US5509404A
Expired / Lapsed
US
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Intrapulmonary drug delivery within therapeutically relevant inspiratory flow/volume values
Assignee: Aradigm Corp
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Filing: 1994-07-11
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Granted: 1996-04-23
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Expires: 2014-07-11
Abstract
Abstract A method of drug delivery is disclosed wherein a patient's inspiratory flow rate and inspiratory volume are simultaneously measured using a portable, hand-held, device which may be electronic and battery-powered or mechanical. Information obtained from the measurement is used to release, into a patient's inspiratory flow path, particles of a pharmaceutically active drug. The released particles have a particle size in the range of from about 0.5 to 12 microns. The drug is released when the patient's measured inspiratory flow rate is in the range of from about 0.10 to about 2.0 liters/second and the patient's inspiratory volume is in the range of from about 0.15 to about 0.8 liters. By measuring inspiratory flow and volume and releasing within the specific parameters with respect to both flow and volume, it is possible to obtain a high degree of repeatability with respect to dosing of a patient and further to deliver a relatively high percentage of the released drug to the patient's circulatory system.
Inventors
- 👤 Lester J. Lloyd
- 👤 Reid M. Rubsamen
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 22:29
CPC Classifications
A; A61; A61M; A61M15/00; A61M15/009; A61M15/0065; A61M15/0068; A61M15/008; A61M11/00; A61M11/001; A61M11/002; A61M16/00; A61M16/0003; A61M2016/0015; A61M2016/0018; A61M2016/0021; A61M2016/003; A61M2016/0033; A61M2016/0039; A61M2202/00; A61M2202/06; A61M2202/064; A61M2205/00; A61M2205/82; A61M2205/8206
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
109 words
A method of drug delivery into a patient's airway, comprising: simultaneously measuring a patient's inspiratory flow rate and inspiratory volume; determining whether the measured inspiratory flow rate and inspiratory volume equals a predetermined inspiratory flow rate and inspiratory volume; and releasing an aerosolized drug responsive to said measured inspiratory flow rate and inspiratory volume being determined to be equal to said predetermined inspiratory flow rate and inspiratory volume into the patient's inspiratory flow at substantially zero velocity at a point of release or at a velocity which reduces to substantially zero after travelling 2 cm or less from a point of release in the absence of the patient's inspiration.
Claim 2
Independent Claim
109 words
A method of drug delivery into a patient's airway, comprising: simultaneously measuring a patient's inspiratory flow rate and inspiratory volume; determining whether the measured inspiratory flow rate and inspiratory volume equals a predetermined inspiratory flow rate and inspiratory volume; and releasing an aerosolized drug responsive to said measured inspiratory flow rate and inspiratory volume being determined to be equal to said predetermined inspiratory flow rate and inspiratory volume into the patient's inspiratory flow at substantially zero velocity at a point of release or at a velocity which reduces to substantially zero after travelling 2 cm or less from a point of release in the absence of the patient's inspiration.
Claim 3
Dependent Claim
38 words
The method of claim 1 wherein the inspiratory flow rate is in the range of from about 0.2 to about 1.8 liters/second and the inspiratory volume is in the range of from about 0.15 to about 0.40 liters.
Claim 4
Dependent Claim
38 words
The method of claim 1, wherein the inspiratory flow rate is in the range of from about 0.15 to about 1.8 liters/second and the inspiratory volume is in the range of from about 0.15 to about 0.25 liters.
Claim 5
Dependent Claim
42 words
The method of claim 1 wherein the aerosolized drug has a particle size in the range of from about 0.5 to 12 microns and wherein the drug is released at a velocity of substantially zero relative to the patient's inspiratory flow path.
Claim 6
Dependent Claim
20 words
The method of claim 1, wherein the measuring and releasing are carried out during a single inhalation of the patient.
Claim 7
Dependent Claim
19 words
The method of claim 1 wherein the aerosolized drug is in the form of aerosolized particles of a solution.
Claim 8
Dependent Claim
12 words
The method of claim 6, wherein the solution is an aqueous solution.
Claim 9
Dependent Claim
18 words
The method of claim 6, wherein the solution is comprised of drug dissolved in a low-boiling point propellant.
Claim 10
Dependent Claim
19 words
The method of claim 1, wherein the aerosolized drug is in the form of aerosolized particles of a suspension.
Claim 11
Dependent Claim
12 words
The method of claim 9, wherein the suspension is an aqueous suspension.
Claim 12
Dependent Claim
18 words
The method of claim 9, wherein the suspension is comprised of drug suspended in a low-boiling point propellant.
Claim 13
Dependent Claim
20 words
The method of claim 1, wherein the aerosolized drug is in the form of aerosolized particles of a dry powder.
Claim 14
Dependent Claim
17 words
The method of claim 1, wherein the measuring is carried out via electronic air flow measurement components.
Claim 15
Dependent Claim
17 words
The method of claim 1, wherein the measuring is carried out via mechanical air flow measurement components.
Claim 16
Dependent Claim
61 words
The method of claim 1, wherein the releasing is begun while the inspiratory flow rate is in the range of from about 0.10 to about 2.0 liters/second and the inspiratory volume is in the range of about 0.15 to about 0.80 liters and the releasing is completed outside the range of inspiratory flow rate of about 0.10 to about 2.0 liters/second.
Claim 17
Dependent Claim
56 words
The method of claim 1, wherein the releasing is begun while the inspiratory flow rate is in the range of from about 0.10 to about 2.0 liters/second and the inspiratory volume is in the range of about 0.15 to about 0.80 liters and the releasing is completed at an inspiratory volume of above about 0.40 liters.
Claim 18
Dependent Claim
29 words
The method of claim 1, wherein the releasing is begun and completed while the inspiratory flow rate is in the range of from about 0.10 to about 2.0 liters/second.
Claim 19
Dependent Claim
27 words
The method of claim 17, wherein the releasing is begun and completed while the inspiratory volume is in the range of about 0.15 to about 0.40 liters.
Claim 20
Dependent Claim
43 words
The method of claim 1, wherein aerosolized drug is released when the inspiratory flow rate is in a range of from about 0.10 to 2.0 liters/second and the patient's inspiratory volume is in a range of from about 0.15 to about 0.80 liters.
Claim 21
Dependent Claim
31 words
The method of claim 1, wherein the aerosolized drug is released at a therapeutically relevant inspiratory flow rate value above about 0.10 liters/second and inspiratory volume value above about 0.15 liters.
Claim 22
Independent Claim
99 words
A method of drug delivery, comprising: simultaneously measuring a patient's inspiratory flow rate and inspiratory volume with a portable, hand-held, battery-powered device; and releasing particles of a pharmaceutically active drug having a particle size in the range of from about 0.5 to 12 microns, the drug being released at a substantially zero rate of velocity relative to the patient's inspiratory flow path and occurring when the patient's measured inspiratory flow rate is in the range of from about 0.10 to 2.0 liters/second and the patient's inspiratory volume is in the range of from about 0.15 to about 0.80 liters.
Claim 23
Independent Claim
99 words
A method of drug delivery, comprising: simultaneously measuring a patient's inspiratory flow rate and inspiratory volume with a portable, hand-held, battery-powered device; and releasing particles of a pharmaceutically active drug having a particle size in the range of from about 0.5 to 12 microns, the drug being released at a substantially zero rate of velocity relative to the patient's inspiratory flow path and occurring when the patient's measured inspiratory flow rate is in the range of from about 0.10 to 2.0 liters/second and the patient's inspiratory volume is in the range of from about 0.15 to about 0.80 liters.
Claim 24
Dependent Claim
32 words
The method of claim 21, wherein the releasing is begun within the inspiratory flow rate of about 0.10 to 2.0 liters/second and the inspiratory volume of about 0.15 to about 0.40 liters.
Claim 25
Dependent Claim
15 words
The method of claim 21, wherein the aerosolized drug is a pharmaceutically active respiratory drug.
Claim 26
Dependent Claim
15 words
The method of claim 21, wherein the aerosolized drug is a pharmaceutically active systemic drug.
Claim 27
Dependent Claim
25 words
The method of claim 21, wherein the aerosolized drug is asteroid selected from the group consisting of beclomethasone dipropionate, flunisolide, fluticasone, budesonide and triamcinolone acetonide.
Claim 28
Dependent Claim
14 words
The method of claim 21, wherein the aerosolized drug is a non-steroidal, anti-inflammatory drug.
Claim 29
Dependent Claim
27 words
The method of claim 21, wherein the aerosolized drug is selected from the group consisting of isoproterenol, cromolyn sodium, albuterol sulfate, metaproterenol sulfate, salmeterol xinafoate and formotorol.
Claim 30
Dependent Claim
17 words
The method of claim 21, wherein the particles have the same size within a range of ±20%.
Claim 31
Dependent Claim
17 words
The method of claim 28, wherein the particles have the same size within a range of ±10%.
Claim 32
Dependent Claim
17 words
The method of claim 29, wherein the particles have the same size within a range of ±5%.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-04-23 | 1999-10-23 | 2000-04-23 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-04-23 | 2003-10-23 | 2004-04-23 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-04-23 | 2007-10-23 | 2008-04-23 | $7700.00 | Window Closed / Lapsed |