles are about 0.5-12 microns in size.

8. The method of claim 4, wherein the dry powder particles are about 0.5-6 microns in size.

9. The method of claim 4, wherein the dry powder particles are about 0.5-3 microns in size.

11. The method of claim 5, wherein the dry powder comprises particles between about 0.5 and 6 microns in size.

12. The method of claim 5, wherein the dry powder comprises particles between about 0.5 and 3 microns in size.

13. The method of claim 5, wherein a repeatable dose is delivered to the patient'"'"'s lungs.

14. The method of claim 5, wherein about 1-30 insulin units are absorbed into the patient'"'"'s circulatory system.

10. A method of treating diabetes in a patient comprising the steps of:

a. providing a dose of dry insulin powder in the range of about 1 to 300 units;

wherein the dry powder comprises particles between about 0.5 and 12 microns in size;

b. aerosolizing the dry powder; and

c. delivering the aerosolized dry powder to the lungs of the patient for pulmonary transport into the patient'"'"'s circulatory system.