THIS INVENTION relates to a method of producing a stimulant chewing gum, and in particular to a method of producing a chewing gum containing Khat (Catha edulis). It further relates to the stimulant chewing gum, and in particular to a Khat-containing chewing gum.

Catha edulis, also known as Khat (or qut, chaat, chat, kaht, tchat, qaad, jaad, miraa, Kus es Salahin, Tchaad, Tschut, Tohat, Tohai, Gat, Qat) or Bushman's tea in English, is a flowering plant native to the Horn of Africa and the Arabian Peninsula. Khat is a green leafed plant that grows to a robust height of 2.7 to 3.7 m that is native to East Africa and the Arabian Peninsula (Kenya, Yemen, and Ethiopia). Khat grows at high elevations. Its soft leaves and twigs are farmed and harvested all throughout the year. Fresh Khat leaves contain the alkaloid cathinone, an amphetamine-like stimulant, which induces excitement, loss of appetite, and euphoria. As the leaves start deteriorating, the chemical composition of cathinone changes to cathine.

Within communities from East African and Arabian Peninsula areas where the plant is native, Khat chewing has a history as a social custom dating back thousands of years and is analogous to coca leaf chewing in South America, tobacco chewing in the United States and raw betel nut chewing in Asia. Chewing is and always has been the primary and traditional method of consumption for Khat. Khat chewing has a particularly rich history as a social custom and an herbal stimulant in countries such as Ethiopia, Kenya, and Somalia where it is used to assist natives with fatigue and loss of energy that comes with living and working in these high- altitude countries. Khat chewing is predominant at social events such as celebrations, meetings and marriages. During such sessions, the leaves and the bark of the plant are chewed slowly over several hours and the juice of the masticated leaves is sucked and swallowed, but not the chewed leaf matter. Khat's stimulating alkaloids are absorbed via the buccal mucosa or the lining of the cheeks and the back of the lips, inside where they touch the teeth. Five naturally occurring alkaloids have been identified in the Khat plant. The principle active alkaloid in Khat is aminopropriophenone or cathinone. Cathinone is a monoamine alkaloid that is chemically similar to ephedrine, cathine, methcathinone and other amphetamines. It is the main contributor to the stimulant effect of Catha edulis. Cathinone differs from many other amphetamines in that it has a ketone functional group. Other alkaloids or phenylalkylamines present in Khat include cathine which comprises norpseudoephedrine and norephedrine, and l-phenyl-l,2-propanedione. Cathinone degrades to cathine and norephedrine once Khat has been harvested.

Khat is a controlled substance in countries such as Canada, Germany, the United Kingdom, and the United States. Its production, sale, and consumption are legal in other countries, including Djibouti, Kenya, Uganda, Ethiopia, Somalia, Somaliland, Yemen and Thailand, where Khat addiction is a significant problem. These countries lose millions of dollars every year from lost productivity, health problems and even loss of life due to the addiction of Khat. Chewing fresh Khat leaves is attributed to a range of harmful health related side effects including tooth decay, chronic gastritis, heart palpitations, tachycardia, ulcers, diminished sex drive, depression, infrequent hallucinations, blurred vision, impaired inhibition, hypertension, insomnia, fibrosis, increased risk of myocardial infarction, dizziness, constipation, anorexia, cerebral edema, lower birth weights, psychosis in extreme cases in the genetically predisposed, and oral cancer.

The present invention discloses a method of producing a Khat-containing chewing gum, marketed as "Chew Chat" or "Qew Qat", to assist individuals who are addicted to chewing fresh Khat leaves. Upon administration, mastication of the chewing gum allows for the Khat to be released into the subject's oral cavity and absorbed by the subject. This chewing gum would provide the stimulant alkaloids of Khat in lower levels than from chewing the fresh leaves themselves. It is a mild, long term, sustainable consumer product that allows individuals addicted to Khat to adapt to lower levels of the stimulant alkaloids and thus potentially wean themselves off Khat altogether.

Khat-containing chewing gum provides a means for Khat addicts to reduce dependence on chewing fresh Khat and is similar in function to nicotine chewing gum as a means for tobacco chewing and/or tobacco smoking addicts to reduce dependence on chewing and/or smoking raw tobacco.

According to a first aspect of the invention, there is provided a method of producing a stimulant-containing chewing gum, the method comprising the steps of preparing a tincture by infusing the stimulant into a solvent; preparing a composition comprising a gum base, and a sweetener; adding the tincture to the composition; heating and mixing the composition to produce a homogenous mixture; and kneading the mixture to produce a dough.

The stimulant may be Khat and may be in the form of fresh leaves or in a dried form, such as a sun-dried or freeze-dried form.

The tincture may be prepared by adding the stimulant to a solvent to produce a mixture; heating the mixture at a low temperature; extracting the stimulant; and straining the mixture.

The solvent may be a vegetable-glycerine, ethanol, propylene glycol, water, or any combination thereof. The gum base may be a natural gum base selected from Sapotaceae, Chicle, Chiquibul, crown gum, Gutta hang kang, Massaranduba balata, Massaranduba chocolate, Nispero, Rosidinha, Venezuelan chicle, Apocynaceae, Jelutong, Leche caspi (sorva), Pendare, Perillo, Moraceae, Leche de vaca, Niger gutta, Tunu, Euphorbiaceae, Chilte, terpene resin or other resins, waxes, beeswax, spruce gum, mastic gum, and natural rubber (latex). The gum base may be a synthetic gum base selected from butadiene-styrene rubber, isobutylene-isoprene copolymer, paraffin wax (microcrystalline wax), petroleum wax, petroleum wax synthetic, polyethylene, polyisobutylene and polyvinyl acetate.

The gum base may be comprised of polymers, plasticisers and resins. Polymers, including elastomers, are responsible for the stretchy and sticky nature of chewing gum. Plasticisers improve flexibility and reduce brittleness, contributing to the plastic and elastic nature of gum. Resins compose the hydrophobic portion of the gum base, responsible for chewiness. Gum base provides basic textural and masticatory properties of gum. It serves as a non nutritive, non-digestible, water-insoluble masticatory delivery system used to carry sweeteners, flavours, and any other related substances such as a plant-based extract with all its active ingredients in a liquid form in chewing gum.

The gum base may comprise 40% to 75% of the total composition by weight.

The sweetener may be selected from sugar; dextrose; glucose; high fructose corn syrup; sugar alcohols such as glycerin, xylitol, sorbitol and isomalt; erythritol; maltitol; mannitol; lactitol; artificial sweeteners such as aspartame, sucralose, acesulfame, potassium and saccharin; neohesperidine; dihydrochalcone; and any combination thereof.

The sweetener may comprise between 10% to 20% of the total composition by weight.

A flavouring agent may be added to the composition. This may be selected from citrus fruit such as lemon, lime and orange; other fruit such as apple, cherry, watermelon, strawberry and raspberry; spices such as cinnamon, ginger, cardamom, clove, coriander seed and nutmeg; menthol; mint; eucalyptus; food acids for sour flavour such as citric, tartaric, malic, lactic, adipic, and fumaric acids; chocolate; vanilla; and any combination thereof.

The flavouring agent may comprise between 10% to 20% of the total composition by weight. A buffering agent may be added to the composition to adjust and maintain the pH level of the composition.

The buffering agent may be selected from sodium bicarbonate, phosphates, glycerophosphates, acetates, glycinates, citrates, alkaline metals such as carbonates and borates, and any combination thereof. The buffering agent may comprise 1% to 5% of the total composition by weight.

An antioxidant may be included in the composition to increase the health benefits of the chewing gum.

The antioxidant may be selected from calcium carbonate, sodium ascorbate, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA) and ascorbyl palmitate. The antioxidant may comprise 0.01% to 1% of the total composition by weight. A binding agent may be added to the composition and may include a softener or plasticiser, filler or a lubricant.

The softener or plasticiser may be selected from lecithin, calcium stearoyl lactylate (CSL), polyglycerol ester (PGE), sorbitan ester (SOE), hydrogenated vegetable oils, glycerol ester, lanolin, methyl ester, other esters of tree resins, rosins, pentaerythritol ester, rice bran wax, stearic acid, sodium and potassium stearates.

The filler may be selected from celluloses and cellulose derivatives including hydroxypropyl- cellulose, sodium carboxymethylcellulose, microcrystalline cellulose, lactose and starches (potato and corn). The lubricant may be selected from magnesium stearate, talc and colloidal silica dioxide.

The binding agent may comprise 0.01% to 1% of the total composition by weight.

The dough may be segmented into smaller pieces and may be processed to form a coated tablet piece with single or multiple coated layers. Coating may reduce the rate at which the stimulant is released when the chewing gum is consumed and chewed and may be composed of a sweetener, flavouring agent, buffering agent, antioxidant and/or a binding agent or any combination thereof.

The chewing gum may be packaged in a blister package, as a stick, in a resealable pouch, with individual wrappers, as rolls or in boxes.

According to a second aspect of the invention there is provided a method of producing a stimulant-containing chewing gum, the method comprising the steps of: preparing a composition comprising a gum base and a sweetener; adding a stimulant to the composition; heating and mixing the composition to produce a homogenous mixture; and kneading the mixture to produce a dough.

The stimulant may be Khat and may be in the form of fresh leaves or in a dried form, such as a sun-dried or freeze-dried form. The Khat may be in the form of an extract.

A soxhlet extractor may be used to obtain the Khat extract from fresh or dried Khat leaves. The Khat extract may be combined with an edible oil, such as olive oil, sunflower oil, peanut oil, palm oil, walnut oil etc, in order to reduce the viscosity of the extract and to increase its oily texture. The stimulant may include at least one active ingredient isolated from Khat and may be an alkaloid selected from cathinone, cathine, norephedrine, norpseudoephedrine, and 1-phenyl- 1,2-propanedione.

The gum base may be a natural gum base selected from Sapotaceae, Chicle, Chiquibul, crown gum, Gutta hang kang, Massaranduba balata, Massaranduba chocolate, Nispero, Rosidinha, Venezuelan chicle, Apocynaceae, Jelutong, Leche caspi (sorva), Pendare, Perillo, Moraceae, Leche de vaca, Niger gutta, Tunu, Euphorbiaceae, Chilte, terpene resins, other resins, waxes, beeswax, spruce gum, mastic gum and natural rubber (latex).

The gum base may be a synthetic gum base selected from butadiene-styrene rubber, isobutylene-isoprene copolymer, paraffin wax (microcrystalline wax), petroleum wax, petroleum wax synthetic, polyethylene, polyisobutylene and polyvinyl acetate.

The gum base may comprise 40% to 75% of the total composition by weight.

The sweetener may be selected from sugar; dextrose; glucose; high fructose corn syrup; sugar alcohols such as glycerin, xylitol, sorbitol and isomalt; erythritol; maltitol; mannitol; lactitol; artificial sweeteners such as aspartame, sucralose, acesulfame, potassium and saccharin, neohesperidine, dihydrochalcone; and any combination thereof.

The sweetener may comprise between 10% to 20% of the total composition by weight.

A flavouring agent may be added to the composition. This may be selected from citrus fruit such as lemon, lime and orange; other fruit such as apple, cherry, watermelon, strawberry and raspberry; spices such as cinnamon, ginger, cardamom, clove, coriander seed and nutmeg; menthol; mint; eucalyptus; food acids for sour flavour such as citric, tartaric, malic, lactic, adipic, and fumaric acids; chocolate; vanilla; and any combination thereof.

The flavouring agent may comprise between 10% to 20% of the total composition by weight. A buffering agent may be added to the composition to adjust and maintain the pH level of the composition.

The buffering agent may be selected from sodium bicarbonate, phosphates, glycerophosphates, acetates, glycinates, citrates, alkaline metals such as carbonates and borates, and any combination thereof.

The buffering agent may comprise 1% to 5% of the total composition by weight.

An antioxidant may be included in the composition to increase the health benefits of the chewing gum.

The antioxidant may be selected from calcium carbonate, sodium ascorbate, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA) and ascorbyl palmitate.

The antioxidant may comprise 0.01% to 1% of the total composition by weight.

A binding agent may be added to the composition and may include a softener or plasticiser, a filler or a lubricant.

The softener or plasticiser may be selected from lecithin, calcium stearoyl lactylate (CSL), polyglycerol ester (PGE), sorbitan ester (SOE), hydrogenated vegetable oils, glycerol ester, lanolin, methyl ester, pentaerythritol ester, other esters of tree resins, rosins, rice bran wax, stearic acid, sodium and potassium stearates.

The filler may be selected from celluloses and cellulose derivatives including hydroxypropyl- cellulose, sodium carboxymethylcellulose, microcrystalline cellulose, lactose and starches (potato and corn).

The lubricant may be selected from magnesium stearate, talc and colloidal silica dioxide.

The binding agent may comprise 0.01% to 1% of the total composition by weight.

The dough may be segmented into smaller pieces for individual consumption and may be processed to form a coated tablet piece with single or multiple coated layers. Coating may reduce the rate at which the stimulant is released when the chewing gum is consumed and chewed and may be composed of a sweetener, flavouring agent, buffering agent, antioxidant and/or a binding agent or any combination thereof. The chewing gum may be packaged in a blister package, as a stick, in a resealable pouch, with individual wrappers, as rolls or in boxes

According to a third aspect of the invention, there is provided a method of preparing a Khat- infused tincture, the method comprising the following steps: adding Khat to a solvent to produce a mixture; heating the mixture at a low temperature; extracting the Khat and straining the mixture.

The Khat may be in the form of fresh leaves or may be in a dried form, such as a sun-dried or freeze-dried form.

The solvent may be a vegetable-glycerine, ethanol, propylene glycol, water or any combination thereof.

The ratio of Khat to solvent may be 1:3.

The mixture may be allowed to stand in the solvent for at least 72 hours.

The mixture may be heated to a low temperature such as 55°C-60°C for at least 1 hour.

The mixture may be left to stand for at least 24 hours to reduce the solvent content through evaporation.

According to a fourth aspect of the invention, there is provided a Khat-containing chewing gum prepared by the method of the first or second aspects of the invention.

The invention will now be described in more detail with reference to the Example hereunder, and the accompanying drawing. In the drawing

FIGURE 1 shows, for the Example, the various formulations that may comprise the Khat-containing chewing gum.

EXAMPLE

Methods and Materials

Tinctures A liquid solvent is used to produce a tincture in order to extract the active ingredients from fresh Khat leaves or from sun-dried or from freeze-dried Khat as a starting material. These solvents include food grade vegetable glycerine, ethanol (vodka), and propylene glycol (50% vegetable glycerine and 50% food grade ethanol vodka), water, or any combination thereof.

While vegetable glycerine is an appealing, non-alcoholic means to extract the active ingredients, it is not as strong, effective or lasting as ethanol. Food grade ethanol (vodka) is considered to be the strongest, most-effective and long-lasting extractive solvent, with level of proof ranging from 40% to 200%. Propylene glycol is the preferred liquid solvent as it comprises a combination of vegetable glycerine and food grade ethanol (usually 50/50). It offers the extractive benefits of ethanol, while mitigating the narcotic effects of ethanol, with the presence of glycerine.

Preparation of vegetable glycerine-based tincture using fresh Khat leaves as a starting material

One part of fresh Khat leaves (100 ml) is placed in a glass mason jar. The jar is filled with three parts of vegetable glycerine (300 ml). The jar is placed in a shaded crockpot of water for 72 hours. The crockpot is set to boil at a low temperature of 55°C-60°C for three to six hours. The solid material is removed, and the tincture is strained until only solvent remains.

Preparation of ethanol (vodka)-based tincture using fresh Khat leaves as a starting material

One part of fresh Khat leaves (100 ml) is placed in a glass mason jar. Three parts of 40% proof ethanol (vodka) (300 ml) is added to the jar. The jar is placed in a shaded crockpot of water for 72 hours. The crockpot of water is boiled at a low temperature of 55°C-60°C for three to six hours with care as the solvent is flammable. The solid material is removed, and the tincture is strained until only solvent remains. The tincture is allowed to stand for 24 hours to allow the ethanol to evaporate.

Preparation of propylene glycol-based tincture (50% ethanol and 50% glycerine) using fresh Khat leaves as a starting material

One part of fresh Khat leaves (100 ml) is placed in a glass mason jar. The jar is filled with three parts of propylene glycol (300 ml). The jar is placed in a shaded crockpot of water for 72 hours. The crockpot of water is boiled at a low temperature of 55°C-60°C for three to six hours with care as the solvent is flammable. The solid material is removed, and the liquid is strained until only solvent remains and left to stand for 24 hours to allow for the ethanol to evaporate.

Preparation of water-based tincture using fresh Khat leaves as a starting material

One part of fresh Khat leaves (100 ml) is placed in a glass mason jar. The jar is filled with three parts water (300 ml). The water and Khat mixture are blended using an electric processor until the leaves have been finely ground in solution with the water. The jar is placed in a shaded crockpot of water for 72 hours. The crockpot is set to boil at a low temperature of 55°C-60°C for an hour. The tincture is strained to remove the solid material until only solvent remains.

Manufacture of Khat-containing chewing gum using a fresh Khat-infused tincture

Natural or synthetic gum base pellets can be used. Natural gum bases include: Sapotaceae, Chicle, Chiquibul, Crown Gum, Gutta hang kang, Massaranduba balata, Massaranduba chocolate, Nispero, Rosidinha, Venezuelan chicle, Apocynaceae, Jelutong, Leche caspi (sorva), Pendare, Perillo, Moraceae, Leche de vaca, Niger gutta, Tunu (tuno), Euphorbiaceae, Chilte, terpene resins, other resins, waxes, beeswax, spruce gum, mastic gum and natural rubber (latex).

Synthetic gum bases include butadiene-styrene rubber, isobutylene-isoprene copolymer (butyl rubber), paraffin wax (microcrystalline wax), petroleum wax, petroleum wax synthetic, polyethylene, polyisobutylene and polyvinyl acetate.

40-50 g of natural rubber (latex) gum base pellets are added to a glass vessel. The gum base pellets are microwaved on high for two minutes to warm and soften the pellets. The pellets are pressed with a plastic spatula to increase malleability. 10-15 g of high fructose corn syrup is added to the cup as a food grade sweetener and microwaved again on high for two minutes. The mixture is stirred and pressed with a plastic spatula until the pellets and syrup form a solution. The microwaving, stirring and pressing is repeated as necessary until the contents are fully dissolved in the heated mixture. 4-5 g of a tincture as prepared above is added to the heated mixture with 2-3 g of glycerin as a food grade sweetener, 0.5 g of sodium bicarbonate as a buffering agent, 0.5 g of sodium ascorbate as an antioxidant and 2 g of lecithin as a softener, plasticiser or a binding agent. The mixture is stirred and pressed again with a plastic spatula until a homogenous mixture is formed. The mixture is poured onto a dry flat surface on top of a powder mixture comprising 10-20 g of dextrose icing sugar as a food grade sweetener and 15-20 g of a powdered flavouring, such as a lemon (yellow coloured) flavouring. The mixture is kneaded until a gum dough forms, with a bread dough-like consistency. The dough is cut into equal bite-sized pieces. The pieces are sprinkled with additional powdered flavouring to enhance the visual and taste appeal.

Sun-dried or freeze-dried Khat as a starting material

Khat is sun-dried by leaving fresh Khat leaves in the sun. This act naturally dehydrates the leaves to increase the shelf life and decrease the weight of the Khat. Drying also results in a decrease in the content of the naturally occurring active stimulants of cathinone, cathine, norpseudoephedrine, norephedrine and l-phenyl-l,2-propanedione from the leaves. Sun- dried Khat is less refined and crunchier in texture than the fresh leaves.

Freeze drying is a more sophisticated process of dehydrating the leaves. During the freezing process, the surrounding air pressure is reduced in a vacuum chamber to enable the frozen water in the Khat leaves to change from a solid state directly to a gas state. This process removes the water from fresh Khat leaves to just a few percent. Freeze drying is considered to be more effective than sun drying because it removes a greater amount of water to increase shelf life and lower weight from fresh Khat while effectively keeping intact Khat's naturally occurring active stimulants from the leaves. Freeze-dried Khat is more refined, less leafy in texture and has a powder consistency.

Both sun-dried and freeze-dried Khat can be used as direct material in a liquid solvent, such as glycerine, ethanol, propylene glycol, water of any combination thereof to produce a tincture or applied directly for the production of Khat-containing chewing gum.

Alternative materials for preparation of Khat extract

Methanol, acetone, benzyl alcohol, isopropyl alcohol, ethyl acetate and hexane are alternative food grade solvents that can be used to extract Khat's active ingredients into a liquid form to produce Khat-containing chewing gum. These solvents may, however, be less appropriate compared to vegetable glycerine, ethanol (vodka), propylene glycol or water due to their acidity, toxicity, density, complexity, organic nature, flammability, extraction yield, commercial availability, costliness and biodegradability. Nevertheless, these solvents can be used for producing Khat-containing chewing gum. Other known alternative food grade solvents are 1,3-butylene glycol, methylene chloride, ethylene dichloride, glyceryl diacetate, glyceryl triacetate, glyceryl tributyrate, hydrogenated sperm oil and castor oil.

One part of freeze-dried or sun-dried Khat leaves (25 ml) is placed in a glass mason jar and filled with eight parts of methanol, acetone, benzyl alcohol, isopropyl alcohol, ethyl acetate or hexane (200 ml). The glass mason jar is placed in a shaded crockpot of water for 72 hours. The crockpot of water is boiled at a low temperature of 55°C-60°C with care for three to six hours. The solid material is removed, and the liquid is strained until only solvent remains, and the liquid is left to stand for 24 hours to allow for excess solvent to evaporate.

Manufacture of Khat-containing chewing gum using a tincture prepared from sun-dried or freeze-dried Khat

One part of dried Khat (100 ml) is placed in a glass mason jar. The jar is filled with three parts (300 ml) of vegetable glycerine, or ethanol (vodka), propylene glycol, water or any combination thereof. The jar is placed in a shaded crockpot of water for 72 hours. The crockpot is set to boil at a low temperature of 55°C-60°C for three to six hours with care as ethanol (vodka) or propylene glycol solvents are flammable. The extracted leaves are removed, and the tincture is strained until only solvent remains.

40-50 g of natural rubber (latex) gum base pellets are added to a glass vessel. The gum base pellets are microwaved on high for two minutes to warm and soften the pellets. The pellets are pressed with a plastic spatula to increase malleability. 10-15 g of high fructose corn syrup as a food grade sweetener is added to the cup and microwaved on high for two minutes. The mixture is stirred and pressed with a plastic spatula until the pellets dissolve into the syrup. The microwaving, stirring and pressing is repeated as necessary until the contents are fully dissolved in the heated mixture. 4-5 g of sun-dried or freeze-dried Khat tincture is added to the heated mixture with 3 g of glycerin, 0.5 g of sodium carbonate, 0.5 g of sodium ascorbate and 2 g of lecithin. The mixture is stirred and pressed with a plastic spatula until a homogenous mixture is formed. The mixture is poured onto a dry flat surface on top of a powder mixture comprising 10 g of dextrose icing sugar as a food grade sweetener and 15 g of a powdered flavouring, such as a lemon (yellow coloured) flavouring. The mixture is kneaded until a gum dough forms, with a bread dough-like consistency. The dough is segmented into smaller bite-sized pieces. The pieces are sprinkled with additional powdered flavouring to enhance the visual and taste appeal.

Manufacture of Khat-containing chewing gum using raw, sun-dried or freeze-dried Khat (no tincture)

40-50 g of natural rubber (latex) gum base pellets are added to a glass vessel. The gum base pellets are microwaved on high for two minutes to warm and soften the pellets. The pellets are pressed with a plastic spatula to increase malleability. 10-15 g of high fructose corn syrup as a food grade sweetener is added to the cup and microwaved on high for two minutes. The mixture is stirred and pressed again with a plastic spatula until the pellets and syrup merge together. The microwaving, stirring and pressing as necessary until the contents are fully dissolved in the heated mixture. 4-5 g of raw, sun-dried or freeze-dried Khat is added to the heated mixture with 3 g of glycerin, 0.5 g of sodium carbonate, 0.5g of sodium ascorbate and 2 g of lecithin. The mixture is stirred and pressed again with a plastic spatula until a homogenous mixture is formed. The mixture is poured onto a dry flat surface on top of a powder mixture comprising 10 g of dextrose icing sugar as a food grade sweetener and 15 g of a powdered flavouring, such as a lemon (yellow coloured) flavouring. The mixture is kneaded until a gum dough forms, with a bread dough-like consistency. The dough is segmented into smaller bite-sized pieces. The pieces are sprinkled with additional powdered flavouring to enhance the visual and taste appeal.

Manufacture of Khat-containing chewing gum using isolated active ingredients from Khat

The chewing gum can be manufactured as set out above and rather than adding fresh Khat, dried Khat or a tincture of Khat, one or more of the isolated active ingredients from Khat can instead be added to the chewing gum dough. These active ingredients may be selected from cathinone, cathine, norephedrine, norpseudoephedrine, and l-phenyl-l,2-propanedione. A single active ingredient may be added or up to all of the active ingredients may be added. The percentage amount of the active ingredients in 100 g of the chewing gum is 4.5 mg of cathinone, 3.3 mg of norpseudoephedrine, 1.8 mg of norephedrine, 0.1 mg of l-phenyl-1,2- propanedione.

Alternative method and materials for preparation of Khat extract

Using a soxhlet extractor, one part of freeze-dried or sun dried Khat leaves (50 ml) is placed into a cellulose paper thimble. Four parts of methanol, acetone, benzyl alcohol, isopropyl alcohol, ethyl acetate, hexane, vegetable glycerine, ethanol (vodka), propylene glycol or water (200 ml) is poured into a soxhlet flask topped with a glass tube. The Khat-filled paper thimble is placed into the extraction chamber. The flask is heated by an isomantle to each solvent's respective boiling point (methanol 64.5°C; acetone 56.1°C; benzyl alcohol 205.4°C; isopropyl alcohol 82.5°C; ethyl acetate 77.1°C; hexane 68.7°C; vegetable glycerine 290°C; ethanol (vodka) 78.37°C; propylene glycol 188.2°C; water 100°C). Vapours from the heated solvent rise up through the soxhlet flask's glass tube to the soxhlet refrigerator chamber, condensing back to liquid which drips vertically into the extraction chamber which contains the Khat-filled paper thimble. A Khat extract is formed as the solvent falls through the Khat- filled paper thimble. Once the extraction chamber is full of extract, it is released further down a siphon and back into the original soxhlet flask.

This process is repeated three to four times. As the original solvent is condensed and filtered through the Khat-filled paper thimble into the flask, it is reheated. As the solvent reaches its boiling point again, vapour rises, condenses and drips through the Khat-filled paper thimble to form the extract again which goes right back into flask.

This Khat extract has a viscous oily texture. When combined with Vitamin E to reduce viscosity and increase oily texture for skin application, this extract is known as "Khat Essential Oil."

When combined with an edible oil (olive, sunflower, peanut, palm, walnut, etc.) to reduce viscosity and increase oily texture for food consumption application, this extract is known as "Khat Edible Oil." Manufacture of Khat-containing chewing gum using Khat extract obtained using a soxhlet extractor

40-50 g of natural rubber (latex) gum base pellets are added to a glass vessel. The gum base pellets are microwaved on high for two minutes to warm and soften the pellets. The pellets are pressed with a plastic spatula to increase malleability. 10-15 g of high fructose corn syrup as a food grade sweetener is added to the cup and microwaved on high for two minutes. The mixture is stirred and pressed again with a plastic spatula until the pellets and syrup merge together. The microwaving, stirring and pressing as necessary until the contents are fully dissolved in the heated mixture.

2-5 g of Khat extract obtained via the soxhlet extractor method above is added to the heated mixture with 3 g of glycerin, 0.5 g of sodium carbonate, 0.5g of sodium ascorbate and 2 g of lecithin. The mixture is stirred and pressed again with a plastic spatula until a homogenous mixture is formed. The mixture is poured onto a dry flat surface on top of a powder mixture comprising 10 g of dextrose icing sugar as a food grade sweetener and 15 g of a powdered flavouring, such as a lemon (yellow coloured) flavouring. The mixture is kneaded until a gum dough forms, with a bread dough-like consistency. The dough is segmented into smaller bite- sized pieces. The pieces are sprinkled with additional powdered flavouring to enhance the visual and taste appeal.

Manufacture of Khat-containing chewing gum using Khat extract obtained using a soxhlet extractor in combined with an edible oil (Khat Edible Oil)

40-50 g of natural rubber (latex) gum base pellets are added to a glass vessel. The gum base pellets are microwaved on high for two minutes to warm and soften the pellets. The pellets are pressed with a plastic spatula to increase malleability. 10-15 g of high fructose corn syrup as a food grade sweetener is added to the cup and microwaved on high for two minutes. The mixture is stirred and pressed again with a plastic spatula until the pellets and syrup merge together. The microwaving, stirring and pressing as necessary until the contents are fully dissolved in the heated mixture.

4 g of Khat Edible Oil (three parts of Khat extract (3 g) obtained using a soxhlet extractor with one part sunflower oil (1 g)) is added to the heated mixture with 3 g of glycerin, 0.5 g of sodium carbonate, 0.5g of sodium ascorbate and 2 g of lecithin. The mixture is stirred and pressed again with a plastic spatula until a homogenous mixture is formed. The mixture is poured onto a dry flat surface on top of a powder mixture comprising 10 g of dextrose icing sugar as a food grade sweetener and 15 g of a powdered flavouring, such as a lemon (yellow coloured) flavouring. The mixture is kneaded until a gum dough forms, with a bread dough- like consistency. The dough is segmented into smaller bite-sized pieces. The pieces are sprinkled with additional powdered flavouring to enhance the visual and taste appeal.

Volunteer Testing

Five healthy volunteers were each given a piece of Khat-containing chewing gum produced using the fresh Khat-infused ethanol (vodka) based tincture. Each volunteer chewed the gum for a period of fifteen minutes. All five volunteers reported an increased sense of positive energy, mood and overall alertness lasting about three hours.

Five healthy volunteers were each given a piece of Khat-containing chewing gum produced using the sun-dried Khat-infused ethanol (vodka) tincture. They chewed the gum for a period of fifteen minutes. All five volunteers reported an increased sense of energy, mood and alertness lasting approximately one to two hours.

Five healthy volunteers were each given a piece of Khat-containing chewing gum containing sun-dried Khat (no tincture). They chewed the gum for a period of fifteen minutes. All five volunteers reported a slightly increased sense of positive energy, mood and alertness lasting from fifteen minutes to one hour.

Results and discussion

The present invention provides a method of producing a Khat-containing chewing gum called "Chew Chat" or "Qew Qat". Ingredients are applied in three phases of assembly. Each phase includes the application of heating, cooling and slow to medium to high speed mechanical mixing. After mixing, the ingredients are consolidated into a dough-like texture. The mixture is segmented into small pieces which are seasoned for improved appearance and taste. Figure 1 illustrates the various methods by which the chewing gum can be prepared. The chewing gum can be packaged in various forms. It is most preferable to package invention in a blister package which is a well-known packaging method in the medicinal and pharmaceutical industries. The blister package adds to the product's appeal as a medicinal product promoting slow consumption to help Khat addicts reduce their cravings for fresh Khat leaves. Other benefits of the blister package include cost savings, advertising space, clear product display, theft and tampering deterrence. Other potential forms of packaging that can be used include, sticks, resealable pouches, individual wrappers, rolls and boxes.

The advantages of the Khat-containing chewing gum include the following:

Convenience via portability - Instead of carrying around a large bag of bundled Khat leaves for consumption, a consumer can discreetly and conveniently carry and consume Khat-containing chewing gum as packaged appropriately and that neatly fits in a pocket or handbag. It is more convenient to purchase and carry portable chewing gum from convenient vending locations for consumption than to chew a large bag of bundled fresh Khat leaves while periodically spitting out macerated leaves in public, which is socially less acceptable and attractive.

Elimination of Khat's bitter flavour and grass like taste - By converting fresh or dried Khat leaves from a solid state to a liquid form in direct combination with chewing gum ingredients, the naturally bitter flavour and grass-like taste of Khat is reduced.

Improved flavour and taste - Khat-containing chewing gum can be formulated with a variety of flavours and tastes, such as lemon, lime and orange; other fruit such as apple, cherry, watermelon, strawberry and raspberry; spices such as cinnamon, ginger, cardamom, clove, coriander seed and nutmeg; menthol; mint; eucalyptus; food acids for sour flavour such as citric, tartaric, malic, lactic, adipic, and fumaric acids; chocolate; vanilla; and any combination thereof.

Improved delivery and absorption of Khat alkaloids over commercially available chewing gum - Some users chew Khat leaves with a piece of commercially available chewing gum. While this practice serves to mask Khat's bitter flavour and grassy taste, it appears to inhibit delivery and absorption of the stimulating alkaloids.

Commercial chewing gum and Khat leaves break apart in a user's mouth, turning the combination into a crunchy mixture that is difficult to chew and where small pieces get stuck between the user's teeth and impacts the dental gum lining. Users find that the mixture becomes unchewable quickly, forcing them to discard it within minutes. It takes longer for a user to the stimulatory effects of Khat because commercial chewing gum appears to inhibit absorption of the alkaloids via the buccal mucosa and the back of the lips. Hence, users are left with an unsatisfying experience.

With the present invention, however, the chewing gum ingredients are initially combined with Khat in a liquid form and then sealed with binding agents. This results in a product that is easily chewable with a smooth texture. Healthy volunteers were able to chew the product for up to three hours without the product getting stuck in between their teeth or any impact on their dental gum lining. Neither did the product become unchewable. Further, there was no delay in the volunteers' being able to feel the effect of the stimulatory alkaloids.

Improved hygiene - Fresh Khat leaves must be cleaned before consumption and can contain residues such as dirt, pesticides, and even manure. Khat-containing chewing gum will be produced in a hygienic manufacturing setting where unwanted residues and contaminants have been removed, and in an environment that is consistent with national health standards. The product will therefore be of high hygienic standards and have less health risks associated due to its method of preparation.

Addiction treatment - Similar to how smokers or tobacco chewers chew nicotine gum to treat or curb addiction to tobacco, Khat-containing chewing gum will assist addicts in alleviating their addiction for Khat. By chewing Khat-containing chewing gum, addicts will be able to reduce their daily intake of Khat's addictive active ingredients cathinone, cathine, norephedrine, norpseudoephedrine, and l-phenyl-1,2- propanedione by chewing small pieces of gum that contain lower doses of Khat. Gradually, addicts will not only reduce their exposure to the health risks associated with Khat (tooth decay, chronic gastritis, heart palpitations, tachycardia, ulcers, diminished sex drive, depression, infrequent hallucinations, blurred vision, impaired inhibition, hypertension, insomnia, fibrosis, increased risk of myocardial infarction, dizziness, constipation, anorexia, cerebral edema, lower birth weights, psychosis in extreme cases in the genetically predisposed, and oral cancer) but also withdrawal symptoms will lessen, such as irritability, restlessness, fatigue and moodiness.

Prevention of lost productivity - Employers encounter tremendous loss of productivity with employees that are Khat addicts who not only leave their work premises to partake of chewing Khat leaves but also take full days away from work due to health problems associated with Khat. With Khat-containing chewing gum on hand, workers can continue to work at their jobs without leaving premises and remain productive while treating their addiction on an active basis and have fewer days of lost productivity due to health problems.

Prevention of overdosing - The Khat-containing chewing gum contains low levels of Khat active ingredients, thereby diminishing the risk of consumers overdosing on Khat.

The present invention provides a novel method of converting fresh or dried Khat leaves from a solid state to a liquid form while conserving the activity of the naturally occurring active ingredients of cathinone, cathine, norephedrine, norpseudoephedrine, and l-phenyl-1,2- propanedione. Once in a semi solid or a liquid form, it can be used to prepare a Khat- containing chewing gum to provide the stimulatory effects of Khat in a convenient, low dosage, appealing form.