Buccal product

Abstract

The invention relates to an oral product. The device comprises at least one porous medium and an active solution, wherein the active solution is adsorbed on the porous medium; the active solution comprises a solvent, an active substance and a polymer base material. In the buccal product, the porous medium is used as a carrier to adsorb the active solution. A porous medium is used as a carrier of the active solution, so that a relatively good slow-release effect of the active solution can be realized. And the release position of the active solution can be controlled by moving the porous medium. Furthermore, the release rate of the active solution can be actively adjusted through chewing and extrusion during use, and the controllability of the slow release effect of the buccal product is relatively good.

Description

Technical Field

[0001] The present application relates to the technical field of oral products, and in particular to an oral product. Background Art

[0002] Nicotine products on the market include nicotine oral dissolving film, nicotine bag etc. Traditional nicotine oral dissolving film is unable to move after being placed in a specific position in the oral cavity due to the strong viscosity of the oral dissolving film in use, and can only be released at a fixed point. And there will be a problem of too fast local release rate in the fitting part of the oral dissolving film and the oral cavity, and the controllability of its sustained release effect is poor, which can cause local transitional stimulation. In traditional nicotine bag, nicotine products are powder and granular, and the controllability of its sustained release effect is also poor. Summary of the invention

[0003] Based on this, it is necessary to provide an oral product. The oral product of the present application has good controllability of sustained release effect.

[0004] The present application provides an oral product, comprising at least one porous medium and an active solution, wherein the active solution is adsorbed on the porous medium; the active solution comprises a solvent, an active substance and a polymer matrix.

[0005] In some embodiments, the porosity of the porous medium is 93% to 99%.

[0006] In some embodiments, the density of the porous medium is 0.05 g / cm 3 ~0.075g / cm 3 .

[0007] In some embodiments, the material of the porous medium includes at least one of polyamide and polyethylene terephthalate and at least includes polyethylene terephthalate.

[0008] In some embodiments, the polymer substrate includes at least one of hydroxypropyl methylcellulose, hydroxypropyl cellulose, ethyl cellulose, polyethylene glycol, pectin, gum arabic, gelatin and starch and at least includes hydroxypropyl methylcellulose.

[0009] In some embodiments, the active substance includes at least one of nicotine and a nicotine derivative.

[0010] In some embodiments, the active solution includes 1 to 10 parts of active material and 10 to 80 parts of polymer matrix, measured by weight.

[0011] In some embodiments, the active solution further comprises 5 to 20 parts of a sweetener.

[0012] In some embodiments, the sweetener includes at least one of xylitol, sorbitol, mannitol, iglesia, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, cyclamate, alitame, steviol glycosides, arabitol and monk fruit sweetener.

[0013] In some embodiments, the active solution further comprises 0.5 to 1 part of a pH adjuster.

[0014] In some embodiments, the active solution further comprises 1 to 3 parts of edible flavor.

[0015] In some embodiments, the active solution further comprises 0.5 to 1 part of a preservative.

[0016] In some embodiments, the pH adjuster includes at least one of malic acid, tartaric acid, fumaric acid, citric acid, carbonate, phosphate and bicarbonate.

[0017] In some embodiments, the preservative includes at least one of ethylparaben, benzoic acid, benzoate, sorbic acid, sorbate, calcium propionate, sodium diacetate, sodium lactate, propylparaben and sodium dehydroacetate.

[0018] In some embodiments, the oral product further comprises a non-woven bag, and the porous medium adsorbed with the active solution is placed inside the non-woven bag.

[0019] In some embodiments, the number of the porous media is at least two.

[0020] In the above-mentioned oral product, the active solution is adsorbed by a porous medium as a carrier. Using a porous medium as a carrier of the active solution can achieve a good sustained release effect of the active solution. The release position of the active solution can also be controlled by moving the porous medium. Furthermore, during use, the release rate of the active solution can be actively adjusted by chewing and squeezing, and the sustained release effect of the oral product of the present application is well controllable. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 Schematic diagram of the dissolution curve of the oral preparation in each embodiment of the present application. DETAILED DESCRIPTION

[0022] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which the present application belongs. The terms used herein in the specification of the present application are only for the purpose of describing specific embodiments and are not intended to limit the present application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0024] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0025] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, "plurality" means at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0026] In this application, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0027] An embodiment of the present application provides an oral product, comprising at least one porous medium and an active solution, wherein the active solution is adsorbed on the porous medium; the active solution comprises a solvent, an active substance and a polymer matrix.

[0028] In the above-mentioned oral product, the active solution is adsorbed by a porous medium as a carrier. Using a porous medium as a carrier of the active solution can achieve a good sustained release effect of the active solution. The release position of the active solution can also be controlled by moving the porous medium. Furthermore, during use, the release rate of the active solution can be actively adjusted by chewing and squeezing, and the sustained release effect of the oral product of the present application is well controllable.

[0029] Furthermore, when the active substance is nicotine or a nicotine derivative, the oral product of the present application may be an oral nicotine product. By moving the porous medium to control the release position of the active solution, local excessive stimulation in the oral cavity caused by nicotine can be avoided. At the same time, the porous medium has a certain water-locking function, which can lock part of the saliva and reduce the burning sensation caused by nicotine.

[0030] In some embodiments, the porosity of the porous medium is 93% to 99%.

[0031] Optionally, the porosity of the porous medium is 93%, 93.5%, 94%, 94.5%, 95%, 95.5%, 96%, 96.5%, 97%, 97.5%, 98%, 98.5% or 99%, or, the porosity of the porous medium may be within a range between any two of the above porosities.

[0032] In some embodiments, the density of the porous medium is 0.05 g / cm 3 ~0.075g / cm 3 .

[0033] Optionally, the density of the porous medium is 0.05 g / cm 3 , 0.052g / cm 3 , 0.055g / cm 3 , 0.058g / cm 3 , 0.06g / cm 3 , 0.062g / cm 3 , 0.065g / cm 3 , 0.068g / cm 3 , 0.07g / cm 3 , 0.072g / cm 3 or 0.075g / cm 3 Alternatively, the density of the porous medium may also be within the range between any two of the above densities.

[0034] The porous medium with the above parameters can achieve a better adsorption effect of the active solution, and at the same time facilitate active adjustment of the release rate of the active solution through chewing and squeezing, so as to achieve better controllability of the sustained release effect of the active solution.

[0035] In some embodiments, the porous medium includes oil storage cotton.

[0036] In some embodiments, the material of the porous medium includes at least one of polyamide and polyethylene terephthalate and at least includes polyethylene terephthalate.

[0037] In some embodiments, the polymer matrix includes at least one of hydroxypropyl methylcellulose, hydroxypropyl cellulose, ethyl cellulose, polyethylene glycol, pectin, gum arabic, gelatin and starch and includes at least hydroxypropyl methylcellulose.

[0038] It is understood that the polymer matrix can play the role of sustained release, filling and film-forming to achieve a better sustained release effect of the active substance. The solvent includes water. Among the above polymer matrix, hydroxypropyl methylcellulose can play a better sustained release effect of the active substance.

[0039] In some embodiments, the active substance includes at least one of nicotine and a nicotine derivative.

[0040] It is understood that the nicotine derivative can be a nicotine salt, nicotine containing a substituent, or a nicotine salt containing a substituent. Exemplarily, the nicotine containing a substituent can be hexamethyl nicotine, and the nicotine salt containing a substituent can be hexamethyl nicotine salt.

[0041] In some embodiments, the active substance may also include other substances with medical properties such as cannabidiol (CBD), or substances with other specific properties, such as caffeine, capsaicin, etc., to meet the needs of different users.

[0042] In some embodiments, the nicotine salt includes one or more of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulfate and nicotine benzoate.

[0043] In some embodiments, the content of the active substance in the oral preparation does not exceed 8 mg / unit.

[0044] It is understood that mg / unit refers to the content of active substances in a single oral product. For example, if the oral product of the present application is made into a bagged product, the content of active substances in the oral product does not exceed 8 mg / bag. Optionally, the content of active substances in the oral product is 7 mg / unit, 6 mg / unit, 5 mg / unit, 4 mg / unit, 3 mg / unit or 2 mg / unit, or the content of active substances in the oral product can also be within the range between any two of the above contents.

[0045] In some of the embodiments, the content of the active substance in the oral preparation is 0.25% to 10% by mass.

[0046] Optionally, the content of active substance in the oral preparation is 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10% by mass, or, measured by mass, the content of active substance in the oral preparation can also be within the range between any two of the above mass percentages.

[0047] In some embodiments, the active solution includes 1 to 10 parts of active material and 10 to 80 parts of polymer matrix, measured by weight.

[0048] Optionally, the mass fraction of the active substance in the active solution is 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts or 10 parts, or, the mass fraction of the active substance in the active solution can also be within the range between any two of the above appropriate fractions.

[0049] Optionally, the mass fraction of the polymer substrate in the active solution is 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts, 55 parts, 60 parts, 65 parts, 70 parts, 75 parts or 80 parts, or, the mass fraction of the polymer substrate in the active solution can also be within the range between any two of the above mass fractions.

[0050] In some embodiments, the active solution further comprises 5 to 20 parts of a sweetener.

[0051] Sweeteners can provide sweetness to the oral product. Optionally, the mass fraction of the sweetener in the active solution is 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts or 20 parts, or the mass fraction of the sweetener in the active solution can also be within the range between any two of the above mass fractions.

[0052] In some embodiments, the sweetener includes at least one of xylitol, sorbitol, mannitol, igloo, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, cyclamate, alitame, steviol glycosides, arabitol and monk fruit sweetener.

[0053] In some embodiments, the active solution further comprises 0.5 to 1 part of a pH adjuster.

[0054] Optionally, the mass fraction of the pH adjuster in the active solution is 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part or 1 part, or the mass fraction of the pH adjuster in the active solution may also be within the range between any two of the above mass fractions.

[0055] In some embodiments, the pH adjuster includes at least one of malic acid, tartaric acid, fumaric acid, citric acid, carbonates, phosphates, and bicarbonates.

[0056] In some embodiments, the pH value of the active solution is 4-9.

[0057] Optionally, the pH value of the active solution is 4, 5, 6, 7, 8 or 9, or the pH value of the active solution may also be within the range between any two of the above pH values.

[0058] In some embodiments, the active solution further comprises 1 to 3 parts of edible flavor.

[0059] Optionally, the mass fraction of the edible flavor in the active solution is 1 part, 1.2 parts, 1.4 parts, 1.6 parts, 1.8 parts, 2 parts, 2.2 parts, 2.4 parts, 2.6 parts, 2.8 parts or 3 parts, or, the mass fraction of the edible flavor in the active solution can also be within the range between any two of the above mass fractions.

[0060] In some embodiments, the active solution further comprises 0.5 to 1 part of a preservative.

[0061] Optionally, the mass fraction of the preservative in the active solution is 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part or 1 part, or the mass fraction of the preservative in the active solution may also be within the range between any two of the above mass fractions.

[0062] In some embodiments, the preservative includes at least one of ethylparaben, benzoic acid, benzoate, sorbic acid, sorbate, calcium propionate, sodium diacetate, sodium lactate, propylparaben and sodium dehydroacetate.

[0063] In some embodiments, the active solution includes the following components, measured in parts by mass: 1 to 10 parts of active substance, 10 to 80 parts of polymer matrix, 5 to 20 parts of sweetener, 0.5 to 1 part of pH adjuster, 1 to 3 parts of edible flavor and 0.5 to 1 part of preservative.

[0064] In some embodiments, the active solution contains the solute in an amount of 10% to 50% by mass.

[0065] Optionally, in the active solution, the content of the solute, measured by mass percentage, is 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45% or 50%, or, in the active solution, the content of the solute, measured by mass percentage, may also be within the range between any two of the above mass percentages.

[0066] In some of the embodiments, the content of the active substance in the active solution is no more than 10% by mass.

[0067] Optionally, the active substance content in the active solution is 1% to 10% by mass. Further optionally, the active substance content in the active solution is 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10% by mass, or the active substance content in the active solution can also be within the range between any two of the above mass percentages by mass.

[0068] In some embodiments, the oral product further comprises a non-woven bag, and the porous medium adsorbed with the active solution is placed inside the non-woven bag.

[0069] The porous medium adsorbed with active solution is placed in a non-woven bag. The non-woven bag can penetrate saliva, which can prevent the porous medium from falling off and ensure the taste.

[0070] Another embodiment of the present application provides a method for preparing an oral product, comprising the following steps:

[0071] The active solution is adsorbed on the porous medium, and the active solution includes a solvent, an active substance and a polymer matrix.

[0072] In some embodiments, the method for preparing the active solution comprises the following steps:

[0073] dissolving the hypromellose using a solvent to obtain a hypromellose solution;

[0074] dissolving active substances, other polymer substrates, and sweeteners in a hydroxypropylmethylcellulose solution to prepare an active solution semi-finished product;

[0075] The pH value of the active solution semi-finished product is adjusted to 4-9 by a pH adjuster.

[0076] In some embodiments, dissolving hypromellose with a solvent comprises the following steps:

[0077] While performing the first stirring, mixing the solvent and the hypromellose to obtain a mixed raw material;

[0078] The mixed raw materials are homogenized until the HPMC is dissolved.

[0079] In some embodiments, the first stirring speed is 50 rpm to 200 rpm.

[0080] Optionally, the rotation speed of the first stirring is 50rpm, 60rpm, 70rpm, 80rpm, 90rpm, 100rpm, 110rpm, 120rpm, 130rpm, 140rpm, 150rpm, 160rpm, 170rpm, 180rpm, 190rpm or 200rpm, or, the rotation speed of the first stirring can also be within the range between any two of the above rotation speeds.

[0081] In some embodiments, the rotation speed of the homogenization process is 10000 rpm to 20000 rpm.

[0082] Optionally, the rotation speed of the homogenization treatment is 10000 rpm, 11000 rpm, 12000 rpm, 13000 rpm, 14000 rpm, 15000 rpm, 16000 rpm, 17000 rpm, 18000 rpm, 19000 rpm or 20000 rpm, or, the rotation speed of the homogenization treatment can also be within the range between any two of the above rotation speeds.

[0083] In some embodiments, a second stirring is performed during the process of dissolving the active substance, other polymer substrates, and sweeteners in the hydroxypropylmethylcellulose solution.

[0084] In some embodiments, the second stirring speed is 50 rpm to 200 rpm.

[0085] Optionally, the second stirring speed is 50rpm, 60rpm, 70rpm, 80rpm, 90rpm, 100rpm, 110rpm, 120rpm, 130rpm, 140rpm, 150rpm, 160rpm, 170rpm, 180rpm, 190rpm or 200rpm, or, the second stirring speed may be within the range between any two of the above speeds.

[0086] In some embodiments, the third stirring is performed during the process of adjusting the pH value of the active solution semi-finished product to 4-9 by a pH adjuster.

[0087] In some embodiments, the third stirring speed is 50 rpm to 100 rpm.

[0088] Optionally, the rotation speed of the third stirring is 50rpm, 55rpm, 60rpm, 65rpm, 70rpm, 75rpm, 80rpm, 85rpm, 90rpm, 95rpm or 100rpm, or, the rotation speed of the third stirring may also be within the range between any two of the above rotation speeds.

[0089] In some embodiments, after adjusting the pH value of the active solution semi-finished product to 4 to 9 by a pH adjusting agent, the following steps are also included:

[0090] The semi-finished active solution after adjusting the pH value is subjected to defoaming treatment.

[0091] In some embodiments, adsorbing the active solution onto the carrier comprises the following steps:

[0092] The active solution is adsorbed on the porous medium by at least one of spraying, dripping and soaking.

[0093] The following are specific embodiments

[0094] Example 1

[0095] In terms of mass percentage, the active solution in Example 1 includes the following components: 2% nicotine, 15% hypromellose E5, 15% xanthan gum, 5% sucralose, 0.5% ethylparaben, 0.5% citric acid and sodium bicarbonate, and 62% purified water.

[0096] The carrier of the active solution in Example 1 is a PET porous medium with a porosity of 95% and a density of 0.05 g / cm 3 , the PET porous medium adsorbed 100 mg of active solution.

[0097] Example 2

[0098] In terms of mass percentage, the active solution in Example 2 includes the following components: 2% nicotine, 20% hydroxypropyl methylcellulose E5, 20% hydroxypropyl cellulose, 5% sucralose, 0.5% ethylparaben, 0.5% citric acid and sodium bicarbonate, and 52% purified water.

[0099] The carrier of the active solution in Example 2 is a PET porous medium with a porosity of 95% and a density of 0.05 g / cm 3, the PET porous medium adsorbed 100 mg of active solution.

[0100] Example 3

[0101] In terms of mass percentage, the active solution in Example 3 includes the following components: 2% nicotine, 15% hypromellose E5, 3% hypromellose E50, 5% sucralose, 0.5% ethylparaben, 0.5% citric acid and sodium bicarbonate, and 74% purified water.

[0102] The carrier of the active solution in Example 3 is a PET porous medium with a porosity of 95% and a density of 0.05 g / cm 3 , the PET porous medium adsorbed 100 mg of active solution.

[0103] The components of the active solutions in Examples 1 to 3 are shown in the following table:

[0104]

[0105] The oral products in Examples 1 to 3 were subjected to dissolution experiments. The dissolution experiments were tested using a dissolution apparatus by a slurry method. The dissolution medium was 60 ml of artificial saliva with a pH value of 6.8. The sampling points were 0.5 min, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min and 30 min. The test conditions were a heating temperature of 37 ° C and a rotation speed of 100 r / min. The analysis method was to detect the nicotine content using a high performance liquid chromatograph.

[0106] Reference Figure 1 The dissolution curve is shown in the following table:

[0107]

[0108] It can be seen from the test results that the oral preparation of the present application can have a good sustained-release effect.

[0109] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0110] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the attached claims, and the description and drawings may be used to interpret the contents of the claims.

Claims

1. An oral product, characterized in that: It comprises at least one porous medium and an active solution, wherein the active solution is adsorbed on the porous medium; the active solution comprises a solvent, an active substance and a polymer substrate.

2. The oral product according to claim 1, characterized in that The porosity of the porous medium is 93% to 99%; and / or, The density of the porous medium is 0.05 g / cm 3 ~0.075g / cm 3 and / or, The material of the porous medium includes at least one of polyamide and polyethylene terephthalate and at least includes polyethylene terephthalate.

3. The oral product according to claim 1, characterized in that The polymer substrate includes at least one of hydroxypropyl methylcellulose, hydroxypropyl cellulose, ethyl cellulose, polyethylene glycol, pectin, gum arabic, gelatin and starch and at least includes hydroxypropyl methylcellulose; and / or, The active substance includes at least one of nicotine and a nicotine derivative.

4. The oral product according to claim 1, characterized in that Measured in parts by mass, the active solution includes 1 to 10 parts of active material and 10 to 80 parts of polymer substrate.

5. The oral product according to claim 4, characterized in that The active solution also includes 5 to 20 parts of a sweetener.

6. The oral product according to claim 5, characterized in that The sweetener includes at least one of xylitol, sorbitol, mannitol, igltol, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriitol, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, cyclamate, alitame, steviol glycoside, arabitol and monk fruit sweetener.

7. The oral product according to claim 4, characterized in that The active solution further comprises 0.5 to 1 part of a pH regulator; and / or, The active solution further comprises 1 to 3 parts of edible flavor; and / or, The active solution also includes 0.5 to 1 part of a preservative.

8. The oral product according to claim 7, characterized in that The pH adjuster comprises at least one of malic acid, tartaric acid, fumaric acid, citric acid, carbonate, phosphate and bicarbonate; and / or, The preservative comprises at least one of ethylparaben, benzoic acid, benzoate, sorbic acid, sorbate, calcium propionate, sodium diacetate, sodium lactate, propylparaben and sodium dehydroacetate.

9. The oral product according to any one of claims 1 to 5, characterized in that The oral product further comprises a non-woven bag, and the porous medium adsorbed with the active solution is placed inside the non-woven bag.

10. The oral product according to claim 9, characterized in that The number of the porous media is at least two.

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