Chewing gum containing nicotine and preparation method thereof

Abstract

The invention discloses nicotine-containing chewing gum and a preparation method thereof. The chewing gum is prepared from (S)-nicotine salt, gum base, xylitol, menthol, buffer salt and talcum powder. The strip-shaped chewing gum prepared by adopting a hot-melt extrusion process is cut into slices after being cooled, so that the chewing gum has the advantages of simplicity in operation, low energy consumption and stable product quality; the softened gum base and other materials are stirred for a long time, so that the materials are fully mixed, the toughness of the gum base is adjusted, and the chewing taste is better. Through research, the (S)-nicotine salt instead of racemic nicotine salt and (R)-nicotine salt is used in a chewing gum formula, and the feeling of smoking quitters during chewing can be consistent with that of smoking cigarettes by using the (S)-nicotine salt. Since nicotine is absorbed in the mouth, discomfort and unpleasant taste may be generated, menthol and xylitol are added to the prescription as taste masking agents to alleviate discomfort. By adding sodium carbonate into the nicotine chewing gum, the pH value can be adjusted, and the nicotine chewing gum is relatively stable when being chewed in the oral cavity. According to the formula, the bad feeling generated in the oral cavity during chewing can be relieved, the acceptability of smoking quitters is improved, the amount of nicotine released by the chewing gum is reduced, the release time is prolonged, the use amount of the chewing gum of the smoking quitters is reduced, and meanwhile effective replacement of cigarettes can be achieved.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical preparations, and particularly to a nicotine-containing chewing gum and a preparation method thereof. Background Art

[0002] As is well known, cigarette combustion produces many harmful substances such as tar, carbon monoxide, and heavy metal elements. These substances are inhaled by smokers along with cigarette combustion and may cause serious health problems. Therefore, to solve the dependence of smokers on cigarettes and at the same time avoid excessive intake of harmful substances produced by cigarette combustion, a common method is to deliver nicotine in other forms rather than burning cigarettes. For example, a nicotine-containing preparation is given as a cigarette substitute to relieve the discomfort symptoms caused by nicotine withdrawal during smoking cessation and help smokers concentrate on quitting the smoking habit. This alternative method can effectively avoid the intake of various harmful substances and gradually relieve smokers' dependence on nicotine, achieving the purpose of reducing smoking. Nicotine chewing gum can replace the taste during smoking and provide nicotine for smokers, and the corresponding effect can be achieved by chewing. Through research, most smokers chew 8 - 12 pieces per day in the first month. When the desire to smoke decreases, the usage can be reduced until the drug is completely stopped. The nicotine chewing gum prepared by the present invention can effectively reduce the usage of nicotine-containing chewing gum during smoking cessation while achieving the smoking cessation effect. Summary of the Invention

[0003] The present invention provides a nicotine-containing chewing gum preparation and a preparation method thereof. This method has a simple process, high production efficiency, and stable product quality. Moreover, the nicotine chewing gum prepared by this method releases nicotine slowly, can reduce the daily demand of smokers, and lower the nicotine intake of smokers.

[0004] To achieve the above, the present invention provides a nicotine-containing chewing gum, which comprises (S)-nicotine salt, gum base, xylitol, menthol, and buffer salt.

[0005] Further, the (S)-nicotine salt is selected from one or more of (S)-nicotine tartrate, (S)-nicotine hydrochloride, (S)-nicotine sulfate, and (S)-nicotine citrate.

[0006] Further, the (S)-nicotine salt accounts for 1% - 2% of the total mass of the chewing gum, the gum base accounts for 60% - 80% of the total mass, and the xylitol accounts for 10% - 20% of the total mass.

[0007] Further, the buffer salt includes one or two of sodium carbonate, sodium bicarbonate, sodium phosphate, and disodium hydrogen phosphate.

[0008] Further, the buffer salt accounts for 4%-20% of the total mass of the chewing gum.

[0009] Further, the formulation of the chewing gum further contains talcum powder.

[0010] Further still, the talcum powder accounts for 2%-5% of the total mass of the chewing gum.

[0011] The present invention provides a method for preparing a nicotine-containing chewing gum, which is carried out according to the following steps: (1) Prepare materials, weigh (S)-nicotine salt, gum base, xylitol, menthol, sodium carbonate, sodium bicarbonate and talcum powder according to the prescription; (2) Hot melt: Put the gum base into a hot melt extruder and heat it to 60-70°C. After the gum base softens, sequentially add xylitol, menthol, buffer salt and (S)-nicotine salt, stir while adding the materials, and continue to stir until the mixture meets the requirements, then turn on the extrusion module to extrude the materials into a long strip with a thickness of about 3-8 mm and a width of 5-20 cm. Sprinkle talcum powder on the surface of the chewing gum during discharging to prevent the chewing gum from sticking to the wall; (3) Slicing: Place the chewing gum in a square slicing mold to cool, and the sheet-shaped nicotine chewing gum can be taken out after the temperature reaches room temperature.

[0012] Further, in step (2), the stirring speed is 700-900 r / min and the stirring time is 3-8 h. Beneficial effects

[0013] The preparation method of the nicotine chewing gum of the present invention is made into a strip-shaped chewing gum by a hot melt extrusion process and then sliced after cooling. It has the advantages of simple operation, low energy consumption and stable product quality; the softened gum base and other materials are stirred for a long time, which not only allows the materials to be fully mixed, but also adjusts the toughness of the gum base to make it taste better when chewed. After research, using (S)-nicotine salt instead of racemic nicotine salt and (R)-nicotine salt in the chewing gum formulation is because using (S)-nicotine salt can make smokers feel the same when chewing as when smoking cigarettes. Since nicotine absorption in the mouth may cause discomfort and unpleasant taste, menthol and xylitol are added as masking agents in the prescription to reduce discomfort. By adding sodium carbonate salt to the nicotine chewing gum, the pH value can be adjusted and it is relatively stable when chewed in the mouth. In summary, the prescription of the present invention can reduce the adverse feelings generated in the mouth during chewing, increase the acceptance of smokers, slow down the amount of nicotine released by the chewing gum, extend the release time, reduce the amount of chewing gum used by smokers, and at the same time can effectively replace cigarettes. Embodiments

[0014] The following further illustrates the present invention through examples, but does not limit the present invention. Example 1

[0015] I. Prescription of Nicotine Chewing Gum

[0016] II. The preparation method is carried out according to the following steps: (1) Prepare materials: Weigh (S)-nicotine salt, gum base, xylitol, menthol, sodium carbonate, sodium bicarbonate and talcum powder according to the prescription; (2) Hot melt: Put the gum base into a hot melt extruder and heat it to 60°C. After the gum base softens, add xylitol, menthol, sodium carbonate, sodium bicarbonate, and nicotine tartrate salt, and stir while adding the materials. After continuous stirring for 5 hours, turn on the extrusion module and extrude the materials into a long strip with a thickness of about 4.8 mm and a width of 14 cm. Sprinkle talcum powder on the surface of the chewing gum during discharging to prevent the chewing gum from sticking to the wall; (3) Slicing: Place the chewing gum in a square slicing mold with a thickness of 4.8 mm, a length of 14 mm, and a width of 14 mm to cool. After the temperature reaches room temperature, the sheet-shaped nicotine chewing gum can be taken out. Example 2

[0017]

[0018] (1) Prepare materials: Weigh (S)-nicotine salt, gum base, xylitol, menthol, sodium carbonate, sodium bicarbonate and talcum powder according to the prescription; (2) Hot melt: Put the gum base into a hot melt extruder and heat it to 60°C. After the gum base softens, add xylitol, menthol, sodium carbonate, sodium bicarbonate, and nicotine tartrate salt, and stir while adding the materials. After continuous stirring for 5 hours, turn on the extrusion module and extrude the materials into a long strip with a thickness of about 4.8 mm and a width of 14 cm. Sprinkle talcum powder on the surface of the chewing gum during discharging to prevent the chewing gum from sticking to the wall; (3) Slicing: Place the chewing gum in a square slicing mold with a thickness of 4.8 mm, a length of 14 mm, and a width of 14 mm to cool. After the temperature reaches room temperature, the sheet-shaped nicotine chewing gum can be taken out. Example 3

[0019]

[0020] The preparation method is carried out according to the following steps: (1) Prepare materials: Weigh (S)-nicotine salt, gum base, xylitol, menthol, sodium phosphate, disodium hydrogen phosphate and talcum powder according to the prescription; (2)Hot melt: Put the gum base into a hot melt extruder and heat it to 60 °C. After the gum base softens, add xylitol, menthol, sodium phosphate, disodium hydrogen phosphate, and nicotine tartrate while stirring. Keep stirring for 5 h, then turn on the extrusion module and extrude the material into a long strip with a thickness of about 4.8 mm and a width of 14 cm. Sprinkle talcum powder on the surface of the chewing gum during discharging to prevent the chewing gum from sticking to the wall; (3)Slicing: Place the chewing gum in a square slicing mold with a thickness of 4.8 mm, a length of 14 mm, and a width of 14 mm to cool. After the temperature reaches room temperature, the sheet-shaped nicotine chewing gum can be taken out. Example 4

[0021]

[0022] The preparation method is carried out according to the following steps: (1)Prepare materials, weigh (S)-citrate, gum base, xylitol, menthol, sodium bicarbonate, and talcum powder according to the prescription; (2)Hot melt: Put the gum base into a hot melt extruder and heat it to 60 °C. After the gum base softens, add xylitol, menthol, sodium bicarbonate, and (S)-nicotine citrate while stirring. Keep stirring for 5 h, then turn on the extrusion module and extrude the material into a long strip with a thickness of about 4.8 mm and a width of 14 cm. Sprinkle talcum powder on the surface of the chewing gum during discharging to prevent the chewing gum from sticking to the wall; (3)Slicing: Place the chewing gum in a square slicing mold with a thickness of 4.8 mm, a length of 14 mm, and a width of 14 mm to cool. After the temperature reaches room temperature, the sheet-shaped nicotine chewing gum can be taken out. Example 5

[0023]

[0024] (1)Prepare materials, weigh (S)-citrate, gum base, xylitol, menthol, sodium carbonate, sodium bicarbonate, and talcum powder according to the prescription; (2)Hot melt: Put the gum base into a hot melt extruder and heat it to 60 °C. After the gum base softens, add xylitol, menthol, sodium carbonate, sodium bicarbonate, and (S)-nicotine citrate while stirring. Keep stirring for 5 h, then turn on the extrusion module and extrude the material into a long strip with a thickness of about 4.8 mm and a width of 14 cm. Sprinkle talcum powder on the surface of the chewing gum during discharging to prevent the chewing gum from sticking to the wall; (3)Slicing: Place the chewing gum in a square slicing mold with a thickness of 4.8 mm, a length of 14 mm, and a width of 14 mm to cool. After the temperature reaches room temperature, the sheet-shaped nicotine chewing gum can be taken out.

[0025] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A nicotine-containing chewing gum, characterized in that, The chewing gum comprises (S)-nicotine salt, a gum base, xylitol, menthol and a buffer salt.

2. The nicotine-containing chewing gum according to claim 1, characterized in that, The (S)-nicotine salt is selected from one or more of (S)-nicotine tartrate, (S)-nicotine hydrochloride, (S)-nicotine sulfate, and (S)-nicotine citrate.

3. The nicotine-containing chewing gum according to any one of claims 1-2, characterized in that, The (S)-nicotine salt accounts for 1% - 2% of the total mass of the chewing gum, the gum base accounts for 60% - 80% of the total mass, and the xylitol accounts for 10% - 20% of the total mass.

4. The nicotine-containing chewing gum according to claim 3, characterized in that, The buffer salt includes one or two of sodium carbonate, sodium bicarbonate, sodium phosphate, and disodium hydrogen phosphate.

5. The nicotine-containing chewing gum according to claim 4, characterized in that, The buffer salt accounts for 4% - 20% of the total mass of the chewing gum.

6. The nicotine-containing chewing gum according to claim 3, characterized in that, The formulation of the chewing gum further contains talcum powder.

7. The nicotine-containing chewing gum according to claim 6, characterized in that, The talcum powder accounts for 2% - 5% of the total mass of the chewing gum.

8. A method for preparing the nicotine-containing chewing gum according to claims 1-7, characterized in that, It is carried out according to the following steps: (1) Prepare materials, weigh (S)-nicotine salt, gum base, xylitol, menthol, buffer salt and talcum powder according to the prescription. (2) Hot melt: Put the gum base into a hot melt extruder and heat it to 60 - 70 °C. After the gum base softens, sequentially add xylitol, menthol, buffer salt and (S)-nicotine salt, stir while adding the materials, continuously stir until the mixture meets the requirements, then turn on the extrusion module, and extrude the materials into a long strip with a thickness of about 3 - 8 mm and a width of 5 - 20 cm. When discharging, spray talcum powder on the surface of the chewing gum to prevent the chewing gum from sticking to the wall. (3) Slicing: Place the chewing gum in a square slicing mold to cool, and the sheet-shaped nicotine chewing gum can be taken out after the temperature reaches room temperature.

9. The method according to claim 8, characterized in that, In step (2), the stirring speed is 700 - 900 r / min, and the stirring time is 3 - 8 h.

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