Systems for the intrapulmonary delivery of aerosolized aqueous formulations

• US 6,123,068 A
• Filed: 04/24/1998
• Issued: 09/26/2000
• Est. Priority Date: 05/21/1993
• Status: Expired due to Fees

• Current Assignee: Aradigm Corporation
• Original Assignee: Aradigm Corporation
• Inventors: Lloyd, Peter M., Lloyd, Lester John, Rubsamen, Reid M., Schuster, Jeffrey Arthur
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/065,753
• Time in Patent Office: 886 Days
• Field of Search: 206/438, 206/439, 220/371, 220/372, 239/331, 239/57, 239/58, 239/59, 604/892.1, 424/473, 215/310, 215/25, 215/DIG. 3, 215/378, 215/381, 210/323.1, 602/59, 128/200.24, 128/200.22, 55/487
• US Class Current: 128/200.24
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 1/1418 Threaded type
• CPC Class Codes: A61J 7/04 Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61K 51/1206 Administration of radioactive gases, aerosols or breath tests
• CPC Class Codes: A61M 11/002 by flow deviation causing inertial separation of transported particles
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/001 using ultrasonic means
• CPC Class Codes: A61M 15/0031 by bursting or breaking the package, i.e. without cutting or piercing
• CPC Class Codes: A61M 15/0043 Non-destructive separation of the package, e.g. peeling
• 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 15/008 Electronic counters
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/40 Respiratory characteristics
• CPC Class Codes: B65D 81/32 for packaging two or more different materials which must be maintained separate prior to use in admixture containers with removable or destructible partitions B65D25/08 ; closures combined with auxiliary containers B65D51/28; in aerosol containers B65D83/682; amalgam capsules A61C5/66; containers for pharmaceutical purposes A61J1/20, A61M5/19; medical syringes A61M3/005, resin cartridges for grouting anchoring-bolts in mines E21D20/026

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.

Claims

1. An elongated flexible tape member comprising a tape body comprised of a polymer material forming an interconnecting body sheet wherein the interconnecting body sheet has a thickness in a range of about 2 to about 20 microns and comprises a non-porous sheet area and a plurality of porous membrane areas having pores therein which pores have a diameter in a range of from about 0.25 microns to about 6 microns wherein the pores are present in each area in a pore density of from about 10 to 10,000 pores over an area in a range of about 1 sq. mm to about 1 sq. cm and wherein the non-porous sheet area comprises a plurality of perforations along an edge for moving the tape through a device from one porous area to another.

2. The elongated tape member as claimed in claim 1, wherein the pores are present in a pore density of about 1×

10⁴ to about 3×

10⁸ pores/cm².

3. The elongated tape member of claim 1, wherein the porous areas are in the shape of elongated rectangles positioned within a distance of about 0.5 centimeters or less of each other.

4. The elongated tape member as claimed in claim 1, further comprising a plurality of additional openings in the tape body which openings are positioned next to the porous areas.

5. The elongated tape member as claimed in claim 1, wherein the tape body has a density in the range of 0.25 to 3.0 mg/cm².

6. The elongated tape member as claimed in claim 1, wherein the thickness is about 8 to 12 microns.

7. The elongated tape member as claimed in claim 1, wherein the pores have a cylindrical configuration.

8. The elongated tape member as claimed in claim 1, wherein the pores have a conical configuration.