Methods of dry powder inhalation

• US 6,116,237 A
• Filed: 04/24/1997
• Issued: 09/12/2000
• Est. Priority Date: 04/29/1996
• Status: Expired due to Term

• Current Assignee: Quadrant Technologies Limited (Vectura Group Ltd.)
• Original Assignee: Dura Pharmaceuticals, Inc. (Perrigo Company PLC)
• Inventors: Hill, Malcolm, Schultz, Robert, Witham, Clyde
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US08/847,287
• Time in Patent Office: 1,237 Days
• Field of Search: 128/203.12, 128/203.15, 128/203.23, 128/200.24
• US Class Current: 128/203.15
• 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 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics

Abstract

A method for inhalation of a dry powder drug includes the steps of providing a dry powder drug composition having a drug particle size of from about 1-7 microns and a mass median aerodynamic diameter of the delivered aerosol of from about 3.5 to 5.5 microns. This composition is loaded into an inhaler which is generally flow rate independent, and with the inhaler having an inspiration flow resistance of about 0.12 to 0.21 (cmH₂ O)^1/2 over the range of about 15-60 L/min. The patient inhales the drug composition from the inhaler with an inspiration flow rate of about 15-60 L/min, resulting in a delivery efficiency measured by respirable fraction greater than 20%.

Claims

1. A method for inhalation of a dry powder drug, comprising the steps of:

a) providing a dry powder drug composition having a drug particle size of from about 1-7 microns and mass median aerodynamic diameter of the delivered aerosol of from about 3 to 6 microns;

b) loading the dry powder drug composition into an inhaler which is generally flow rate independent, and with the inhaler having an inspiration flow resistance of about 0.12 to 0.21 (cm H₂ O)^1/2) over the range of about 10-60 L/min;

c) inhaling the drug composition from the inhaler with an inspiration flow rate of about 15-60 L/min, resulting in a delivery efficiency measured by respirable fraction of at least 20%.

2. The method of claim 1 wherein the drug composition includes active particles and the aerodynamic particle size of the active particles is about 4.5 microns.

3. The method of claim 1 wherein the drug comprises a systemic or a topical drug for treating asthma.

4. The method of claim 1 wherein the drug comprises a protein, a polypeptide, or a hormone.

5. The method of claim 1 wherein the percent of particles greater than 5 microns is about 30-90.

6. The method of claim 1 wherein the inhaler has a flow resistance of from about 0.12 to 0.18 (cm H₂ O)^1/2.

7. The method of claim 1 wherein the drug composition includes an inert carrier.

8. The method of claim 1 wherein the drug comprises beclomethasone.

9. The method of claim 1 wherein the respirable fraction (fraction of particles penetrating the impactor inlet with a particle size less than about 5.8 microns) is at least 20%.

10. The method of claim 1 wherein the flow resistance is about 0.12 to 0.21 (cmH₂ O)^1/2 over the range of 15-60 L/min.

11. The method of claim 1 wherein the mass median aerodynamic diameter of the delivered aerosol is from about 3.5 to 5.5 microns.

12. A method for inhalation of a dry powder drug, comprising the steps of:

a) providing a dry powder drug composition having a drug particle size of from about 1-7 microns and mass median aerodynamic diameter of the delivered aerosol of from about 3 to 6 microns;

b) loading the dry powder drug composition into an inhaler which is generally flow rate independent, and with the inhaler having an inspiration flow resistance of about 0.12 to 0.21 (cm H₂ O)^1/2) over the range of about 10-60 L/min;

c) inhaling the drug composition from the inhaler with an inspiration flow rate of about 15-60 L/min, resulting in a delivery efficiency measured by respirable fraction of at least 20%.