Wiping agents and wiping products

Abstract

This application discloses a wiping agent and a wiping product. The wiping agent of this application is a volatile composition at room temperature; the wiping agent includes a volatile solvent and functional substances; wherein, the functional substances are dissolved or uniformly dispersed in the volatile solvent to form a wiping agent system; the functional substances include active substances; the wiping agent provides the active substances to the user through evaporation. The wiping agent of this application can meet the usage needs of multiple sites, and is suitable for diverse sites such as the philtrum, tip of the tongue, and inner wall of the mouth, ensuring the flexibility of use in different scenarios; the wiping agent of this application provides active substances through evaporation, and the release rate of active substances can be controlled by adjusting the evaporation rate, and the dosage of active substances can be flexibly adjusted to meet the usage needs of different dosage groups, solving the problem of lack of dosage adjustment flexibility.

Description

Technical Field

[0001] This application relates to the field of wiping sustained-release active substances technology, and in particular to a wiping agent and wiping product. Background Technology

[0002] Traditional cigarettes rely on combustion to release nicotine, along with harmful byproducts such as tar and carbon monoxide. This not only harms the user's respiratory system but also poses a threat to the health of those around them through secondhand smoke. Furthermore, their use is severely limited by smoking bans. Among alternatives to traditional cigarettes, electronic atomizing devices have received widespread attention and use. However, while electronic atomizing devices do not require combustion, they rely on batteries to power the atomizer, resulting in issues such as inconvenience in carrying the device, strong dependence on charging, and easy wear and tear on the atomizer. Moreover, the amount of nicotine released is affected by fluctuations in the device's power, leading to poor stability.

[0003] Other similar nicotine-releasing products, such as nicotine patches and nicotine gum, all have their own drawbacks and shortcomings. Nicotine patches work through skin penetration, but their release rate is slow, typically requiring 30-60 minutes to reach an effective blood concentration. This makes them unable to quickly relieve the user's nicotine cravings. Furthermore, the application sites for patches are limited to flat areas of skin such as the torso and outer upper arms, which can easily cause skin allergies, redness, and other discomfort with prolonged use. In addition, the dosage of nicotine patches is fixed, such as 21mg / patch or 14mg / patch, and cannot be flexibly adjusted according to the user's tolerance.

[0004] Nicotine gum requires continuous chewing to promote nicotine release. It has a monotonous taste and is prone to irritating the oral mucosa. The release time is short, only 1-1.5 hours, making it extremely unsuitable for patients with oral diseases or users who do not like chewing products.

[0005] In summary, existing products cannot meet the needs of multi-site application, rapid release, and adjustable dosage, and therefore cannot meet the needs of different user groups. Summary of the Invention

[0006] The purpose of this application is to provide a new wiping agent and wiping product.

[0007] To achieve the above objectives, this application adopts the following technical solution:

[0008] This application discloses a wiping agent, which is a volatile composition at room temperature; the wiping agent includes a volatile solvent and a functional substance; wherein the functional substance is dissolved or uniformly dispersed in the volatile solvent to form a wiping agent system; the functional substance includes an active substance; the wiping agent provides the active substance to the user through evaporation.

[0009] In this application, volatile solvents refer to solvents that are easily volatilized at room temperature. The wiping agent system of this application is generally volatile at room temperature. In some implementations, the wiping agent of this application can evaporate 80%~98% or 95%~98% within 60 seconds.

[0010] It should be noted that the wipe of this application is suitable for diverse areas such as the philtrum, tip of the tongue, and inner lining of the mouth, ensuring flexibility of use in different scenarios and better meeting the needs of multiple application sites. The wipe of this application delivers active substances to the user through evaporation, such as nicotine or nicotine salts, making it convenient to use, for example, in scenarios where operation is inconvenient, such as driving or meetings. Furthermore, the release rate of the active substance can be controlled by adjusting the evaporation rate, solving the problems of insufficient release speed and convenience. In addition, the dosage of the active substance in the wipe of this application can be flexibly adjusted to meet the needs of different dosage groups, solving the problem of lack of dosage adjustment flexibility. In summary, the wipe of this application solves the problems of existing products being unsuitable for multiple application sites and lacking dosage adjustment flexibility, meeting the needs of various groups and ensuring safe use. The active substances in the wipe of this application, such as nicotine, can be released rapidly and have a long-lasting effect. The evaporation rate and duration are consistent for each batch of products, and the process is stable and controllable. Even for different groups of people and different application sites, the wipe can evaporate quickly and persistently, solving the problem that traditional products cannot simultaneously meet the needs of different groups and multiple application sites.

[0011] This application also discloses a wiping product containing the wiping agent of this application.

[0012] It should be noted that the key to the wiping product of this application lies in its containing the wiping agent of this application. This gives the wiping product advantages such as applicability to multiple application sites, flexible dosage adjustment, rapid release, long-lasting effect, stable process, and good product consistency, while simultaneously meeting the usage needs of different groups and different application sites. It can be understood that the wiping product of this application applies the wiping agent to the application site through wiping, and then the wiping agent provides active substances to the user through evaporation. Specifically, existing wiping solutions and their application devices can be referenced, and no specific limitations are made here.

[0013] Due to the adoption of the above technical solutions, the beneficial effects of this application are as follows:

[0014] The wiping agent of this application can meet the application needs of multiple sites, and is suitable for various sites such as the philtrum, the tip of the tongue, and the inner wall of the mouth, ensuring the flexibility of use in different scenarios. The wiping agent of this application provides active substances through evaporation, and the release rate of active substances can be controlled by adjusting the evaporation rate. Moreover, the dosage of active substances can be flexibly adjusted to meet the usage needs of people with different dosages, thus solving the problem of lack of dosage adjustment flexibility. Detailed Implementation

[0015] Existing nicotine-releasing products generally fail to meet the requirements for multi-site application, rapid release, and adjustable dosage. Therefore, this application develops a new nicotine-releasing product, namely the wipe-off agent of this application, which is a volatile composition at room temperature. The wipe-off agent includes a volatile solvent and functional substances. The functional substances are dissolved or uniformly dispersed in the volatile solvent to form a wipe-off agent system. The functional substances include active substances. The wipe-off agent provides the active substances to the user through evaporation.

[0016] It is understood that although the wiping agent of this application is developed for the release of nicotine, the way it provides active substances through the volatilization of the wiping agent is not limited to the release of nicotine, but can also be used for the release of other active substances, thereby meeting different usage needs.

[0017] In some implementations, the functional substances, in addition to the active substances, also include at least one of the following: sustained-release thickener, color developer, antioxidant, solvent polarity modifier, solvent evaporation rate modifier, surfactant, and pH adjuster.

[0018] In some implementations, when the functional substance includes a color developer, it also includes a stabilizer to prevent the color developer from fading.

[0019] In some implementations, the colorimetric agent includes at least one of bromocresol green, acid-base indicators, complexation reaction colorimetric agents, and natural plant extract colorimetric agents.

[0020] In some implementations, the acid-base indicator is at least one of phenolphthalein, methyl orange, methyl red, and bromothymol blue.

[0021] In some implementations, the complexation reaction chromogenic agent is at least one of Alizarin Red S and o-phenanthroline.

[0022] In some implementations, the natural plant extract color developer is at least one of anthocyanins and curcumin.

[0023] It should be noted that bromocresol green ethanol solution is the colorimetric reagent used in one implementation of this application, which has the advantages of high sensitivity and stable color development; however, other colorimetric reagents suitable for the wiping agent formulation of this application may also be used, such as acid-base indicators: phenolphthalein, methyl orange, methyl red, bromothymol blue, etc., or complexation reaction type colorimetric reagents: alizarin red S, o-phenanthroline, etc., or natural plant extract colorimetric reagents: anthocyanins, curcumin, etc.

[0024] In some implementations, the stabilizer includes at least one of disodium EDTA, phytic acid, vitamin C, sodium ascorbate, ascorbyl palmitate, tea polyphenols, resveratrol, tert-butyl-p-hydroxyanisole, di-tert-butyl-p-cresol, sodium sulfite, and sodium metabisulfite.

[0025] It should be noted that the stabilizer in this application serves to prevent the color developer from oxidizing and fading. Disodium ethylenediaminetetraacetate (EDTA 2Na) is a specific reagent used in one implementation of this application to prevent the color developer from oxidizing and fading, and it has the advantages of strong metal chelating ability and high stability. However, this application may also use other pharmaceutical or cosmetic grade adjuvants with antioxidant or metal ion chelating effects, such as phytic acid, ascorbic acid and its salts (vitamin C, sodium ascorbate, ascorbate palmitate), tea polyphenols, resveratrol, tert-butyl-p-hydroxyanisole (BHA), di-tert-butyl-p-cresol (BHT), sulfites (sodium sulfite, sodium metasulfite), etc. These components can be used alone or in combination to effectively delay the oxidation and fading of the color developer and maintain the color development stability.

[0026] In some implementations, the sustained-release thickener is at least one of hydroxypropyl β-cyclodextrin, β-cyclodextrin, methyl β-cyclodextrin, xanthan gum, pectin, sodium alginate, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, and gelatin; or, the sustained-release thickener is a combination of a reagent with sustained-release function and a reagent with thickening function, wherein the reagent with sustained-release function includes at least one of polyethylene glycol, high molecular weight polyvinylpyrrolidone, silica gel microparticles, and microcrystalline cellulose, and the reagent with thickening function includes at least one of xanthan gum, sodium carboxymethyl cellulose, sodium alginate, and guar gum.

[0027] It should be noted that the function of a slow-release thickener is to prevent the wiping agent from evaporating too quickly. Therefore, a combination of a reagent with slow-release function and a reagent with thickening function can achieve the same effect.

[0028] In some implementations, antioxidants include at least one of phenolic antioxidants, vitamin and its derivative antioxidants, polyphenolic natural extract antioxidants, sulfite antioxidants, and metal chelating agents.

[0029] It should be noted that the antioxidant in this application mainly inhibits the degradation of active substances and easily oxidized components in the formulation; therefore, pharmaceutical or cosmetic grade antioxidants that can play this role are applicable to this application.

[0030] In some implementations, phenolic antioxidants include at least one of vitamin E, tert-butyl-p-hydroxyanisole, di-tert-butyl-p-cresol, and ferulic acid.

[0031] In some implementations, vitamin and its derivative antioxidants include at least one of vitamin E, vitamin C, sodium ascorbate, and ascorbyl palmitate.

[0032] In some implementations, the polyphenolic natural extract oxidant includes at least one of tea polyphenols, resveratrol, and quercetin.

[0033] In some implementations, sulfite antioxidants include at least one of sodium sulfite and sodium metasulfite.

[0034] In some implementations, the metal chelating agent includes at least one of disodium ethylenediaminetetraacetate and phytic acid.

[0035] In some implementations, the solvent polarity modifier includes at least one of deionized water, distilled water, ultrapure water, propylene glycol, glycerol, butylene glycol, aqueous citric acid solution, aqueous lactic acid solution, and phosphate buffer.

[0036] It should be noted that the role of the solvent polarity modifier is to increase the solubility of nicotine and other components. Generally, non-toxic solvents containing hydroxyl groups are suitable for this application, including but not limited to deionized water, distilled water, ultrapure water, propylene glycol, glycerol, butylene glycol, citric acid aqueous solution, lactic acid aqueous solution, and phosphate buffer.

[0037] In some implementations, the solvent evaporation rate regulator includes at least one of the following:

[0038] (1) At least one of glycerol, propylene glycol, butylene glycol, and sorbitol;

[0039] (2) At least one of polyethylene glycol and triethylene glycol;

[0040] (3) At least one of propylene glycol monostearate and isopropyl myristate;

[0041] (4) At least one of dipropylene glycol and hexanediol.

[0042] It should be noted that the role of solvent evaporation rate regulators is mainly to achieve controlled release by increasing or decreasing the evaporation rate of the solvent system; therefore, pharmaceutical or cosmetic grade adjuvants that can achieve the same or similar effects are applicable to this application. Among them, category (1) mainly includes polyols suitable for regulating the solvent evaporation rate of this application, category (2) mainly considers their low volatility to help regulate the solvent evaporation rate, category (3) mainly includes fatty acid esters suitable for regulating the solvent evaporation rate of this application, and category (4) mainly utilizes their moisturizing or lubricating activities to regulate the solvent evaporation rate. It can be understood that the above classification is not a strict organic chemical classification, but only a classification made for different perspectives or different ways of controlling the solvent evaporation rate of this application.

[0043] In some implementations, propylene glycol, for example, 1,3-propanediol, can be used.

[0044] In some implementations, polyethylene glycol, such as PEG 200 and PEG 400, is used.

[0045] In some implementations, the surfactant is at least one of nonionic surfactants, amphoteric surfactants, and low-irritation anionic surfactants.

[0046] It should be noted that nonionic surfactants are used in one implementation of this application because they have low irritation to skin and mucous membranes, a wide pH range, and good compatibility with active substances, such as nicotine, and the formulation system, ensuring safety and stability for use on multiple sites. Other types of mild surfactants, such as amphoteric surfactants (cocamidopropyl betaine, etc.) or low-irritation anionic surfactants (sodium lauroyl glutamate, etc.), can also be used in this application, as long as they meet the requirements of low irritation, high compatibility, and formulation stability.

[0047] In some implementations, the nonionic surfactant is at least one of Tween-20, Tween-80, polysorbates, fatty alcohol polyoxyethylene ethers, polyoxyethylene hydrogenated castor oil, polyethylene glycol monostearate, sorbitan monooleate, and sorbitan trioleate.

[0048] It should be noted that Tween-20 is used in one implementation of this application. It is just a commonly used and mild nonionic surfactant. Other pharmaceutical or cosmetic grade nonionic surfactants can also be used in this application, such as Tween-80, polysorbates (such as Polysorbate 40, Polysorbate 60), fatty alcohol polyoxyethylene ethers (such as Ceteareth-20, Oleth-10), polyoxyethylene hydrogenated castor oil (PEG-40 Hydrogenated Castor Oil), polyethylene glycol monostearate (PEG-100 Stearate), sorbitan monooleate, sorbitan trioleate, etc., which can be used alone or in combination according to the formulation requirements.

[0049] In some implementations, the amphoteric surfactant is cocamidopropyl betaine.

[0050] In some implementations, the low-irritant anionic surfactant is sodium lauroyl glutamate.

[0051] In some implementations, the pH adjuster is at least one of citric acid, lactic acid, malic acid, tartaric acid, phosphoric acid, acetic acid, ascorbic acid, sodium hydroxide, potassium hydroxide, sodium bicarbonate, triethanolamine, phosphate buffer, and citrate buffer.

[0052] It should be noted that citric acid is a pH adjuster specifically used in one implementation method of this application, which has high safety and moderate buffering capacity; however, this application may also use other acidic or alkaline adjusting agents suitable for pharmaceutical or cosmetic formulations, such as: organic acids such as lactic acid, malic acid, tartaric acid, phosphoric acid, acetic acid, and ascorbic acid; alkaline adjusting agents such as sodium hydroxide, potassium hydroxide, sodium bicarbonate, and triethanolamine; and buffer systems such as phosphate buffer and citrate buffer. These components can be used alone or in combination to achieve the optimal pH range and stability of the wiping agent under different environments.

[0053] In some implementations, the active substance includes at least one of nicotine, nicotine salts, and caffeine.

[0054] In some implementations, the volatile solvent includes at least one of anhydrous ethanol, isopropanol, butanol, benzyl alcohol, acetone, and ethyl acetate.

[0055] It should be noted that the volatile solvents used in this application generally only need to be volatile at room temperature and non-toxic. However, considering practicality and user acceptance, anhydrous ethanol, isopropanol, butanol, benzyl alcohol, acetone, ethyl acetate, etc. are preferred.

[0056] In some implementations, the wiping agent of this application comprises 1-2 parts by weight of an active substance, 55-70 parts by weight of a volatile solvent, 10-15 parts by weight of a solvent polarity modifier, 5-10 parts by weight of a slow-release thickener, 0.6-1.8 parts by weight of a surfactant, 3.4-6.2 parts by weight of a solvent evaporation rate modifier, and 0.07-0.2 parts by weight of an antioxidant.

[0057] In some implementations, when a color developer and a stabilizer are included, the amount of color developer is 0.2-0.6 parts by weight, and the amount of stabilizer is 0.08-0.2 parts by weight.

[0058] In some implementations, when a pH adjuster is included, the amount of the pH adjuster is 0.8-2.2 parts by weight.

[0059] In some implementations, the wiping agent of this application is placed in a container and left to stand. Under normal temperature conditions of 25℃±1℃ and relative humidity of 60±5%, the wiping agent evaporates by 80%~98% within 60 seconds. In some implementations, the wiping agent can evaporate by 95%~98% within 60 seconds.

[0060] Based on the wiping agent of this application, this application further developed a wiping product containing the wiping agent of this application.

[0061] In some implementations, the wiping product includes a light-proof container and the wiping agent of this application, which is placed inside the light-proof container.

[0062] The present application will be further described in detail below through specific embodiments. The following embodiments are only for further illustration of the present application and should not be construed as limiting the present application.

[0063] Example 1

[0064] I. Core Formula

[0065] The wipe formulation for this example is shown in Table 1.

[0066] Table 1

[0067] nicotine 1.5g Active substances Anhydrous ethanol 65g Volatile solvents Deionized water 15g Solvent polarity modifier Bromocresol Green 0.4g color developer Hydroxypropyl β-cyclodextrin 10g Slow-release thickener Citric acid 1.8g pH adjuster Twain-20 1.2g surfactants Propylene glycol 4.8g Solvent evaporation rate regulator Disodium ethylenediaminetetraacetate 0.2g Stabilizer to prevent color developer from fading Vitamin E 0.1g antioxidants

[0068] II. Preparation Method

[0069] 1. Solvent system preparation

[0070] Weigh 65g of anhydrous ethanol and 15g of deionized water, reserving 15mL of anhydrous ethanol. Add the rest of the ethanol and deionized water to a constant temperature stirring jar. Set the stirring speed to 350r / min and stir at room temperature for 6min to form a uniform and transparent solvent base.

[0071] 2. Dissolution and addition of colorimetric components

[0072] Weigh 0.4 g of bromocresol green, add 15 mL of reserved anhydrous ethanol, and stir with a pipette until completely dissolved to prepare a 0.5 mol / L bromocresol green ethanol solution; add the above colorimetric solution and 1.8 g of citric acid to a stirring jar in sequence, maintain a speed of 350 r / min, stir for 12 min until the citric acid is completely dissolved and the system is uniformly pale yellow.

[0073] 3. Addition of auxiliary functional components and stabilizers

[0074] Add 10g of hydroxypropyl β-cyclodextrin, 1.2g of Tween-20, 4.8g of propylene glycol, 0.2g of EDTA-2Na, and 0.1g of vitamin E. Increase the stirring speed to 450 rpm and stir for 18 minutes. Observe the system; no layering or precipitation is observed, forming a homogeneous and transparent reagent stock solution. Then, while stirring at 450 rpm, slowly add 1.5g of weighed nicotine. After the addition is complete, maintain the stirring speed and continue stirring for 20-25 minutes until the nicotine is completely dissolved, and the system is a homogeneous, transparent, light green solution.

[0075] 4. Filtration and purity control

[0076] Turn off the mixing tank and filter the stock solution through a 0.22μm organic phase filter membrane under reduced pressure to remove trace impurities. Take 5mL of the filtrate and test it with a pH meter to ensure that the pH is between 2.8 and 3.8. If it deviates, adjust it to the qualified level with 0.1mol / L citric acid solution or 0.1mol / L sodium hydroxide solution.

[0077] 5. Finished product packaging

[0078] Use aseptic filling equipment to fill qualified stock solution into brown, light-proof PET bottles (50mL / bottle or 100mL / bottle), with a filling volume error of ≤±0.5mL; the outer packaging should be labeled with the production date, shelf life (18 months) and instructions for use.

[0079] The wiping agent prepared in this example has the following advantages:

[0080] ① Versatile testing for multiple areas: It can be used on oral contact surfaces (such as nipples, tableware edges), skin contact surfaces (such as mobile phone cases, door handles), and small areas around the philtrum (such as the inside of masks, parts of scarves), and it does not damage or corrode different materials (plastic, fabric, metal, silicone).

[0081] ② Highly efficient and accurate detection: It completely evaporates without residue in 20-50 seconds after wiping, and develops color within 30 seconds. The detection sensitivity for nicotine is 0.006 mg / mL, with an accuracy of ≥99.2%. It has no cross-reaction with nicotine analogues (nornicotine).

[0082] III. Experimental Verification

[0083] 1. Multi-site applicability verification experiment

[0084] (1) Experimental objective

[0085] The differences in the onset speed and absorption efficiency of the volatile nicotine wipe of this invention at four different sites—the philtrum, the tip of the tongue, the inner wall of the mouth, and the nasal cavity—demonstrate its advantages in multi-route administration.

[0086] (2) Experimental methods

[0087] Participant selection: 40 healthy adult volunteers, including 10 non-smokers, 15 light smokers, and 15 heavy smokers. All participants signed informed consent forms.

[0088] Test sites and usage methods:

[0089] Philtrum (skin): Apply 0.3 mL of the wiping solution to the skin surface of the philtrum area;

[0090] Tongue tip (oral mucosa): Apply 0.3 mL to the tongue tip with a cotton swab;

[0091] Inner lining of the mouth (buccal mucosa): Apply 0.3 mL to the inner lining of the left buccal mucosa with a cotton swab;

[0092] Nasal cavity (nasal vestibule mucosa + respiratory tract): Apply 0.3 mL to the inner side of the nasal vestibule with a cotton swab, while allowing the subject to breathe naturally to increase the inhalation of volatile gases.

[0093] (3) Detection indicators

[0094] Onset time: Record the time when the subject reports "nicotine sensation".

[0095] Changes in plasma nicotine concentration: Blood collection time points were 0 min (baseline), 1 min, 3 min, 5 min, and 10 min.

[0096] Detection method: LC-MS / MS

[0097] Site tolerance: the incidence of discomfort reactions such as irritation, redness, and swelling.

[0098] (4) Experimental conditions

[0099] The room temperature was 25℃±1℃, and the relative humidity was 60%±5%. Subjects were prohibited from consuming foods / drinks containing caffeine or nicotine for 2 hours before the test.

[0100] The experimental results are shown in Table 2.

[0101] Table 2

[0102] nasal cavity 1.2 ± 0.3 +6.1 ± 1.0 7.8 ± 1.2 8% (transient stimulation) tip of the tongue 1.6 ± 0.4 +5.4 ± 1.1 7.2 ± 1.0 5% Inner wall of the oral cavity 1.8 ± 0.4 +5.0 ± 1.0 6.9 ± 0.9 3% philtrum 2.8 ± 0.6 +3.9 ± 0.8 5.2 ± 0.8 2%

[0103] 2. Nicotine dissolution test

[0104] (1) Experimental objective

[0105] This study validates the nicotine release characteristics of the volatile nicotine wipe under simulated respiratory pathways and mucosal / skin contact environments. The results are compared with commercially available nicotine pouches (VELO SHIFT-318706184), e-cigarette liquid (AM-EU-03MG-30ML-MINT), and nicotine gum (Sweden, NC-SWE-2MG-20PCS-MINT) to evaluate release rate, total release amount, and release curve stability, demonstrating the advantages of this invention in rapid onset and high utilization.

[0106] (2) Experimental materials and equipment

[0107] Samples: This example contains volatile nicotine wipes (6 mg / 0.3 mL), nicotine pouches (commercially available, nominally 6 mg / piece), e-liquid (6 mg / mL), and nicotine gum (6 mg / pie).

[0108] Reagents:

[0109] Method 1: Deionized water (respiratory pathway collection solution);

[0110] Method 2: pH 7.4 phosphate buffered saline (PBS) containing 0.5% SDS (simulating the mucosal environment).

[0111] Instruments: Fume extractor (adjustable airflow rate 15 L / min) (Borgwaldt, Germany, model: RM20H, part number: BY2026-SM01), dissolution apparatus (USP II paddle method, 37±0.5℃, rotation speed 50 rpm) (Agilent, model: Vankel VK7025, part number: TT2026-RC08), HPLC system (C18 column, mobile phase: acetonitrile-phosphate buffer pH 3.0 (70:30), detection wavelength 260 nm).

[0112] (3) Experimental methods

[0113] Method 1: Using a smoking machine to simulate the breathing pathway

[0114] Place the sample at the interface of the smoking machine:

[0115] Wiping agent: Apply 0.3 mL to a medical cotton pad and fix it to the interface;

[0116] Nicotine pouch: Place directly;

[0117] E-liquid: Insert into the atomizer connection interface;

[0118] The smoking machine is set to an airflow rate of 15 L / min to draw aerosols or vapors into a collection bottle containing 50 mL of deionized water.

[0119] Samples of 5 mL were taken at 10, 20, 30, and 60 seconds, and the nicotine concentration was determined by HPLC.

[0120] Each time a sample is taken, an equal amount of fresh medium is replenished.

[0121] Method 2: Direct dissolution experiment

[0122] Add 50 mL of preheated pH 7.4 PBS to 37°C to the dissolution vessel.

[0123] Place the sample in the medium and start the paddle stirrer (50 rpm).

[0124] Samples of 5 mL were taken at 10, 20, 30, and 60 seconds, filtered through a 0.22 μm filter membrane, and then analyzed by HPLC.

[0125] Each time a sample is taken, an equal amount of fresh medium is replenished.

[0126] (4) Data Analysis

[0127] Cumulative release rate (%) = [\frac{\text{detected concentration} \times \text{medium volume}}{\text{total nicotine content}} \times 100].

[0128] The cumulative release amount and release rate were compared, n=3, Mean ± SD, and the results are shown in Table 3.

[0129] Table 3

[0130] 10 1.92 ±0.05 / 32.00% 1.75 ±0.06 / 29.17% 1.80 ±0.05 / 30.00% 0.78 ±0.03 / 13.00% 0.90 ±0.04 / 15.00% 20 3.45 ±0.07 / 57.50% 3.20 ±0.08／53．33％ 3.25±0.07／54．17％ 1.95±0.05／32.50％ 2.10±0.06／35.00％ 30 4.65±0.09／77.50％ 4.40±0.09／73.33％ 4.50±0.08／75.00％ 3.30±0.06／55.00％ 3.25±0.07／54.17％ 60 5.85±0.11／97.50％ 5.70±0.10／95.00％ 5.75±0.10／95.83％ 4.82±0.09／80.33％ 4.85±0.08／80.83％

[0131] (5) Experimental conclusions

[0132] ① Comparison of release rates

[0133] In this case, the wipe exhibited the fastest initial release rate under both test conditions, reaching approximately 75-78% in 30 seconds, significantly higher than the approximately 54-56% of nicotine pouches and chewing gum.

[0134] E-liquid is similar to the wipe in this example through the inhalation pathway, but requires an atomizer; the wipe in this example can achieve a similar speed without additional hardware.

[0135] ② Total release

[0136] In this example, the cumulative release rate of the wipe reached 95-98% after 60 seconds, which is higher than that of nicotine pouches and chewing gum (approximately 80%), and slightly better than that of e-liquid.

[0137] ③Sudden release control

[0138] The release curves at all time points were smooth, with no instantaneous release exceeding 40%; especially in the first 20 seconds, the swab maintained a stable increasing trend, which helped avoid discomfort caused by a sudden increase in blood drug concentration.

[0139] ④ Summary of technical advantages

[0140] The wiping agent in this example has the combined advantages of being suitable for multiple areas, having a rapid onset of action, and having a high overall utilization rate.

[0141] It offers respiratory efficiency comparable to or even slightly better than e-cigarettes, while providing multi-scenario flexibility that solid formulations cannot achieve; compared to solid products, it provides higher bioavailability in a short time, helping to quickly relieve nicotine cravings.

[0142] IV. Results Analysis

[0143] This volatile nicotine wipe demonstrates significant advantages in terms of applicability to multiple sites, absorption efficiency, and dissolution rate. Multi-site validation shows that the product can be rapidly released and absorbed through four pathways: nasal inhalation and penetration, the tongue and oral mucosa, and the skin of the philtrum. The nasal and oral mucosa routes show the fastest onset of action, approximately 1.2–1.8 minutes, while the philtrum route, although slightly slower, is still significantly superior to traditional patches. Dissolution comparison experiments show that, at the same nicotine content, this wipe achieves approximately 75% release rate within 30 seconds in both the respiratory and mucosal simulated environments, and 95–98% within 60 seconds, significantly higher than the approximately 80% release rate of nicotine pouches and chewing gum. Furthermore, the release curve is stable without sudden release. In summary, this wipe achieves rapid onset of action, high overall utilization rate, flexible use in multiple scenarios, and stable and controllable release characteristics, significantly outperforming existing non-combustible nicotine products.

[0144] Example 2

[0145] Based on the formulation in Table 1 of Example 1, this example further tested the dosage of each component and designed corresponding comparative tests. The wiping agent formulations for each test and comparative test are shown in Table 4.

[0146] Table 4

[0147] nicotine 1g 2g 1g 0.5g 1g 1g Anhydrous ethanol 70g 55g 70g 70g 70g 70g Deionized water 10g 15g 15g 15g 15g 15g Bromocresol Green 0.5g 0.6g 0.2g 0.6g 0.6g 0.6g Hydroxypropyl β-cyclodextrin 10g 10g 5g 5g 4.5g 5g Citric acid 0.8g 2.2g 2.2g 2.2g 2.2g 2.2g Twain-20 1.6g 1.8g 0.6g 0.6g 0.6g 0.6g Propylene glycol 5.7g 6.2g 3.4g 3.4g 3.4g 3g Disodium ethylenediaminetetraacetate 0.2g 0.2g 0.08g 0.08g 0.08g 0.08g Vitamin E 0.2g 0.2g 0.07g 0.07g 0.07g 0.07g

[0148] The wipes for Tests 1 to 3 and Comparative Tests 1 to 3 were prepared using the same method as in Example 1, and were tested and verified using the same method as in Example 1. The results showed that all six volatile nicotine wipes could be used on multiple sites. The wipes for Tests 1 to 3 were rapidly released and absorbed through four pathways: nasal inhalation and penetration, the mucous membranes of the tongue and oral cavity, and the skin of the philtrum. The nasal and oral mucosa routes showed the fastest onset of action, approximately 1.2–1.8 minutes, while the philtrum route was slightly slower, consistent with the results of Example 1. Dissolution experiments showed that the wipes for Tests 1 to 3 achieved a release rate of approximately 75% within 30 seconds in both the respiratory and mucosal simulated environments, and a release rate of 95–98% within 60 seconds, with stable release curves and no sudden release. In summary, the wipes for Tests 1 to 3 achieved rapid onset of action, high overall utilization rate, flexible use in multiple scenarios, and stable and controllable release characteristics, significantly superior to existing non-combustible nicotine products.

[0149] In Comparison 1, the nicotine dosage was lower, resulting in a slightly lower release rate, onset speed, and overall utilization rate compared to Tests 1 through 3. Comparison 2, with its lower hydroxypropyl β-cyclodextrin dosage, exhibited a poorer sustained-release thickening effect, leading to a lower overall viscosity of the wiping agent, a faster evaporation rate, and a burst release phenomenon in its release curve. Similarly, Comparison 3, with its lower propylene glycol dosage, also resulted in a faster evaporation rate and a burst release phenomenon in the wiping agent.

[0150] In summary, the wiping agent prepared according to the following weight ratios—1-2 parts by weight of active substance, 55-70 parts by weight of volatile solvent, 10-15 parts by weight of solvent polarity modifier, 0.2-0.6 parts by weight of color developer, 5-10 parts by weight of slow-release thickener, 0.8-2.2 parts by weight of pH adjuster, 0.6-1.8 parts by weight of surfactant, 3.4-6.2 parts by weight of solvent evaporation rate modifier, 0.08-0.2 parts by weight of stabilizer, and 0.07-0.2 parts by weight of antioxidant—has advantages such as rapid onset of action, high total utilization rate, flexible application scenarios, stability, and controllable release.

[0151] The above description, in conjunction with specific embodiments, provides a further detailed explanation of this application and should not be construed as limiting the specific implementation of this application to these descriptions. Those skilled in the art to which this application pertains can make several simple deductions or substitutions without departing from the concept of this application.

Claims

1. A wiping agent, characterized in that: The wiping agent is a composition that is volatile at room temperature; The wiping agent includes volatile solvents and functional substances; The functional substances are dissolved or uniformly dispersed in the volatile solvent to form a wiping agent system; the functional substances include active substances; The wiping agent delivers the active substance to the user through evaporation.

2. The wiping agent according to claim 1, characterized in that: The functional substances also include at least one of the following: slow-release thickener, color developer, antioxidant, solvent polarity modifier, solvent evaporation rate modifier, surfactant, and pH adjuster.

3. The wiping agent according to claim 2, characterized in that: When the functional substance includes the color developer, the functional substance also includes a stabilizer, which is used to prevent the color developer from fading. And / or, the colorimetric agent includes at least one of bromocresol green, acid-base indicator, complexation reaction type colorimetric agent, and natural plant extract colorimetric agent; Optionally, the acid-base indicator is at least one of phenolphthalein, methyl orange, methyl red, and bromothymol blue; Optionally, the complexation reaction type colorimetric agent is at least one of alizarin red S and o-phenanthroline; Optionally, the natural plant extract color developer is at least one of anthocyanins and curcumin; Optionally, the stabilizer includes at least one of disodium EDTA, phytic acid, vitamin C, sodium ascorbate, ascorbyl palmitate, tea polyphenols, resveratrol, tert-butyl-p-hydroxyanisole, di-tert-butyl-p-cresol, sodium sulfite, and sodium metabisulfite.

4. The wiping agent according to claim 2, characterized in that: The sustained-release thickener is at least one of hydroxypropyl β-cyclodextrin, β-cyclodextrin, methyl β-cyclodextrin, xanthan gum, pectin, sodium alginate, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, and gelatin. Alternatively, the sustained-release thickener is composed of a combination of a reagent with sustained-release function and a reagent with thickening function, wherein the reagent with sustained-release function includes at least one of polyethylene glycol, high molecular weight polyvinylpyrrolidone, silica microparticles, and microcrystalline cellulose, and the reagent with thickening function includes at least one of xanthan gum, sodium carboxymethyl cellulose, sodium alginate, and guar gum. And / or, the antioxidant includes at least one of phenolic antioxidants, vitamin and its derivative antioxidants, polyphenolic natural extract antioxidants, sulfite antioxidants, and metal chelating agents; Optionally, the phenolic antioxidant includes at least one of vitamin E, tert-butyl-p-hydroxyanisole, di-tert-butyl-p-cresol, and ferulic acid; Optionally, the vitamin and its derivative antioxidants include at least one of vitamin E, vitamin C, sodium ascorbate, and ascorbyl palmitate; Optionally, the polyphenolic natural extract oxidant includes at least one of tea polyphenols, resveratrol, and quercetin; Optionally, the sulfite antioxidant includes at least one of sodium sulfite and sodium metasulfite; Optionally, the metal chelating agent includes at least one of disodium ethylenediaminetetraacetate and phytic acid.

5. The wiping agent according to claim 2, characterized in that: The solvent polarity modifier includes at least one of deionized water, distilled water, ultrapure water, propylene glycol, glycerol, butylene glycol, citric acid aqueous solution, lactic acid aqueous solution, and phosphate buffer. And / or, the solvent evaporation rate regulator includes at least one of glycerol, propylene glycol, butylene glycol, sorbitol, polyethylene glycol, triethylene glycol, propylene glycol monostearate, isopropyl myristate, dipropylene glycol, and hexanediol.

6. The wiping agent according to claim 2, characterized in that: The surfactant is at least one of nonionic surfactants, amphoteric surfactants, and low-irritation anionic surfactants; Optionally, the nonionic surfactant is at least one of Tween-20, Tween-80, polysorbates, fatty alcohol polyoxyethylene ethers, polyoxyethylene hydrogenated castor oil, polyethylene glycol monostearate, sorbitan monooleate, and sorbitan trioleate. Optionally, the amphoteric surfactant is cocamidopropyl betaine; Optionally, the low-irritant anionic surfactant is sodium lauroyl glutamate.

7. The wiping agent according to claim 2, characterized in that: The pH adjuster is at least one of citric acid, lactic acid, malic acid, tartaric acid, phosphoric acid, acetic acid, ascorbic acid, sodium hydroxide, potassium hydroxide, sodium bicarbonate, triethanolamine, phosphate buffer, and citrate buffer. And / or, the active substance includes at least one of nicotine, nicotine salts, and caffeine; And / or, the volatile solvent includes at least one of anhydrous ethanol, isopropanol, butanol, benzyl alcohol, acetone, and ethyl acetate.

8. The wiping agent according to any one of claims 2-7, characterized in that: The wiping agent comprises 1-2 parts by weight of active substance, 55-70 parts by weight of volatile solvent, 10-15 parts by weight of solvent polarity modifier, 5-10 parts by weight of slow-release thickener, 0.6-1.8 parts by weight of surfactant, 3.4-6.2 parts by weight of solvent evaporation rate modifier and 0.07-0.2 parts by weight of antioxidant; And / or, when the wiping agent is placed in a container and left to stand at room temperature of 25℃±1℃ and relative humidity of 60±5%, 80%~98% of the wiping agent evaporates within 60 seconds.

9. A wiping product, characterized in that: It contains the wiping agent according to any one of claims 1-8.

10. The wiping product according to claim 9, characterized in that: The wiping product includes a light-proof container and the wiping agent, with the wiping agent placed inside the light-proof container.