Buccal composition and buccal product
The slow release of nicotine in the oral cavity through the temperature-sensitive gel system solves the problems of high local concentration and strong irritation caused by existing oral nicotine-containing products, providing a more comfortable user experience and a stable sustained release effect.
Patent Information
- Application Number
- CN202411730316.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-28
- Publication Date
- 2025-01-17
AI Technical Summary
Existing oral-containing nicotine products such as oral-soluble films, bags, chewing gum and hard candies lead to high local concentrations and strong irritation when used, which cannot move or spit out, resulting in a large amount of saliva, resulting in poor user experience and controllable sustained release effect. Poor nature and risk of powder leakage.
The temperature-sensitive gel system is adopted, including temperature-sensitive gelling agents, functional substances and other auxiliary components. The temperature-sensitive gelling agent is converted into a gel state from 20℃ to 32℃, providing a sustained release and soft and moist taste to avoid local irritation. Controlling the slow release of nicotine through the gel network.
The slow and slow release of nicotine is achieved, which reduces the local concentration and irritation, provides a more comfortable taste experience, avoids the problems of excessive saliva and frequent chewing, and the gel is chemically stable and does not react with functional substances.
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Figure CN119318397A_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of nicotine products, and in particular to an oral composition and an oral product. Background Art
[0002] The current oral nicotine products mainly include nicotine orodispersible film, nicotine pouch, nicotine gum and nicotine hard candy. Nicotine orodispersible film is placed between the oral wall and the gums when used. Due to the strong viscosity of the orodispersible film, it cannot be moved after being placed in a specific position and can only be released at a specific position. The orodispersible film has good adhesion to the use site and a fast release rate, which will lead to high local concentration and strong irritation, causing strong discomfort at the contact site, and the orodispersible film cannot be easily moved or spit out. At the same time, a large amount of saliva will be produced when using the orodispersible film, the swallowing frequency will increase, and there will be a spiciness in the throat and burning in the stomach. Many discomforts cause poor user experience. Nicotine pouches contain powder or granules, and the controllability of its sustained release effect is poor, and there is a risk of powder leakage. Nicotine gum produces a large amount of saliva when chewing, the swallowing frequency will increase, there will be a spiciness in the throat and burning in the stomach, and many discomforts cause poor user experience. Putting hard candy products in the mouth will produce a lot of saliva, increase the frequency of swallowing, cause a sore throat and burning stomach sensation, and many other discomforts result in a poor user experience.
[0003] Therefore, there is an urgent need to develop an oral product that can improve user experience. Summary of the invention
[0004] Based on the above problems, the purpose of the present application is to provide an oral composition and an oral product that can improve the user's taste and experience.
[0005] This application adopts the following technical solutions:
[0006] The present application discloses an oral composition, comprising a thermosensitive gel system and a functional substance. The thermosensitive gel system comprises a thermosensitive gelling agent. When the critical gelling temperature of the thermosensitive gelling agent is higher than the critical gelling temperature, the thermosensitive gel system changes from a liquid state to a gel state. The critical gelling temperature is 20°C to 32°C.
[0007] In one implementation of the present application, the temperature-sensitive gelling agent includes at least one of a polymer, a natural macromolecule and an organic small molecule.
[0008] In one implementation of the present application, the polymer includes at least one of poly (N-isopropylacrylamide), poloxamer, polyethylene glycol-polypropylene glycol block copolymer and poly (N,N-dimethylacrylamide-co-acrylic acid).
[0009] In one implementation of the present application, the natural polymer includes at least one of xyloglucose, sodium alginate and gelatin.
[0010] In one implementation of the present application, the organic small molecules are configured to form a gel network by self-assembly, and the organic small molecules include at least one of fatty acids and amino acid derivatives.
[0011] In one implementation of the present application, the functional substance includes nicotine and / or nicotine derivatives.
[0012] In one implementation of the present application, the critical gelling temperature of the temperature-sensitive gelling agent is 25°C to 32°C.
[0013] In one implementation of the present application, the oral composition comprises, by weight: 5 to 80 parts of the temperature-sensitive gelling agent and 1 to 20 parts of the functional substance.
[0014] In one implementation of the present application, the oral composition comprises 15 to 50 parts of the temperature-sensitive gelling agent by weight.
[0015] In one implementation of the present application, the oral composition further comprises at least one of a solvent, a viscosity enhancer, a thickener, a sweetener, a cooling agent, a flavor, an antibacterial agent and a pH adjuster.
[0016] In one implementation of the present application, the viscosity enhancer includes at least one of hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, polyethylene glycol, pectin, gum arabic, gelatin and starch.
[0017] In one implementation of the present application, the oral composition further includes, by weight: 5 to 80 parts of a viscosity enhancer, 1 to 20 parts of a thickener, 1 to 20 parts of a sweetener, 1 to 3 parts of a cooling agent, 1 to 3 parts of a flavor, 0.1 to 2 parts of an antibacterial agent, and 0.5 to 1 part of a pH adjuster.
[0018] The present application also provides an oral product, comprising any one of the above-mentioned oral compositions and a carrier for carrying the oral composition.
[0019] The beneficial effects of this application are:
[0020] The critical gelling temperature of the thermosensitive gelling agent is 20°C to 32°C. When the user consumes the oral composition or oral product, the oral composition comes into contact with the human body. Since the oral composition contains a thermosensitive gelling agent, the temperature rises and reaches the critical gelling temperature. The thermosensitive gelling system is transformed into a gel state, which can achieve the sustained release of functional substances. The gel has a moist and soft taste and has a good taste. BRIEF DESCRIPTION OF THE DRAWINGS
[0021] Figure 1 It is a dissolution curve diagram of the oral product of the embodiment of the present application.
[0022] Figure 2 4 is a state diagram of the oral composition of the embodiment of the present application at different temperatures. DETAILED DESCRIPTION
[0023] The present invention is further described in detail below by specific embodiments in conjunction with the accompanying drawings. In the following embodiments, many detailed descriptions are intended to enable the present application to be better understood. However, those skilled in the art can effortlessly recognize that some of the features can be omitted in different situations, or can be replaced by other materials and methods. In some cases, some operations related to the present application are not shown or described in the specification, in order to avoid the core part of the present application being overwhelmed by too much description, and for those skilled in the art, it is not necessary to describe these related operations in detail, and they can fully understand the related operations according to the description in the specification and the general technical knowledge in the art.
[0024] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate manner to form various implementations. At the same time, the steps or actions in the method description can also be interchanged or adjusted in a manner that is obvious to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment and are not meant to be a required sequence, unless otherwise specified that a certain sequence must be followed.
[0025] The serial numbers assigned to the components in this article, such as "first", "second", etc., are only used to distinguish the objects described and do not have any order or technical meaning.
[0026] At present, there are nicotine products in the form of nicotine orodispersible film, nicotine pouches, nicotine gum and hard candy. There is no nicotine gel product without oral dispersible film. Nicotine orodispersible film causes many discomforts when used. When used, it is placed between the oral wall and the gums. Due to the strong viscosity of the orodispersible film, it cannot be moved after being placed in a specific position and can only be released at a specific position. The good adhesion of the orodispersible film to the use site and the fast release rate will lead to high local concentration and strong irritation, which will cause strong discomfort at the contact site and make it impossible to move the orodispersible film or spit it out. At the same time, a large amount of saliva will be produced when using the orodispersible film, the swallowing frequency will increase, and there will be a spiciness in the throat and burning sensation in the stomach. Many discomforts will cause poor customer experience. High molecular weight sustained-release materials can help solve the sustained-release problem of orodispersible film. However, the high molecular weight material molecules have a high viscosity, which is easy to stick to the mouth and teeth when used by users, causing discomfort and poor user experience. Nicotine pouches contain powder and granules, and their sustained-release effect is poorly controllable and there is a risk of powder leakage. Nicotine chewing gum and hard candy products produce a large amount of saliva when placed in the mouth, and frequent chewing and swallowing movements are required when taking them, which causes a sore throat and burning stomach, causing discomfort and a poor user experience.
[0027] In view of this, the present application creatively proposes an oral composition and an oral product, which includes a thermosensitive gel, which is a liquid at room temperature (about 20°C) or below room temperature, and can quickly form a semi-solid gel in the oral cavity (about 37°C) as the temperature rises, and can control the sustained release of functional substances in the oral cavity without causing high local concentrations and strong irritation. The gel has a softer and moister texture, does not stimulate the production of a large amount of saliva, does not require chewing and swallowing when used, does not cause irritation to the throat and tail, and can bring a more comfortable taste experience to the user. In addition, the chemical properties of the gel are stable and will not react with functional substances (nicotine, nicotine salts, etc.).
[0028] The present application relates to an oral composition.
[0029] In one embodiment, the oral composition comprises a temperature-sensitive gel system and a functional substance.
[0030] In a specific embodiment, the functional substance includes nicotine and / or nicotine derivatives, and the nicotine derivatives include nicotine salts and nicotine containing substituents, such as nicotine tartrate, nicotine lactate, hexamethyl nicotine, etc. When the functional substance is nicotine or a nicotine derivative, the oral composition is also referred to as an "oral nicotine composition". In some embodiments, the functional substance can also be caffeine and other common active ingredients to meet the user's demand for functional substances.
[0031] In one embodiment, the functional substance is dispersed in the thermosensitive gel system.
[0032] In a specific embodiment, the thermosensitive gel system includes a thermosensitive gelling agent, and when the critical gel temperature (Tgel) of the thermosensitive gelling agent is higher than the critical gel temperature (Tgel), the thermosensitive gel system changes from a liquid state to a gel state. The critical gel temperature (Tgel) refers to the gelation temperature, that is, the gelation point. It refers to the temperature at which a polymer solution or sol system changes from a flow state to a gel state at a certain temperature. At this temperature, the viscosity of the system increases sharply, the fluidity is lost, and a three-dimensional network structure is formed.
[0033] In a specific embodiment, the critical gel temperature of the thermosensitive gel is 20° C. to 32° C. For example, the critical gel temperature of the thermosensitive gel may be 20° C., 21° C., 22° C., 23° C., 24° C., 25° C., 26° C., 27° C., 28° C., 29° C., 30° C., 31° C. or 32° C. The critical gel temperature of the thermosensitive gel is 20° C., which means that when the temperature rises to 20° C., the thermosensitive gel system can be transformed from a solution state to a gel state.
[0034] In a specific embodiment, the critical gelling temperature of the thermosensitive gel is 25° C. to 32° C. Thus, the oral composition is in a liquid state at room temperature, which can be easily stored and transported, and the functional substance can be evenly dispersed in the liquid, making the product more stable.
[0035] In a specific embodiment, the temperature-sensitive gelling agent includes at least one of a polymer, a natural macromolecule and an organic small molecule.
[0036] In a specific embodiment, the polymer includes at least one of poly (N-isopropylacrylamide) (PNIPAM), poloxamer, polyethylene glycol-polypropylene glycol block copolymer (PEG-PPG-PEG) and poly (N, N-dimethylacrylamide-co-acrylic acid) (PDMAAm-co-AA). It should be noted that poloxamer can include a variety of models, such as Pluronic F127, Pluronic F68, Pluronic F108, which are not listed one by one here, and their critical gel temperature meets the requirements. The critical gel temperature of PEG-PPG-PEG is usually between 30°C and 50°C, which is specifically related to the molecular weight, monomer ratio, etc. of PEG-PPG-PEG, and is not limited here. Its critical gel temperature meets the requirements. The critical gelation temperature of PDMAAm-co-PAA is generally between 20°C and 40°C, which is related to the molecular weight, monomer ratio, etc. of PDMAAm-co-PAA and is not limited here. It is sufficient that the critical gelation temperature meets the requirements.
[0037] In a specific embodiment, the natural polymer includes at least one of xyloglucose, sodium alginate and gelatin.
[0038] In a specific embodiment, the organic small molecules include at least one of fatty acid and amino acid derivatives. These small molecules can form a gel network by self-assembly.
[0039] In one embodiment, the thermosensitive gelling agent is selected from at least one of poly N-isopropylacrylamide and poloxamer. The critical gelling temperature of poly N-isopropylacrylamide is about 32°C. When the temperature is lower than 32°C, the poly N-isopropylacrylamide solution is in a transparent liquid state. When the temperature exceeds 32°C, the poly N-isopropylacrylamide solution becomes turbid and forms a gel. The critical gelling temperature of poloxamer is about 25°C to 32°C. When the temperature is lower than the critical gelling temperature, the poloxamer solution is in a transparent liquid state. When the temperature exceeds the critical gelling temperature, the poloxamer solution becomes turbid and forms a gel.
[0040] In a specific embodiment, the thermosensitive gel system can provide a stable matrix for the functional substance. In the liquid state, the functional substance can be evenly dispersed in the thermosensitive gel system for preservation and transportation. When in use, it comes into contact with the oral cavity. Since the human body temperature is about 37°C, the thermosensitive gel system changes to a gel state, and the functional substance in the gel is slowly released from the gel. Specifically, it is through the physical barrier effect of the gel. The gel is a three-dimensional network structure formed by cross-linking. This network structure can capture and accommodate functional substances, forming a physical barrier to limit the free diffusion of functional substances; in addition, the pore size of the gel can control the release rate of the functional substance.
[0041] In a specific embodiment, the thermosensitive gel system can provide a soft, moist, and mild taste. The gel is water-absorbent and can swell when exposed to water, thereby providing a soft, moist, and mild taste. In addition, the swelling will also change the pore structure of the gel, further controlling the release rate of the functional substance.
[0042] In a specific embodiment, the oral composition includes 5 to 80 parts of the thermosensitive gelling agent by weight. For example, by weight, it can include 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 65, 70, 75 or 80 parts of the thermosensitive gelling agent. Preferably, the oral composition includes 15 to 50 parts of the thermosensitive gelling agent by weight.
[0043] In a specific embodiment, the temperature-sensitive gel system comprises a temperature-sensitive gelling agent and a solvent. In other words, the oral composition may comprise a solvent.
[0044] In a specific embodiment, the solvent may include at least one of water and ethanol, thereby being able to dissolve other components of the oral composition to form a solution in which the solute is evenly dispersed.
[0045] In a specific embodiment, the oral composition may include 20 to 85 parts of solvent by weight. Preferably, the oral composition includes 30 to 50 parts of solvent by weight.
[0046] In a specific embodiment, the oral composition further comprises at least one of a viscosity enhancer, a thickener, a sweetener, a cooling agent, a flavor and a pH adjuster.
[0047] In a specific embodiment, the viscosity enhancer may include at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, polyethylene glycol, pectin, gum arabic, gelatin and starch. The viscosity enhancer has an auxiliary effect. As the thermosensitive gelling agent is transformed into a gel state, the viscosity enhancer can also be transformed into a gel state, thereby enhancing the gel strength and gel rate.
[0048] In a specific embodiment, the oral composition may include 5 to 80 parts of a viscosity enhancer by weight. For example, the oral composition may include 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 or 80 parts of a viscosity enhancer by weight. Preferably, the oral composition includes 5 to 50 parts of a viscosity enhancer by weight. Further, the oral composition includes 10 to 20 parts of a viscosity enhancer by weight.
[0049] In a specific embodiment, the thickener may include at least one of xanthan gum, guar gum, carrageenan, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, and ethyl cellulose. The thickener may improve the taste.
[0050] In a specific embodiment, the oral composition may include 1 to 20 parts of thickener by weight. For example, the oral composition may include 1 part, 5 parts, 10 parts, 15 parts or 20 parts of thickener by weight. Preferably, the oral composition includes 5 to 10 parts of thickener by weight.
[0051] In a specific embodiment, the sweetener can be selected from at least one of the following substances: xylitol, sorbitol, mannitol, igloool, lactitol, maltitol, isomalt, hydrogenated starch hydrolysate, erythritol, maltotriose, aspartame, acesulfame potassium, saccharin sodium, sucralose, neotame, sodium cyclamate, alitame, steviol glycosides, arabitol and monk fruit sweetener. The sweetener can also be selected from other edible grade substances, which will not be described one by one in this article.
[0052] In a specific embodiment, the oral composition may include 1 to 20 parts of a sweetener by weight. For example, the oral composition may include 1, 5, 10, 15 or 20 parts of a sweetener by weight. Preferably, the oral composition includes 1 to 10 parts of a sweetener by weight.
[0053] In a specific embodiment, the cooling agent can be selected from at least one of the following substances: menthol, isomenthol, WS-3, WS-5, WS-23, WS-27 and WS-12. The cooling agent can also be selected from other edible grade substances, which will not be described in detail herein.
[0054] In a specific embodiment, the buccal composition may include 1 to 3 parts of cooling agents by weight. For example, the buccal composition may include 1 part, 1.5 parts, 2 parts, 2.5 parts or 3 parts of cooling agents by weight.
[0055] In a specific embodiment, the flavor is an edible flavor, which may include at least one of bergamot flavor, eucalyptus flavor, citrus flavor, lemon flavor, peppermint flavor, mint flavor, menthol, licorice flavor, wintergreen flavor, tobacco flavor, coffee flavor, vanilla flavor, lime flavor, apple flavor, peach flavor, mango flavor, cherry flavor, blueberry flavor, strawberry flavor, cola flavor, cinnamon flavor, vanilla flavor, and watermelon flavor. The flavor may also be other types of edible flavors, which will not be described in detail herein.
[0056] In a specific embodiment, the oral composition may include 1 to 3 parts of flavors by weight. For example, the oral composition may include 1 part, 1.5 parts, 2 parts, 2.5 parts or 3 parts of flavors by weight.
[0057] In a specific embodiment, the antibacterial agent (or preservative) can be selected from at least one of the following substances: ethylparaben, benzoic acid, sodium benzoate, potassium sorbate, benzalkonium chloride. The antibacterial agent can also be selected from other edible antibacterial substances, which will not be described in detail herein.
[0058] In a specific embodiment, the oral composition may include 0.1 to 2 parts of the antibacterial agent by weight. For example, the oral composition may include 0.1 parts, 0.5 parts, 1 parts, 1.5 parts or 2 parts of the antibacterial agent by weight.
[0059] In a specific embodiment, the pH adjuster includes at least one of sodium carbonate, sodium bicarbonate, potassium carbonate, magnesium carbonate, potassium bicarbonate, tromethamine and phosphate buffer.
[0060] In a specific embodiment, the oral composition may include 0.5 to 1 part of a pH adjuster by weight. For example, the oral composition may include 0.5, 0.6, 0.7, 0.8, 0.9 or 1 part of a pH adjuster by weight.
[0061] In a specific embodiment, the pH of the oral composition is 4 to 9. For example, the pH of the oral composition can be 4, 5, 6, 7, 8 or 9. A suitable pH is conducive to maintaining a good taste of the functional substance, for example, nicotine tartrate has a sour taste when the pH is too low.
[0062] In one embodiment, all components used in the oral composition are food grade.
[0063] In a specific embodiment, the oral composition is stored in a dark container, which can help prevent nicotine and other components from changing color and deteriorating.
[0064] The present application relates to a method for preparing an oral composition, comprising the following steps:
[0065] 1) Dissolve the thermosensitive gelling agent in the solvent and stir until it is completely dissolved at a stirring speed of 50 to 200 rpm;
[0066] 2) Add the thickener and stir until completely dissolved at a stirring speed of 50 to 200 rpm;
[0067] 3) Add functional substances, thickeners, sweeteners, flavors, cooling agents, and antibacterial agents, and stir until completely dissolved at a stirring speed of 50 to 200 rpm;
[0068] 4) Under the condition of stirring speed of 50-200 rpm, the pH of the solution is adjusted to 4-9 using a pH adjuster.
[0069] 5) The solution was bottled in brown glass bottles and stored at 20°C.
[0070] The present application relates to an oral product, which includes the oral composition. In some embodiments, the functional substance is nicotine or a nicotine derivative, and the oral product can also be referred to as an "oral nicotine product".
[0071] In a specific embodiment, the oral product further includes a carrier for carrying the oral composition.
[0072] In a specific embodiment, when a user uses the oral product, the oral composition and the carrier are placed together in the user's mouth (for example, between the gums and lips (or cheeks), between the tongue and the upper palate (or lower jaw)).
[0073] In a specific embodiment, when a user uses the oral product, the oral composition can be placed in a carrier first, and then placed in the user's mouth together.
[0074] In a specific embodiment, the shape of the carrier can be bag-shaped, sheet-shaped, sponge-shaped, etc.
[0075] In a specific embodiment, the carrier can be a non-woven fabric. The non-woven fabric can absorb the oral composition. When in use, the oral composition required by the user (the dosage can be adjusted according to the user's own situation) can be dripped onto the non-woven fabric and then placed in the mouth. As the temperature rises to about 37°C, the oral composition can be transformed into a gel state to achieve the slow release of functional substances. At the same time, saliva can be absorbed by the non-woven fabric to avoid excessive stimulation.
[0076] In a specific embodiment, the width of the non-woven fabric is in the range of about 8 mm to about 20 mm; preferably, about 10 mm to about 16 mm. The length of the pouch is in the range of about 15 mm to about 40 mm; preferably, about 20 mm to about 30 mm. It should be noted that such a size is conducive to placing the non-woven fabric in the oral cavity, such as between the cheek and the gum or between the lip and the gum.
[0077] In a specific embodiment, the carrier can be a small bag, and the oral composition can be first placed in the small bag and then placed in the oral cavity. The small bag can keep the gel-like oral composition in the small bag and allow saliva to penetrate, so that the water-soluble functional substance (such as nicotine) and other ingredients can be dissolved in the saliva and enter the oral cavity.
[0078] In a specific embodiment, the oral product may further include a tool for picking up the oral composition, such as a small spoon, a measuring cup, a dropper, etc. Thus, the dosage can be determined according to the user's own needs.
[0079] The present application is further described in detail below by specific examples and comparative examples. The following examples are only further described for the present application and should not be construed as limiting the present application. In the present examples and comparative examples, unless otherwise specified, the reagents and instruments used are all commercially available, and the experimental operations are carried out in accordance with the product instructions and conventional experimental specifications.
[0080] The formula of the oral composition of Example 1 is as follows:
[0081] name Element Mass parts (parts) Thermoresponsive gel Poloxamer 188 20 Functional substances nicotine 10 Tackifier Hydroxypropyl methylcellulose 10 Sweeteners Sucralose 5 preservative Benzalkonium chloride 0.5 pH Adjusters Citric acid, sodium bicarbonate 0.50 Solvents Purified water 54
[0082] The formula of the oral composition of Example 2 is as follows:
[0083] name Element Mass parts (parts) Thermoresponsive gel Poloxamer 188 20 Functional substances nicotine 10 Tackifier Hydroxyethyl Cellulose 15 Thickener Xanthan gum 5 Sweeteners Sucralose 5 preservative Benzalkonium chloride 0.5 pH Adjusters Citric acid, sodium bicarbonate 0.5 Solvents Purified water 44
[0084] The formula of the oral composition of Example 3 is as follows:
[0085]
[0086] The preparation process is as follows:
[0087] (1) Pour an appropriate amount of solvent into a stirring tank, start stirring (50-200 rpm), and slowly pour the thermoresponsive gel into the stirring tank until the thermoresponsive gel is completely dissolved;
[0088] (2) Slowly pour the thickener into the stirring tank and stir (50-200 rpm) until it is completely dissolved;
[0089] (3) Add functional substances, sweeteners, thickeners (if any), and flavorings (if any), and stir (50-200 rpm) until completely dissolved;
[0090] (4) Adjust the solution pH to 4-9 with citric acid and sodium bicarbonate, stirring at 50-100 rpm, and set aside after reaching the appropriate pH;
[0091] (5) The solution was filled into a brown glass bottle and stored at 20°C to obtain an oral composition.
[0092] Select non-woven fabric as the carrier, cut the non-woven fabric to control the length and width of each piece of fabric: 1cm*2cm.
[0093] Dissolution curve analysis:
[0094] The dissolution apparatus-paddle method was used to test the nicotine dissolution rate of the oral products of each embodiment at different time points. The dissolution medium was 900 mL of a pH 6.8 phosphate solution, heated to 37°C, to simulate saliva. 1 mL of the oral composition was dropped into the non-woven fabric, and then placed in the dissolution medium. The conditions were a temperature of 37°C and a rotation speed of 50 r / min. Samples were taken at different time points, and the nicotine content was detected by high performance liquid chromatography. The sampling points were: 0.5 min, 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min, and 30 min.
[0095] The results are shown in the following table:
[0096]
[0097]
[0098] Figure 1 This is a dissolution curve diagram of the oral product of the embodiments of the present application. It can be seen that the dissolution rate of the oral composition of each embodiment is relatively fast in the initial stage, which may be related to the fact that it takes a certain time for the oral composition to heat up and transform from a solution state to a gel state. After the gel is formed, the release rate slows down, and there is a certain sustained-release effect. Figure 2 is a state diagram of the oral composition of the embodiment of the present application at different temperatures, Figure 2 In the symbol, "A37°C" represents the state of the oral composition sample of Example 1 at 37°C, "B 37°C" represents the state of the oral composition sample of Example 2 at 37°C, "A 20°C" represents the state of the oral composition sample of Example 1 at 20°C, and "B 20°C" represents the state of the oral composition sample of Example 2 at 20°C. It can be seen that the oral compositions of Examples 1 and 2 are in a clear solution state at 20°C and in a viscous gel state at 37°C.
[0099] The above contents are further detailed descriptions of the present application in combination with specific implementation methods, and it cannot be determined that the specific implementation of the present application is limited to these descriptions. For ordinary technicians in the technical field to which the present application belongs, several simple deductions or substitutions can be made without departing from the concept of the present application.
Claims
1. An oral composition, characterized in that The invention comprises a thermosensitive gel system and a functional substance. The thermosensitive gel system comprises a thermosensitive gelling agent. When the temperature is higher than the critical gelling temperature of the thermosensitive gelling agent, the thermosensitive gel system changes from a liquid state to a gel state. The critical gelling temperature is 20°C to 32°C.
2. The oral composition according to claim 1, characterized in that The temperature-sensitive gelling agent includes at least one of a polymer, a natural macromolecule and an organic small molecule.
3. The oral composition according to claim 2, characterized in that The polymer comprises at least one of poly (N-isopropylacrylamide), poloxamer, polyethylene glycol-polypropylene glycol block copolymer and poly (N, N-dimethylacrylamide-co-acrylic acid); and / or, The natural polymer comprises at least one of xyloglucose, sodium alginate and gelatin; and / or, The small organic molecules are configured to form a gel network by self-assembly, and the small organic molecules include at least one of fatty acid and amino acid derivatives.
4. The oral composition according to any one of claims 1 to 3, characterized in that The functional substance includes nicotine and / or nicotine derivatives.
5. The oral composition according to claim 1, characterized in that The oral composition comprises, by weight, 5 to 80 parts of the temperature-sensitive gelling agent and 1 to 20 parts of the functional substance.
6. The oral composition according to claim 5, characterized in that The oral composition comprises 15 to 50 parts of the temperature-sensitive gelling agent by weight.
7. The oral composition according to claim 1, characterized in that The oral composition further comprises at least one of a viscosity enhancer, a thickener, a sweetener, a cooling agent, a flavor, an antibacterial agent and a pH adjuster.
8. The oral composition according to claim 7, characterized in that The viscosity enhancer includes at least one of hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, polyethylene glycol, pectin, gum arabic, gelatin and starch.
9. The oral composition according to claim 5 or 6, characterized in that The oral composition further comprises, by weight: 5 to 80 parts of a viscosity enhancer, 1 to 20 parts of a thickener, 1 to 20 parts of a sweetener, 1 to 3 parts of a cooling agent, 1 to 3 parts of an essence, 0.1 to 2 parts of an antibacterial agent, and 0.5 to 1 part of a pH adjuster.
10. An oral product, characterized in that: The invention comprises the oral composition according to any one of claims 1 to 9 and a carrier for carrying the oral composition.
Citation Information
Patent Citations
Reverse thermo-sensitivity reversible aquogel composite
CN102639097A
Reversible transformation carrier gel as well as preparation method and application thereof
CN114983002A
Nicotine controlled-release nicotine buccal tablet product and preparation method thereof
CN116585279A
Nicotine compositions and method for formulation thereof
CN1278174A
Reversibly hot gelified water soluble medicine composition
CN1706365A