GB2337933A - Treating or prophylaxis of smoking related diseases - Google Patents

Abstract

This invention relates to confectionery and other edible preparations such as chewing gum, sweets or tablets fortified with a proportion of the recommended daily allowance of dietary supplements or other beneficial substances, especially vitamins, minerals and antioxidants. One such form of the preparation may be a breath freshener taken prior to, during or after smoking tobacco. This will ensure that a habit of association will be formed, linking the use of the preparation with the habit of smoking. This may have the effect of ensuring or encouraging use of the preparation on a regular basis thereby providing an enhanced or more balanced diet.

Description

1 Method and composition for dietary supplements 2337933

Technical field

This invention relates to a method and composition for the administration of dietary supplements.

Background Poor diet and exposure to environmental toxins such as air pollution and food additives may lead to the depletion of certain vitamins, minerals and antioxidants making it desirable to supplement the diet with vitamins, minerals and other dietary supplements to restore the balance. Dietary supplements in daily dosage forms are common and provide the recommended daily allowance (RDA) for many vitamins and minerals in a single daily dosage form. Such products include: Sanatogen (Registered Trade Mark of Roche Consumer Health, UK) ONE-A-DAY multivitamins and minerals; Seven Seas (Registered Trade Mark of Seven Seas Health Care Ltd. , UK) ONE-A-DAY vitamin E; Once a day Effervescent vitamin C tablets (The Boots Company PLC, UK); One a day antioxidants vitamin formula (Marks and Spencer plc, UK). The common distinguishing feature of these products is that they are all in the form of a single daily dose. Other products which are fortified with dietary supplements include breakfast cereals. Again these products are intended to be consumed in a single daily serving and often contain a source of vitamin and mineral supplements.

Currently preferred methods for the administration of dietary supplements include single vitamin or mineral formulations, multi-vitamin formulations,, multi-vitamin formulations with added minerals, and multivitamin 2 formulations with antioxidants. These formulations take the form of tablets,, effervescent tablets, capsules, oils, and drinks.

US patent 5654011 describes dietary supplements for women to prevent or reduce health risks associated with pre-menopause, menopause and postmenopause life stages.

US patent 4599234 describes dietary supplements with selenium, butylated hydroxytoluene and beta-carotene for negating the effects of chemical 10 carcinogens in lower animals.

US patent 4833128 describes dietary supplements for suppression of appetite.

15US patent 5560928 describes a method and composition of providing dietary supplements in a single daily dose for immediate and sustained release.

US patent 4576932 describes a dietary supplement for the control of insulin and inhibition of insulin-rebound effects.

US patent 4897380 describes compositions relating to a daily dietary supplement for treating disorders responsive to treatment with serotoninUS patent 5569477 describes a chewing gum containing vitamins or other 25 active materials.

Dietary supplements are desirable to alleviate the potential effects caused by insufficient or poor dietary consumption of necessary vitamins and minerals and exposure to air and chemical pollutants, including tobacco smoke, 3 which may deplete the body of certain vitamins, minerals and antioxidants. Detrimental effects can- occur in people exposed to environmental pollutants, this may be prevented by supplementation of the diet with vitamin C or other vitamins. Potential sources of environmental pollutants and toxins are alcohol, air pollution, sunlight, pesticides, chemical food additives, and tobacco smoke.

Tobacco smoke is a significant source of chemical pollutants such as free radicals, carcinogens and irritants. Smoking is an habitual activity that has been shown to correlate with increased risks of developing cancers, heart and lung diseases and vascular disorders. The estimated disease and death rate attributed to smoking is substantial. It has been estimated that between - 50% of smokers die from smoking-related diseases (Adweek Southwest, October 1997. p33). Recently the WHO estimated that there are 1. 1 billion smokers, and that 500 million of these people will die from smoking related diseases if current trends continue. Figures for the USA estimate that 20% of deaths in the USA are smoking related and that smokers have a much increased chance of dying prematurely (Disease Weekly Plus, June 1997). The future trend for smoking related disease and death estimates that by 2025 10 million people will die of smoking related diseases (Independent, August 1997, p9).

Tobacco smoke is composed of two phases, gas and tar phases. Both contain high levels of oxidants, free radicals, nitrogen oxides and other potentially toxic chemicals, all of which may be detrimental to human health. The effects caused or mediated by the products of tobacco smoking may be short-lived acute events but can develop into chronic long-term events or diseases and even death.

4 Cigarette tar can induce DNA single strand breakage which is synergistically enhanced in the presence of nitric oxide (NO). The effects can be prevented by superoxide dismutase, or N-acetyl cysteine. However, hydoxy-radical scavengers such as DMSO were not shown to inhibit strand breakage (Yoshie, Y and Ohshima, H. (1997). Carcinogenesis. 18:1359 1361). NO can be formed in the lung by NO synthase, and in the presence Of 02-, generated by compounds such as catechol and 1,4-hydroquinone in tar, may react with the NO to form peroxynitrite which can contribute to lung damage and smoking related disease. (Yoshie, Y and Ohshima, H.

(1997). Carcinogenesis. 18:1359-1363.) Smoking tobacco is associated with increased risk of lung cancer, bladder cancer, hepatocellular carcinoma (Hietanen, E. et al. (1997) Environ. Health Perspectives. 105:749-754) and ulcer perforation (Svanes, C. et al. (1997) Gut. 41:177-180). The cervical mucus of women smokers has been reported to contain a higher amount of a tobacco specific carcinogen (a nitrosamine), which has been related to DNA damage in the cervical epithelium. The increased levels of smoking related nitrosamines may be linked to cervical cancer. (Prokopczyk,B. et al. (1997). Journal of the National Cancer Institute. 89:868-873).

Cigarette smoking has also been reported to have a prothrombotic effect. This may manifest as increased risks to health due to unwanted thrombosis leading to strokes or heart attacks. Smoking causes leukocyte adhesion to endothelial cells and leads to leukocyte-platelet aggregates. This phenomenon is thought to be caused by platelet activating factor (PAF)like mediators created by oxidative modification of lipids in smokers. Supplementation of the diet with vitamin C prevented the accumulation of the PAF-like lipids and formation of platelet aggregates. (Lehr, H. et al. (1997) Journal of Clinical Investigation. 99: 2358-2364).

There is also evidence to suggest that passive smoking carries a 30% greater risk of developing heart disease. This is approximately half the risk of a 20 a day smoker, but from only 1 % of the exposure. Lung cancer risk is also increased by 26% for passive smokers, who also have increased blood and urine levels of tobacco specific carcinogens. (Cancer Weekly Plus. November 1997).

Currently preferred methods for inhibition of the harmful effects associated with smoking tobacco include cessation of smoking, replacement of nicotine through the use of transdermal patches or tablets, substitution of the smoking habit with another habit, and use of filters to remove potentially 15 harmful agents present in tobacco smoke and tar.

US patent 4832994 describes the use of a lozenge containing a silver compound and a sweetener that has an unpleasant taste upon smoking. The use is based on the generated bad taste dissuading the smoker from smoking.

US patent 3876804 describes a chewing gum containing a silver salt and an ammonium compound which develops an unpleasant taste on smoking. The use is based on the generated bad taste dissuading the smoker from smoking.

US patent 4276890 describes a method for inhibiting the desire to smoke by administering a gamma pyrone compound to the smoker throughout the day.

6 US patent 5560379 describes a dental cleaning instrument or flosser that may be prepared with embedded microspheres containing anti-smoking agents.

US patent 5487902 describes a chewing gum composition containing an active agent including anti-smoking agents.

Supplementation of smokers diets with vitamins, antioxidants and minerals is desirable to ensure that vitamins, antioxidants and minerals that may be depleted by pollutants and toxins in tobacco smoke are replenished by the dietary supplement. Depleted levels of these substances may render smokers susceptible to cellular damage by the pollutants in tobacco smoke which may lead to ill health and disease. For example, tobacco smoke may lead to depleted antioxidant defences in smokers, which renders the smokers susceptible to the pro-oxidant chemicals present in tobacco smoke. Supplementation of the smokers diet with vitamins, antioxidants or minerals will help maintain a healthy level of defence against the prooxidants present in tobacco smoke. If these supplements are taken at regular intervals, for example just prior to, during or after smoking then the body's defences will be regularly bolstered at times when the tobacco smoke is depleting and overwhelming the defences and causing cellular damage. Additionally, small regular doses of supplements is generally regarded as being of greater benefit than large single doses.

An additional problem with the consumption of dietary supplements is that as they are usually in the form of a single daily dose, consumers often forget to take the supplements on a daily basis and thus negate much of the benefit derived from regular consumption of the supplements. Therefore, association of consuming a dietary supplement with another regular act, 7 such as smoking, will help to ensure compliance with regular consumption and help to maintain a healthy balance of the vitamins, antioxidants and minerals to prevent cellular damage and ill health due to their depletion and to help the body neutralise ingested pollutants such as tobacco smoke.

Essential technical features The present invention describes preparations in the form of confectionery or other edible forms fortified with dietary supplements which may be taken at any time. Each edible unit dosage form may contain from 1 to 20% of the recommended daily allowance of the dietary supplements, such that multiple units of the dosage form may be consumed per day, each unit contributing a proportion of the recommended daily allowance (RDA) of the dietary supplement. It can take the fonn of a sweet (confectionery), lozenge, pastille, chewing gum, nougat, toffee, tablet or capsule that can be chewed, sucked or swallowed. The preparation may contain vitamins, minerals, antioxidants or other dietary supplements. The supplements may include any substance or supplement thought to impart a benefit to the consumer.

However, preferably the preparation is in the form of a chewing gum or tablet which is encouraged to be taken prior to, during or after smoking tobacco. This will ensure that a habit of association will be formed, linking the use of the preparation with the habit of smoking. This may have the effect of ensuring or encouraging use of the preparation on a regular basis which is thought to be more beneficial than single dose therapies.

Preferably, the preparation contains antioxidants, vitamins and minerals (in the range of 1 % to 20% of the recommended daily allowance of each supplement per single edible unit) beneficial for the treatment, alleviation or prevention of smoking related diseases, disorders, conditions or ailments. Preferably, these substances may include vitamin C, vitamin E, vitamin B2, 8 beta carotene,, zinc, folic acid and other supplements thought to impart a benefit to smokers. Preferably, the preparation may contain agents that freshen breath or otherwise mask the smell of malodorous breath such as bad breath caused by smoking tobacco. Preferably, the breath freshening agents will be mint flavours such as peppermint or spearmint or mixtures of mint oils. The preparation may also contain agents that improve the taste or enhance the palatability of the preparation.

An alternative preferred embodiment of the present invention may take the form of preparations for pre-menopause, menopause and post-menopause dietary supplementation. Such preparations may be fortified with supplements suitable for the life stages described such as folic acid, calcium, vitamin E and vitamin D. Further embodiments of the present invention may be formulated for elderly people, active people, passive smokers, people exposed to environmental pollution, children and other life stages and lifestyles.

Without wishing to be bound by any theory, it is thought that antioxidants, vitamins and minerals are beneficial to the treatment, alleviation or prevention of smoking related diseases, disorders, conditions or ailments by supplementing the body's natural defences against toxic and pro- oxidant substances present in tobacco smoke and other pollutants, and by directly reacting with the toxins and pro-oxidants to render them less harmful. It is the presence of tobacco and pollution derived toxins that may lead to tissue damage, cellular damage and sub-cellular damage. For example, pro-oxidant species present in tobacco smoke and other pollutants may directly or indirectly lead to the damage or re-arrangement of DNA or the activation of oncogenes. This may lead to the development of a cancer. Supplementation 9 with antioxidants, vitamins and minerals may prevent this cascade resulting in oncogenesis.

Alternatively, pro-oxidants and other toxins present in tobacco smoke and other pollutants may enter the blood stream and lead to damage and activation of the endothelial cells lining the blood vessels. The endothelial cells become more adherent as a consequence due to the expression of adhesion molecules on their surface. The endothelial cells also secrete proinflammatory cytokines into the blood stream and surrounding tissues. This may result in thrombosis or increased risk of thrombosis, plaque formation on the blood vessel walls, fibrosis of the surrounding tissue. These consequences may result in poor or blocked blood flow leading to ischaemia, anoxia, cell damage and tissue necrosis. If this occurs in coronary arteries or other vessels supplying the heart then a heart attack may result. If this occurs in the brain then a stroke may be the result. If this sequence of events occurs in the peripheral vasculature then peripheral vascular disease may result. All of these outcomes have potentially life threatening or chronic long term health implications. Therefore, inhibition or prevention of these outcomes due to smoking or pollution is desirable. Vitamins, antioxidants and minerals can inhibit or help prevent key components of the above pathologies, or supplement the host defences to inhibit or minimise the initiation of the pathologies described.

The following examples illustrate the invention described above.

Example 1. Fortified smokers chewing gum. This preparation is formulated into a chewing gum for use before, during or after smoking. It is intended for smokers and recent ex-smokers to provide a combination of vitamins, antioxidants and minerals that may benefit the health of the individuals by supplementing the body's natural defences against the harmful effects of tobacco smoke. It is also intended to provide freshening of the breath by the addition of mint oils to the formulation. The manufacture of chewing gum and the use of gum base in said manufacture is well known to those skilled in the art, and may be found in US patent number 4238475 (to Witzel et al.), US patent number 4671961 (to Mansukh et al.) and 'Sugar confectionery and chocolate manufacture' (R.Lees and E.B.Jackson, 1992). A chewing gum formulation is prepared containing mint oils as breath fresheners and the active ingredients in the proportions stated below. Active ingredients are expressed as percent of RDA in each edible unit. One unit represents one stick, tablet or ball of chewing gum.

Active ingredient Amount %RDA per unit Vitamin E 2mg 20% Vitamin C 12mg 20% Riboflavin 80gg 5% Zinc 0.75mg 5% Vitamin B 12 50ng 5% Folic acid 20pig 10% Manganese 75gg No RDA Copper 25gg No RDA Selenium logg No RDA Beta carotene lmg No RDA 11 Example 2 Fortified smokers breath freshener (tablet). This preparation is formulated into a suckable sweet or tablet for use before, during or after smoking. It is intended for smokers and recent ex-smokers to provide a combination of vitamins, antioxidants and minerals that may benefit the health of the individuals by supplementing the body's natural defences against the harmful effects of tobacco smoke. It is also intended to provide freshening of the breath by the addition of mint oils to the formulation.

Tablets incorporating the composition of the present invention can be manufactured by well known tableting methods as known by those skilled in the art and described in 'Sugar confectionery manufacture' (Ed. E.B. Jackson, 1990). A tablet formulation is prepared containing mint oils as breath fresheners and the active ingredients in the proportions stated below.

Active ingredients are expressed as percent of RDA in each edible unit. One unit represents one tablet.

Active ingredient Amount.%RDA per unit Vitamin E 2mg 20% Vitamin C 12mg 20% Riboflavin 80pg 5% Zinc 0.75mg 5% Vitamin B 12 50ng 5% Folic acid 20gg 10% Manganese 75gg No RDA Copper 25gg No RDA Selenium logg No RDA Beta carotene Img No RDA 12 The base composition of the tablet may consist of sugar and glucose syrup as base materials and sweeteners, modified starch as a binding agent, stearic acid as a lubricant and mint oils as flavouring in proportions suitable to produce a consistent manufacturing process and product.

Example 3 Fortified smokers sugar-free chewing gum. This preparation is formulated into a chewing gum as described in Example 1 above, except that sweetening of the preparation is achieved by the 10 addition of a suitable amount of a low calorie sweetening agent.

Example 4 Fortified smokers sugar-free breath freshener (tablet). This preparation is formulated into a suckable sweet or tablet as described in Example 2 above, except that sweetening of the preparation is achieved by the addition of a suitable amount of a low calorie sweetening agent.

Example 5

Fortified chewing gum for general dietary supplementation.

This preparation is formulated as described in Example 1 or Example 3 above. except that the active ingredients are those listed below. The chewing gum is manufactured such that each edible unit of chewing gum contains about 8% of the RDA for each of the active ingredients listed below. The chewing gum is formulated for use by people who desire to supplement their diet with a general multi-vitamin, antioxidant and mineral preparation in a form that allows multiple doses to be taken throughout the day. The preparation may benefit the health of the individuals by supplementing the body's natural defences against the harmful effects of environmental 13 pollution, and by supplementing poor dietary intake of beneficial vitamins, antioxidants and minerals.

Active ingredient Vitamin D Calcium Vitamin A Vitamin E Vitamin C Thiamin (vitamin B) Riboflavin (vitamin B2) Niacin Vitamin B6 Folic acid Vitamin B12 Biotin Pantothenic acid Iron Magnesium Zinc Iodine Beta carotene Amount 0Agg 64mg 64gg 0.8mg 4.8mg 0. 1 12mg 0. 128mg 1.44mg 0.16mg 16gg 80ng 12gg 0.48mg 1. 12mg 23.5mg 1.2mg 12gg 32gg 14

Claims (1)

1. Claims

   1. A preparation in edible unit dosage form comprising one or more substances beneficial for the treatment, alleviation or prevention of 2.

   6.

   smoking related diseases, disorders, conditions, or ailments, other than nicotine or a nicotine substitute, characterised in that each edible unit contains from 1 to 20% of the adult recommended daily allowance of said one or more substances. The preparation according to claim 1 wherein the preparation is in the form of, but not restricted to, tablets, lozenges, pastilles, capsules, boiled sweets, gum, biscuits, cookies, cakes, pastries, aerosol, mouthwash, toothpaste, liquid or other confectionery, food, drink, personal hygiene or other such presentations skilled to those in the art 3. A preparation according to claim 1 or claim 2 wherein each edible unit comprises from 2 to 10% of the adult recommended daily allowance of said one or more substances. The preparation according to any preceding claim, wherein each said edible unit contains from 4 to 8% of said adult recommended daily allowance of said one or more substances. The preparation according to any preceding claim wherein the preparation taken or consumed before, during or after smoking. The preparation according to any preceding claim wherein the preparation is taken or consumed immediately prior to smoking The preparation according to any preceding claim wherein the preparation is taken or consumed during smoking 8. The preparation according to any preceding claim wherein the preparation is taken or consumed immediately after smoking 9. The preparation according to any preceding claim wherein the preparation additionally contains one or more substances selected from the group consisting of (with adult RDA in parenthesis) vitamin E (10mg), vitamin C (60mg), folic acid (200ig), zinc and zinc salts (1 5mg), magnesium and magnesium salts (3 00mg), selenium and selenium salts (no RDA), vitamin D (5Rg), calcium (800mg), vitamin A (800 ptg), Thiamin (vitamin B,, 1Amg), riboflavin (vitamin B2, 1. 6mg), niacin (1 8mg), vitamin B6(2mg), vitamin B12 (1 gg), biotin (0. 15mg), pantothenic acid (6mg), iron (1 4mg), iodine (150 Rg), beta carotene (no RDA), manganese (no RDA), copper (no RDA), free radical scavengers, sulphydryl agents, DNA protecting agents, salts, energy supplements, electrolytes, antacids and other dietary supplements, vitamins, antioxidants and minerals, or other such substances obvious to those skilled in the art.

   10. A package containing a plurality of preparations in unit dosage form according to any preceding claim.

   11. A preparation in edible unit dosage form fortified with one or more substances or dietary supplements, characterised in that each edible unit contains from 1 to 20% of the adult recommended daily allowance of said one or more substances.

   12. The preparation according to claim 11 wherein the preparation is in the form of, but not restricted to, tablets, lozenges, pastilles, capsules, boiled sweets, gum, biscuits, cookies, cakes, pastries, aerosol, mouthwash, toothpaste, Hquid or other confectionery, food, drink, personal hygiene or other such presentations skilled to those in the art 13. A preparation according to claim 11 or claim 12 wherein each edible unit comprises from 2 to 10% of the adult recommended daily allowance of said one or more substances.

   14. The preparation according to any preceding claim, wherein each said edible unit contains from 4 to 8% of said adult recommended daily allowance of said one or more substances.

   16 15. The preparation according to any preceding claim wherein the preparation additionally contains one or more substances selected from the group consisting of (with adult RDA in parenthesis) vitamin E (1 Omg), vitamin C (60mg), folic acid (20OpLg), zinc and zinc salts (15mg), magnesium and magnesium salts (300mg), selenium and selenium salts (no RDA), vitamin D (5 pig), calcium (800mg), vitamin A (800 ptg), Thiamin (vitamin B,, 1Amg), riboflavin (vitamin B2, 1.6mg), niacin (1 8mg), vitamin B6(2mg), vitamin B12 (1 gg), biotin (0. 15mg), pantothenic acid (6mg), iron (1 4mg), iodine (15 0 PLg), beta carotene (no RDA), manganese (no RDA), copper (no RDA), free radical scavengers, sulphydryl agents, DNA protecting agents, salts, energy supplements, electrolytes, antacids and other dietary supplements, vitamins, antioxidants and minerals, or other such substances obvious to those skilled in the art.

   16. The preparation according to any preceding claim wherein the preparation additionally contains one or more substances that improve the palatability and taste of the preparation. Such substances may include, but are not restricted to, spearmint, peppermint, mint, menthol, camphor, eucalyptus, fruit flavours, sweetening agents, texture enhancers and antacids or other such substances obvious to those skilled in the art.

   17. The preparation according to any preceding claim wherein the preparation additionally contains breath freshening or odour masking agents.

   18. The preparation according to any preceding claim wherein the preparation contains one or more substances or dietary supplements for the treatment or prevention of periodontal related disorders and diseases.

   17 19. A preparation substantially as described herein with reference to claims 1 to 18.

   20. A package containing a plurality of preparations in unit dosage form according to any preceding claim.