Filling material for oral pouches and oral pouches containing the same

Abstract

The present invention relates to an oral pouch filler containing an active substance, characterized in that it comprises an excipient containing cellulose and a sugar alcohol, a binder, a pH adjuster, and a flavoring agent, wherein the sugar alcohol contains sorbitol. By using the oral pouch filler, the release rate of the active substance can be adjusted, and the absorption rate of the active substance into the user's body can be adjusted.

Description

Technical Field

[0001] The present invention relates to a filler for an oral pouch and an oral pouch containing the same.

Background Art

[0002] An oral pouch is used in a user's oral cavity for the absorption of an active substance such as nicotine. A pouch-shaped oral use product such as snus is produced by packaging granules in a granular form containing an active substance such as nicotine in an appropriate form using a pouch packaging material. A consumer can place the pouch-shaped product between the gum and the upper lip in the oral cavity and feel a sense of satisfaction due to the transfer of the active substance for a certain period of time. The elution characteristics of such an active substance can be adjusted according to the characteristics of the pouch material as the most core characteristic of the oral product, but can be affected by the formulation and manufacturing method of the filler.

[0003] Therefore, research is required for more effective elution characteristics of active substances such as nicotine from oral pouch fillers.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The present invention provides a filler for an oral pouch with improved elution characteristics of an active substance such as nicotine, and provides a filler for an oral pouch in which the types and addition ratios of sugar alcohols that can delay the release of the active substance are specified, limited to sugar alcohols among the components of the bulking agent contained in the filler.

[0005] However, the problems to be solved by the present invention are not limited to those mentioned above, and for other problems not mentioned, those skilled in the art will clearly understand them from the following description.

Means for Solving the Problems

[0006] According to one embodiment of the present invention, there is an oral pouch filler containing an active substance, comprising an excipient containing cellulose and a sugar alcohol, a binder, a pH adjuster, and a flavoring agent, wherein the sugar alcohol contains sorbitol.

[0007] According to one embodiment of the present invention, an oral pouch is provided that includes an oral pouch filler and a packaging material surrounding the filler. [Effects of the Invention]

[0008] By using an oral pouch filler according to one embodiment of the present invention, the release rate of active substances such as nicotine can be appropriately adjusted (specifically, nicotine release delay) and the rate of absorption of the active substance into the user's body can be adjusted, thereby providing the user with a smoking satisfaction.

[0009] The effects of the present invention are not limited to those described above, but should be understood to include all effects that can be inferred from the detailed description of the present invention or the configuration of the invention as described in the claims. [Brief explanation of the drawing]

[0010] [Figure 1] This figure shows a cumulative nicotine leaching graph over time for each oral pouch according to one embodiment of the present invention. [Figure 2] This figure shows a graph of nicotine leaching over time for each oral pouch according to one embodiment of the present invention. [Figure 3] This figure shows the dissolution rate of an oral pouch based on its microcrystalline cellulose content according to one embodiment of the present invention. [Modes for carrying out the invention]

[0011] The embodiments will be described in detail below with reference to the attached drawings. However, various modifications can be made to the embodiments, and the scope of the patent application is not limited or restricted by these embodiments. All modifications, equivalents, or substitutes to the embodiments should be understood to be included in the scope of the patent.

[0012] The terms used in the embodiments are for illustrative purposes only and should not be construed as limiting. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, terms such as “includes” or “has” should be understood as specifying the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, and not as preemptively excluding the presence or possibility of adding one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0013] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as those generally understood by a person of ordinary skill in the art to which the embodiments belong. Terms defined in commonly used dictionaries, for example, should be interpreted as having the meaning they have in the context of the relevant art, and not as having an ideal or overly formal meaning unless explicitly defined herein.

[0014] Furthermore, when explaining with reference to the attached drawings, the same reference numerals will be used for identical components, regardless of the reference numerals in the drawings, and redundant explanations will be omitted. When describing embodiments, if it is determined that a specific explanation of related prior art may unnecessarily obscure the gist of the embodiment, such detailed explanation will be omitted.

[0015] Furthermore, when describing the components of the embodiment, terms such as first, second, A, B, (a), (b), etc., may be used. These terms are used to distinguish a component from other components, and the terms do not limit the nature, order, or sequence of the component.

[0016] Components that have functions common to components included in any embodiment will be described using the same name in other embodiments. Unless otherwise stated, descriptions in any embodiment are applicable to other embodiments, and specific descriptions will be omitted to the extent that they overlap.

[0017] When a part of the specification is said to "include" a certain component, this does not mean that it excludes other components, but rather that it may further include other components.

[0018] According to one embodiment of the present invention, an oral pouch filler containing an active substance is provided, comprising an excipient containing cellulose and a sugar alcohol, a binder, a pH adjuster, and a flavoring agent, wherein the sugar alcohol contains sorbitol.

[0019] An oral pouch filler according to one embodiment of the present invention, by including the above-described configuration, can achieve desirable elution characteristics for the active substance present in the pouch.

[0020] The effective dissolution characteristics of pouch-type products mean that, from the consumer's perspective, rapid recognition or satisfaction due to the dissolution of the active substance during use is necessary, and at the same time, all of the applied active substance must be dissolved within a certain time. For example, in the case of a mini-sized pouch product, the size is 30mm x 12mm and the amount is at the 0.3-0.5g level, and it is preferable that the active substance dissolves within a usage time of approximately 20 minutes.

[0021] An oral pouch filler according to one embodiment of the present invention may contain, along with the active substance, excipients, a binder, a pH adjuster, and a flavoring agent.

[0022] The active substance is a substance that can be absorbed through the oral mucosa, gums, etc. Specifically, it may include nicotine, vitamins, caffeine, amino acids, salts and derivatives thereof, etc. Preferably, it may include nicotine and nicotine salts. The nicotine may be synthetic nicotine and / or a nicotine extract of tobacco plants. The type of the nicotine salt is not limited, and examples thereof include nicotine salt benzoate, nicotine salt tartrate, nicotine salt malate, nicotine salt salicylate, etc.

[0023] Particularly, when applying a nicotine derivative or the like as the active substance, in order to create a basic environment during product use to generate free nicotine, a pH adjuster can be applied, and the pH of the filler for the oral pouch can be specifically adjusted to 7-9 through the pH adjuster. Specific examples of the pH adjuster include metal hydroxides such as sodium hydroxide and potassium hydroxide, metal carbonates such as sodium carbonate and potassium carbonate, sodium hydrogen carbonate, sesquicarbonate of sodium (Na3H(CO3)2), etc. Particularly, it is preferable that the pH adjuster is added so that the pH of the filler is at the level of 8.3-8.5 for effective nicotine absorption. Thus, the pH adjuster includes sodium hydrogen carbonate and sodium carbonate, and the ratio thereof is preferably 7:3-6:4.

[0024] The excipient can include cellulose, sugar alcohol, non-tobacco plant materials, etc. In one embodiment of the present invention, the excipient includes cellulose and sugar alcohol. The cellulose can serve as a carrier for active substances such as nicotine, and further as a diluent, having a high water holding capacity, promoting the wetting of the powder mixture through swelling and wicking, and playing a role in quickly releasing saliva and nicotine. Moreover, cellulose provides a sense of use. Without the addition of cellulose, the filling agent for the oral pouch may dissolve.

[0025] The cellulose includes microcrystalline cellulose, cellulose, cellulose derivatives, etc. Specific examples thereof include Microcrystalline cellulose (MCC), methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, etc.

[0026] More specifically, the cellulose includes microcrystalline cellulose, and the content of the microcrystalline cellulose is 1 to 2 times the content of active substances such as nicotine, and can only contain 5 to 20% by weight of the solid content of the filler. When the content of cellulose is less than the above numerical range, it cannot properly play the role of a carrier for substances such as nicotine, and the filling agent for the oral pouch may dissolve in a short time. On the other hand, when the content of cellulose exceeds the above numerical range, the nicotine dissolution rate may be excessively delayed due to the water-insoluble characteristics of cellulose.

[0027] On the other hand, sugar alcohol dissolves well in saliva and binds to the solvent more gently than cellulose. Therefore, nicotine release can be controlled within the usage time, bitterness can be suppressed, and a cooling effect can be provided when dissolved in the mouth. In addition, sugar alcohol can promote the formation of nuclei and the growth of granules in the high-shear wet granulation process of the filling agent for the oral pouch.

[0028] The sugar alcohol content may be 50 to 70% by weight, preferably 60 to 70% by weight, relative to the total solid contents of the oral pouch filler. If the sugar alcohol content is below the above range, the nuclei of the oral pouch filler particles may not be sufficiently formed. On the other hand, if the sugar alcohol content exceeds the above range, clumping may become severe or powder clumps may occur, making it difficult to manufacture the oral pouch filler.

[0029] In one embodiment of the present invention, considering the effect of delaying the nicotine release rate, the sugar alcohol preferably contains sorbitol, and it is more preferable for the sorbitol to be present in an effective amount of 50% by weight or more relative to the total sugar alcohol. In addition to sorbitol, the sugar alcohol may further contain isomalt, erythritol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, and the like. Furthermore, the non-tobacco plant material is not particularly limited and can be described as coconut shell, vegetable fiber, tea, herbs, coffee, or fruit.

[0030] The binder may contain one or more selected from the group consisting of hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone (PVP), sodium alginate, xanthan gum, guar gum, gellan gum, and gum arabic, and its usage volume may be 10% by weight or less, preferably 5 to 8% by weight, relative to the filler.

[0031] The aforementioned flavorings are also called "flavoring agents" and refer to any aromatic substances that can alter the sensory characteristics associated with an oral product. Flavorings may be natural or synthetic, and may include, but are not limited to, vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, and strawberry.

[0032] Furthermore, the oral pouch filler according to one embodiment of the present invention may contain not only the above-mentioned composition, but also sweeteners, humectants, antioxidants, preservatives, etc., depending on the intended use and as needed.

[0033] The aforementioned sweeteners may be natural or artificial sweeteners, and specific examples include, but are not limited to, fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, sucralose, isomaltose, maltodextrin, saccharin, and aspartame.

[0034] The aforementioned humectant may, for example, include at least one of glycerin and propylene glycol.

[0035] According to one embodiment of the present invention, an oral pouch can be provided that includes an oral pouch filler and packaging material surrounding the filler, as described in detail above.

[0036] The aforementioned oral pouch packaging material is safe for the human body, can effectively retain saliva, has a certain strength to prevent tearing, and has sealing properties. The material of the oral pouch packaging material may be a nonwoven type or a woven type, preferably a nonwoven type. Unlike the woven type, the nonwoven type has intertwined fibers, so there is no directionality between the warp and weft, and the cut edges may not unravel.

[0037] The aforementioned oral pouch packaging material may specifically include cellulose fibers and thermoplastic material fibers.

[0038] In this case, the cellulose fiber may include not only cellulose but also cellulosophical fibers, and the cellulosophical fiber may include at least one of natural cellulosophical fibers or artificial cellulosophical fibers.

[0039] Furthermore, the natural cellulosic fibers may include at least one selected from the group consisting of seed hair fibers, bast fibers, leaf fibers, and wood fibers (pulp). Examples of seed hair fibers may include cotton, bombax cotton, and kapok. Examples of bast fibers may include hemp, flax, jute, ramie, paper mulberry, and mitsumata. Examples of leaf fibers may include Manila hemp and New Zealand hemp. Depending on the type and characteristics of the wood, the wood fibers (pulp) may include at least one softwood pulp or hardwood pulp, and examples may include coniferous tree fibers and hardwood tree fibers.

[0040] Artificial cellulose fibers may include at least one of regenerated cellulose fibers or semi-synthetic fibers. Examples of regenerated cellulose fibers may include viscose, rayon, and polynosic. Examples of semi-synthetic fibers may include acetate rayon. Rayon may include not only rayon but also rayon-based fibers that complement the shortcomings of rayon. Examples of rayon-based fibers may include Tencel, lyocell, and modal.

[0041] On the other hand, the thermoplastic fiber may include at least one selected from the group consisting of nylon, polyethylene, polylactic acid, polypropylene, polyethersulfone, and polyethylene terephthalate, and by including the thermoplastic fiber, the oral pouch packaging material may be heat-sealable.

[0042] The present invention will be described in more detail below with reference to embodiments, but the present invention is not limited to the embodiments described below.

[0043] 1. Example 1: Experimental evaluation based on the type and content of sugar alcohols

[0044] (1) Manufacturing Example 1-1: Manufacturing of Filling for Oral Pouches

[0045] Example 1-1: Nicotine, excipients (microcrystalline cellulose, maltitol), binder, pH adjuster, and flavoring were first mixed, and then an oral pouch filler was produced by spraying water alone, water + alcohol, or alcohol alone as a solvent, and proceeding through a granulation step. At this time, the content of microcrystalline cellulose (MCC) and maltitol was 25% by weight and 50% by weight of maltitol, respectively, based on the total solid contents of the oral pouch filler.

[0046] Example 1-2: A filler was prepared in the same manner as in Example 1-1, except that the excipient consisted of 25% by weight of MCC, 25% by weight of maltitol, and 25% by weight of sorbitol relative to the solid content.

[0047] Example 1-3: A filler was prepared in the same manner as in Example 1-1, except that the excipient consisted of 25% by weight of microcrystalline cellulose (MCC) and 50% by weight of sorbitol relative to the solid content.

[0048] (2) Experimental Example 1-1: Physical property analysis of oral pouches

[0049] Prior to this, the total nicotine content, pH, average particle size, and moisture content of the pouches of Examples 1-1 to 1-3, which were manufactured in Production Example 1-1, were analyzed, and the results are shown in Table 1 below.

[0050] [Table 1]

[0051] (3) Experimental Example 1-2: Evaluation of Nicotine Dissolution Characteristics

[0052] For the oral pouches of Examples 1-1 to 1-3 produced in Manufacturing Example 1-1, the average nicotine content and cumulative nicotine content were measured over time periods. The results are shown in Table 2 below.

[0053] [Table 2]

[0054] (4) Experimental Examples 1-3: Sensory evaluation of oral pouches

[0055] For the oral pouches of Examples 1-1 to 1-3 manufactured in the above-mentioned Manufacturing Example 1-1, a sensory evaluation was conducted on our own panel of participants using the oral pouches for 30 minutes, followed by a 1-hour break. The results are shown in Table 3 below.

[0056] [Table 3]

[0057] 2. Example 2: Nicotine elution rate based on microcrystalline cellulose content

[0058] (1) Manufacturing Example 2-1: Manufacturing of oral pouch filler

[0059] Example 2-1: Nicotine, microcrystalline cellulose, maltitol, binder, pH adjuster, and flavoring were first mixed, and then a solvent, either water alone, water + alcohol, or alcohol alone, was sprayed to produce an oral pouch filler through a granulation step. At this time, the binder was hydroxypropyl cellulose, and the microcrystalline cellulose content was 20% by weight relative to the total solid contents of the oral pouch filler.

[0060] Example 2-2: This product was prepared in the same manner as in Example 2-1, except that the microcrystalline cellulose content was 25% by weight.

[0061] Comparative Example 2-1: This was prepared in the same manner as in Example 2-1, except that the microcrystalline cellulose content was 40% by weight.

[0062] Comparative Example 2-2: This was manufactured in the same manner as in Example 2-1, except that the microcrystalline cellulose content was 55% by weight.

[0063] (2) Experimental Example 2-1: Evaluation of Nicotine Dissolution Characteristics

[0064] The nicotine elution rates of Examples 2-1 to 2-2 and Comparative Examples 2-1 to 2-2 were analyzed. Nicotine elution rates were evaluated by using a USP paddle apparatus to allow the examples and comparative examples to stand for 1 minute in 1 liter of phosphate buffer maintained at 37°C and pH 7.4, and then measuring the amount of nicotine released. The results are shown in Figure 3 and Table 4.

[0065] [Table 4]

[0066] In Example 2-1, 90% of the added nicotine content was released after the initial 1 minute, and the dissolution rate after the initial 4 minutes was 17.5%, showing the highest dissolution rate. In Example 2-2, the dissolution rate after the initial 4 minutes was 16.1%, showing the second highest result. However, as the microcrystalline cellulose content increased, the dissolution rate after the initial 4 minutes tended to decrease sharply due to the water-insoluble properties of microcrystalline cellulose (Comparative Examples 2-1 to 2-2).

[0067] 3. Example 3: Nicotine elution rate by sugar alcohol addition

[0068] (1) Manufacturing Example 3-1: Manufacturing of oral pouch filler

[0069] Example 3-1: An oral pouch filler was manufactured in a manner similar to Example 2-1, in which case the maltitol content was 70% by weight relative to the total solid contents weight of the oral pouch filler, and the microcrystalline cellulose content was 5% by weight relative to the total solid contents weight.

[0070] Example 3-2: This product was manufactured in the same manner as in Example 3-1, except that the maltitol content was 55% by weight relative to the total solids weight, resulting in a microcrystalline cellulose content of 20% by weight relative to the total solids weight.

[0071] (2) Experimental Example 3-1: Evaluation of Nicotine Dissolution Characteristics

[0072] The nicotine dissolution rates of Examples 3-1 and 3-2 were analyzed. The nicotine dissolution rates were evaluated using the same method as in the previously described experimental examples.

[0073] As a result, Example 3-1 showed a nicotine elution rate of 20% after the initial 4 minutes and 80% after 20 minutes, while Example 3-2 showed a nicotine elution rate of 14% after the initial 4 minutes and 51.6% after 20 minutes. This is judged to be because, as the microcrystalline cellulose content increases, the elution rates after the initial 4 minutes and 20 minutes decrease due to the water-insoluble properties of microcrystalline cellulose.

[0074] 4. Example 4: Particle size distribution and nicotine elution rate depending on binder type

[0075] (1) Manufacturing Example 4-1: Manufacturing of oral pouch filler

[0076] Example 4-1: After primary mixing of nicotine, microcrystalline cellulose, maltitol, binder, pH adjuster, and flavoring, an oral pouch filler was produced by spraying water alone, water + alcohol, or alcohol alone as a solvent, and then proceeding through a granulation step.

[0077] The binder was hydroxypropyl cellulose, and its content was 8% by weight relative to the total weight of the filler.

[0078] Example 4-2: This was manufactured in the same manner as in Example 4-1, except that povidone K-25 was used as the binder.

[0079] Example 4-3: This product was prepared in the same manner as in Example 4-1, except that low-substituted hydroxypropyl cellulose was used as the binder.

[0080] (2) Experimental Example 4-1: Evaluation of Nicotine Dissolution Characteristics

[0081] The nicotine elution rates of Examples 3-1 and 4-1 to 4-3 were analyzed. The nicotine elution rates were evaluated using the same method as in the previously described experimental examples. The results are shown in Table 5 below.

[0082] [Table 5]

[0083] In Examples 3-1 and 4-1, 66.7% or more of the oral pouch filler particles were 200 μm or larger, and no oral pouch filler particles were present that were 50 μm or smaller. Compared to Examples 4-2 and 4-3, Examples 3-1 and 4-1 showed a higher nicotine elution rate not only initially but also after 20 minutes.

[0084] 5. Example 5: Free base nicotine production ratio based on pH range and pH adjusting agent ratio

[0085] (1) Manufacturing Example 5-1: Manufacturing of oral pouch filler

[0086] Example 5-1: The oral pouch filling material contained a pH adjuster, and sodium bicarbonate and sodium carbonate were used as the pH adjuster in a ratio of 6:4.

[0087] Example 5-2: This product was prepared in the same manner as in Example 5-1, except that sodium bicarbonate and sodium carbonate were used as pH adjusters in a ratio of 7:3.

[0088] Comparative Example 5-1: This product was prepared in the same manner as in Example 5-1, except that sodium bicarbonate and sodium carbonate were used as pH adjusters in an 8:2 ratio.

[0089] 2. Experimental Example 5-1: Evaluation of Nicotine Dissolution Characteristics

[0090] The pH and free base nicotine generation ratio of the oral pouch fillers in Examples 5-1, 5-2, and Comparative Example 5-1 were investigated, and the results are shown in Table 6.

[0091] [Table 6]

[0092] Unlike Comparative Example 5-1, Examples 5-1 and 5-2 showed saliva pH values ​​of 8.8 and 8.4, respectively, and a free base nicotine production rate of 76% or higher. This confirms that when saliva with a pH of 6.5-7.7 flows in, the pH rises to 8.02 or higher, resulting in the production of more free base nicotine.

[0093] As described above, the embodiments have been illustrated with limited drawings, but a person with ordinary skill in the art can apply various technical modifications and variations based on the above. For example, the described techniques may be performed in a different order than described, and / or the components of the described systems, structures, devices, circuits, etc. may be combined or assembled in a different manner than described, or substituted or replaced by other components or equivalents, and still achieve the desired results.

[0094] Therefore, other implementations, other embodiments, and those equivalent to the claims described below also fall within the scope of the claims.

Claims

1. An oral pouch filler containing an active substance, Excipients containing cellulose and sugar alcohols, Binder, pH adjusters, and Contains flavorings, The aforementioned sugar alcohol is characterized by containing sorbitol, and is a filler for oral pouches.

2. The filler for oral pouches according to claim 1, wherein the sorbitol is present in an amount of 50% by weight or more relative to the total sugar alcohol.

3. The oral pouch filler according to claim 1, wherein the active substance comprises one or more selected from the group consisting of nicotine, vitamins, caffeine, salts thereof, and derivatives thereof.

4. The cellulose comprises one or more selected from the group consisting of microcrystalline cellulose (MCC), methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, and carboxymethylcellulose. The oral pouch filler according to claim 1, wherein the sugar alcohol comprises, in addition to sorbitol, one or more selected from the group consisting of isomalt, erythritol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, and lactitol.

5. The cellulose mentioned above includes microcrystalline cellulose. The oral pouch filler according to claim 1, wherein the content of the microcrystalline cellulose is 1 to 2 times the nicotine content and is 5 to 20% by weight relative to the total solid contents of the oral pouch filler.

6. The filler for oral pouches according to claim 1, wherein the binder comprises one or more selected from the group consisting of hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone (PVP), sodium alginate, xanthan gum, guar gum, gellan gum, and gum arabic.

7. The binder comprises hydroxypropyl cellulose (HPC), The oral pouch filler according to claim 1, wherein the content of hydroxypropyl cellulose (HPC) is 5 to 8% by weight relative to the filler.

8. The pH adjusting agents include sodium hydroxide, potassium hydroxide, sodium carbonate, potassium carbonate, sodium bicarbonate, and sodium sesquicarbonate (Na ３ H(CO) ３ ) ２ The oral pouch filler according to claim 1, comprising one or more selected from the group consisting of ).

9. The pH adjusting agent comprises sodium bicarbonate and sodium carbonate. The sodium bicarbonate and sodium carbonate are contained in a weight ratio of 7:3 to 6:

4. The oral pouch filler according to claim 8, wherein the pH of the oral pouch filler is 8.3 to 8.

5.

10. The oral pouch filler according to claim 1, wherein the flavoring comprises one or more selected from the group consisting of vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, and strawberry.

11. The oral pouch filler according to claim 1, further comprising one or more of a sweetener, a humectant, an antioxidant, and a preservative.

12. An oral pouch comprising an oral pouch filler as described in claim 1 and packaging material surrounding the oral pouch filler.

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