# Patent

## Title
Nicotine delivery system

## Abstract

The present invention relates to a nicotine inhaling device and a method for making the same. Such device allows a user to ingest nicotine vapours orally and it is primarily intended to be used as a smoking cessation aid.

## Background
The present invention relates to a nicotine delivery system and a method for making the same. Additionally the invention relates to a nicotine inhaling device which allows a user to ingest nicotine vapours orally. The nicotine inhaling device of the present invention is primarily directed to a device which can be used as a smoking cessation aid.
BACKGROUND OF THE INVENTION
A number of attempts have been made over the years to create useful aids to assist the smokers to deal with their nicotine addictions. The most successful product for this purpose has been nicotine chewing gums. Another type of product for this purpose was a smokeless cigarette which however could not satisfy FDA requirements. Since oral ingestion of nicotine vapours was considered to be a very effective way to aid in smoking cessation a lot of developments have been made to create good and safe products in this respect. Such products have been described in detail in e.g. the U.S. Pat. Nos. 4,736,755, 4,917,120, 5,167,242, 5,400,808, 5,501,236 and 6,098,632, the contents of which are incorporated in this patent application. A product based on one or more of these patents have been developed and marketed under the brand name Nicorette® Inhaler®. In this product the nicotine is loaded in a porous polyolefin plug which plug is enclosed in a cylinder (cartridge) being made of an injection moulded impact modified acrylonitrile-methyl acrylate copolymer (Barex® from BP Lima Chemicals, 1900 FORT AMANDA ROAD, LIMA, Ohio, US). The atmosphere in the cylinder is evacuated and replaced by nitrogen gas. Both ends of the cylinder are sealed with aluminium foil. The foil has also a layer of the same copolymer (Barex®) that is heat sealed on the cylinder edges.
The very specific modified acrylonitrile-methyl acrylate copolymer used for this purpose has turned out to be very expensive. It has now surprisingly been found that a much less expensive material may be used to replace this copolymer and the invention is based on this finding.


THE INVENTION
Studies have shown that it should be possible to use a polymer material such as polyethyleneterephtalate (PET) which has been subjected to surface modification by deposition of Inorganic Oxides or Amorphous Carbon coatings. The coating provides about 5-10× improvement of the oxygen impermeability and 2-4× of the water vapor impermeability.
The required investments in machinery are reasonable and the capacity will enable a short payback time and a considerable sustainable cost saving.
The technique for surface modification has developed so the application can be realised. Coating the inside and/or outside of 3D polymeric surfaces and for coating 2D surfaces with Inorganic Oxides or Amorphous Carbon to enhance their gas and vapour barrier properties as well as their electrical, optical, tribological and other properties is already commonly used.
Current areas of application include:

    
    
        Beverages (including water, alcoholic and non-alcoholic)
        Food Packaging
        Medical Plastics and Packaging
        Semiconductors
        Lithium Batteries
    
    


There are different techniques available for achieving the desired plasma coating. Among those we have found that the methods and devices for plasma coating described in e.g. the U.S. Pat. Nos. 6,015,595, 6,112,695, 6,180,191, 6,177,142, 6,180,185 and 6,539,890 are very useful. The contents of these patents are incorporated in this application.
Other examples of coating with Inorganic Oxides or Amorphous Carbon we incorporated in this application are the following:

    Felts, John T., “Plasma Deposited Silica Coatings for High Barrier Film and Rigid Containers”, COEX 89 Conference, Princeton, N.J., 1989
    Pasqui, A., Scateni, G., Beccaria, C., “Review of Processes for Clear Barrier Coating Today Available on the Market”, First Symposium of European Vacuum Coaters, Anzio, Italy, June 20-22, 1994
    Johansson, Kenth S., “Gas Barrier Properties of Plasma-deposited coatings—Substrate Effects”, Polymer Surface Modification: Relevance to Adhesion, vol. 2 (Ed. K. L. Mittal), VSP, 2000
    Naima Boutroy, Yann Pernel, J. M. Rius, Florence Auger, H. J. von Bardeleben, J. L. Cantin, F. Abel, Andreas Zeinert, C. Casiraghi, A. C. Ferrari and J. Robertson “Hydrogenated amorphous carbon film coating of PET bottles for gas diffusion barriers”, Diamond and related Matters, Volume 15, Issues 4-8, April-August 2006, Pages 921-927


By for example using these techniques described above, plastic and metallic based vacuum system for RF (kHz and MHz) or micro wave PECVD (Plasma Enhanced Chemical Vapor Deposition) or PVD (Physical Vapour Deposition) deposition of Inorganic Oxides or Amorphous Carbon onto the inside and/or outside of containers will create the following advantages over the prior art:

    
    
        Extensive use of inexpensive plastics (cost reduction/simplification)
        Good barrier properties inside cylinder with Inorganic Oxide or Amorphous Carbon coating.
        End-User verified Product Performance—Passes all tests
        Modular design—readily scalable
        Coat inside and outside at the same time
    
    


The equipment based on the technique described above covers the surfaces precisely considering the size and geometry of the part. It is no problem to coat a cylindrical part with open ends. The system is currently able to hold +/−10% uniformity for a 15-20 nm thick coating from the opening to the centre.
Both inner and/or outer surfaces would be covered with the process. This is advantageous as it could give a double barrier in a one or several step process.
The thickness of the coating is controlled by power and speed in the machine. One way that a pinhole free coating can be guaranteed is if the surface to be coated would be particle free. This is achieved by installing laminar flow surroundings between moulding and the coating machine and running it on line.
PET is the recommended polymer since we have the most experience with it and due to that it have the right surface structure for nano coating. Typically, the coating provides 5-10× improvement for oxygen barrier and 2-4× for water vapour barrier.
The compatibility to aggressive substances for the plasma-coated PET surface is excellent as the coating would be characterised as quartz i.e. more clean than glass as it does not contain iron and sodium. This means that substances may not migrate into the material or vice versa. The coating was tested with typical food additives and some solvents including acetone. The coating allowed PET containers to remain structurally sound when filled with acetone and stored.

## Claims

1. A nicotine inhaling device with an extended shelf life, containing a measured amount of nicotine in a gas atmosphere which can selectively be made accessible to a user by oral ingestion of vapors, comprising:
a) a nicotine reservoir for holding and dispersing a measured amount of nicotine;
b) a substantially cylindrical nicotine impermeable barrier formed as part of the nicotine reservoir, having a first open end and a second open end and an internal surface and an external surface, said nicotine barrier layer consisting essentially of a polyethylene terephthalate (PET) which has been subjected to surface modification with Inorganic Oxides or Amorphous Carbon on both the internal and external surfaces; and
c) a first seal and a second seal, the first seal being heat sealed to the first open end and the second seal being heat sealed to the second open end to form a continuous nicotine impermeable barrier so that the nicotine is prevented from migrating outside the reservoir.

2. The nicotine inhaling device of claim 1, wherein said polymer has been subjected to surface modification with Amorphous Carbon.

3. The nicotine inhaling device of claim 1, wherein said polymer has been subjected to surface modification with Inorganic Oxides.

4. A nicotine inhaling device with an extended shelf life, containing a measured amount of nicotine in a gas atmosphere which can selectively be made accessible to a user by oral ingestion of vapors, comprising:
a) a nicotine reservoir for holding and dispersing a measured amount of nicotine;
b) a substantially cylindrical nicotine impermeable barrier formed as part of the nicotine reservoir, having a first open end and a second open end and an internal surface and an external surface, said nicotine barrier layer consisting of a polyethylene terephthalate (PET) polymer which has been subjected to surface modification with Inorganic Oxides or Amorphous Carbon on both the internal and external surfaces; and
c) a first aluminum seal and a second aluminum seal, the first aluminum seal being heat sealed to the first open end and the second aluminum seal being heat sealed to the second open end to form a continuous nicotine impermeable barrier so that the nicotine is prevented from migrating outside the reservoir.

5. The nicotine inhaling device of claim 1, wherein said surface modification of inorganic oxides or amorphous carbon is from about 15 nm to about 20 nm thick.

6. The nicotine inhaling device of claim 1, wherein said surface modification of said impermeable barrier is a pinhole free coating.