Nicotine interlayer oral soluble film and preparation method thereof
The nicotine-interlayer oral dissolving membrane, with its three-layer structure design, solves the problems of poor user experience and health risks associated with existing nicotine replacement therapies, achieving rapid and balanced release of nicotine and improving the product's portability and safety.
Patent Information
- Application Number
- CN202510974597.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-15
- Publication Date
- 2025-11-07
AI Technical Summary
Existing nicotine replacement therapy products have issues such as poor user experience and potential health risks during use, including uneven dissolution of nicotine pouches, powder leakage, skin irritation, and other health problems.
The nicotine sandwich oral lysis membrane, which adopts a three-layer structure design, includes a hydrophobic polypropylene nonwoven outer layer, a nicotine oral lysis membrane middle layer, and a biodegradable spunlace cellulose nonwoven outer layer. It is combined and printed with patterns by hot pressing to prepare a specific shape, so as to achieve rapid release and slow release control of nicotine.
It provides portable, precise nicotine release, avoids the shortcomings of traditional products, improves user experience, and achieves balanced release through saliva buffering, resulting in high bioavailability.
Smart Images
Figure CN120899671A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application belongs to the technical field of pharmaceutical preparations and nicotine products, and particularly relates to a nicotine sandwich mouth dissolving film and a preparation method thereof. BACKGROUND
[0002] Nicotine is a kind of alkaloid existing in tobacco, which has addiction. Traditional cigarettes release nicotine by burning tobacco, but at the same time, a large amount of harmful substances are also produced, which endanger human health. In recent years, with the improvement of people's health consciousness, new types of nicotine products have gradually emerged, such as electronic cigarettes, nicotine patches, nicotine chewing gum, etc. These products aim to provide nicotine while reducing the intake of harmful substances. At present, there are various smoking cessation aids on the market, such as nicotine patches, nicotine chewing gum and electronic cigarettes, etc. These products help users gradually reduce their dependence on nicotine by providing a controllable dose of nicotine.
[0003] However, there are some inconveniences in the use of these products, such as oral patches that may cause oral discomfort, and electronic cigarettes that have health risks and usage restrictions. In the prior art, nicotine bags are filled with auxiliary materials, and nicotine or flavoring agents are not uniformly dissolved, and the filler may have a powder leakage phenomenon due to processing technology, etc., which gives a bad experience, nicotine patches absorb nicotine through the skin, but fast release of nicotine may cause skin irritation, nicotine chewing gum releases nicotine by chewing, which may cause oral discomfort, and electronic cigarettes produce steam by heating nicotine liquid for users to inhale, which may have health risks and usage restrictions. SUMMARY
[0004] The main defect of the prior art is poor user experience and potential health risks. In view of the deficiencies of the prior art, the present application provides a nicotine sandwich mouth dissolving film for nicotine replacement therapy (NRT) and a preparation method thereof. The nicotine sandwich mouth dissolving film product realizes fast release and slow release control of nicotine through the innovative three-layer structure design, and is suitable for smoking cessation auxiliary treatment. Its core features are portability, precise dosage, slow release and control release, while avoiding the shortcomings of traditional oral bags or patches. The preparation method has the advantages of simplicity and easy operation. The nicotine sandwich mouth dissolving film of the present application can be prepared into different shapes and patterns according to the taste (such as strawberry flavor can be prepared into the shape of strawberry).
[0005] The preparation method of the nicotine sandwich mouth dissolving film of the present application comprises the following steps: S1. Take 3-15 parts by mass of nicotine salt aqueous solution, add 10-25 parts by mass of plasticizer, 1-2.5 parts by mass of flavoring agent, and appropriate amount of colorant, add water to make up to 30-40 parts by mass of total system, and stir uniformly to form a mixed solution; S2. Adding 60-70 parts by mass of film-forming material to the mixed solution, stirring to obtain a uniform continuous film liquid, and controlling the viscosity to be 8000-50000 mpa.s, and removing air bubbles by ultrasonic treatment; S3. Coating the film liquid to form a film, drying at 50-60°C, to obtain a nicotine oral film; S4. Using a hot-pressing method to superimpose and press the outer layer 1, the nicotine oral film, and the outer layer 2 in sequence, and cutting and forming to obtain a nicotine sandwich oral film; the outer layer 1 is a hydrophobic polypropylene non-woven fabric, and the outer layer 2 is a degradable water-jet cellulose non-woven fabric or an HPMC non-woven fabric.
[0006] Preferably, the nicotine salt aqueous solution is prepared by mixing nicotine and an organic acid in a molar ratio of 1:1 and dissolving in water, and the organic acid is tartaric acid, lactic acid, malic acid, citric acid, benzoic acid, gluconic acid, acetic acid, acetylpropionic acid, salicylic acid, or sorbic acid.
[0007] Preferably, the nicotine content in the nicotine salt aqueous solution is 40% by mass fraction.
[0008] Preferably, the plasticizer is at least one of glycerol, polyethylene glycol, propylene glycol, and Tween 80.
[0009] Preferably, the flavoring agent is at least one of food essence, mint essence, strawberry essence, cherry essence, litchi essence, lemon essence, citronella essence, grape essence, and sweet orange essence.
[0010] Preferably, the film-forming material is one or a combination of two of hydroxypropyl methylcellulose, polyvinyl alcohol, hydroxypropyl cellulose, polyvinylpyrrolidone, and polyoxyethylene.
[0011] Preferably, the ultrasonic treatment is performed at a frequency of 20-40 kHz, and the hot-pressing parameters are: hot-pressing at 45-60°C and a pressure of 0.3-0.5 MPa for 2-3 s, so that the bonding force between the non-woven fabric and the nicotine oral film is ≥0.2 N / cm.
[0012] Preferably, the nicotine content of the nicotine sandwich oral film is 1-30 mg per piece.
[0013] Preferably, the method comprises the following steps: S1. Taking 5 parts by mass of tartaric acid nicotine salt aqueous solution, adding 16 parts by mass of glycerol, 1 part by mass of strawberry essence, and an appropriate amount of colorant, adding water to make up to a total system of 30 parts by mass, and stirring to obtain a mixed solution; S2. Add 45 parts by mass of hydroxypropyl methylcellulose and 25 parts by mass of polyvinyl alcohol to the mixed solution, stir to obtain a uniform continuous film liquid, and control the viscosity to be 8000-50000 mpa.s, remove the bubbles under the condition of 30 kHz ultrasonic; S3. The film liquid is coated into a film, the wet film thickness is controlled to be 200 µm, and dried at 55°C to obtain a nicotine oral dissolving film; S4. The outer layer 1, the nicotine oral dissolving film, and the outer layer 2 are overlapped in turn by using a hot pressing method, and are pressed and cut to form a nicotine sandwich oral dissolving film; the outer layer 1 is a hydrophobic polypropylene non-woven fabric, the outer layer 2 is a degradable water-jet cellulose non-woven fabric; the parameters of the hot pressing are: hot pressing at 50°C and a pressure of 0.4 MPa for 2-3 s, so that the bonding force between the non-woven fabric and the nicotine oral dissolving film is ≥0.2 N / cm.
[0014] The application also provides a nicotine sandwich oral dissolving film prepared by the method.
[0015] The application can combine the three layers by using the hot pressing method, and print corresponding lines and cut shapes corresponding to the flavors, for example, red corresponds to strawberry flavor, yellow corresponds to orange flavor, etc. The nicotine dose of the nicotine sandwich oral dissolving film can be adjusted to 1 mg-30 mg / tablet or more preferably 2-6 mg / tablet according to needs.
[0016] By using the above method, the oral dissolving film prepared by the application is slowly dissolved in the oral cavity by saliva, and the pH buffering effect of the saliva makes the nicotine change from an ionic state to a free state that can be absorbed by the oral mucosa, thereby playing a slow-release role and achieving a relatively balanced release rate.
[0017] The application has the following advantages: The nicotine sandwich oral dissolving film of the application adopts a three-layer composite design, the outer layer 1: a hydrophobic polypropylene (PP) non-woven fabric (gram weight 30-50 g / m²) provides mechanical support and prevents adhesion, facilitating hand holding; the outer layer 1 can be printed with instructions; the middle layer: a nicotine oral dissolving film (containing a suitable proportion of nicotine salt, plasticizer, flavoring agent, film-forming material, etc.) dissolves quickly (10-30 s), and nicotine is absorbed through the oral mucosa, with a bioavailability of > 90%. Figure 1 FIG. 1 is a front and back appearance state of a strawberry-flavored nicotine sandwich oral dissolving film prepared in Example 1. DETAILED DESCRIPTION
[0018] The following examples are further illustrations of the application, but are not intended to limit the application.
[0019] Example 1: Strawberry-flavored nicotine sandwich oral dissolving film The three-layer structure of the nicotine interlayer oral film is composed of: outer layer 1: hydrophobic polypropylene (PP) non-woven fabric (30-50 g / m²); middle layer: nicotine oral film; outer layer 2: degradable water-jet cellulose non-woven fabric (partially dissolves after contacting with the mucosa).
[0020] The preparation process of the nicotine interlayer oral film is as follows: S1. Place the nicotine salt aqueous solution (tartaric acid nicotine salt aqueous solution 5 g, which is prepared by mixing nicotine and tartaric acid in a molar ratio of 1:1 and dissolving in water, and the nicotine content is 40% by mass fraction) in a suitable container, add plasticizer (glycerol 16 g), flavoring agent (strawberry flavor 1 g), appropriate colorant, add pure water to make up to a total mass of 30 g, stir uniformly to form a mixed solution; S2. Add film-forming material (hydroxypropyl methyl cellulose (HPMC) 45 g and polyvinyl alcohol (PVA) 25 g) to the mixed solution, stir at room temperature to obtain a uniform continuous film solution, and measure the viscosity of the film solution until the viscosity of the film solution is 8000-50000 mpa.s; ultrasonic degassing of the film solution under the condition of 30 kHz, standby; S3. The film solution is coated on a plastic film, and the wet film thickness is controlled to be about 200 µm using a doctor blade. After coating, the wet film is placed in a forced air drying oven at 55°C for drying. The dried film (the thickness of the dried film is 100±10 µm) is peeled off from the plastic film to obtain a nicotine oral film; S4. The outer layer 1, the middle layer (the nicotine oral film), and the outer layer 2 are combined in sequence by hot pressing, and strawberry patterns are printed and strawberry shapes are cut, and packaged, to obtain the finished product, i.e. the nicotine interlayer oral film. Figure 1 The hot pressing parameters are: 50°C, 0.4 MPa pressure, hot pressing for 2-3 s, to ensure that the bonding force between the non-woven fabric and the nicotine oral film is ≥0.2 N / cm. The size of the strawberry shape designed in this embodiment is such that the nicotine interlayer oral film contains a nicotine dose of 6 mg / piece.
[0021] Example 2: Strawberry-flavored nicotine interlayer oral film The difference from Example 1 is that the outer layer 2 is replaced by: HPMC (hydroxypropyl methyl cellulose) non-woven fabric (the soluble part accounts for 60%), which is a degradable non-woven fabric.
[0022] Examples 3-8 The difference from Example 1 is that the specific types and amounts of nicotine salt, plasticizer, flavoring agent, and film-forming material used in the preparation process are different, and the drying temperature is different, as shown in Table 1.
[0023] Table 1 Component amount and preparation process of examples 3-8 Comparative examples 1-6 The difference from example 1 is that the specific type and amount of plasticizer, film-forming material used in the preparation process, and the drying temperature are different, specifically as shown in Table 2.
[0024] Table 2 Component amount and preparation process of comparative examples 1-6 Performance test: Select 140 consumers, divided into 14 groups, each group of 10 people, respectively, contain oral nicotine interlayer film products of examples 1, 2-8 and comparative examples 1-6, and carry out sensory evaluation when taking, evaluation index see table 3, test results as shown in table 4.
[0025] Results: from examples 1-8, the product prepared by the application has good appearance, and can be well dissolved in the oral cavity after containing; while the oral film prepared by comparative examples 1-6 has poor appearance than examples due to different process, high content of film-forming material, slow dissolution; low content of film-forming material, soft film; high content of plasticizer, high hardness; low plasticizer, film not shaped; while high drying temperature, easy to melt; low drying temperature, too high moisture, not shaped.
[0026] Table 3 Evaluation index Note: [2, 5) min indicates greater than or equal to 2 and less than 5 min, [5, 7) min indicates greater than or equal to 5 and less than 7 min, [7, 10) min indicates greater than or equal to 7 and less than 10 min.
[0027] Table 4 Evaluation results
Claims
1. A method of making a nicotine interlayer oral film, characterized by, The method comprises the following steps: S1. Take 3-15 parts by mass of a nicotine salt aqueous solution, add 10-25 parts by mass of a plasticizer, 1-2.5 parts by mass of a flavoring agent, and an appropriate amount of a colorant, and add water to make up to a total system of 30-40 parts by mass, and stir to obtain a mixed solution; S2. Add 60-70 parts by mass of a film-forming material to the mixed solution, stir to obtain a uniform continuous film liquid, control the viscosity to be 8000-50000 mpa.s, and remove air bubbles by ultrasonic treatment; S3. The film liquid is coated into a film, dried at 50-60°C, and a nicotine oral film is obtained; S4. The outer layer 1, the nicotine oral film, and the outer layer 2 are overlapped in sequence by hot pressing, and then are cut and shaped to obtain a nicotine sandwich oral film; the outer layer 1 is a hydrophobic polypropylene non-woven fabric, and the outer layer 2 is a degradable water-jet cellulose non-woven fabric or an HPMC non-woven fabric.
2. The method of claim 1, wherein, The nicotine salt aqueous solution is prepared by mixing nicotine and an organic acid in a molar ratio of 1:1 and dissolving in water, and the organic acid is tartaric acid, lactic acid, malic acid, citric acid, benzoic acid, gluconic acid, acetic acid, acetylpropionic acid, salicylic acid, or sorbic acid.
3. The method of claim 2, wherein, The nicotine content in the nicotine salt aqueous solution is 40% by mass.
4. The method of claim 1, wherein, The plasticizer is at least one of glycerol, polyethylene glycol, propylene glycol, and Tween 80.
5. The method of claim 1, wherein, The flavoring agent is at least one of edible essence, mint essence, strawberry essence, cherry essence, litchi essence, lemon essence, citronella essence, grape essence, and sweet orange essence.
6. The method of claim 1, wherein, The film-forming material is one or a combination of two of hydroxypropyl methylcellulose, polyvinyl alcohol, hydroxypropyl cellulose, polyvinylpyrrolidone, and polyoxyethylene.
7. The method of claim 1, wherein, The ultrasonic treatment is performed at 20-40 kHz, and the hot pressing is performed at 45-60°C and a pressure of 0.3-0.5 MPa for 2-3 s to make the bonding force between the non-woven fabric and the nicotine oral film be greater than or equal to 0.2 N / cm.
8. The method of claim 1, wherein, The nicotine content of the nicotine sandwich oral film is 1-30 mg per tablet.
9. The method of claim 1, wherein, The method comprises the following steps: S1. Take 5 parts by mass of a tartaric acid nicotine salt aqueous solution, add 16 parts by mass of glycerol, 1 part by mass of strawberry essence, and an appropriate amount of a colorant, and add water to make up to a total system of 30 parts by mass, and stir to obtain a mixed solution; S2. Add 45 parts by mass of hydroxypropyl methylcellulose and 25 parts by mass of polyvinyl alcohol to the mixed solution, stir to obtain a uniform continuous film liquid, control the viscosity to be 8000-50000 mpa.s, and remove air bubbles by ultrasonic treatment under the condition of 30 kHz; S3. The film liquid is coated into a film, the wet film thickness is controlled to be 200 µm, and the film is dried at 55°C to obtain a nicotine oral film; S4. The outer layer 1, nicotine oral film, outer layer 2 three layers are overlapped in turn and are imprinted by hot pressing method, and are cut into shapes, to obtain a nicotine sandwich oral film; the outer layer 1 is a hydrophobic polypropylene non-woven fabric, the outer layer 2 is a degradable water-jet cellulose non-woven fabric; the parameters of the hot pressing are as follows: 50 DEG C, 0.4 MPa pressure, hot pressing for 2-3 s, so that the bonding force of the non-woven fabric and the nicotine oral film is greater than or equal to 0.2 N / cm.
10. The nicotine sandwich oral film prepared by the method according to any one of claims 1-9.