Method of treating a systemic disease

• US 7,056,494 B2
• Filed: 03/18/2003
• Issued: 06/06/2006
• Est. Priority Date: 09/03/2002
• Status: Expired due to Fees

• Current Assignee: Kos Life Sciences, Inc. (Abbvie Incorporated)
• Original Assignee: KOS Pharmaceuticals Incorporated (Abbvie Incorporated)
• Inventors: Sexton, Federick, Zhu, Yazping, Genova, Perry, Adjei, Akwete L.
• Primary Examiner(s): Padmanabhan, Sreeni
• Assistant Examiner(s): Haghighatian, Mina
• Application Number:
  US10/391,053
• Publication Number:
  US 20040042967A1
• Time in Patent Office: 1,176 Days
• Field of Search: 424/45, 424/46, 424/489, 128/200.14, 128/200.22, 128/204.18, 128/204.23, 128/200.24, 514/2
• US Class Current: 424/45
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system

Abstract

A method and dispenser for treating a systemic disease in a patient in need of such treatment is disclosed. The method comprising maintaining the inspiratory flow rate and volume of the patient to a certain value and then administering a medicament aerosol formulation to the patient using a breath activated inhalation device.

Claims

1. A method of treating a systemic disease via interpulmonary administration in a patient in need thereof, which consists essentially of:

(a) maintaining the inspiratory flow rate in the patient in a range of about 0.05 to about 2 liters per second and the inspiratory volume of the patient in the range of about 0.1 to about 5 liters; and

(b) administering to the patient, using a pressurized breath activated metered dose device, a medicinal aerosol formulation comprising (a′

) a medicament suitable for systemic absorption via aerosol delivery present in an effective amount; and

(b′

) a fluid propellant carrier for carrying and transporting said medicament at about 50 to about 2000 milliseconds for about 1 to about 4 sprays of the aerosol formulation about every 3 to 4 hours and (c′

) and a stabilizer selected from the group consisting of an amino acid, a derivative thereof, a water addition stabilizer and a mixture of any of the foregoing stabilizers.

2. The method as defined in claim 1 wherein said device has a triggering force of about 0.01 to about 20 cm of water.

3. The method as defined in claim 1 wherein said effective amount of medicament comprises from about 0.00001 parts by weight to about 10 parts by weight based on 100 parts by weight of said carrier.

4. The method as defined in claim 3 wherein said medicament is a solubilized or suspended particulate medicament having a diameter ranging from about 1 to about 7 micrometers.

5. The method as defined in claim 3 wherein said medicament comprises a protein or peptide medicament having a molecular size ranging from about 0.5 K Dalton to about 250 K Daltons.

6. A breath activated metered dose inhalation device for delivering to a person in need thereof a medicament in aerosol form for treating a systemic disease, which consists essentially of:

(a) a container for controlling the medicament for treating systemic disease, a fluid propellant for carrying and transporting the medicament as an aerosol and a stabilizer selected from the group consisting of an amino acid, a derivative thereof, a water addition and a mixture of any of the foregoing stabilizers,

(b) a triggering means such that when triggered by the inhalation of a patient releases said propellant and the medicament from said container; and

(c) a sensing means for triggering said triggering means when the inspiratory flow rate in the patient is in the range of about 0.05 to about 2 liters per second and the inspiratory flow volume is in the range of about 0.1 to about 5 liters.

7. The device as defined in claim 6 which further includes a valve means for metering and dispensing the medicament and dispensing the medicament, said valve means comprising elements made from nitrile rubber, EPDM rubber, polyolefin or thermoplastic elastomeric material.