Method of Treating Diabetes Mellitus in a Patient

• US 20080264416A1
• Filed: 07/02/2008
• Published: 10/30/2008
• Est. Priority Date: 01/29/1993
• Status: Abandoned Application

• Current Assignee: Aradigm Corporation
• Original Assignee: Novo Nordisk A/S
• Inventors: Farr, Stephen J., Gonda, Igor, Rubsamen, Reid M.
• Application Number:
  US12/166,711
• Publication Number:
  US 20080264416A1
• Time in Patent Office: Days
• US Class Current: 128/203.15
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0427 with direct interaction with a dispensing or delivery system
• CPC Class Codes: A61J 7/0445 for preventing drug dispensing during a predetermined time period
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0031 by bursting or breaking the package, i.e. without cutting or piercing
• 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 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• 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 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 16/142 with semi-permeable walls separating the liquid from the respiratory gas
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2202/062 : Desiccants
• CPC Class Codes: A61M 2202/064 : Powder
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 : battery-operated

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 for treating diabetes mellitus in a patient who cannot regulate blood glucose levels on its own as a result of the diabetes, the method comprising the steps of:

a. supplying a predetermined amount of dry insulin powder to an inhalation device;

b. releasing a pressurized gas over the predetermined amount of dry insulin powder to create an aerosolized suspension comprising powder suspended in air, wherein the aerosolized suspension contains an amount of insulin that is 2-10 times higher than the amount needed to be absorbed in the bloodstream of the patient; and

c. inhaling the aerosolized suspension at a flow rate and volume sufficient to allow the patient to absorb in the bloodstream a controlled dose of insulin that comprises between 1-50 units of insulin.

2. The method of claim 1, wherein steps a-c may be repeated periodically as needed to treat the patient and wherein the amount of insulin supplied to the bloodstream in step c remains relatively constant for each repetition of steps a-c.

3. A repeatable method of regulating blood glucose levels in a diabetic human patient who cannot regulate blood glucose levels own its own as a result of diabetes, the method comprising the steps of:

a. supplying a fixed quantity of dry insulin powder to a portion of a hand held inhalation delivery device;

b. propelling a gas over the fixed quantity of dry powder to produce, in a repeatable manner, an aerosolized suspension of insulin, the aerosolized suspension containing more insulin than is required in the bloodstream of the patient to achieve a satisfactory blood glucose level; and

c. flowing at least a portion of the aerosolized suspension through a mouth piece on the device and into the lungs of the patient in a manner sufficient to cause the patient to absorb in the patient'"'"'s bloodstream a sufficient, controlled quantity of insulin to achieve acceptable blood glucose level following treatment.

4. The method of claim 3, wherein steps a-c may be repeated periodically as needed to treat the patient and wherein the amount of insulin supplied to the bloodstream in step c remains relatively constant for each repetition of steps a-c.

5. A repeatable method of lowering a diabetic patient'"'"'s serum glucose level to acceptable value, the method comprising the steps of:

a. supplying a predetermined amount of dry insulin powder to a medical device;

b. releasing a compressed gas over the dry insulin powder to form a suspension comprised of dry insulin powder and air; and

c. inhaling at least a portion of the suspension at a flow rate and volume sufficient to deposit a sufficient, controlled quantity of insulin in the patient'"'"'s lungs so that the patient absorbs into the blood between 1 and 50 units of insulin, thereby lowering the patient'"'"'s blood glucose level to an acceptable value between 50 mg/dl and 300 mg/dl.

6. A method of administering insulin to a diabetic patient to control serum glucose levels via a hand held inhalation device, the method comprising the steps of:

a. supplying a predetermined quantity of insulin powder to a portion of the device;

b. aerosolizing the insulin powder to form a cloud of insulin within the device, the cloud comprised of air and suspended insulin particles, the quantity of insulin particles being 2-10 times the dosage of insulin required to be delivered into the patient'"'"'s blood to achieve acceptable blood glucose level;

c. administering to the patient'"'"'s bloodstream via the patient'"'"'s lungs a sufficient controlled and repeatable quantity of insulin from the cloud to produce an acceptable blood glucose level in the patient.

7. A method for treating diabetes mellitus in a patient comprising the steps of:

a. supplying a predetermined amount of dry insulin powder to an inhalation device;

b. releasing a pressurized gas over the predetermined amount of dry insulin powder to create an aerosolized suspension comprising powder suspended in air, wherein the aerosolized suspension contains an amount of insulin that is 2-10 times higher than the amount needed to be absorbed in the bloodstream of the patient; and

c. inhaling the aerosolized suspension at a flow rate and volume sufficient to allow the patient to absorb in the bloodstream a controlled dose of insulin that comprises between 1-50 units of insulin.

8. The method of claim 7, wherein steps a-c may be repeated periodically as needed to treat the patient and wherein the amount of insulin supplied to the bloodstream in step c remains relatively constant for each repetition of steps a-c.

10. The method of claim 7, wherein steps a-c may be repeated periodically as needed to treat the patient and wherein the amount of insulin supplied to the bloodstream in step c remains relatively constant for each repetition of steps a-c.

9. A repeatable method of regulating blood glucose levels in a human patient, the method comprising the steps of:

a. supplying a fixed quantity of dry insulin powder to a portion of a hand held inhalation delivery device;

b. propelling a gas over the fixed quantity of dry powder to produce, in a repeatable manner, an aerosolized suspension of insulin, the aerosolized suspension containing more insulin than is required in the bloodstream of the patient to achieve a satisfactory blood glucose level; and

c. flowing at least a portion of the aerosolized suspension through a mouth piece on the device and into the lungs of the patient in a manner sufficient to cause the patient to absorb in the patient'"'"'s bloodstream a sufficient, controlled quantity of insulin to achieve acceptable blood glucose level following treatment.

11. A repeatable method of lowering a patient'"'"'s serum glucose level to acceptable value, the method comprising the steps of:

a. supplying a predetermined amount of dry insulin powder to a medical device;

b. releasing a compressed gas over the dry insulin powder to form a suspension comprised of dry insulin powder and air; and

c. inhaling at least a portion of the suspension at a flow rate and volume sufficient to deposit a sufficient, controlled quantity of insulin in the patient'"'"'s lungs so that the patient absorbs into the blood between 1 and 50 units of insulin, thereby lowering the patient'"'"'s blood glucose level to an acceptable value between 50 mg/dl and 300 mg/dl.

12. A method of administering insulin to a diabetic patient to control serum glucose levels via a hand held inhalation device, the method comprising the steps of:

a. supplying a predetermined quantity of insulin powder to a portion of the device;

b. aerosolizing the insulin powder to form a cloud of insulin within the device, the cloud comprised of air and suspended insulin particles, the quantity of insulin particles being 2-10 times the dosage of insulin required to be delivered into the patient'"'"'s blood to achieve acceptable blood glucose level;

c. administering to the patient'"'"'s bloodstream via the patient'"'"'s lungs a sufficient controlled and repeatable quantity of insulin from the cloud to produce an acceptable blood glucose level in the patient.