Patent US5544646A successfully refreshed from Google Patents.
US5544646A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Systems for the intrapulmonary delivery of aerosolized aqueous formulations
Assignee: Aradigm Corp
•
Filing: 1994-05-20
•
Granted: 1996-08-13
•
Expires: 2014-05-20
Abstract
Abstract A disposable package, tape, and cassette are provided which makes it possible to hold and disperse therefrom liquid, flowable formulations including aqueous formulations (solutions or dispersions with particles less than 0.25 microns in diameter) of a pharmaceutically active drug. In one embodiment formulation is packaged in individual dosage unit containers which containers are preferably interconnected. The package is designed to be integrated into a cassette which can be loaded into a dispersing device capable of individually opening dosage unit containers and aerosolizing the contents through a porous membrane, into a mouth piece on the cassette, for delivery to a patient. In addition to and alongside of each porous membrane, the package may include one or more openings through which air is forced in order to aid in avoiding the accumulation of aerosolized particles. The package may be configured so that the formulation is held in a container not positioned directly vertical to and below the porous membrane, thus making it necessary to channel formulation horizontally to the porous membrane and making it possible to include a vibrating mechanism directly below a chamber covered by the porous membrane. Release of aerosolized drug is breath actuated based on simultaneous measurements of inspiratory flow and volume so as to provide for repeatable dosing of drug to the patient.
Inventors
- 👤 Lester J. Lloyd
- 👤 Peter M. Lloyd
- 👤 Reid M. Rubsamen
- 👤 Jeffrey A. Schuster
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-26 09:01
CPC Classifications
A; A61; A61K; A61K51/00; A61K51/12; A61K51/1206; A61J; A61J7/00; A61J7/04; A61M; A61M15/00; A61M15/0001; A61M15/0005; A61M15/001; A61M15/0028; A61M15/003; A61M15/0031; A61M15/0043; A61M15/0045; A61M15/0046; A61M15/0051; A61M15/0053; A61M15/0055; A61M15/0065; A61M15/0068; A61M15/008; B; B65; B65D; B65D81/00; B65D81/32; A61J1/00; A61J1/03; A61J1/035; A61J1/14; A61J1/1412; A61J1/1418; A61J7/0409; A61J7/0418; A61M11/00; A61M11/001; A61M11/002; A61M15/0085; A61M16/00; A61M16/0003; A61M2016/0015; A61M2016/0018; A61M2016/0021; A61M2016/003; A61M2016/0033; A61M2016/0039; A61M2205/00; A61M2205/82; A61M2205/8206; A61M2230/00; A61M2230/40
Claims Analysis
Total Claims: 20
Claim 1
Independent Claim
111 words
A disposable package, comprising: a container having at least one wall which is collapsible by the application of a force the container having therein a dry pharmaceutically active drug with at least one wall having an opening; a porous membrane covering the opening wherein the membrane pores have a diameter in the range of from about 0.25 micron to about 6 microns; and a liquid container having a flowable liquid therein, the liquid container being in fluid connection with the container having the dry drug therein, wherein the liquid container is separated from the container having the dry drug therein by a membrane which is ruptured upon the application of force.
Claim 2
Dependent Claim
111 words
A disposable package, comprising: a container having at least one wall which is collapsible by the application of a force the container having therein a dry pharmaceutically active drug with at least one wall having an opening; a porous membrane covering the opening wherein the membrane pores have a diameter in the range of from about 0.25 micron to about 6 microns; and a liquid container having a flowable liquid therein, the liquid container being in fluid connection with the container having the dry drug therein, wherein the liquid container is separated from the container having the dry drug therein by a membrane which is ruptured upon the application of force.
Claim 3
Dependent Claim
57 words
The disposable package as claimed in claim 1, further comprising one or more additional containers interconnected together by an interconnecting component wherein each addition container has an opening covered by a porous membrane with pores having a diameter in the range of about 0.25 to about 6 microns and is in fluid connection with a liquid container.
Claim 4
Dependent Claim
40 words
The disposable package as claimed in claim 1, wherein the porous membrane is comprised of an area of a surface of the container which area includes pores having a diameter in a range of 0.25 micron to about 6 microns.
Claim 5
Dependent Claim
38 words
The disposable package as claimed in claim 3, wherein the membrane includes from 10 to 10,000 pores positioned over the area having a size in the range of from about 1 mm. sq. to about 1 cm. sq.
Claim 6
Dependent Claim
52 words
The disposable package as claimed in claim 1, wherein the pores are present in the porous membrane with a pore density of from about 1×10 4 through about 1×10 8 pores/cm 2 and the wall is collapsed by the application of force causing a pressure of about 20 psi to 100 psi.
Claim 7
Dependent Claim
34 words
The disposable package as claimed in claim 1, wherein the container includes a barrier separating the content of the container from the porous membrane the barrier being rupturable upon the application of a force.
Claim 8
Dependent Claim
92 words
The disposable package of claim 1, wherein the container and the liquid container are each collapsible by the application of force to a bottom wall so as to collapse each side wall and can be collapsed in a manner so as to force essentially all of the flowable liquid out of the liquid container into the container to contact with the dry drug to form a formation which is forced out of the porous membrane and aerosolized into particles having a diameter in the range of from about 0.5 to 12 microns.
Claim 9
Dependent Claim
27 words
The disposable package of claim 1, further comprising a removable cover sheet positioned over the porous membrane, the cover sheet being held in place by a seal.
Claim 10
Dependent Claim
97 words
A disposable package, comprising: a container having an opening leading to a channel, the container having a liquid, flowable formulation therein which formulation comprises a pharmaceutically active drug, wherein at least one wall of the container is collapsible in a manner so as to allow the formulation in the container to be forced out of the opening into the channel; a resonance cavity in fluid connection with the container by means of the channel, the resonance cavity having a porous membrane wherein pores of the membrane have a diameter in the range of 0.25 to 6 microns.
Claim 11
Dependent Claim
97 words
A disposable package, comprising: a container having an opening leading to a channel, the container having a liquid, flowable formulation therein which formulation comprises a pharmaceutically active drug, wherein at least one wall of the container is collapsible in a manner so as to allow the formulation in the container to be forced out of the opening into the channel; a resonance cavity in fluid connection with the container by means of the channel, the resonance cavity having a porous membrane wherein pores of the membrane have a diameter in the range of 0.25 to 6 microns.
Claim 12
Dependent Claim
15 words
The disposable package of claim 9, wherein the pharmaceutically active drug is a respiratory drug.
Claim 13
Dependent Claim
15 words
The disposable package of claim 9, wherein the pharmaceutically active drug is a systemic drug.
Claim 14
Dependent Claim
27 words
The disposable package of claim 9, wherein the pharmaceutically active drug is asteroid selected from the group consisting of beclomethasone dipropionate, flunisolide, fluticasone, budesonide and triamcinolone acetonide.
Claim 15
Dependent Claim
16 words
The disposable package of claim 9, wherein the pharmaceutically active drug is a non-steroidal, anti-inflammatory drug.
Claim 16
Dependent Claim
29 words
The disposable package of claim 9, wherein the pharmaceutically active drug is selected from the group consisting of isoproterenol, cromolyn sodium, albuterol sulfate, metaproterenol sulfate, salmeterol xinaforate and formotorol.
Claim 17
Dependent Claim
131 words
A disposable drug delivery cassette for use in aerosolized delivery of drugs to lungs, comprising: an outer protective cover having positioned therein; a disposable package comprised of a plurality of interconnected individual disposable drug containers, with each container having an opening which opening leads to an open channel which includes an abutment which is broken on the application of force and an area beyond the abutment which is covered by a disposable porous membrane having pores with a diameter of about 0.25 to 6 microns, with each container containing a liquid formulation comprising a pharmaceutically active drug; wherein the formulation has a viscosity of which is sufficiently low such that the formulation is aerosolized to particles having a diameter of about 0.5 to 12 microns when moved out of the pores.
Claim 18
Dependent Claim
131 words
A disposable drug delivery cassette for use in aerosolized delivery of drugs to lungs, comprising: an outer protective cover having positioned therein; a disposable package comprised of a plurality of interconnected individual disposable drug containers, with each container having an opening which opening leads to an open channel which includes an abutment which is broken on the application of force and an area beyond the abutment which is covered by a disposable porous membrane having pores with a diameter of about 0.25 to 6 microns, with each container containing a liquid formulation comprising a pharmaceutically active drug; wherein the formulation has a viscosity of which is sufficiently low such that the formulation is aerosolized to particles having a diameter of about 0.5 to 12 microns when moved out of the pores.
Claim 19
Dependent Claim
64 words
The cassette as claimed in claim 15, further comprising: an air dispersion vent having an opening positioned in a manner such that air exiting the vent will exit in substantially the same direction as liquid formulation exiting from the porous membrane, the porous membrane having 10 to 10,000 pores over an area of from about 1 mm 2 to about 1 cm 2 .
Claim 20
Dependent Claim
26 words
The cassette as claimed in claim 15, further comprising: a vibrating device capable of vibrating at a frequency in the range of 800 to 4,000 kilohertz.
References Cited (Backward Citations)
US3187748A
Cited
US3861386A
Cited
US3658059A
Cited
US3565070A
Cited
US3826413A
Cited
US3814297A
Cited
US3757782A
Cited
US3812854A
Cited
US3991304A
Cited
US4119096A
Cited
US4090642A
Cited
GB1518998A
Cited
US4361401A
Cited
DE2837040A1
Cited
US4275840A
Cited
US4294407A
Cited
US4334531A
Cited
GB2055046A
Cited
US4465234A
Cited
US4484577A
Cited
GB2104393A
Cited
US4533082A
Cited
FR2516387A1
Cited
US4627432A
Cited
US4604847A
Cited
US4790479A
Cited
US4677975A
Cited
US4648393A
Cited
EP0186280A2
Cited
US4592348A
Cited
US4803978A
Cited
US4926852A
Cited
US4790305A
Cited
US4926852B1
Cited
US4877989A
Cited
US4896832A
Cited
US4852582A
Cited
US5134993A
Cited
WO1990013327A1
Cited
US5114240A
Cited
US5033463A
Cited
US5152456A
Cited
US5348191A
Cited
GB2256805B
Cited
WO1991014468A1
Cited
WO1992007599A1
Cited
WO1992009322A1
Cited
WO1992011050A1
Cited
GB2255918A
Cited
DE4133274A1
Cited
WO1993003785A2
Cited
EP0530625A1
Cited
WO1993009832A1
Cited
EP0546607A1
Cited
WO1993017728A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-08-13 | 2000-02-12 | 2000-08-13 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-08-13 | 2004-02-12 | 2004-08-13 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-08-13 | 2008-02-12 | 2008-08-13 | $7700.00 | Window Closed / Lapsed |