COMPOSITION FOR SMOKELESS TOBACCO AND ORALLY DISSOLVABLE FILM-TYPE SMOKELESS TOBACCO COMPRISING SAME

Abstract

The present invention relates to a composition for smokeless tobacco and orally dissolvable film-type smokeless tobacco comprising same. More specifically, the present invention relates to a composition for orally dissolvable film-type smokeless tobacco, which is capable of improving the intraoral uptake rate, moldability, and taste of nicotine while reducing harmfulness to the human body, orally dissolvable film-type smokeless tobacco comprising same, and a manufacturing method thereof.

Claims

1. A composition for smokeless tobacco, the composition containing: a nicotine activator of 0.01 to 4 parts by weight; a binder of 40 to 80 parts by weight; and a plasticizer of 2 to 10 parts by weight.

2. The composition of claim 1, wherein the nicotine activator is nicotine oil and has a purity equal to or above 99%.

3. The composition of claim 1, wherein the binder is hydroxypropylmethylcellulose or hydroxypropylcellulose.

4. The composition of claim 1, wherein the binder is contained in 40 to 60 parts by weight.

5. The composition of claim 1, further containing water as a solvent.

6. The composition of claim 1, wherein viscosity is 15,0005,000 cps.

7. The composition of claim 1, further containing: a flavor; and at least one of a surfactant, a sweeting agent, and a coloring agent.

8. A smokeless tobacco comprising: a first region formed by coating the composition for the smokeless tobacco of claim 1 in a film form, wherein the smokeless tobacco is in an orally dissolvable film-type.

9. The smokeless tobacco of claim 8, further comprising: a second region formed by coating a flavor composition, a functional food composition, a beauty treatment composition, a pharmaceutical composition, or a mixture thereof in the film form to be adjacent to the first region.

10. The smokeless tobacco of claim 8, wherein at least one of the composition for the smokeless tobacco, the flavor composition, the functional food composition, the beauty treatment composition, the pharmaceutical composition, and the mixture thereof further contains a coloring agent.

11. The smokeless tobacco of claim 8, wherein the smokeless tobacco is disintegrated within 5 minutes after being placed in an oral cavity.

12. A method for manufacturing orally dissolvable film-type smokeless tobacco, the method comprising: discharging the composition for the smokeless tobacco of claim 1 in a single dose through a first nozzle such that the discharged composition is coated on a first region of a packaging material, thereby forming a first region coating; discharging a flavor composition, a functional food composition, a beauty treatment composition, a pharmaceutical composition, or a mixture thereof in a single dose through a second nozzle such that the discharged composition is coated on a second region of the packaging material adjacent to the first region, thereby forming a second region coating; and drying the first region coating and the second region coating.

13. The method of claim 12, wherein the drying of the first region and the second region is performed at a temperature in a range from 50 to 90 C.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 is a view showing a packaging state of orally dissolvable film-type smokeless tobacco including a first region according to an embodiment.

[0031] FIG. 2 is a schematic perspective view of orally dissolvable film-type smokeless tobacco including a first region and a second region according to an embodiment.

[0032] FIG. 3 is a view showing a packaging state of orally dissolvable film-type smokeless tobacco including a first region and a second region according to an embodiment.

[0033] FIG. 4 is a graph showing a result of a test of nicotine elution by time of orally dissolvable film-type smokeless tobaccos according to an example and a comparative example.

DETAILED DESCRIPTIONS

[0034] Purposes, specific advantages, and novel features of the present disclosure will become more apparent from the following detailed description and embodiments associated with the accompanying drawings.

[0035] Prior to this, terms or words used in the specification and claims should not be interpreted in a conventional and dictionary meaning, and should be interpreted as a meaning and concept consistent with the technical idea of the present disclosure based on the principle that the inventor is able to properly define the concept of terms to describe the invention thereof in the best way.

[0036] In the present specification, when a component such as a layer, a portion, or a substrate is described as being on, connected to, or coupled to another component, it may be directly on, connected to, or coupled to another element, or one or more intervening components may be present. In contrast, when a component is described as being directly on, directly connected to, or directly coupled to another component, no other component may be interposed between the two components.

[0037] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the present disclosure. As used herein, the singular forms a and an are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0038] It will be further understood that the terms comprises, comprising, includes, and including when used in this specification, specify the presence of the stated features, integers, operations, components, parts, and/or combinations thereof, but do not preclude the presence or addition of one or more other features, integers, operations, components, parts, and/or combinations thereof.

[0039] In the present specification, when a certain portion includes a certain component, it means that other components may be further included rather than excluding other components unless otherwise specified. In addition, throughout the specification, the term on means to be positioned on or beneath the target portion, and does not necessarily mean to be positioned at an upper side with respect to the direction of gravity.

[0040] The present disclosure is intended to illustrate specific embodiments in the drawings and to describe the specific embodiments in detail in the detailed description as various transformations may be applied and various embodiments may be applied. However, this is not intended to limit the present disclosure to the specific embodiments, and it is to be understood as including all modifications, equivalents, and alternatives included in the spirit and scope of the present disclosure. In describing the present disclosure, when it is determined that a detailed description of a related known technology may obscure the gist of the present disclosure, a detailed description thereof will be omitted.

[0041] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the description with reference to the accompanying drawings, the same or corresponding components are assigned the same reference numerals, and redundant descriptions thereof will be omitted.

[0042] Composition for Smokeless Tobacco

[0043] According to an embodiment, a composition for smokeless tobacco contains a nicotine activator of 0.01 to 4 parts by weight; a binder of 40 to 80 parts by weight; and a plasticizer of 2 to 10 parts by weight.

[0044] The composition for the smokeless tobacco contains the nicotine activator in a low dose to reduce harmfulness to a human body, and at the same time, improve acceptability and intraoral disintegration degree of film-type smokeless tobacco.

[0045] The nicotine activator is a main component of the composition for the smokeless tobacco, which may be nicotine or a nicotine derivative. The nicotine derivative may be a nicotine salt (tartaric acid, citric acid, and the like) or a nicotine complex. The nicotine activator is nicotine oil, which may be suitable to have a purity equal to or higher than 99%, but is not limited thereto. Because the composition for the smokeless tobacco does not contain tobacco particles, components, such as tar and the like, harmful to the human body are excluded, thereby reducing the harmfulness of the smokeless tobacco to the human body.

[0046] The nicotine activator may be contained in 0.01 to 4 parts by weight based on a solid weight of the composition for the smokeless tobacco. Although not limited thereto, when the nicotine activator of less than 0.01 parts by weight is contained based on the solid weight of the composition for the smokeless tobacco, it is difficult to meet needs of a user who needs the nicotine. Further, when the nicotine activator is contained in excess of 4 parts by weight, a very bitter taste may be produced, the acceptability may be reduced, and intraoral disintegration time may be lengthened. The harmfulness to the human body may be reduced by containing the nicotine activator in a low dose. In addition, even when the nicotine activator is contained in the low dose, an absorption rate of the nicotine may become relatively high compared to a high dose because of a reaction of the body for maintaining a nicotine content in a blood at a level equal to or above a certain level.

[0047] The nicotine activator may be contained, based on the solid weight of the composition for the smokeless tobacco, in 0.01 to 4 parts by weight, in 0.01 to 3.5 parts by weight, in 0.01 to 2.5 parts by weight, in 0.01 to 1.0 parts by weight, in 0.01 to 0.5 parts by weight, in 0.05 to 4 parts by weight, in 0.05 to 3.5 parts by weight, in 0.05 to 2.5 parts by weight, in 0.05 to 1.0 parts by weight, in 0.05 to 0.5 parts by weight, in 0.1 to 4 parts by weight, in 0.1 to 3.5 parts by weight, in 0.1 to 2.5 parts by weight, in 0.1 to 1.0 parts by weight, and in 0.1 to 0.5 parts by weight. The content of the nicotine activator may be suitably 0.01 to 2.5 parts by weight, more suitably 0.01 to 1.0 parts by weight, and even more suitably 0.01 to 0.5 parts by weight, but may not be limited thereto.

[0048] The binder is decomposed by saliva in an oral cavity to release the nicotine into the oral cavity, and allows the nicotine activator to be molded in a film form. The binder may be hydroxypropylmethylcellulose or hydroxypropylcellulose. The hydroxypropylmethylcellulose may be suitable in terms of moldability, the acceptability, and the intraoral disintegration time when the smokeless tobacco is manufactured as the film, but the present disclosure may not be limited thereto. Therefore, because the composition for the smokeless tobacco does not contain a metharylic acid ethyl acrylate copolymer, problems of lowering of the acceptability and prolonged intraoral disintegration time resulted from the metharylic acid ethyl acrylate may be solved. In addition, unlike in the prior art, the smokeless tobacco may be rapidly disintegrated in the oral cavity even though the smokeless tobacco does not contain an alkaline buffer.

[0049] The binder may be contained in 40 to 80 parts by weight based on the solid weight of the composition for the smokeless tobacco. When the binder is contained in less than 40 parts by weight of the composition for the smokeless tobacco, the moldability may be rapidly deteriorated when the smokeless tobacco is manufactured as the film. In addition, when the binder is contained in excess of 80 parts by weight, the moldability, the acceptability, and the intraoral disintegration degree may be deteriorated when the smokeless tobacco is manufactured as the film, but the present disclosure may not be limited thereto. The binder may be contained, based on the solid weight of the composition for the smokeless tobacco, in 40 to 80 parts by weight, in 40 to 70 parts by weight, in 40 to 60 parts by weight, in 40 to 50 parts by weight, in 50 to 80 parts by weight, in 50 to 70 parts by weight, in 50 to 60 parts by weight, in 60 to 80 parts by weight, and in 60 to 70 parts by weight. The content of the binder may be suitably 40 to 70 parts by weight, and more suitably 40 to 60 parts by weight, but may not be limited thereto.

[0050] At least one type of the plasticizer may be contained in the composition for the smokeless tobacco. The plasticizer may include glycerin, propylene glycol, ethylene glycol, polyethylene glycol, sorbitol, xylitol, maltitol, erythritol, tributhyl citrate, triethyl citrate, triacetin, and glycerol triacetate, but may not be limited thereto.

[0051] The plasticizer may be contained in 2 to 10 parts by weight based on the solid weight of the composition for the smokeless tobacco. When the plasticizer is contained in less than 2 parts by weight based on the solid weight of the composition for the smokeless tobacco, the moldability may be rapidly deteriorated when the smokeless tobacco is manufactured as the film. In addition, when the plasticizer is contained in excess of 10 parts by weight, the moldability, the acceptability, and the intraoral disintegration degree may be deteriorated when the smokeless tobacco is manufactured as the film, but the present disclosure may not be limited thereto. The plasticizer may be contained, based on the solid weight of the composition for the smokeless tobacco, in 2 to 10 parts by weight, in 2 to 7 parts by weight, in 2 to 5 parts by weight, or in 2 to 3 parts by weight. The content of the plasticizer may be suitably 2 to 7 parts by weight, and more suitably 2 to 5 parts by weight, but may not be limited thereto.

[0052] The composition for the smokeless tobacco may contain water as a solvent. Using the water as the solvent instead of an organic solvent such as ethanol and the like may be suitable in terms of the moldability, the acceptability, and the shortening of the disintegration time when the smokeless tobacco is manufactured as the film. Purified water may be used as the water, and may be contained in 180 to 250 parts by weight based on 100 parts by weight of a solid content, but the present disclosure may not be limited thereto.

[0053] The composition for the smokeless tobacco may have a viscosity of 15,0005,000 cps. When the viscosity of the composition for the smokeless tobacco is out of the above range, the moldability may be lowered when the smokeless tobacco is manufactured as the film, but the present disclosure may not be limited thereto.

[0054] The composition for the smokeless tobacco may further contain at least one of a flavor, a surfactant, a sweeting agent, and a coloring agent. These components may improve the acceptability and the moldability of the smokeless tobacco.

[0055] The flavor may improve the acceptability of the smokeless tobacco as a flavoring agent. Although not limited thereto, the flavor may include natural and artificial flavors, and may include, for example, peppermint, spearmint, winter green, menthol, cinnamon, chocolate, vanillin, licorice, clove, anise, sandalwood, geranium, rose oil, vanilla, lemon oil, cassia, fennel, ginger, ethyl acetate, isoamyl acetate, propyl isobutylate, isobutyl butyrate, ethyl butyrate, ethyl valerate, benzyl formate, limonene, cymene, pinene, linalol, geraniol, citronellol, citral, orange oil, coriander oil, borneol, fruit extract, and the like. Although not limited thereto, the flavor may be contained in 0.50 to 5 parts by weight based on the solid weight of the composition for the smokeless tobacco. In an embodiment, L-menthol, peppermint flavor, and peppermint oil were used as the flavors.

[0056] There is no particular limitation as long as the surfactant is able to be used as an edible emulsifier. Although not limited thereto, the surfactant includes glycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, soybean phospholipid, stearyl lactylate, sorbitan oleate, sodium lauryl sulfate, hydrogenated polyoxyethylene castor oil, polyoxyethylene octylphenyl ether, and the like. Although not limited thereto, the surfactant may be contained in 1 to 10 parts by weight based on the solid weight of the composition for the smokeless tobacco. In an embodiment, polysorbate 80 was used as the plasticizer.

[0057] The sweeting agent may include both natural and artificial sweeting agents. Although not limited thereto, the sweeting agent includes a water-soluble sweeting agent such as monosaccharide, disaccharide and polysaccharide (i.e., xylose, ribose, sucrose, maltose, fructose, glucose, maltose, mannose), sucralose, aspartame, sodium saccharin, stevioside, rebaudioside, and thaumatin. Although not limited thereto, the sweeting agent may be contained in 0.001 to 1.0 parts by weight based on the solid weight of the composition for the smokeless tobacco. In an embodiment, the sucralose, the xylitol, the stevioside, and the like were used as the sweeting agents.

[0058] There is no particular limitation as long as the coloring agent is able to be used as a food coloring agent. The coloring agent may include both natural and artificial coloring agents. As limited thereto, the coloring agent may include green No. 3, red No. 2, red No. 3, blue No. 1, blue No. 2, yellow No. 4, and yellow No. 5 as tar-based coloring agents. In addition, -carotene, water-soluble annatto, copper sulfate, ferric oxide, caramel, copper and sodium iron chlorophyllin, titanium oxide, and the like may be included as non-tar-based coloring agents. Although not limited thereto, the coloring agent may be contained in 0.0001 to 1.0 parts by weight based on the solid weight of the composition for the smokeless tobacco. In an embodiment, the blue No. 1 was used as the coloring agent.

[0059] In addition, the composition for the smokeless tobacco may additionally contain at least one type of known diluents.

[0060] Orally Dissolvable Film-Type Smokeless Tobacco

[0061] FIG. 1 is a view showing a packaging state of orally dissolvable film-type smokeless tobacco including a first region according to an embodiment. FIG. 2 is a schematic perspective view of orally dissolvable film-type smokeless tobacco including a first region and a second region according to an embodiment. In addition, FIG. 3 is a view showing a packaging state of orally dissolvable film-type smokeless tobacco including a first region and a second region according to an embodiment.

[0062] As shown in FIG. 1, the orally dissolvable film-type smokeless tobacco may be formed as orally dissolvable film-type smokeless tobacco 1 composed of only a first region. The first region may be formed by coating the composition for the smokeless tobacco containing 0.01 to 4 parts by weight of the nicotine activator; 40 to 80 parts by weight of the binder; 2 to 10 parts by weight of the plasticizer; the flavor, the surfactant, the coloring agent, the sweeting agent, and the diluent. A reference numeral 22 of FIG. 1 denotes a lower packaging material of the smokeless cigarette 1, a reference numeral 24 denotes an upper packaging material of the smokeless cigarette 1, and a numeral 26 denotes an adhesive.

[0063] In addition, as shown in FIG. 2, the smokeless tobacco may be formed as orally dissolvable film-type smokeless tobacco 10 including both a first region 12 and a second region 14. The orally dissolvable film-type smokeless tobacco 10 includes the first region 12 formed by coating the composition for the smokeless tobacco in the film form; and the second region 14 formed by coating a flavor composition, a functional food composition, a beauty treatment composition, a pharmaceutical composition, or a mixture thereof in the film form to be adjacent to the first region.

[0064] That is, the orally dissolvable film-type smokeless tobacco 10 including both the first region 12 and the second region 14 may be formed of the smokeless tobacco composition containing the nicotine activator as the main component in the first region 12, and the second region 14 may be formed of the flavor composition, the functional food composition, the beauty treatment composition, the pharmaceutical composition, or the mixture thereof, excluding the nicotine activator.

[0065] When the second region 14 formed of the flavor composition is further included, the acceptability of the smokeless tobacco may be improved. Although not limited thereto, the flavor composition may contain the plasticizer, the surfactant, the flavor, the coloring agent, the sweeting agent, and the diluent. There is no particular limitation as long as the plasticizer, the surfactant, the flavor, the coloring agent, the sweeting agent, and the diluent are able to improve the acceptability and are suitable for the coating process. A person skilled in the art may appropriately select and use a known material for the flavor composition.

[0066] In addition, when the second region 14 formed of the functional food composition, the beauty treatment composition, or the pharmaceutical composition is further included, the harmfulness to the human body resulted from absorption of the nicotine may be reduced or eliminated. There is no particular limitation as long as the functional food composition, the beauty treatment composition, or the pharmaceutical composition is beneficial to the human body and is suitable for the coating process. A person skilled in the art may appropriately select and use a known functional food composition, such as red ginseng for enhancing immunity with beneficial functionality, vitamin, a nutritional supplement, food good for a bronchial tube and/or a lung. Although not limited thereto, the food good for the bronchial tube and/or the lung may include schisandra, quince, loofah, radish, ginseng, bellflower, pumpkin, pear, persimmon, citron, and the like. The food good for the bronchial tube and/or the lung may help to prevent or alleviate cough, bronchitis, pneumonia, and the like resulted from the absorption of the nicotine. In addition, the beauty treatment or the pharmaceutical composition includes a dental whitening material, a mouthwash, an anticaries compound, an anti-tartar compound, an antioxidant, an anti-inflammatory agent, a pain reliever, an antihistaminic agent, a topical anesthetic, an antibacterial compound, a germicide, an antibiotic, an antiasthmatic agent, and the like.

[0067] Furthermore, the smokeless tobacco 10 may further include one or more additional regions adjacent to the first region 12 or the second region 14. Thus, for example, a smokeless tobacco that is divided into a second region and a third region with different functions may be formed. Only the first region of the smokeless tobacco may be ingested as needed based on the above component, or the second region and/or the third region may be ingested based on the acceptability.

[0068] At least one of the composition for the smokeless tobacco, the flavor composition, the functional food composition, the beauty treatment composition, the pharmaceutical composition, and the mixture thereof may further contain the coloring agent. When the coloring agent is contained as described above, the first region 12 and the second region 14 may be distinguished from each other, so that the first region 12 and the second region 14 of the smokeless tobacco may be selectively ingested. That is, only the first region 12 of the smokeless tobacco may be ingested as needed, or the first region 12 and only a portion of the second region 14 may be ingested based on the acceptability. In addition, when the coloring agent is contained as described above, aesthetics of the smokeless tobacco may be improved.

[0069] The smokeless tobacco may be in a form of a rectangular or elliptical film to properly adjust a disintegration speed while being placed in the oral cavity of the user.

[0070] The smokeless tobacco may have a surface area of 400 to 800 mm.sup.2 and a thickness of 50 to 100 m, but may not be limited thereto. When the surface area and the thickness of the smokeless tobacco are respectively out of the above ranges, the intraoral disintegration speed and the intraoral intake rate may be lowered.

[0071] The smokeless tobacco may have a moisture content of 3 to 5 parts by weight and a pH of 7 to 9, but may not be limited thereto.

[0072] The smokeless tobacco may be substantially completely disintegrated within 5 minutes after being placed in the oral cavity. It may be appropriate that the smokeless tobacco is substantially completely disintegrated within 3 minutes after being placed into the oral cavity, and it may be more appropriate that the smokeless tobacco is substantially completely disintegrated within 2 minutes, but the present disclosure may not be limited thereto. Therefore, the smokeless tobacco may be immediately released so as to quickly meet needs of the user who needs the nicotine.

[0073] The smokeless tobacco may be disintegrated within 5 minutes after being placed into the oral cavity and gradually release the nicotine until about 50 minutes has elapsed to induce sustained release. Accordingly, the smokeless tobacco may satisfy both rapid nicotine craving relief and continuous nicotine craving relief.

[0074] As described above, the orally dissolvable film-type smokeless tobacco may use the composition for the smokeless tobacco containing the nicotine activator of the low dose, so that the absorption of the nicotine may be increased and the intraoral disintegration time may be shortened. In addition, because the smokeless tobacco is in the orally dissolvable film-type, the intraoral intake rate of the nicotine may be improved. The orally dissolvable film-type smokeless tobacco rapidly dissolves in the oral cavity, so that the nicotine at a level substantially equivalent to that of a high-dose smokeless tobacco product may be absorbed through capillaries of oral mucosa. This is because, as described above, even though the nicotine activator is contained in the low dose in the smokeless tobacco, the absorption of the nicotine may become relatively high because of a reaction of the body for maintaining a nicotine content in a blood at a level equal to or above a certain level. In addition, as described above, the smokeless tobacco may satisfy both the rapid nicotine craving relief and the continuous nicotine craving relief

[0075] Method for Manufacturing Orally Dissolvable Film-Type Smokeless Tobacco

[0076] According to an embodiment, the method for manufacturing the orally dissolvable film-type smokeless tobacco includes forming the first region by discharging the composition for the smokeless tobacco in a single dose through a first nozzle and coating the discharged composition on a packaging material; discharging the flavor composition, the functional food composition, the beauty treatment composition, the pharmaceutical composition, or the mixture thereof in a single dose through a second nozzle and coating the same on the packaging material to be adjacent to the first region to form the second region; and drying the first region and the second region.

[0077] The composition for the smokeless tobacco for forming the first region may be prepared, for example, by following processes.

[0078] First, the plasticizer and the surfactant are dissolved in purified water in a first preparation tank.

[0079] The solution in which the plasticizer and the surfactant are dissolved in the first preparation tank is homogenized by optionally adding the flavor, the sweeting agent, and the like thereto.

[0080] Then, the additional flavor (the L-menthol) that was dissolved in purified water in a separate container is optionally added into the first preparation tank to homogenize the solution in the first preparation tank.

[0081] Then, the nicotine oil and the binder, which are the main components, and optionally the additional flavor are added into the first preparation tank to homogenize the solution in the first preparation tank.

[0082] The first preparation tank is depressurized, so that the composition for the smokeless tobacco in the first preparation tank is cooled and degassed to remove air bubbles.

[0083] In addition, the flavor composition for forming the second region may be prepared by following processes.

[0084] First, the plasticizer and the surfactant are dissolved in purified water in a second preparation tank.

[0085] The solution in which the plasticizer and the surfactant are dissolved in the second preparation tank is homogenized by optionally adding the flavor, the coloring agent, the sweeting agent, and the like.

[0086] Then, the flavor (the L-menthol) that was dissolved in purified water in a separate container is optionally added into the second preparation tank to homogenize the solution in the second preparation tank.

[0087] Then, the binder and optionally the additional flavor are added into the second preparation tank to homogenize the solution in the second preparation tank.

[0088] The second preparation tank is depressurized, so that the flavor composition in the second preparation tank is cooled and degassed to remove air bubbles.

[0089] The first region is formed by discharging the composition for the smokeless tobacco prepared above in the single dose through the first nozzle and coating the discharged composition on the packaging material.

[0090] Then, the second region is formed by discharging the flavor composition prepared above in the single dose through the second nozzle and coating the discharged flavor composition on the packaging material to be adjacent to the first region.

[0091] FIG. 3 is a view showing a packaging state of the orally dissolvable film-type smokeless tobacco 10 including the first region 12 and the second region 14 according to an embodiment.

[0092] Referring to FIG. 3, as described above, the coating of the first region 12 and the second region 14 does not require additional slitting and cutting processes because the compositions are discharged in the single dose. In addition, the coating of the first region 12 and the second region 14 is perform on a top face of the lower packaging material 22 and dried, then covered with the upper packaging material 24 after foreign matter inspection is performed, and then is sealed by the adhesive 26 on the packaging material, so that there is no need for a separate storage step and productivity is improved.

[0093] The drying step may be performed at 50 to 90 C. As described above, the entire processes including the drying process are performed at a temperature lower than 100 C., so that process cost may be reduced compared to conventional processes requiring a high-temperature melting process.

[0094] The coating step of the first region 12 and the second region 14 may be performed by an apparatus for manufacturing a multi-column multi-medicine oral dissolving film disclosed in Korean Patent No. 10-1547219 of the present applicant.

[0095] In the method for manufacturing the orally dissolvable film-type smokeless tobacco, the orally dissolvable film-type smokeless tobacco is manufactured by being coated with predetermined size and thickness. Thus, the slitting and cutting processes are unnecessary, so that the processes are simple and the productivity is excellent. Further, in the method for manufacturing the orally dissolvable film-type smokeless tobacco, the orally dissolvable film-type smokeless tobacco is manufactured by being directly coated on the packaging material, so that there is no need to store the semi-finished product separately, thereby solving a problem associated with the semi-finished product storage. In addition, in the method for manufacturing the orally dissolvable film-type smokeless tobacco, the orally dissolvable film-type smokeless tobacco is formed in a single layer and formed in a single process and does not require the extrusion or the high-temperature melting process, so that the number of processes is small and the productivity is excellent.

[0096] Hereinafter, the present disclosure will be described in more detail through examples.

EXAMPLES

Example 1. Manufacture of Film-Type Smokeless Tobacco Based on Nicotine Content

[0097] The glycerin as the plasticizer, the polysorbate 80 as the surfactant, the L-menthol as the flavor, the blue No. 1 as the coloring agent, the sucralose, the peppermint, the xylitol, and the stevia as the sweeting agent, and the diluent were added into the purified water, and stirred to be dissolved or dispersed, and then the solution was homogenized using a homogenizer (PL-HMZ30DN Poong Lim Tech).

[0098] The nicotine oil with various contents and the hydroxypropylmethylcellulose as the binder were added to the solution, and then the solution was homogenized again using the same homogenizer. After gas in the film preparation solution was removed under a vacuum condition, the solution was coated on a pouch, which is the packaging material, with a casting machine to have a size of 22 mm in width and 28 mm in length, and a thickness of about 91 m. Thereafter, the solution was dried for 10 to 20 minutes at a temperature in a range from 50 to 90 C. to manufacture the film-type smokeless tobacco containing the nicotine.

[0099] Acceptability and disintegration degree of the film-type smokeless tobacco manufactured as described above were identified. Table 1 shows acceptability and a disintegration time based on a nicotine content of each of Example 1 and Comparative example 1. Comparative example 1-1 used Niquitin, a smoking aid product of GlaxoSmithKline, with a nicotine content of 25 mg.

TABLE-US-00001 TABLE 1 Comparative Example Mixing Component 1-1 ( Nicotine Example (%) Purpose Name 2.5 mg) 1-1 1-2 1-3 1-4 1-5 1-6 Main Nicotine Oil (%) 0.017 0.084 0.168 0.502 0.833 0.653 Component mg 0.01 0.05 0.1 0.3 0.5 1.0 Binder Polymer 54.207 Plasticizer Plasticizer 2.50 Surfactant Surfactant 3.762 Sweeting Sweeting 18.39 agent agent Flavor Flavor 19.962 Coloring Coloring 0.342 agent agent Supplementary Diluent Material Taste test Effect of 1 4 4 4 4 4 4 taste masking Disintegration Disintegration 1 4 4 4 4 3 3 Time time(sec) Comparative Example Mixing Component 1-1 ( Nicotine Example (%) Comparative Example Purpose Name 2.5 mg) 1-7 1-8 1-2 1-3 1-4 Main Nicotine Oil (%) 2.459 3.252 4.032 7.752 10.526 Component mg 1.5 2.0 2.5 5.0 7.0 Binder Polymer 54.207 Plasticizer Plasticizer 2.50 Surfactant Surfactant 3.762 Sweeting Sweeting 18.395 Agent Agent Flavor Flavor 19.962 Coloring Coloring 0.342 Agent Agent Supplementary Diluent Material Taste Test Effect of 1 4 3 2 2 1 taste masking Disintegration Disintegration 1 3 3 3 3 3 Time time(sec) * taste masking value 1poor Retention time of Bitter, burning effects: 61 min~ 2not good Retention time of Bitter, burning effects: 21~60 min 3not bad Retention time of Bitter, burning effects: 6~20 min 4excellent Retention time of Bitter, burning effects: ~5 min * Disintegration time: This test is performed using Disintegration tester 1poor Retention time of ODF in sinker: 11 min~ 2not good Retention time of ODF in sinker: 8~10 min 3not bad Retention time of ODF in sinker: 2~5 min 4excellent Retention time of ODF in sinker: ~1 min indicates data missing or illegible when filed

Example 2. Manufacture of Film-Type Smokeless Tobacco Based on Binder Type

[0100] In the same manner as in Example 1, the plasticizer, the surfactant, the flavor, the coloring agent, the sweeting agent, and the diluent were added into the purified water, and stirred to be dissolved or dispersed, and then the solution was homogenized using the homogenizer (PL-HMZ30DN Poong Lim Tech).

[0101] The nicotine oil and various types of binders were applied and added to the solution, and then the solution was homogenized again using the same homogenizer. After gas in the film preparation solution was removed under the vacuum condition, the solution was coated on the pouch with the casting machine to have the size of 22 mm in width and 28 mm in length, and the thickness of about 91 m. Thereafter, the solution was dried for 10 to 20 minutes at the temperature in the range from 50 to 90 C. to manufacture the film-type smokeless tobacco containing the nicotine.

[0102] Moldability, acceptability, and disintegration degree of the film-type smokeless tobacco manufactured as described above were identified. Table 2 shows moldability, acceptability, and a disintegration time based on the binder type of each of Example 2 and Comparative example 2.

TABLE-US-00002 TABLE 2 Comparative Mixing Component Example Example Example Example Example Purpose Name 2-1 2-2 2-1 2-3 2-4 Main Nicotine Oil (%) 0.165 Component mg 0.1 Binder 50 40 40 Binder HydroxyPropyl- 10 10 Cellulose Binder HydroxyPropy- 40 50 MethylCellulose Binder Methacrylic Acid 10 Ethyl Acrylate Copolymer Plasticizer Plasticizer 2.50 Surfactant Surfactant 3.762 Sweeting Sweeting 18.395 agent agent Flavor Flavor 19.082 Coloring Coloring 0.342 agent agent Solvent Water Solvent Ethanol Film Filming Fair Fair Fair Good Good Formation Degree Taste Test Effect of 3 3 2 4 4 taste masking Disintegration Disintegration 4 4 3 4 4 Time time(sec) Comparative Mixing Component Example Example Example Example Example Purpose Name 2-5 2-6 2-2 2-7 2-8 Main Nicotine Oil (%) 0.502 Component mg 0.3 Binder 50 40 40 Binder HydroxyPropyl- 10 10 Cellulose Binder HydroxyPropy- 40 50 MethylCellulose Binder Methacrylic Acid 10 Ethyl Acrylate Copolymer Plasticizer Plasticizer 2.50 Surfactant Surfactant 3.762 Sweeting Sweeting 18.395 agent agent Flavor Flavor 19.082 Coloring Coloring 0.342 agent agent Solvent Water Solvent Ethanol Film Filming Fair Fair Fair Good Good Formation Degree Taste Test Effect of 3 3 2 4 4 taste masking Disintegration Disintegration 4 4 3 4 4 Time time(sec) Comparative Mixing Component Example Example Example Example Example Purpose Name 2-9 2-10 2-3 2-11 2-12 Main Nicotine Oil (%) 0.833 Component mg 0.5 Binder 50 40 40 Binder HydroxyPropyl- 10 10 Cellulose Binder HydroxyPropy- 40 60 MethylCellulose Binder Methacrylic Acid 10 Ethyl Acrylate Copolymer Plasticizer Plasticizer 2.50 Surfactant Surfactant 3.762 Sweeting Sweeting 18.395 agent agent Flavor Flavor 19.962 Coloring Coloring 0.342 agent agent Solvent Water Solvent Ethanol Film Filming Fair Fair Fair Good Good Formation Degree Taste Time Effect of 3 3 2 4 4 taste masking Disintegration Disintegration 4 4 3 4 4 Time time(sec) Comparative Mixing Component Example Example Example Example Example Purpose Name 2-13 2-14 2-4 2-15 2-16 Main Nicotine Oil (%) 1.653 Component mg 1.0 Binder 50 40 40 Binder HydroxyPropyl- 10 10 Cellulose Binder HydroxyPropy- 40 60 MethylCellulose Binder Methacrylic Acid 10 Ethyl Acrylate Copolymer Plasticizer Plasticizer 2.50 Surfactant Surfactant 3.762 Sweeting Sweeting 18.395 agent agent Flavor Flavor 19.962 Coloring Coloring 0.342 agent agent Solvent Water Solvent Ethanol Film Filming Fair Fair Fair Good Good Formation Degree Taste Time Effect of 3 3 2 4 4 taste masking Disintegration Disintegration 4 4 3 4 4 Time time(sec) * taste masking value: 1poor Retention time of Bitter, burning effects: 61 min~ 2not good Retention time of Bitter, burning effects: 21~60 min 3not bad Retention time of Bitter, burning effects: 6~20 min 4excellent Retention time of Bitter, burning effects: ~5 min * Disintegration time: This test is performed using Disintegration tester 1poor Retention time of ODF in sinker: 11 min~ 2not good Retention time of ODF in sinker: 8~10 min 3not bad Retention time of ODF in sinker: 2~5 min 4excellent Retention time of ODF in sinker: ~1 min indicates data missing or illegible when filed

Example 3. Manufacture of Film-Type Smokeless Tobacco Based on Binder Content

[0103] In the same manner as in Example 1, the plasticizer, the surfactant, the flavor, the coloring agent, the sweeting agent, and the diluent were added into the purified water, and stirred to be dissolved or dispersed, and then the solution was homogenized using the homogenizer (PL-HMZ30DN Poong Lim Tech).

[0104] The nicotine oil and the hydroxypropylmethylcellulose as the binder were applied and added to the solution in various weight ratios (w/w), and then the solution was homogenized again using the same homogenizer. After gas in the film preparation solution was removed under the vacuum condition, the solution was coated on the pouch with the casting machine to have the size of 22 mm in width and 28 mm in length, and the thickness of about 91 m. Thereafter, the solution was dried for 10 to 20 minutes at the temperature in the range from 50 to 90 C. to manufacture the film-type smokeless tobacco containing the nicotine.

[0105] Moldability, acceptability, and disintegration degree of the film-type smokeless tobacco manufactured as described above were identified. Table 3 shows moldability, acceptability, and a disintegration time based on components and contents of each of Example 3 and Comparative example 3.

TABLE-US-00003 TABLE 3 Comparative Comparative Comparative Comparative Mixing Component Example Example Example Example Example Example Purpose Name 3-1 3-1 3-2 3-3 3-2 3-3 3-4 3-5 3-6 3-4 Binder HydroxyPropyl- 20 40 60 80 90 20 40 60 80 90 Cellulose(%) Main Nicotine Oil 0.1 mg 0.3 mg Component Plasticizer Plasticizer 2 mg Surfactant Surfactant 3 mg Sweeting Sweeting 10 mg agent agent Supplementary Diluent Material Solvent Water 100 mg Film Filming Poor Good Good Fair Poor Poor Good Good Fair Poor Formation Degree Taste Test Effect of 4 4 4 3 2 4 4 4 3 2 taste masking Disintegration Disintegration 4 3 3 2 2 4 3 3 2 2 Time time(sec) Comparative Comparative Comparative Comparative Mixing Component Example Example Example Example Example Example Purpose Name 3-5 3-7 3-8 3-9 3-6 3-7 3-10 3-11 3-12 3-8 Binder HydroxyPropyl- 20 40 60 80 90 20 40 60 80 90 Cellulose(%) Main Nicotine Oil 0.5 mg 1.0 mg Component Plasticizer Plasticizer 2 mg Surfactant Surfactant 3 mg Sweeting Sweeting 10 mg agent agent Supplementary Diluent Material Solvent Water 100 mg Film Filming Poor Good Good Fair Poor Poor Good Good Fair Poor Formation Degree Taste Test Effect of 4 4 4 3 2 4 4 4 3 2 taste masking Disintegration Disintegration 4 3 3 2 2 4 3 3 2 2 Time time(sec) * taste masking value: 1poor Retention time of Bitter, burning effects: 61 min~ 2not good Retention time of Bitter, burning effects: 21~60 min 3not bad Retention time of Bitter, burning effects: 6~20 min 4excellent Retention time of Bitter, burning effects: ~5 min * Disintegration time: This test is performed using Disintegration tester 1poor Retention time of ODF in sinker: 11 min~ 2not good Retention time of ODF in sinker: 8~10 min 3not bad Retention time of ODF in sinker: 2~5 min 4excellent Retention time of ODF in sinker: ~1 min indicates data missing or illegible when filed

Example 4. Manufacture of Parallel Coating Film-Type Smokeless Tobacco Including Nicotine-Containing Film and Flavor-Containing Film

[0106] First Preparation TankPreparing Smokeless Tobacco Composition Containing Main Components

[0107] In the same manner as in Example 1, the plasticizer, the surfactant, the sweeting agent, and the diluent were added into the purified water, and stirred to be dissolved or dispersed, and then the solution was homogenized using the homogenizer (PL-HMZ30DN Poong Lim Tech).

[0108] The nicotine oil and the hydroxypropylmethylcellulose as the binder were applied and added to the solution in the various weight ratios (w/w), and then the solution was homogenized again using the same homogenizer.

[0109] Second Preparation TankPreparing Composition Containing Flavor and Coloring Agent

[0110] In the same manner as in Example 1, the plasticizer, the surfactant, the flavor, the coloring agent, the sweeting agent, and the diluent were added into the purified water, and stirred to be dissolved or dispersed, and then the solution was homogenized using the homogenizer (PL-HMZ30DN Poong Lim Tech). The hydroxypropylmethylcellulose as the binder was applied and added to the solution in the weight ratio (w/w), and then the solution was homogenized again using the same homogenizer.

[0111] Gas in the film preparation solution was removed under the vacuum condition. When the single dose of the nicotine oil is 0.5 mg, the first region and the second region were coated in parallel on the pouch with the casting machine such that each of the first region and the second region has a size of 22 mm in width and 14 mm in length and a thickness of about 91 m. Thereafter, the first region and the second region were dried for 10 to 20 minutes at the temperature in the range from 50 to 90 C. to manufacture the film-type smokeless tobacco containing the nicotine.

[0112] Moldability, acceptability, and disintegration degree of the film-type smokeless tobacco manufactured as described above were identified. Table 4 shows moldability, acceptability, and a disintegration time based on components and contents of each of Examples 4-1 to 4-3 and Comparative example 4-1.

TABLE-US-00004 TABLE 4 Comparative Example Example 4-1 4-2 4-3 4-1 Mixing Component First Second First Second First Second First Second Purpose Name Unit Region Region Region Region Region Region Region Region Main Nicotine Oil mg 0.5 0.5 0.5 0.5 Component Binder HydroxyPropy- % 20 20 40 40 60 60 80 80 MethylCellulose Plasticizer Plasticizer % 2.9 2.6 2.9 2.6 2.9 2.6 2.9 2.6 Surfactant Surfactant % 4.4 4.0 4.4 4.0 4.4 4.0 4.4 4.0 Sweeting Sweeting % 20 20 20 20 20 20 20 20 agent agent Flavor Flavor % 15 15 15 15 Coloring Coloring % 1.0 1.0 1.0 1.0 agent agent Supplementary Diluent Material Solvent Water 100 mg Film Filming Good Good Good Good Good Good Fair Fair Formation Degree Taste Test Effect of 4 4 4 4 4 4 4 4 taste masking Disintegration Disintegration 3 3 3 3 3 3 2 2 Time time(sec) * taste masking value: 1poor Retention time of Bitter, burning effects: 61 min~ 2not good Retention time of Bitter, burning effects: 21~60 min 3not bad Retention time of Bitter, burning effects: 6~20 min 4excellent Retention time of Bitter, burning effects: ~5 min * Disintegration time: This test is performed using Disintegration tester 1poor Retention time of ODF in sinker: 11 min~ 2not good Retention time of ODF in sinker: 6~10 min 3not bad Retention time of ODF in sinker: 2~5 min 4excellent Retention time of ODF in sinker: ~1 min indicates data missing or illegible when filed

Example 5. Manufacture of Parallel Coating Film-Type Smokeless Tobacco Including Nicotine-Containing Film and Flavor and Functional Food Composition-Containing Film

[0113] First Preparation TankPreparing Smokeless Tobacco Composition Containing Main Components

[0114] In the same manner as in Example 1, the plasticizer, the surfactant, the sweeting agent, and the diluent were added into the purified water, and stirred to be dissolved or dispersed, and then the solution was homogenized using the homogenizer (PL-HMZ30DN Poong Lim Tech).

[0115] The nicotine oil and the hydroxypropylmethylcellulose as the binder were applied and added to the solution in the weight ratio (w/w), and then the solution was homogenized again using the same homogenizer.

[0116] Second Preparation TankPreparing Composition Containing Flavor, Coloring Agent, and Functional Food Composition

[0117] In the same manner as in Example 1, the plasticizer, the surfactant, the flavor, the coloring agent, the sweeting agent, and the diluent were added into the purified water, and stirred to be dissolved or dispersed, and then the solution was homogenized using the homogenizer (PL-HMZ30DN Poong Lim Tech). The functional food composition and the hydroxypropylmethylcellulose as the binder were applied and added to the solution in the weight ratio (w/w), and then the solution was homogenized again using the same homogenizer. Red ginseng extract oil (60 brix based on a solid content) having immunity enhancing, anti-cancer, and anti-pneumonia effects, bellflower extract oil (60 brix based on the solid content) having phlegm loosening, blood sugar lowering, and cholesterol lowering effects, or vitamin C was used as the functional food composition.

[0118] Gas in the film preparation solution was removed under the vacuum condition. When the single dose of the nicotine oil is 0.5 mg, the first region and the second region were coated in parallel on the pouch with the casting machine such that each of the first region and the second region has a size of 22 mm in width and 14 mm in length and a thickness of about 91 m. Thereafter, the first region and the second region were dried for 10 to 20 minutes at the temperature in the range from 50 to 90 C. to manufacture the film-type smokeless tobacco containing the nicotine.

[0119] Moldability, acceptability, and disintegration degree of the film-type smokeless tobacco manufactured as described above were identified. Table 5 shows moldability, acceptability, and a disintegration time based on components and contents of each Example 5.

TABLE-US-00005 TABLE 5 Example 5-1 5-2 5-3 Mixing Component First Second First Second First Second Purpose Name Unit Region Region Region Region Region Region Main Nicotine Oil mg 0.5 0.5 0.5 Component Binder HydroxyPropy- % 20 20 40 40 60 60 MethylCellulose Plasticizer Plasticizer % 2.9 2.6 2.9 2.6 2.9 2.6 Surfactant Surfactant % 4.4 4.0 4.4 4.0 4.4 4.0 Sweeting Sweeting % 20 20 20 20 20 20 agent agent functional food fucntional food % Red Bellflower Vitamin 12 Composition & Flavor Ginseng 12 & Flavor 12 Flavor 3 Flavor 3 Flavor 3 Coloring Coloring % 1.0 1.0 1.0 agent agent Supplementary Diluent Material Solvent Water 100 mg Film Filming Good Good Good Good Good Good Formation Degree Taste Test Effect of 4 4 4 4 4 4 taste masking Disintegration Disintegration 3 3 3 3 3 3 Time time(sec) * taste masking value: 1poor Retention time of Bitter, burning effects: 61 min~ 2not good Retention time of Bitter, burning effects: 21~60 min 3not bad Retention time of Bitter, burning effects: 6~20 min 4excellent Retention time of Bitter, burning effects: ~5 min * Disintegration time: This test is performed using Disintegration tester 1poor Retention time of ODF in sinker: 11 min~ 2not good Retention time of ODF in sinker: 6~10 min 3not bad Retention time of ODF in sinker: 2~5 min 4excellent Retention time of ODF in sinker: ~1 min indicates data missing or illegible when filed

Example 6. Disintegration Degree and Nicotine Elution Degree of Film-Type Smokeless Tobacco Based on Nicotine Content

[0120] Disintegration degrees and nicotine elution degrees of Comparative example 1-1 (the Niquitin 2.5 mg (a G S K product)), Example 3-5 (a film-type smokeless tobacco containing 0.5 mg of the nicotine), Example 3-8 (a film-type smokeless tobacco containing 0.3 mg of the nicotine), and Example 4-3 (a parallel coating film-type smokeless tobacco of the nicotine 0.5 mg+a flavor film) are compared to each other and shown in Table 6, Table 7, and FIG. 4. In this connection, a disintegration experiment was performed using a disintegration tester of International Engineering Co., and a result thereof was shown in Table 6. Table 7 and FIG. 4 show a result of a test of nicotine elution by time under a pH 6.8 condition.

TABLE-US-00006 TABLE 6 Evaluation Item Comparative Example 1-1 (Niquitin:Nicotine Example Example Example 0.5 mg) 3-5 3-8 4-3 Disintegration Equal to or 64 6 60 3 70 4 (Water) sec Higher than 600 Disintegration 127 15 81 5 63 4 78 5 (pH 6.8) sec

TABLE-US-00007 TABLE 7 Comparative Example 1-1 (Niquitin:Nicotine Example Example Example Minute 2.5 mg) 3-5 3-8 4-3 0 0 0 0 0 5 81.9 85 88.7 80 10 80.9 86.7 86.2 81.5 15 81.4 87.1 87.5 85.7 30 80.6 86.8 86.1 90.5 45 79.4 88.1 36.9 92.4

[0121] From the above description, those skilled in the art to which the present disclosure belongs will understand that the present disclosure may be implemented in other specific forms without changing the technical idea or essential features. In this regard, it should be understood that the embodiments described above are illustrative in all respects and are not limiting. The scope of the present disclosure should be construed as including the meaning and scope of the claims to be described later rather than the detailed description, and all changes or modified forms derived from the equivalent concepts in the scope of the present disclosure.

REFERENCE NUMERALS

[0122]

TABLE-US-00008 1, 10: smokeless tobacco 12: first region 14: second region 22: lower packaging material 24: upper packaging 26: adhesive material