Dry powder inhalation device having deagglomeration/aerosolization structure responsive to patient inhalation

• US 5,655,523 A
• Filed: 05/22/1995
• Issued: 08/12/1997
• Est. Priority Date: 04/28/1989
• Status: Expired due to Term

• Current Assignee: Adamas Pharmaceuticals, Inc. (Supernus Pharmaceuticals, Inc.)
• Original Assignee: 3M Company
• Inventors: Hodson, Peter David, Wass, Anthony Charles Lammond, Smith, David Keith
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/446,446
• Time in Patent Office: 813 Days
• Field of Search: 128/203.12, 128/203.15, 128/200.14, 128/200.16, 128/200.17, 128/200.21, 128/200.22, 128/200.24, 128/203.21, 128/203.23, 128/204.1 3, 604/56
• US Class Current: 128/203.15
• CPC Class Codes: A61M 15/0013 with inhalation check valves
• CPC Class Codes: A61M 15/0016 located downstream of the dispenser, i.e. traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0025 with caps
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• 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 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0055 the used dosages being coiled
• CPC Class Codes: A61M 15/0078 on a strip
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 15/0093 without arming or cocking, e.g. acting directly on the delivery valve
• CPC Class Codes: A61M 15/02 with activated or ionised fluids, e.g. electrohydrodynamic [EHD] or electrostatic devices; Ozone-inhalators with radioactive tagged particles
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/8206 battery-operated

Abstract

An inhalation device for dry powder containing a chamber capable of receiving a dose of powdered medicament. The chamber is in communication with a patient port in the form of a mouthpiece or nasal adapter. The inhalation device also contains a deagglomeration/aerosolization apparatus capable of deagglomerating and/or aerosolizing a dose of powdered medicament and is operable by a patient-independent energy output source. The inhalation device further includes detection apparatus that ascertains patient inspiration through the patient port, and a control apparatus that actuates the deagglomeration/aerosolization apparatus in response to detection of patient inspiration.

Claims

1. A dry powder inhaler comprising a housing defining a chamber for receiving a dose of powdered medicament in communication with a patient port in the form of a mouthpiece or nasal adapter, the inhaler additionally comprising:

deagglomeration/aerosolisation means to deagglomerate and/or assist aerosolization of a dose of powdered medicament, which means is operable by a patient-independent energy output source,

detection means to detect patient inspiration through the patient port, and,

control means to actuate said deagglomeration/aerosolisation means in response to detection of patient inspiration by said detection means.

2. A dry powder inhaler as claimed in claim 1 further comprising a dose of powdered medicament and an elongate carrier, wherein the dose of powdered medicament is carried upon said elongate carrier, and in which the inhaler is constructed and arranged such that areas of said carrier, of a predetermined size, are sequentially exposed within said chamber.

3. A dry powder inhaler as claimed in claim 2 in which a the elongate carrier is preloaded with a medicament and is in the form of a tape.

4. A dry powder inhaler as claimed in claim 3 in which the deagglomeration/aerosolization means is selected from the group consisting of (i) means for brushing or scraping an exposed area of the tape or powder transfer member by rotary or reciprocal motion, (ii) means for dragging the tape or powder transfer member across a surface having irregularities, or an edge or corner having a small radius such that the surface of the elongate carrier material bearing powdered medicament is given a sharp convex curvature, (iii) means causing an unexposed area of the elongate carrier or powder transfer member to advance rapidly into the chamber during inhalation by the patient and come to an abrupt halt causing medicament release, and, (iv) means causing an unexposed length of elongate carrier to take the form of a slackened loop, which upon inhalation is rapidly straightened to cause medicament release.

5. A dry powder inhaler as claimed in claim 1 additionally comprising a storage reservoir for powdered medicament and a powder transfer member, and in which the inhaler is constructed and arranged such that the transfer member passes through or past the storage reservoir so that a controlled quantity of medicament is coated onto the surface of said member before passage into said chamber.

6. A dry powder inhaler as claimed in claim 1 in which the dose of powdered medicament is enclosed in a rupturable capsule and the inhaler is adapted to receive said capsule and comprises means for breaching the capsule.

7. A dry powder inhaler as claimed in claim 1 in which the patient-independent energy output is derived from a source selected from the group consisting of a spring, or other biasable resilient energy storage means, a battery and a source of compressed or liquefied gas.

8. A dry powder inhaler as claimed in claim 7 in which the means for impacting or striking is selected from the group consisting of a biased hammer arrangement and a solenoid and plunger rod.

9. A dry powder inhaler as claimed in claim 1 in which the deagglomeration/aerosolization means comprises means selected from the group consisting of impacting, striking and vibrating the dose of powdered medicament.

10. A dry powder inhaler as claimed in claim 9 in which said deagglomeration/aerosolization means produces vibrations in the frequency of from 5 to 250,000 Hz and is selected from the group consisting of an electrical, piezoelectric, electromagnetic and mechanical means.

11. A dry powder inhaler as claimed in claim 9 in which the means for vibrating is selected from the group consisting of a solenoid-type vibrator, rotating cams and serrated wheels.

12. A dry powder inhaler as claimed in claim 1 in which the deagglomeration/aerosolisation means comprises a propeller or an impeller generating a flow of air turbulence causing medicament release.

13. A dry powder inhaler as claimed in claim 1 in which the detection means comprises a movable vane, the vane being movable upon inhalation through the patient port to trigger said control means to actuate said deagglomeration/aerosolisation means.

14. A dry powder inhaler as claimed in claim 1 which further comprises a dose of powdered medicament having a particle size in the range of 1 to 10 um and comprises one or more drags selected from the group consisting of bronchodilators, corticosteroids, anorectics, anti-depressants, anti-hypertensive agents, anti-neoplastic agents, anti-cholinergic agents, dopaminergic agents, narcotic analgesics, β

-adrenergic blocking agents, prostoglandins, sympathomimetics, tranquilizers, steroids, proteins, peptides, vitamins, sex hormones and drugs for the phophylaxis of asthma.

15. A dry powder inhaler as claimed in claim 14 in which the medicament is selected from the group consisting of Salbutamol, Terbutaline, Rimiterol, Fentanyl, Fenoterol, Pirbuterol, Reproterol, Adrenaline, Isoprenaline, Ociprenaline, Ipratropium, Beclomethasone, Betamethasone, Budesonide, Disodium Cromoglycate, Nedocromil Sodium, Ergotamine, Salmeterol, Fluticasone, Formoterol, Insulin, Atropine, Preunisolone, Benzphetamine, Chlorphentermine, Amitriptyline, Imipramine, Chloridine, Actinomycin C, Bromocriptine, Buprenorphone, Propranolol, Lacicortone, Hydrocortisone, Fluocinolone, Trimcincione, Dinoprost, Xylometazoline, Diazepam, Lorazepam, Folic acid, Nicotimamide, Clenbuterol, Bitolterol, Ethinyloestradiol and Levenorgestrel and pharmaceutically acceptable salts thereof.