Drug delivery method and inhalation device therefor

• US 4,484,577 A
• Filed: 05/12/1982
• Issued: 11/27/1984
• Est. Priority Date: 07/23/1981
• Status: Expired due to Term

• Current Assignee: Key Pharmaceuticals, Inc. (Merck & Co., Inc.)
• Original Assignee: Key Pharmaceuticals, Inc. (Merck & Co., Inc.)
• Inventors: Sackner, Marvin A., Watson, Herman
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): Reichle, Karin M.
• Application Number:
  US06/377,469
• Time in Patent Office: 930 Days
• Field of Search: 128/200.14, 128/200.18, 128/200.21, 128/200.22, 128/200.23, 128/200.24, 128/203.25, 128/203.28, 128/203.29, 128/204.18 , 128/205.13, 128/205.17, 128/205.21, 128/207.14, 128/207.16, 128/716, 128/719, 128/720, 128/725, 128/727, 128/728, 128/730, 46/44, 92/34-47, 92/9, 73/729
• US Class Current: 128/203.28
• 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: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/0088 with variable volume
• 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 2205/42 Reducing noise

Abstract

A method and an apparatus for administering a drug through a breathing passage for absorption on the mucous tissue of a patient includes introducing an aerosol of the drug into an expanded bag and bidirectional channel for communicating the drug with the breathing passage of the patient and otherwise is substantially impervious to the passage of air, collapsing the expanded bag while the bidirectional channel for communicating with the breathing passage is in position to deliver the drug into the breathing passage of the patient. A signal in a bidirectional channel indicates when the rate of passage of the drug exceeds a desirable limit, whereby the patient taking the drug is reminded to decrease the rate of collapse of the airbag, thereby maximizing drug utilization. The drug delivery device admits a drug-containing aerosol through a drug introduction opening while the collapsible airbag is at least partially expanded, the drug being introduced into the breathing passage with the contraction of the collapsible airbag.

Claims

1. A method of administering a drug through a patient'"'"'s breathing passage for absorption on the mucous tissue of the patient which comprises:

(a) introducing a aerosol containing a predetermined amount of said drug into an expanded collapsible bag of fixed maximum dimension having means for communicating the aerosolized drug with a breathing passage of the patient and being otherwise substantially impervious to the passage of air;

(b) collapsing said expanded bag while said means for communicating with a breathing passage is in position to deliver said aerosolized drug into the breathing passage of the patient, wherein said collapsing of said expanded bag takes place through inhalation by said patient, and wherein said patient is given a signal when the maximum desired rate of inhalation is reached;

whereby the predetermined dosage of said drug is delivered to said mucous tissue in a manner substantially without absorption of said drug via the gastrointestinal tract.

2. A method of claim 1, wherein said signal is a whistle housed in said means for communicating with a breathing passage which is activated by air passing through said whistle at a rate in excess of the desired rate for delivery of said drug.

3. A method of claim 1, wherein the breathing passage is the mouth.

4. A method of claim 3, wherein the drug is delivered for absorption on the tracheobronchial tree.

5. A method of claim 4 for the delivery of a pulmonary medicine.

6. A method of claim 5, wherein said pulmonary medicine is a bronchodilator.

7. A method of claim 6, wherein said bronchodilator is 5-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]-benzene diol.

8. A method of claim 6, wherein said bronchodilator is 4-hydroxy-3-hydroxymethyl-alpha-[(tert-butylamino)methyl]benzyl alcohol.

9. A method of claim 1, wherein the breathing passage is the nose.

10. A method of claim 9, wherein the amount of drug which enters the system of the patient other than through the nasal mucous membranes is minimized by said patient and maximum contact with the nasal mucous tissue is enhanced, further comprising the step, after said collapsing said expanded bag, of maintaining said means for communicating with a breathing passage in contact with the nose and then reexpanding said expanded bag, whereby the drug passes over the mucous tissues of the nasal passage a second time and the amount of drug which goes beyond the nasal passage for communication with the tracheobronchial or gastrointestinal routes is minimized.

11. A method of claim 9 or 10, wherein said drug is a nasal decongestant.

12. A method of claim 9 or 10, wherein said drug is 5-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]-benzene diol.

13. A method of claim 9 or 10, wherein said drug is 4-hydroxy-3-hydroxymethyl-alpha-[(tert-butylamino)methyl]benzyl alcohol.

14. A method of claim 9 or 10, wherein said drug is a systemically active drug.

15. A drug delivery device for administering a drug contained in an aerosol to a breathing passage of a patient for absorption on the mucous tissue of the patient which comprises

(a) a collapsible airbag of fixed maximum dimensions which is impervious to passage of air except for an airbag opening;

(b) a piece having one end adapted for communication with the breathing passage and connected by a bidirectional channel through said piece to the opposite end thereof to said airbag opening, said piece having a drug introduction opening for the introduction of an aerosol spray containing a predetermined amount of a drug, said drug introduction opening disposed such that said aerosol spray is introduced directly into said airbag through said piece and said airbag opening, in a direction away from said one end; and

(c) signal means in said bidirectional channel to indicate when the rate of inhalation of said aerosol spray from said airbag exceeds a desirable limit, whereby the patient taking said drug is reminded to decrease the rate of collapse of said airbag, thereby maximizing drug utilization;

said drug delivery device admitting a drug-containing aerosol through said drug introduction opening while said collapsible airbag is at least partially expanded, said drug being introduced into said the breathing passage with the contraction of said collapsible airbag through inhalation by said patient.

16. A drug delivery device of claim 15, wherein said signal means is a whistle activated by passage of air from said airbag into said bidirectional channel at a rate in excess of the desirable limit for effective drug utilization.

17. A drug delivery device of claim 16, wherein said whistle is a reed.

18. A drug delivery device of claim 16, wherein said piece is a mask adapted for communication with the nose, whereby said drug is delivered to the nasal mucous membranes.

19. A drug delivery device of claim 15, wherein said piece is a tube adapted for communication with the mouth, whereby said drug is delivered to the tracheobronchial tree.

20. A drug delivery device of claim 19, wherein said collapsible bag has a first apertured end cap having said airbag opening and a second end cap facing said first apertured end cap, said two end caps being connected by a collapsible material.

21. A drug delivery device of claim 20, wherein said collapsible material is attached to said two end caps and is adapted such that as said airbag collapses, the facing end caps rotate in relation to each other.

22. A drug delivery device of claim 16, 17, 19, 20 or 21, wherein said drug is a bronchodilator.

23. A drug delivery device of claim 16, 17, 19, 20 or 21, wherein said drug is 5-[1-hydroxy-2-[(1-methylethyl)amino]-ethyl]-benzene diol.

24. A drug delivery of claim 16, 17, 19, 20 or 21, wherein said drug is 4-hydroxy-3-hydroxymethyl-alpha-[(tert-butylamino)methyl]benzyl alcohol.