WO2006004418A2

WO2006004418A2 - Encapsulated tobacco smoke

Info

Publication number: WO2006004418A2
Application number: PCT/NO2005/000233
Authority: WO
Inventors: Erik LÅBAKK; Nils Erik Skeide
Original assignee: Laabakk Erik; Nils Erik Skeide
Priority date: 2004-07-05
Filing date: 2005-06-27
Publication date: 2006-01-12
Also published as: NO20042835D0; WO2006004418A3

Abstract

Disclosed herein is an ingestible and/or chewable non-toxic capsule containing tobacco smoke corresponding to up to five cigarettes of tobacco smoke to provide recreationally relevant quantities of such tobacco smoke for ingestion and appreciation of the physiological effects of such ingestion.

Description

Encapsulated tobacco smoke

Field of invention

The present invention relates to tobacco smoke contained within a non-toxic, ingestible and/or chewable capsule. A method for their preparation as well as the use thereof.

Background of the invention

Tobacco smoking is recognized as one of the major health problems throughout the world and is a major cause of morbidity and mortality. The tobacco smoke affects not only the smokers themselves but also passive smokers, individuals who inhale environmental tobacco smoke. It is now generally accepted that tobacco smoking is dangerous, and as a consequence, smoking is increasingly prohibited in public places, workplaces, restaurants and bars, aeroplanes, buses etc. Nicotine is considered to be one of the disease associated risk factors in tobacco smoke. Other important risk factors are substances that are formed during the combustion of tobacco, such as carbon monoxide, tar products, aldehydes and hydrocyanic acid.

However, tobacco smokers, especially heavy smokers (i.e., those who smoke a lot) , find it difficult to stop smoking, even for a limited period of time. It is generally accepted that this difficulty results from the fact that many smokers are dependent on nicotine. The morning craving for a cigarette experienced by smokers is a manifestation of the very low nicotine plasma level that occurs after 8 to 12 hours without smoking.

Nicotine is a volatile and strongly hydrophobic substance. At room or body temperature, nicotine is a reactive liquid and a strong solvent. Nicotine is a known skin irritant and a very toxic substance. The lethal unit dose for an average adult is about 60 mg; one cigarette delivers about 1 mg nicotine. Due to the harmful effects of smoking, several products have been developed to help smokers to reduce or even stop smoking completely. A known product, which is used as a smoking substitute and/or as a smoking cessation aid, is the chewing gum markedet as Nicorette^®. This product is available with different quantities of nicotine. In this chewing gum, nicotine is complexed with an insoluble cation-exchanger that is dispersed in a gum base. This product is described in U.S. patents 3,877,468, 3,901,248 and 3,845,217. Nicotine chewing gums provide direct delivery of nicotine to the systemic circulation by buccal absorption, however, the effect of nicotine ocurres later than by smoking. In chewing gums, where the nicotine is complexed with an insoluble cation-exchanger resin, the nicotine is released from the resin only after extensive chewing; the consumer must chew for a long time before the full effect of the nicotine is achieved. Flavor corrigents are added to nicotine chewing gums to mask the tase of nicotine. Such nicotine gum products have a number of side effects, and are typically used only after consultation with, and on the recommendation of a physician. Indeed, the formulations currently available are barely palatable, which impedes treatment compliance.

Another product in this field is the Favor^® delivery device, which is a nicotine inhalation device consisting of an elongated tube in which a porous polymer plug including nicotine free base, is arranged. The nicotine delivery system is described in U.S. patents 4,248,089 and 4,800,903. The body takes up the nicotine via the mucous membrane in the mouth when air is sucked through the inhaler mouthpiece. Inhalers are used as a means against nicotine abstinence, as a smoking substitute, and/or as a smoking cessation aid. A problem that concerned this delivery system was the volatility of the nicotine free base, which rapidly disappeared from the system.

Yet another product that has been developed is a nicotine nasal solution disclosed in U.S. 4,579,858, which is based on the use of nicotine free base. Other compositions for nasal application are disclosed in US 4,655,231.

WO 91/09599 discloses a smoking substitute composition wherein nicotine is in the form of an inclusion complex of nicotine and a cyclodextrin compound. The compositions can be used for different types of pharmaceutically acceptable preparations, such as tablets, capsules, powders, and chewing gums. The examples given in the application describe tablets composed of the inclusion complex.

Preparations such as nicotine tablets contain nicotine, and a palatable flavor to mask the taste of nicotine. The tablets are to be sucked and the release of nicotine occurs slowly. The nicotine is taken up buccally and the effect of nicotine occures later than by smoking. Such preparations are 'used against nicotine abstinence in smoke free periods and as a smoking cessation aid. Products like this have a number of^" side effects and are typically used only after consultation with, and on the recommendation of a physician.

Depot tablets are also available, which are only available to consumers on prescription. Depot tablets contain bupropione hydrochloride. One tablet is taken every day, and a number of side effects are known. Depot tablets are typically used only after consultation with, and on the recommendation of a physician.

EP 0366240 describes another product for administering nicotine, namely a transdermal patch that can deliver nicotine for a period of one day or more. The patch is composed of a nicotine supplement layer, an obstructive backing layer which covers the skin-distal layer of the nicotine supplement layer, and a supplement rate control means provided for the face of the nicotine supplement layer which comes into contact with the skin. A transdermal patch is also described in US Patent 4,597,961. In these products, nicotine is released from the patch over a prolonged period of time and is slowly taken up by the blood through the skin. Such products have a number of side effects and are typically used only after consultation with, and on the recommendation of a physician.

Other old, but well-known tobacco products, not least in the Nordic counties, are (moist) snuff and chewing tobacco, which are free of smoke. Snuff is usually placed under the upper lip where it is left to lie still, while chewing tobacco is actively chewed and moved around in the mouth.

As can be seen from the above, a number of different products are available to facilitate treatment of nicotine addiction in one way or another. Common for several of the products is that a flavor corrigent is used to mask the taste of nicotine. This is believed to be advantageous because nicotine has an unpalatable taste, but also reduces the chance that the smoker will recall the taste and sensation of smoking. This is an obvious choice when the preparation is used as a smoking cessation aid. Particularly, in such cases, it is desirable to remind the former smoker of smoking and the taste of smoking, as little as possible, preferably not at all. The provision of nicotine alone may be sufficient to promote a change in the users smoking habit .

An overwhelming proportion of smokers will not stop smoking, even when they know that smoking is dangerous for their health. They enjoy smoking and will continue to do so, even when they are aware of the health damaging effects. For them to chew chewing gum, take a tablet, etc., which does not remind them of smoking but which only provides the nicotine, is unsatisfying. This kind of product will ease the craving for nicotine, but will not provide such users with the subjective good feeling associated with smoking. Afterwards, when the tablet or chewing gum is consumed, such users do not experience the satisfactory feeling of having smoked, including the absence of taste that typically remains. Therefore there remains a need for a product that can provide a smoker with the sensation of having smoked a cigarette without actually smoking, i.e., a readily available smoke preparation for recreational ingestion of tobacco smoke wherein a sufficient amount of smoke is contained within an ingestible and/or chewable capsule to permit one or a plurality of such capsules to be ingested, chewed or dissolved to provide the recreational physiological effects of smoking.

Disclosure of the invention

An object of the present invention is thus to provide tobacco smoke to consumers in a way that avoids the need to smoke a cigarette, cigar or pipe, etc. Thus, the invention provides tobacco smoke without smoking. This is achieved by enclosing the nicotine, and desired flavors of tobacco smoke in an appropriate administration form suitable for per oral delivery, such as a capsule or caplet that is chewable and/or can be swallowed.

The present invention solves the above problem by encapsulating tobacco smoke in an ingestible and/or chewable non-toxic capsule containing sufficient quantities of smoke to facilitate transport, storage, delivery and consumption of recreational quantities of such smoke compositions. The compositions according to the invention will deliver a sufficient quantity of tobacco smoke in an encapsulated form to induce a recreational effect comparable to smoking upto five cigarettes. The present invention is particularly related to ingestible and/or chewable non-toxic capsules, containing tobacco smoke corresponding to up to five cigarettes of tobacco smoke, to provide recreationally relevant quantities of such tobacco smoke, for ingestion and appreciation of the physiological effects of such ingestion. The amount of smoke per capsule can of course also correspond to less than one cigarette, such as, for example, the amount of two to three drags or 10-20% of a cigarette. Another important feature of the present invention is that the consumer will be left with the feeling of having just been smoking, as the taste of the composition will remind the user of smoking, or be the same as if they had been smoking.

In principle, both gaseous tobacco smoke and liquefied tobacco smoke can be encapsulated. More specifically, the present invention relates to liquefied tobacco smoke containing, among other smoke substances, nicotine in encapsulated form. The tobacco smoke can also be carried by a suitable carrier. The origin of the smoke can be cigarette smoke, cigar smoke, and/or pipe tobacco smoke, or similar.

The composition of the smoke can be that contained in ordinary tobacco smoke, being composed of a large number of different substances, among others nicotine and other taste imparting compounds. In addition, different components can be removed from the smoke. Components can be removed by ordinary chemical methods such as extraction, chromatography, distillation etc. One component that typically may be removed is tar or parts thereof.

Furthermore, components can be added to the smoke containing capsules. In particular, substances that reduce the harmful effects of tobacco smoke, or substances that have a positive and/or stimulatory effect on the body are contemplated. Positive effects might be achieved by substances such as vitamins, taurine, seaweed, etc. The additives can be combined or mixed with the smoke, or can be provided in separate compartments of the capsules.

The capsule shell can be of both vegetable and animal origin. Several materials for preparing capsules are known in the art, such as for example gelatin, vegetable cellulose, carrageenan, hydroxypropyl starch, etc. The capsules can also be soft gelatin capsules containing animal material such as bovine (from cows) and poreyen (from pigs) , or they can contain vegetable materials such as red seaweed, alginates, etc. The capsules of the present invention can be of any useful form or composition for containing within the capsules body, the desired amount of smoke. The shape of the capsule can be spherical, oblong, elliptic, tubular, bottle shaped, coned or more like an elongated tube, pleasant to hold in the mouth. The capsules can be prepared with all possible colors available to such products, for instance red, orange, green, black, white, blue, or transperent . The capsules can be composed of all substances compatible with the smoke to produce capsules of the desired shape and colours, in accordance with the knowledge of a person skilled in the art.

Accordingly, one object of the invention is to provide an easily transportable recreational quantity of smoke in an ingestible container, such as a capsule.

Another object of the invention is to provide an easily transportable recreational quantity of smoke in a chewable container, such as a capsule.

Yet another object of the invention is to provide capsules containing smoke as a product, or provide a plurality of such smoke filled capsules for commercial and recreational use. Such a product will comprise a number of capsules according to the present invention in the form of a set, together with instructions for use of the capsules.

As used herein and in the appended claims, the term "recreational quantities" of tobacco smoke refers to any amount of a smoke contained within a capsule which, alone or in combination with repeated doses of the same amount of smoke, produces a noticeable recreational physiological effect on the consumer of such a quantity of smoke. Thus consumption of between one and ten capsules (?) according to the present invention is considered to be within the scope of this definition of recreationally relevant quantities of smoke containing capsules. Preferably, on a per capsule basis, a recreationally quantity of smoke will be that equivalent to one cigarette.

The smoke in an intoxicating and recreational amount provided in the capsules will be released either in the mouth for buccal absorption or in the stomach or intestine, where it will enter the circulatory system. The amount of nicotine will be in an amount up to 5 mg. The total volume of the capsule is between 20 microlitres to 20 millilitres. Preferably the capsule is between 20 microlitres and 1 millilitres. The most common sizes are 500 mg being equal to 10 oval and 1 g being equal to 22 oblong

As mentioned above the consumers shall, after consumption of one capsule, be delighted by the sensation as if they had been smoking, which includes the taste of tobacco smoking. This is achieved by sucking, chewing or swallowing the capsules. In cases where the consumer just sucks the capsule before it is swallowed, the composition might be coated with a coating composition comprising the taste of smoke.

The smoke contained within the cavity formed by the encapsulating material may be pure, substantially pure or relatively diluted smoke. If the capsule is to be dissolved in the consumer mouth, the concentration of the smoke must be relatively diluted, so as not to cause any harm to the mucous membranes. Alternatively, the capsule is chewed or only swallowed before the contents are released in the stomach or further down the gastrointestinal system.

The encapsulating material should preferably be digestible, in instances where the encapsulating material is designed to be ingested along with its content.

The capsules might also comprise pH sensitive components such that desired solution characteristics may be imparted within the digestive tract. In this way, the capsules can be prepared according to known methods within the art, to dissolve at specified elevated or decreased pH as desired. Preferably, the capsule will dissolve in the pH of the stomach, or the small intestine. The encapsulating material will then be dissolved, be permeable for flux of the smoke across its surface or the like, and the desired amount of smoke will be deliver to the circulatory system.

Another object of the invention is to provide a method for producing such capsules containing smoke.

Cigarettes etc are lit and "inhaled" (smoked) by an apparatus, which collects and preserves the smoke in a gaseous or liquid form, as desired. Then the preserved smoke in the desired form is encapsulated within a capsule.

Production of gelatin capsules is, inter alia., known from the pharmaceutical and health food industry. Techniques for encapsulating liquids and powders are well known for the person skilled in the art . Examples are described for instance in the following patents: U.S. Patent No. 3,653,934 describes a method for preparing a gastro-resistant gelatin capsule, U.S. Patent No. 3,656,997 discloses a method for making coated gelatin capsules, U.S. Patent No. 3,959,540 discloses gelatin capsules resistant to gastric juice dissolution, U.S. Patent No 6,280,767 provides capsules with improved vapour barrier while the U.S. Patent publication No. US 2003/0124225 Al discloses a capsule containing ethanol . The above list of patents is given only to illustrate the enormous amount of knowledge available in the art .

In its time, the cigarette was invented to reduce the harmful effects of using rolling tobacco. In the same way, this invention can reduce the damaging effects of smoking. Likewise, this is the first way to "smoke" without smoking. Thus, at least two effects are achieved as the "smoker" avoids inadvertently harming other people through passive smoking arising from cigarettes, cigars, etc. Secondly, the smokers themselves avoid inhaling the smoke. Applications other than to facilitate curing nicotine addiction are contemplated. To help cut down, without eliminating cigarette consumption, or to supply nicotine in a way that does not damage the lungs, is also contemplated.

One aspect of the invention is thus to provide encapsulated smoke which can be consumed when smoking is prohibited or undesired. The present invention can be used to regulate, and thus reduce, the consumption of nicotine. The present invention can be useful as a smoking cessation aid, and may for example be used to facilitate gradual reduction of smoking and to break free from the habit. Furthermore, the invention can be used to satisfy the demand for nicotine in places where smoking is prohibited, illegal, or otherwise undesired, such as at workplaces, in restaurants and at bars, in public places, in aeroplanes or other means of transport, etc., due to the fact that it will help against nicotine abstinence in smoke free periods .

Use of the invention can also reduce the consumption of nicotine in that the body is provided with less nicotine each time the user craves for nicotine. This will of course require that the capsule taken contains less nicotine than a cigarette. Only one capsule is typically taken, which furnishes the exact need as opposed to smoking cigarettes or similar whereupon the whole cigarette is usually smoked once lit.

Capsules according to the invention will also reduce the harmful effects of substances contained in the smoke that is inhaled by the smoker. For instance, contamination of the lungs by tar can be avoided.

Examples

Example 1

An oblong capsule being 0.8 mg. The capsule is red and the content thereof is liquefied tobacco smoke. Example 2

An oval capsule being 1.2 mg. The capsule is orange and the content thereof is liquefied tobacco smoke.

Example 3

A spherical capsule being 0.4 mg. The capsule is black and the content thereof is liquefied tobacco smoke.

Example 4

A bottle shaped (tube) capsule being 3 mg. The capsule is blue and the content thereof is liquefied tobacco smoke and flavour such as tuarine and caffeine.

Example 5

A capsule shaped as a cone (suppository) of 1 mg. The capsule is white and the content thereof is liquefied tobacco smoke and eucalyptus .

Example 6

An oblong capsule being 10 ml. The capsules transparent and consists of two chamber, which can be bi-colored. The content of one camber is tobacco smoke, while the content of the second chamber is one which will give fresh breath (such as mint) . The chambers are designed to be broken down at different time points.

Example 7

An oblong capsule being 15 ml. The capsule is transparent and is added coffee taste. The capsule has two chambers, one with tobacco smoke and one with coffee.

Example 8

A spherical capsule being 0.1 mg. The capsule is green having added taste. The content of the capsule is tobacco smoke.

Claims

1. Ingestible and/or chewable non-toxic capsule containing tobacco smoke corresponding to up to five cigarettes of tobacco smoke to provide recreationally relevant quantities of such tobacco smoke for ingestion and appreciation of the physiological effects of such ingestion.

2. Capsule containing tobacco smoke according to claim 1, wherein the tobacco smoke is cigarette smoke, cigar smoke, or pipe tobacco smoke.

3. Capsule containing tobacco smoke according to claim 1 or 2, wherein the amount of tobacco smoke corresponds to 2 to 3 drags corresponding to 10 to 20 % of a cigarette.

4. Capsule according to claims 1-3, wherein substances have been removed from the smoke, preferably harmful substances.

5. Capsule containing tobacco smoke according to claims 1-4, wherein further substances have been added to the formulation.

6. Capsule containing tobacco smoke according to any of the preceding claims, wherein the encapsulating material is selected from the group comprising gelatin, cellulose, carrageenan, hydroxypropyl starch, bovine material, poreyen material, red seaweed and alginates.

7. Capsule containing tobacco smoke according to any of the preceding claims, wherein the capsule comprises pH sensitive components.

8. Product comprising a number of capsules according to claims 1-7 in the form of a set together with instructions regarding use of the capsules.

9. Method for producing capsules containing smoke according to claim 1, characterized in that a) tobacco cigarettes, cigars, and/or pipe tobacco, etc. are lit and inhaled or smoked by an apparatus and collected therein, b) the smoke in a gaseous or liquid form is preserved by the apparatus and σ) the preserved smoke from step b) in the desired form is encapsulated within a capsule.

10. Use of a capsule according to any of the claims 1-7 for making a medicament suitable for reducing nicotine abstinence and/or addiction.