Device for controlled release of vaporous medications through nasal route

• US 5,455,043 A
• Filed: 06/28/1991
• Issued: 10/03/1995
• Est. Priority Date: 06/13/1990
• Status: Expired due to Fees

• Current Assignee: Fariba Fischel-Ghodsian
• Original Assignee: Fariba Fischel-Ghodsian
• Inventors: Fischel-Ghodsian, Fariba
• Primary Examiner(s): Zirker, Daniel R.
• Application Number:
  US07/722,704
• Time in Patent Office: 1,558 Days
• Field of Search: 424/448, 424/449, 428/905, 428/343, 428/354, 523/102
• US Class Current: 424/448
• CPC Class Codes: A01M 1/2055 Holders or dispensers for solid, gelified or impregnated insecticide, e.g. volatile blocks or impregnated pads
• CPC Class Codes: A01M 29/12 using odoriferous substances, e.g. aromas, pheromones or chemical agents
• CPC Class Codes: A01N 25/18 Vapour or smoke emitting compositions with delayed or sustained release
• CPC Class Codes: A44C 15/002 Jewellery dispersing perfume or the like
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61L 9/12 Apparatus, e.g. holders, therefor
• CPC Class Codes: A61Q 17/02 containing insect repellants
• CPC Class Codes: Y10S 428/905 Odor releasing material
• CPC Class Codes: Y10T 428/2848 Three or more layers

Abstract

A controlled release device useful for the release of vapors or liquids to the surrounding of the user is described. The device is a multilayered laminate consisting of a reservoir layer which incorporates an active compound, such as a nasally delivered therapeutic medication or insect repellant, an impermeable membrane layer adjacent the reservoir layer and a diffusion rate limiting membrane layer adjacent the reservoir layer. The device preferably includes an adhesive layer for adhering the device to skin or a surface and an ornamental decorative layer.

Claims

1. A device useful for the controlled release of therapeutic agents to the nasal cavity and respiratory airway of patients, said device forming a laminate comprising:

a diffusion rate limiting membrane layer comprising a polymer selected from the group consisting of nonporous polymeric membranes and microporous polymeric membranes having a pore size of form about 0.02 microns to about 0.6 microns;

a reservoir layer adjacent said diffusion rate limiting membrane layer, said reservoir layer comprising one or more therapeutic agents incorporated in a polymer, said therapeutic agent selected from the group of vapor emitting compounds or aerosols consisting of antihistamines, bronchodilators, decongestants, mucolytics, anti-tussives, anti-inflammatory steroids, anti-virals, peptides and hormones;

a vapor and liquid impermeable backing layer adjacent said reservoir layer; and

a pressure sensitive contact adhesive layer adjacent said vapor and liquid impermeable backing layer, said adhesive layer comprising a biocompatible, hypoallergenic pressure sensitive adhesive.

2. The device of claim 1 wherein said polymer is selected from the group consisting of polyethylene, polypropylene, polyvinylchloride, cellulose acetate, cellulose nitrate, polyacrylonitrile, polytetrafluorethylene, and ethylenevinyl acetate.

3. The device of claim 1 wherein said vapor and liquid impermeable backing layer is a metal foil polymer laminate, said polymer selected from the group consisting of polyethylene terephthalate, high density polyethylene, low density polyethylene, polypropylene, polyvinylchloride, ethylene vinyl acetate, and polyester.

4. The device of claim 1 wherein said reservoir layer comprises a porous polymer, said polymer having pores sized from about 0.02 microns to about 0.6 microns, and said therapeutic agent incorporated within said pores.

5. The device of claim 1 wherein said reservoir layer comprises a polymer and said active compound is dissolved in said polymer or the polymer is polymerized in the presence of active compound.

6. The device of claim 1 wherein said reservoir layer comprises a gelled mixture of a polymer, a liquid, and said therapeutic agent.

7. The device of claim 1 further including an outer decorative layer adjacent said diffusion rate limiting membrane layer.

8. The device of claim 1 wherein said membrane layer, said reservoir layer, said impermeable backing layer and said pressure sensitive adhesive layer are secured together at their edges by a sealing technique selected from the group consisting of solvent sealing and heat sealing.