GB2289204A - A chewing gum for use as a nicotine substitute and slimming aid - Google Patents

Abstract

A chewing gum containing a capsaicinoid at a level (0.01-0.02% capsaicinoid or 0.11-0.22% oleoresin capsicum) which mimics the mild burning sensation of nicotine for use as a replacement for nicotine chewing gum. This level of capsaicinoid is 5-10 times the maximum previously used in chewing gums to enhance the flavour duration without creating any detectable flavour of its own. The concentration of capsaicinoid is increased to about 0.1% (or 1% oleoresin capsicum) for use as a slimming aid or confectionery substitute for people habituated to high levels of dietary capsaicinoids. The additional ingredients sodium chloride, potassium chloride, monosodium glutamate and oleoresins of coriander, cumin, thyme, marjoram, rosemary, sage, oregano and savory may be added in various combinations to improve the aroma and flavour of the gum.

Description

TITLE A Chewing Gum for Use as a Nicotine Substitute and Slimming Aid FIELD This invention relates to a new strategy and product for alleviating nicotine addiction.

HISTORY In this field it is already known that smoking tobacco is very hazardous to health.

However, it is not nicotine per se which makes smoking a health hazard, but rather the carcinogens and carbon monoxide produced by the pyrolysis of tobacco. Chewing tobacco and snuff would therefore be expected to be safe methods of taking nicotine.

Unfortunately both of these forms of tobacco cause cancer, and must therefore contain carcinogenic chemicals which either occur naturally in the tobacco leaves or are produced during the fermentation process used to make them palatable.

These problems have been reduced by extracting the nicotine from tobacco, purifying it and incorporating it into chewing gum from which it is gradually released by chewing.

To our knowledge this gum is produced under only one trademark "Nicorntte' whose product licence is held by Kabi Pharmacia, Box 941, S-251 09 Helsingborg, Sweden.

The theory of this Nicorettes strategy is that the habits, fetishes and paraphernalia of smoking can be discarded and forgotten without simultaneously having any nicotine withdrawal symptoms. The withdrawal symptoms are overcome with the later gradual reduction in Nicorettes dose.

This has the disadvantage that although the nicotine is not highly toxic when taken in this way (particularly to smokers who have built up a tolerance) there can be side effects such as nausea, dizziness, indigestion, chest pain and heart palpitations. It is clear then that taking nicotine, even in this way, is not to be considered a totally innocuous and healthy habit. Indeed, Kabi Pharmacia recommend that the consumption of Nicorettes should be gradually cut down after about three months' use and finally stopped completely as soon as possible. Also, the smoking fetish can be replaced by a chewing fetish which has to be overcome, or rendered innocuous.

The use of a nicotine containing gum may be replaced or succeeded by an edible gum comprising a gum base material and a capsaicinoid which creates a burning sensation in the mouth of the user.

Typically, such an edible gum could be used as a substitute for nicotine-containing gum as an aid to stopping tobacco smoking and/or as a slimming aid to reduce food intake, especially for users who eat a lot of spicy food, such as curries or chillies.

The new strategy is to replace the nicotine-loaded gum with gum which is innocuous and which can therefore be chewed without ill-effects. It also allows the addict to fool himself into thinking that he is still getting his dose of nicotine. The flavour of nicotine at the doses used may be described as a slight burning sensation in the mouth.

According to the invention therefore nicotine is replaced with low doses of naturally occurring capsaicinoids which produce a mild burning sensation to the mouth.

Capsaicinoids are the "hot" components of chillies and curries and are regularly eaten (in much higher doses than required for a mild burning sensation) by many people without any apparent harm. These compounds have also recently been shown to stimulate the eater to produce endorphins which give a mild sense of euphoria which may compensate for the absence of nicotine.

Stronger capsaicinoid gums are also useful among people who have already become habituated to capsaicinoids by eating highly spiced foods, but who need to reduce their food intake.

By occupying the mouth, chewing capsaicinoid gum will reduce food intake even for non-smokers and hence is useful as a slimming aid.

According to the present invention therefore there is provided a chewing gum comprising a capsaicinoid, characterized in that said capsaicinoid is present in an amount which is consciously detectable by the tongue. The minimum amount of purified capsaicinoid is about 0.01 %, but up to about 0.11% may be required for those habituated to capsaicinoids. Additional ingredients may be added to improve the aroma and flavour of the gum. These additional ingredients may be one or more of sodium chloride, potassium chloride, monosodium glutamate and oleoresins of coriander, cumin, thyme, marjoram, rosemary, sage, oregano and savory.

Although capsaicinoids have acute toxicity values of the same order of magnitude as nicotine, they cause a mild burning sensation in the mouth at much lower concentrations. They are therefore used at several orders of magnitude below their toxic concentrations. At these levels they do not have any significant chronic toxicity since millions of people ingest very much higher levels (in curries and chillies) over prolonged periods without apparent harm.

It is therefore possible to continue to chew the gum of the invention as long as desired and the danger of reverting to tobacco caused by the lack of oral stimulation is averted.

Although oleoresin capsicum has previously been incorporated in chewing gums by Wrigley (PCT/US89/02137), this was expressly stated to be at levels imparting no detectable flavour. The crux of our invention is that the capsaicinoid is used at a concentration high enough to impart its characteristic flavour, i.e. a mild burning sensation.

The invention will now be described, by way of illustration only, in the following example.

EXAMPLE Samples were made using chewing gum ingredients and methods well known in the art, but incorporating the new ingredient (capsaicinoid). The typical components of a chewing gum are the gum base, a sugar alcohol such as sorbitol and the desired flavourings. The gum base itself is a complex mixture of elastomers and resins, plasticisers, antioxidants and inorganic fillers such as calcium carbonate or talc. A proprietary gum base "Nostic TWA" manufactured by Gum Base Company SpA, Lainate, Italy, was used for the prototypes described herein. Nostic TWA contains talc as the filler and butylated hydroxyanisole (BHA) as the antioxidant. There is no prima facie reason why other gum bases should not be equally efficacious.

The capsaicinoid used was oleoresin capsicum (Macfarlan Smith, Edinburgh) with a capsaicin assay of 9%.

The ingredients shown in Table 1 were warmed over a steam bath to melt the gum base and then mixed until a uniform colour was achieved (about 5 min).

Table 1 Gum base 8.89 g 70% sorbitol 1 ml Oleoresin capsicum (9% capsaicin) 0.11 ml This formulation contains 1.1% oleoresin capsicum (oleo. caps.), and gives an active ingredient (capsaicin) concentration of 0.1%. Examples containing lower amounts of capsaicin were made by mixing this gum with suitable proportions of gum base and 70% sorbitol such that the 70% sorbitol remained constant.

Tests Pieces of gum of approximately 0.5 g were chewed and assessed for the delay time before any burning sensation was felt in the mouth, the intensity of the buming at its maximum and the duration of the chewing time at which the sensation was still detectable. The results are shown in table 2. Intensity is denoted by a + sign: from detectable (+) to high buming sensation (+++++).

Table 2 Oleo.caps.Capsaicin Dose Delay Intensity Duration (%) (%) 1.1 0.1 5.0 mg -50 sec +++ > 1h 20min 1.1 0.1 0.5 g -35 sec +++++ n.d.* 0.22 0.02 0.5 g -60 sec +++ > 1 h 0.165 0.015 0.5 g -50 sec ++ > 1h 30min 0.11 0.01 0.5 9 -2 min + > 3h *n.d. denotes not determined (because buming sensation was too high to endure for more than a few minutes) It was concluded that 0.015% capsaicin (0.165% oleoresin capsicum) gives a sensation similar to "2 mg* Nicorette. However, the intensity of the sensation is judged somewhat differently by different individuals, and the range of optimum concentration is probably between 0.01 and 0.02% capsaicin (0.11 and 0.22% oleoresin capsicum). This is 5-10 times the maximum concentration previously used in chewing gums where 0.001-0.0256 oleoresin capsicum was added to enhance the flavour duration without creating any detectable flavour of its own (PCT/US89/02137, Wrigley). Even higher concentrations (0.1% capsaicin/1.1% oleoresin capsicum) will be required to satisfy people habituated to high dietary levels of capsaicinoids.

Claims (9)

1. A chewing gum comprising a capsaicinoid, characterized in that said capsaicinoid is present in an amount which is consciously detectable by the tongue.

2. A chewing gum according to claim 1 comprising at least 0.01 % by weight of purified capsaicinoid, or an amount of a capsaicinoid-containing composition to provide an equivalent effect.

3. A chewing gum according to claim 2 comprising 0.01% to 0.11% purified capsaicinoid or an amount of a capsaicinoid-containing composition to produce an equivalent effect.

4. A chewing gum according to any preceding claim wherein the capsaicinoid is derived from oleoresin capsicum.

5. A chewing gum according to claims 1-4 wherein additional ingredients are added to improve the aroma and flavour of the gum.

6. A chewing gum according to claim 5 wherein the additional ingredients are oleoresin coriander and oleoresin cumin.

7. A chewing gum according to either of claims 5 or 6 wherein the additional ingredients are oleoresins of one or more of thyme, marjoram, rosemary, sage, oregano and savory.

8. A chewing gum according to any preceding claim further comprising a flavour enhancer selected from sodium chloride, potassium chloride and monosodium glutamate.

Amendments to the claims have been filed as follows 1. A chewing gum comprising a capsaicinoid, characterized in that said capsaicinoid is present in an amount which is consciously detectable by the tongue.

2. A chewing gum according to claim 1 comprising at least 0.01% by weight of purified capsaicinoid, or an amount of a capsaicinoid-containing composition to provide an equivalent effect.

3. A chewing gum according to claim 2 comprising 0.01% to 0.11% purified capsaicinoid or an amount of a capsaicinoid-containing composition to produce an equivalent effect.

4. A chewing gum according to any preceding claim wherein the capsaicinoid is derived from oleoresin capsicum.

5. A chewing gum according to claims 14 wherein additional ingredients are added to improve the aroma and flavour of the gum.

6. A chewing gum according to claim 5 wherein the additional ingredients are oleoresin coriander and oleoresin cumin.

7. A chewing gum according to either of claims 5 or 6 wherein the additional ingredients are oleoresins of one or more of thyme, marjoram, rosemary, sage, oregano and savory.

8. A chewing gum according to any preceding claim further comprising a flavour enhancer selected from sodium chloride, potassium chloride and monosodium glutamate.

9. The use in the manufacture of a chewable pharmaceutical composition for the alleviation of nicotine addiction which composition comprises a capsaicinoid in an amount which is consciously detectable by the tongue.