U.S. patent application number 10/783309 was filed with the patent office on 2004-09-23 for container comprising nicotine and the use and manufacture thereof.
Invention is credited to Andersson, Sven-Borje, Bosson, Bengt Ake, Turner, James Edward, Wingo, James Peyton.
Application Number | 20040182403 10/783309 |
Document ID | / |
Family ID | 32995669 |
Filed Date | 2004-09-23 |
United States Patent
Application |
20040182403 |
Kind Code |
A1 |
Andersson, Sven-Borje ; et
al. |
September 23, 2004 |
Container comprising nicotine and the use and manufacture
thereof
Abstract
The present invention relates to a container comprising nicotine
to be inhaled, which is able to retain and release nicotine, and
which comprises a shaped mass of fibers and/or filaments. Further,
the present invention relates to the use of said container in an
inhaling device for obtaining a quick and/or complete reduction of
the urge to smoke or use of tobacco and/or for providing a sense of
smoking satisfaction without smoking and to the use of said
container in smoking cessation therapy.
Inventors: |
Andersson, Sven-Borje;
(Helsingborg, SE) ; Bosson, Bengt Ake;
(Helsingborg, SE) ; Turner, James Edward; (San
Antonio, TX) ; Wingo, James Peyton; (Fairburn,
GA) |
Correspondence
Address: |
Warner-Lambert Company, LLC
201 Tabor Rd.
Morris Plains
NJ
07950
US
|
Family ID: |
32995669 |
Appl. No.: |
10/783309 |
Filed: |
February 20, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60458159 |
Mar 27, 2003 |
|
|
|
Current U.S.
Class: |
131/270 ;
131/271 |
Current CPC
Class: |
A24F 40/42 20200101;
A24F 40/10 20200101 |
Class at
Publication: |
131/270 ;
131/271 |
International
Class: |
A24F 047/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 28, 2003 |
SE |
0300520-4 |
Claims
1. A container comprising a shaped mass of fibers and/or filaments;
and nicotine releasable retained in said shaped mass.
2. The container according to claim 1, wherein said container has a
flow resistance of gas being lower than the equivalent of about 1.0
kPa at a gas flow rate of about 1000 ml/min.
3. The container according to claim 1, wherein said container has a
flow resistance of gas being lower than the equivalent of about 0.6
kPa at a gas flow rate of about 1000 ml/min.
4. The container according to claim 1, wherein said container has a
flow resistance of gas being lower than the equivalent of about 0.3
kPa at a gas flow rate of about 1000 ml/min.
5. The container according to claim 1, wherein said nicotine is
retained by means selected from the group consisting of chemical
binding, adsorption, absorption or mixtures thereof, and released
by breaking these mechanisms.
6. The container according to claim 1, wherein said container
further comprises non-fibrous material.
7. The container according claim 1, wherein said fibers or
filaments are non-sintered.
8. The container according to claim 1, wherein said container
further comprises sintered material.
9. The container according to claim 1, wherein said fibers or
filaments comprise a member selected from the group consisting of
glass, metals, paper, cellulose, or cloth.
10. The container according to claim 9, wherein said fibers or
filaments comprise aluminum or steel.
11. The container according to claim 1, wherein said fibers or
filaments comprise polymeric material.
12. The container according to claim 11, wherein said polymeric
material comprises a member selected from the group consisting of
polyolefin, polyester and/or polyamide.
13. The container according to claim 12, wherein said polymeric
material comprises comprises a member selected from the group
consisting of polyethylene, polypropylene, polybutadiene,
poly-1-butene, polyisobutene, polyisoprene, polyvinylidene
chloride, ethylene vinyl alcohol, polylactide-glycolide copolymer,
polycarbonate, polyethylene naphthalene, polytrimethylene
naphthalene, polyethylene terephthalate, terephthalate-isophthalate
polyesters, polybutylene terephthalate, liquid crystalline polymer
that comprises hydroxy benzoic acid and hydroxy naphtenic acid, a
copolymer of acrylonitrile and methacrylate nylon 66, or nylon 6 or
copolymers thereof or combinations thereof.
14. The container according to claim 13, wherein said polymeric
material comprises polyethylene.
15. The container according to claim 13, wherein said polymeric
material comprises polyethylene terephtalate.
16. The container according to claim 1, wherein said fibers or
filaments are produced by spinning and/or extrusion.
17. The container according to claim 5, wherein said retaining
and/or release of nicotine is electrically enhanced and/or modified
by temperature.
18. A method for producing a container according to claim 1,
wherein said container is loaded with nicotine by using a gas that
comprises nicotine.
19. The method according to claim 18, wherein said loading is done
in an oxygen-free environment.
20. The method for producing a container according to claim 1,
wherein said container is loaded with nicotine by immersing said
container in a solution comprising nicotine.
21. The method according to claim 20, wherein said loading is done
in an oxygen-free environment.
22. The method according to claim 20, wherein said solution used
for loading comprises nicotine and an organic solvent.
23. The method according to claim 22, wherein said organic solvent
is selected from organic solvents that are more volatile than
nicotine.
24. The method according to claim 23, wherein said organic solvent
is selected from the group of ethers, ketones and alcohols.
25. The method according to claim 24, wherein said organic solvent
is selected from alcohols.
26. The method according to claim 25, wherein said organic solvent
is ethanol.
Description
[0001] This application hereby claims priority from Swedish patent
application 0300520-4, filed Feb. 28, 2003 and U.S. provisional
application 60/458,159, filed Mar. 27, 2003.
TECHNICAL FIELD
[0002] This invention relates to a container comprising nicotine.
The container is for use in an inhaling device. Such a device is
for use in nicotine replacement therapy treatment (NRT) and tobacco
dependence treatment.
BACKGROUND OF THE INVENTION
[0003] Tobacco Dependence and Reduction Thereof
[0004] In recent years, with the recognition of the harmful effects
of tobacco smoking, there have been numerous campaigns and programs
by governmental agencies and various health groups and other
interested organizations to disseminate information about the
adverse health effects resulting from tobacco smoking. Moreover,
and as a result of this recognition of the harmful effects, there
have been many programs directed to attempts in reducing smoking
incidence.
[0005] Nicotine (C.sub.10H.sub.14N.sub.2) is an organic compound
and is the principal alkaloid of tobacco and it is the chief
addictive ingredient in the tobacco used in cigarettes, cigars,
snuff and the like. Nicotine is also an addictive drug and smokers
characteristically display a strong tendency to relapse after
having successfully stopped smoking for a time. Nicotine is among
the world's most used drug, along with alcohol and caffeine from
coffee and tea. It is an addictive poisonous alkaloid. And it is
also used as an insecticide. The minimal acute lethal dose of
nicotine in human adults is 40 to 60 mg.
[0006] The main problem with tobacco smoking is its enormous
implications on health. Today it is estimated that smoking-related
diseases cause some 3-4 million deaths per year. It was estimated,
in the US Surgeon General's 1988 report on The Health Consequences
of Smoking, that in the US alone diseases related to cigarette
smoking cause about 300.000 deaths each year. In fact, excessive
smoking is now recognized as one of the major health problems
throughout the world. This grim consequence of tobacco smoking has
urged many medical associations and health authorities to take very
strong actions against the use of tobacco.
[0007] Even though tobacco smoking is decreasing in many developed
countries today it is hard to see how the societies could get rid
of the world's second most used drug or even decrease the use
thereof.
[0008] The most advantageous thing a heavy smoker can do is to
completely stop, or at least reduce, his/her smoking. Experience
shows, however, that most smokers find it extremely difficult to
stop or even to reduce smoking since, mostly, smoking tobacco
result in a dependence disorder or craving. The WHO has in its
International Classification of Disorders a diagnosis called
Tobacco Dependence. Others like the American Psychiatric
Association call the addiction Nicotine Dependence. It is generally
accepted that these difficulties to stop or reduce smoking result
from the fact that those heavy smokers are dependent on nicotine.
The most important risk factors are, however, substances that are
formed during the combustion of tobacco, such as carbon monoxide,
tar products, aldehydes, and hydrocyanic acid.
[0009] Effects of Nicotine
[0010] The administration of nicotine usually provides a pleasant
feeling. The usual method of administration is by intake via the
mouth, either by smoking e.g. a cigarette, a cigar or a pipe, or
snuffing or chewing tobacco. However, smoking has, as earlier
mentioned, health hazards and it is therefore desirable to
formulate an alternative manner of administering nicotine in a
pleasurable manner that can be used to facilitate withdrawal from
smoking and/or used as a replacement for smoking.
[0011] Upon the smoking of a cigarette, nicotine is quickly
absorbed into the smoker's blood and reaches the brain within
around ten seconds after inhalation. This quick uptake of nicotine
gives the consumer a rapid satisfaction, or kick, and this
satisfaction lasts during the smoking time of the cigarette and for
a period of time thereafter. The poisonous, toxic, carcinogenic,
and addictive nature of smoking has provided efforts for methods,
compositions and devices, which help in breaking the habit of
smoking cigarettes.
[0012] Nicotine Replacement Products
[0013] One way to reduce smoking is to provide nicotine in a form
or manner other than by smoking and some products have been
developed to fulfill this need. Use of such nicotine-containing
formulations is currently the dominating treatment for tobacco
dependence.
[0014] The present successes in achieving reduction in the
incidence of smoking have been relatively poor using presently
known products. The present state of the art involves both
behavioral approaches and pharmacological approaches. More than 80
% of the tobacco smokers who initially quit smoking after using
some behavioral or pharmacological approach to singly reduce
smoking incidence generally relapse and return to the habit of
smoking at their former rate of smoking within about a one year's
period of time.
[0015] As an aid for those who are willing to stop smoking there
are several ways and forms of nicotine replacement products
available on the market and several methods and means have been
described for diminishing the desire of a subject to use tobacco,
which comprises the step of administering to the subject nicotine
or a derivative thereof as described in e g U.S. Pat. No. 4,967,773
(nicotine containing lozenge) and U.S. Pat. No. 5,939,100 (nicotine
containing microspheres).
[0016] The use of skin patches for transdermal administration of
nicotine has been reported (Rose, in Pharmacologic Treatment of
Tobacco Dependence, (1986) pp. 158-166, Harvard Univ. Press).
Nicotine-containing skin patches, which are in wide use today, may
cause local irritation and the absorption of nicotine is slow and
affected by cutaneous blood flow. Different types of such patches
are also patented, see e.g. U.S. Pat. No. 4,915,950 and U.S. Pat.
No. 4,597,961.
[0017] Nicotine-containing nose drops have been reported (Russell
et al., British Medical Journal, Vol. 286, p. 683 (1983); Jarvis et
al., British Journal of Addiction, Vol. 82, p. 983 (1987)). Nose
drops, however, are difficult to administer and are not convenient
to use at work or in other public situations. Ways of
administrating nicotine by delivering directly into the nasal
cavity by spraying are known from U.S. Pat. No. 4,579,858, DE 32 41
437 and WO 93/12764. There may, though, be local nasal irritation
with use of nasal nicotine formulations. The difficulty in
administration also results in unpredictability of the dose of
nicotine administered.
[0018] Nicotine mouth sprays (see e.g. U.S. Pat. No. 6,024,097 and
U.S. Pat. No. 5,810,018) and nicotine chewing gums (see e.g. U.S.
Pat. No. 3,845,217) are also known.
[0019] Also, inhaling devices resembling a cigarette are known for
uptake of nicotine vapors orally as suggested in U.S. Pat. No.
5,167,242, wherein the inhaling device contains a nicotine
reservoir. The present invention relates primarily, but not
exclusively, to a novel and inventive improvement of the nicotine
reservoir (plug) disclosed in U.S. Pat. No. 5,167,242.
[0020] Prior Art and Problems Thereof
[0021] One embodiment of the inhaling device disclosed in U.S. Pat.
No. 5,167,242 comprises a cylindrical cartridge in which is placed
a nicotine reservoir. Such a reservoir consists of a porous plug
made of polymer or other suitable material, which is loaded with
nicotine. Suitable materials for such a plug are e.g. those
mentioned in U.S. Pat. No. 4,284,089, U.S. Pat. No. 4,800,903 and
U.S. Pat. No. 4,813,437 e.g. polymeric material containing
polyolefin, polyethylene, polypropylene, polybutadiene,
poly-1-butene, polyisobutylene, polyisoprene,
poly-4-methyl-1-pentene or combinations thereof, a fibrous material
which may comprise cellulose-acetate polypropylene, polyester,
polyethylene and combinations thereof. The above-mentioned porous
plugs are manufactured through a sintering process. U.S. Pat. No.
4,793,366 discloses a device for inhaling nicotine with a "draw"
similar to that of a conventional cigarette--though without showing
that such a "draw" may be obtained with the claimed device. U.S.
Pat. No. 5,101,838 discloses a device for smoking simulation where
the carrier for nicotine preferably is made of spherical particles.
U.S. Pat. No. 5,167,242, U.S. Pat. No. 4,284,089, U.S. Pat. No.
4,800,903, U.S. Pat. 4,813,437, U.S. Pat. No. 4,793,366 and U.S.
Pat. No. 5,101,838 are hereby incorporated by reference.
[0022] The presently known porous nicotine containing plug releases
nicotine to the air sucked through it by the user when the user
puff on the inhaling device. However, it has now been found that
the user does not inhale enough nicotine per puff (Schneider et
al.; Clin. Pharmacokinetics 2001; 40 (9) 661-684 and Russel;
British J. of Addiction (1991) 86, 653-658) in order to experience
complete satisfaction. Therefore the user must puff intensively in
order to achieve a basal, but oftentimes still non-sufficient,
concentration of drug (Schneider et al.; Clin. Pharmacokinetics
2001; 40 (9) 661-684). Hence, such an inhaling device often does
not sufficiently well counteract the craving experience by the
tobacco addict, who therefore is likely to relapse to use of
tobacco. To date no solution to the problem of the user not
inhaling enough nicotine per puff has been presented.
[0023] Definitions
[0024] The term "nicotine" is intended to include nicotine,
3-(1-methyl-2-pyrrolidinyl)-pyridine, with its base form, racemic
form, R- and S-forms, including synthetic nicotine as well as
nicotine extracts from tobacco plants, or parts thereof, such as
the genus Nicotiana alone or in combination; or pharmaceutically
acceptable salts.
[0025] The term "container comprising nicotine", or equivalent
terms, is intended to include a nicotine reservoir loaded with
nicotine that will allow air to pass through and that will deliver
nicotine in gaseous or liquid aerosol form to a subject.
[0026] The term "fast reduction of the urge to smoke or use
tobacco" is herein intended to mean an initial priming of the
subject so as to achieve a reduction of the urge to smoke or use
tobacco.
[0027] The term "complete reduction" is herein intended to mean
complete or substantially complete reduction.
[0028] The terms "fibers" and "filaments" are intended to mean any
of the thread-like parts that are formed from plant and/or
artificial material with arbitrary cross sections.
[0029] The term "tobacco-containing material" may be material used
for e g smoking, snuffing or chewing and may comprise a cigarette,
a cigar, snuff, pipe tobacco and chewing tobacco.
[0030] The term "shaped mass" is intended to mean a mass of
material deliberately shaped.
SUMMARY OF THE INVENTION
[0031] The present invention is intended to solve the
above-mentioned problem, i.e. that the user does not receive enough
nicotine per puff to experience satisfaction. We have however found
that said problem couldn't be solved by increasing the amount of
nicotine in the container since the air inhaled with the existing
device is already saturated with nicotine and hence cannot be
loaded with more nicotine. In the present invention we have
surprisingly found said problem is solved by increasing the volume
of air inhaled per puff thereby increasing the amount of nicotine
being inhaled per puff--this being achieved by using a nicotine
container comprising a shaped mass of fibers or filaments.
[0032] The main object of the present invention is thus to provide
a container comprising nicotine and a shaped mass of fibers or
filaments, which is able to reversibly retain and release nicotine.
This container allow a larger amount of air being inhaled per puff
and also provide that the air is inhaled with less efforts compared
to the above-mentioned presently known plugs. The flow resistance
through the present container is thus lower than the flow
resistance through the existing plugs. It has also been found that
with the present invention the flow resistance may be lowered to
below a half, and even below a fourth, of the flow resistance of
presently used plugs in nicotine inhalers. The air passing through
the container is adequately saturated with nicotine in spite of the
low airflow resistance.
[0033] The present invention also provides a method for obtaining
reduction of the urge to smoke or use tobacco containing material
and/or for providing a fast sense of smoking satisfaction without
smoking, comprising the steps of replacing at least partly the
tobacco containing material used with an inhaling device that
comprises the above-mentioned container comprising nicotine.
[0034] Furthermore, the present invention also provides a system
for delivering nicotine to a subject, which comprises said
container comprising nicotine and at least one other means for
obtaining reduction of the urge to smoke or use of tobacco and a
system for obtaining reduction of the urge to smoke or otherwise
use of tobacco and/or for providing a sense of smoking satisfaction
without smoking, comprising said container comprising nicotine and
at least one other method for obtaining reduction of the urge to
smoke or otherwise use of tobacco. Said system may be a system
wherein the at least one other method is selected from the group
consisting of administration through chewing gums, nasal sprays,
transdermal patches, mouth sprays, lozenges, tablets and parenteral
methods, subcutaneous methods, intravenous methods, rectal methods,
vaginal methods and transmucousal methods; or otherwise use of
tobacco.
[0035] The present invention also relates to the use of said
product that will according to the invention rapidly deliver
nicotine to a subject and also to the use of the present invention
for obtaining a quick and/or sustained and/or complete reduction of
the urge to smoke or use tobacco and/or for providing a sense of
smoking satisfaction without smoking resembling the sense of
smoking satisfaction and/or for obtaining a reduction of the urge
to smoke obtained after regular smoking or use of tobacco.
DETAILED DESCRIPTION OF THE INVENTION
[0036] In one embodiment said container comprising nicotine has
fibers or filaments that comprise polymeric substances. The
polymeric substances may be selected from polyolefin, polyester or
polyamide and are preferably selected from the group consisting of
polyethylene, polyethylene, preferably high-density polyethylene or
ultra high molecular weight polyethylene, polypropylene,
polybutadiene, poly-1-butene, polyisobutene, polyisoprene,
polyvinylidene chloride, ethylene vinyl alcohol,
polylactide-glycolide copolymer, polycarbonate, polyethylene
naphthalene, polytrimethylene naphthalene, polyethylene
terephthalate, terephthalate-isophthalate polyesters, polybutylene
terephthalate, liquid crystalline polymer that comprises hydroxy
benzoic acid and hydroxy naphtenic acid, a copolymer of
acrylonitrile and methacrylate grafted to nitrile rubber, which is
commercially available under the trademark Barex.RTM., nylon 66, or
nylon 6 or combinations thereof and paper, cellulose and/or cloth.
Preferably the fibers or filaments are non-sintered. The container
may though comprise also non-sintered material. The fibers or
filaments may comprise also non-polymeric materials, such as glass,
metals, e g aluminum and/or steel. The fibers or filaments may
optionally be coated.
[0037] The container may also comprise non-fibrous material.
Preferably the shaped mass of fibers or filaments is non-sintered.
The container may though comprise also non-sintered material. The
shaped mass of fibers or filaments may comprise non-polymeric
material, such as glass, metals, e g aluminum and/or steel, paper,
cellulose and/or cloth.
[0038] A preferred type of fibers or filaments is made of
polyethylene terephtalate, preferably covered with
copolyolefin.
[0039] The fibers or filaments may be manufactured in a number of
different ways known in the art, such as through extrusion and
spinning.
[0040] Preferably the container should have a flow resistance of
gas being lower than around 0,6 kPa, more preferably lower than
around 0,3 kPa at an airflow rate of 1000 ml/min.
[0041] The nicotine is preferably retained to the shaped mass of
fibers or filaments by chemical binding and/or by adsorption and/or
by absorption and released by breaking these mechanisms. The
absorption and/or adsorption processes, which release nicotine may
further be electrically enhanced and/or modified by
temperature.
[0042] The container is for use in a nicotine-inhaling device,
which is adapted to be received in the mouth or in the nose.
[0043] The container should preferably be encapsulated in such a
way that nicotine will not unintentionally migrate out from the
container and so that environmental oxygen will not enter the
container. For such encapsulation of the container a
nicotine-impermeable copolymer made of acrylonitrile and
methacrylate and grafted to nitrile rubber can be used, said
copolymer being commercially available under the trademark
Barex.RTM.. Polyethylene naphtalate, known under the name PEN,
and/or a liquid crystalline polymer comprising hydroxy benzoic acid
and hydroxy naphtenic acid, known under the name Vectra.RTM. A530,
can also be used for such encapsulation. Optionally said polymers
can be laminated, e g with aluminum layer. Preferably said
encapsulation should be made in an oxygen-free environment. Upon
use of the container the encapsulation is broken in order for the
user to inhale through the container. Said encapsulation is essence
is done according to the disclosure of the above-mentioned patent
U.S. Pat. No. 5,167,242.
[0044] Methods of Production
[0045] One preferred embodiment of loading the containers with
nicotine is to let a gas comprising nicotine pass through the
containers thus allowing the nicotine to be absorbed and/or
adsorbed by the material of the container.
[0046] Another preferred embodiment of loading the containers with
nicotine is immersing the containers into a solution comprising
nicotine in its free base form. Preferably the solvent is an
organic solvent, preferably an organic solvent having a low boiling
point and being more volatile than nicotine, more preferably an
organic solvent being selected from the group of ethers, ketons and
alcohols, even more preferably being an organic solvent being
selected from alcohols, and most preferably being ethanol.
[0047] Still another preferred embodiment of loading the containers
with nicotine is to inject a solution comprising nicotine, with
e.g. a syringe, in the containers.
[0048] The containers may also be loaded with nicotine by spraying
or soaking or immersing the fibers or filaments with nicotine or
with a nicotine-containing liquid directly upon the fibers or
filaments, and the optional non-fibrous material, having been
manufactured, e g upon them having been extruded or spun, prior to
the fibers or filaments being formed to a shaped mass. The same
loading principle could be applied if the containers optionally
comprise also non-fibrous material.
[0049] Different additives may optionally be added to the
containers, e g one or more stabilizing additives, such as those
selected from the group consisting of antioxidants including
vitamin E, i.e. tocopheroles, vitamin C, i.e. ascorbic acid, sodium
pyrosulfite, butylhydroxytoluene, butylated hydroxyanisole; and
preservatives including parabenes, citric acid, tartaric acid,
lactic acid, malic acid, acetic acid, benzoic acid, and sorbic
acid; and chelating agents, such as EDTA; and galates, such as
propyl galate.
[0050] Further optional additives can comprise one or more
additives selected from the group consisting of enhancers, such as
azone, vitamins, such as vitamins B, C and E, minerals, such as
fluorides, especially sodium fluoride, sodium monofluoro phosphate
and stannous fluoride, anti-odors, such as zinc and cyclodextrins,
propellants, such as 1,1,2,2-tetrafluoroethane (HFC-134a),
optionally being liquefied, and 1,1,1,2,3,3,3-heptafluororpropane
(HFC-227), optionally being liquefied, sweeteners including one or
more synthetic or natural sugars, such as those selected from the
group consisting of artificial sweeteners such as saccharin, sodium
saccharin, aspartame, e g NutraSweet, acesulfame or acesulfame K
(also called potassium acesulfame), thaumatin and glycyrrhizin;
sugar alcohols, such as sorbitol, xylitol, single sugars including
sugars extracted from sugar cane and sugar beet (sucrose), dextrose
(also called glucose), fructose (also called laevulose), and
lactose (also called milk sugar); mannitol, glycerol; and mixtures
of sugars including glucose syrup, e g starch hydrolysates,
containing a mixture of dextrose, maltose and a range of complex
sugars, invert sugar syrup, e g sucrose inverted by invertase (also
called sucrase or sacchrase) containing a mixture of dextrose and
fructose, high sugar content syrups such as treacle and honey
containing a mixture of particularly laevulose, dextrose, maltose,
lactitole, sucrose, resins, dextrin and higher sugars; and malt or
malt extracts; and mixtures thereof.
[0051] Flavor and aroma additives can also be added. These may
comprise one or more synthetic or natural flavoring or aromatizing
agents. Flavor and aroma agents may be selected from the group
comprising essential oils and preparations thereof including
distillations, solvent extractions, or cold expressions of chopped
flowers, leaves, peel or pulped whole fruit comprising mixtures of
alcohol, esters, aldehydes and lactones; essences including either
diluted solutions of essential oils, or mixtures of synthetic
chemicals blended to match the natural flavor of the fruit, e g
strawberry, raspberry and black currant; artificial and natural
flavors of brews and liquors, e.g. cognac, whisky, rum, gin,
sherry, port, and wine; tobacco, coffee, tea, cocoa, and mint;
fruit juices including expelled juice from washed, scrubbed fruits
such as lemon, orange, and lime; spear mint, pepper mint,
wintergreen, cacoe/cocoa, vanilla, liquorice, menthol, eucalyptus,
aniseeds, nuts, e.g. peanuts, coconuts, hazelnuts, chestnuts,
walnuts, cola nuts; almonds, raisins; barks, e.g. cinnamon, roots,
e.g. ginger, and mixtures thereof.
[0052] The nicotine should be in gaseous or liquid aerosol form
when inhaled in order to facilitate the absorption and uptake
anywhere in the mouth or oral cavity and/or the upper respiratory
tract and/or lungs.
[0053] The nicotine may act as a substituted stimulant e.g. to
obtain a rapid reduction of the urge to smoke or to use tobacco.
The effect may be to provide a sense of smoking satisfaction
without smoking. Another effect of the administered nicotine may be
a reduction of the urge to smoke or use tobacco.
[0054] The effect may also be a combination of reduction of said
urge and providing a sense of smoking satisfaction without smoking.
The amount of the nicotine should be sufficient to provide such an
effect in a subject. This amount may, of course, vary from person
to person.
EXAMPLE 1
[0055] Process for the manufacturing of nicotine-comprising
containers with 15 mg nicotine/container for use with inhaling
devices
1 Manufacturing formula: Batch size: 100 000 units Formula: Loading
solution: Nicotine 1 545 g Levomenthol 150 g Ethanol* 16 000 g
Loading of containers: Containers from a shaped mass of 100 000
pieces fibers or filaments of polyethylene terephtalate covered
with a copolyolefin sheath. Loading solution 17 695 g Nitrogen q.s.
Assembly: Nicotine-loaded containers 100 000 pieces Plastic
cartridges made of Barex .RTM. 100 000 pieces Barex .RTM.-coated
aluminum foil q.s. Nitrogen q.s. *Removed during manufacture
[0056] The manufacturing phases were:
[0057] Loading solution:
[0058] Levomenthol and nicotine were dissolved in ethanol.
[0059] Loading of containers:
[0060] The containers were added to a vacuum cone blender. The
loading solution was added to a blender and the containers were
mixed with the loading solution. A vacuum was applied and the
temperature was increased to about 50.degree. C. in order to remove
ethanol. The drying process was terminated by cooling the jacket of
the blender. The nicotine-loaded containers were transferred to
airtight bulk containers, which were evacuated and filled with
nitrogen.
[0061] Assembly and sealing:
[0062] The assembly of the nicotine-loaded containers into the
plastic cartridges was performed in separated zones, involving
feeding of the containers and cartridges from a first zone, and the
subsequent assembly in a second zone. Sealing of the plastic
cartridges was made by welding with Barex.RTM.-coated aluminum
foil. All zones were separately fed with nitrogen.
[0063] Method for Delivering Nicotine to a Subject
[0064] According to the invention, a method for delivering nicotine
to a subject comprises the steps of
[0065] a) administering to a subject air loaded with nicotine by
using an inhalation device containing the container comprising
nicotine and
[0066] b) allowing the nicotine to be released in the mouth/oral
cavity and/or the upper respiratory tract and/or the lungs and then
being absorbed into the blood plasma of the subject.
[0067] Method for Obtaining Reduction of the Urge to Smoke or Use
of Tobacco
[0068] A method for obtaining reduction of the urge to smoke or use
tobacco-containing material and/or for providing a sense of smoking
satisfaction without smoking according to the invention comprises
the steps of:
[0069] a) replacing at least partly the tobacco containing material
with an inhaling devise comprising the container comprising
nicotine,
[0070] b) administering to a subject nicotine according with the
help of the container comprising nicotine into the oral cavity
and/or the upper respiratory tract and/or the lungs of the subject,
and
[0071] c) allowing the nicotine to be absorbed by the subject.
[0072] The administration of nicotine takes place by the subject
inhaling air loaded with nicotine i.e. the subject puffs on the
inhaler comprising the container comprising nicotine as the air
passes said container the nicotine is released from said container
and the subject will thus receive air loaded with nicotine. The
administration is essentially intended for the mouth/oral cavity
and/or the upper respiratory tract and/or the lungs.
[0073] Even further embodiments of the method for delivering
nicotine to a subject may comprise the steps of combining the
method of using the present inhaling device with at least one other
method for obtaining reduction of the urge to smoke or use of
tobacco.
[0074] The container comprising nicotine may be used for obtaining
a quick and/or sustained and/or complete reduction of the urge to
smoke or use of tobacco and/or for providing a sense of smoking
satisfaction without smoking as further discussed below. The fast
relief provides the subject with a sense of rapid smoking
satisfaction without smoking.
[0075] Systems for Delivering Nicotine and for Obtaining Craving
Relief
[0076] According to the present invention is also provided a system
for delivering nicotine to a subject. Such a system comprises the
container comprising nicotine according to the present invention
and an inhalation device, and at least one other means for
obtaining reduction of the urge to smoke.
[0077] Another system according to the invention may also be a
system for obtaining reduction of the urge to smoke or use of
tobacco and/or for providing a sense of smoking satisfaction
without smoking. Such a system comprises the container comprising
nicotine according to the invention and at least one other means
for obtaining reduction of the urge to smoke or use tobacco. Other
means/methods may also be a concomitant or concurrent method
selected from the group consisting of administration through nasal
sprays, transdermal patches, lozenges, tablets and parenteral
methods, subcutaneous methods, intravenous methods, rectal methods,
vaginal methods and transmucosal methods; or use of tobacco.
[0078] In a specific embodiment, the at least one other
method/method comprises administration of nicotine.
[0079] Use of the Container Comprising Nicotine
[0080] The use of the container comprising nicotine according to
the invention for obtaining a fast and/or sustained and/or complete
reduction of the urge to smoke and use tobacco or for providing a
sense of smoking without smoking as described above.
[0081] The dose of the nicotine is chosen to give the subject an
individual sensory perception and nicotine satisfaction. The use of
the container comprising nicotine according to the invention may
also be a sole use according to the invention or a combination with
other means or methods known in the field of drug abuse.
Specifically, the present invention may be used in combination with
other means as described above in the methods in the paragraphs
above. The use may give a quick reduction of the urge to smoke or
use tobacco.
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