WO2010150930A1

WO2010150930A1 - Fast dissolving film for oral administration which prevents unpleasant taste effectively

Info

Publication number: WO2010150930A1
Application number: PCT/KR2009/003451
Authority: WO
Inventors: 박진규; 양원석; 정경태
Original assignee: (주)벡스코아
Priority date: 2009-06-25
Filing date: 2009-06-25
Publication date: 2010-12-29

Abstract

The present invention relates to a fast dissolving film for oral administration which dissolves rapidly in the mouth, and more particularly, to a fast dissolving film for oral administration which comprises a stevioside-based sweetener and an intense sweetener with the ratio (w/w) of 1:3 to 3:1. The fast dissolving film for oral administration of the present invention prevents the unpleasant taste of drugs effectively and has an effect of improving the aftertaste of drugs, and patients can dissolve the film rapidly in the mouth without water and thus the compliance of patients in taking medication can be improved.

Description

[Revision 22.07.2009] by Rule 26 Oral generic film effectively concealing unpleasant taste

The present invention relates to a film for oral use effectively concealing an unpleasant taste, more specifically, stevioside-based sweeteners and high sweeteners are contained in a ratio (w / w) of 1: 3-3: 1, drug It effectively masks the unpleasant taste of, and relates to the oral film for oral use, which enhances the patient's dose compliance, that is, the after-improving effect that can be dissolved quickly in the oral cavity without water.

The recent increase in lifespan has increased the social composition of the elderly population, which requires deterioration of vision, hearing, memory and physical ability as well as pharmacokinetic changes. In particular, there is a difficulty in taking general tablets or capsules, and in view of these, alternative preparations of oral administration agents for the elderly are required.

Because the disintegrating film easily disintegrates or dissolves in the mouth, it can be taken without water, so it is very useful for children with disabilities, patients lying in bed, and busy modern people, as well as elderly people who have difficulty taking tablets or capsules. to be. While it is possible to prescribe liquid solutions in place of tablets or capsules for the elderly and children, liquid formulations have the disadvantage of poor stability and inaccurate dosage.

In particular, when the drug is absorbed into the oral mucosa, the liver can also be avoided, so the fast-release film can be applied to drugs that are highly metabolized among the drugs absorbed from the digestive tract.

However, the film formulations that dissolve easily in the oral cavity absorb the drug through the oral mucosa, and therefore, a method of shielding the taste and discomfort upon absorption of the drug is required.

International Publication No. WO 2001/70194 prepared a fast dissolving oral consumption film by adsorbing an active ingredient to an ion exchange resin as a taste blocker. However, the ion exchange resin is included in the water-soluble polymer, there is a risk of scratching during molding and the operation is complicated.

WO 2003/070227 masks the taste by containing a carbon dioxide forming material such as sodium bicarbonate. In the case of sodium bicarbonate, a drug with a strong bitter taste has a limit on concealment.

International Publication WO 2008/040534 discloses a film formulation that does not adhere to the oral mucosa and disintegrates and is swallowed up. However, in this case, since the manufacturing method is used to prevent the absorption of the oral mucosa as much as possible, the manufacturing method is complicated, and effects such as gastrointestinal tract protection through oral absorption cannot be obtained.

US 2008/0044454 discloses a uniform film by coating an active material using various coating techniques and injecting it into a film former. This also makes the coating process cumbersome.

The present inventors have tried to solve the above disadvantages, as a result of using aspartame, acesulfame potassium, sucralose, neotime in combination with stevioside and its derivatives to mask the bitter and unpleasant taste without significant change in the manufacturing method Could.

That is, the present inventors solved the problems of the prior art, and as a result of research to develop the most preferred form of the active ingredient-containing oral film, as a result of the high sweetness sweetener is particularly known as steviosides and derivatives thereof By co-administration with a high sweetening sweetener, it was found that the unpleasant taste can be effectively shielded without a separate coating process, and completed the present invention.

Accordingly, it is an object of the present invention to provide an oral fast-acting film containing a therapeutically effective amount of a medically active ingredient, steviosides and stevioside derivatives, and at least one high sweetener, film former and one or more pharmaceutically acceptable additives. It is.

Another object of the present invention is to provide an oral cavity film that effectively masks the unpleasant taste of a therapeutically effective amount of a medically active ingredient and dissolves quickly in the oral cavity.

The present invention has been made in order to achieve the above object, at least one water-soluble polymer, at least one medical active ingredient, stevioside-based sweetener as a tail enhancer, and at least one high sweetener as a taste blocker (first sweetener) It provides an oral rapid use film comprising a.

Oral quick-release film of the present invention is not only excellent in the unpleasant taste blocking effect, but also can be easily produced by a low cost and simplified recipe, oral cleansers, bad breath removers, nutritional supplements for oral and gastrointestinal tract cleaning It can be usefully used as a snow-soluble agent for the absorption of the drug in.

1 is a diagram showing the results of comparative dissolution experiments of oral fast-acting film prepared according to Example 9 at pH 1.2 and the control drug (zofran tablet, GlaxoSmithKline, 8 mg).

2 is a sweetness profile of each kind of high sweetener (first sweetener) according to an embodiment of the present invention. According to Figure 2, the sweetness expression rate is slow in the order of acesulfame potassium (ACK), aspartame (AST), stevioside (STS).

The present invention relates to an oral cavity film composition containing a pharmaceutically active ingredient, effectively masking an unpleasant taste and dissolving rapidly in the oral cavity.

Preferred fast-acting films according to the present invention comprise a pharmaceutical active agent, stevioside and / or stevioside derivatives, one or more high sweetener (first sweetener), a film former and one or more of the following additional ingredients.

The additional components consist of pharmaceutically acceptable additives such as saliva stimulants, thickeners, fillers, plasticizers, second sweeteners, acidulants, flavors, emulsifiers, surfactants, binders, preservatives, colorants, coolants and the like. The components are described in detail as follows.

In the present invention, a drug having a high taste and a high sweetener (first sweetener) and stevioside and its derivatives which improve the aftertaste are dissolved in water or oil, emulsified and mixed with a water-soluble polymer and other additives to form a rapid film.

The fast-drying film of this invention contains the 1st sweetener which is a high sweetness sweetener.

In one embodiment, the high sweetening sweetener (first sweetener) is in the group consisting of aspartame, acesulfame salt, sucralose, saccharin salt, neotime, cyclate salt, tau martine, Nahan fruit extract, licorice extract It may be one or more high sweetening sweeteners selected. More preferably, at least one high sweetener sweetener selected from aspartame, sucralose, neotime, acesulfame salts.

In the case of drugs with a strong unpleasant taste, especially sweet and unpleasant tastes are strongly felt at the rear, and when used together with 0.1 to 10% by weight of stevioside-based sweeteners, that is, stevioside and / or derivatives thereof, the taste and unpleasant taste are Can be shielded.

Specific examples of stevioside include stevittenite (over 98% stevioside), stevitenrich (100% enzymatically treated stevia) and stevia extract REB-A73% (rebaudioside A 73% or more) produced by Daepyung ), And the like.

In the above, the enzyme-treated stevia is a product in which glucose is added to the stevia extract by using a sugar transfer enzyme, which is a microporous improvement product that reduces the intrinsic bitter taste of stevioside and enhances solubility. In addition, the stevia extract REB-A 73% is the highest sweetness and excellent sweetness of the seven sweet components of stevia, is produced through a separate separation operation in stevia.

As shown in FIG. 2, the maximum sweetness of the high-sweetness sweetener over time is expressed in acesulfame potassium first, and the maximum sweetness is expressed in the order of aspartame, sucralose and stevioside. Therefore, steviosides with a late sweetness are preferred for the control of the unpleasant taste that is felt when the drug is absorbed and left in the oral cavity.

Oral rapid-release film of the present invention contains a water-soluble polymer.

The water-soluble polymer is pullulan, gelatin, pectin, low viscosity pectin, hydroxypropyl methyl cellulose, low viscosity hydroxypropyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinyl alcohol, polyacrylic acid, Methyl methacrylate copolymer, carboxyvinyl polymer, polyethylene glycol, alginic acid, low viscosity alginic acid, sodium alginate, carrageenan, modified starch, casein, whey protein isolate, soy protein isolate, zein, levan, elcinane, gluten, acacia At least one water-soluble polymer selected from the group consisting of gums, carrageenan, gum arabic, guar gum, locust bean gum, xanthan gum, gellan gum and agar. Preferably, the water-soluble polymer may be at least one water-soluble polymer selected from the group consisting of pullulan, gelatin, pectin, low viscosity pectin, low viscosity alginic acid, hydroxypropylmethylcellulose and modified starch.

The water-soluble polymer may contain 50 to 90% by weight, preferably 60 to 80% by weight, and more preferably 60 to 70% by weight, based on the total weight of the flux film.

The pharmacologically active ingredient used in the rapid-release film of the present invention may be a pharmacologically active ingredient orally administered, but particularly, a drug capable of quickly exhibiting medicinal effects by exhibiting rapid dissolution is preferable. Antidiabetic agents such as, for example, glimepiride, pioglitazone, and the like; Agents for treating insomnia such as zolpidem, eszopiclone and the like; Urogenital therapeutics such as tolterodine, tropium and the like; Anti-obesity agents such as sibutramine and the like; Enzymes such as streptokinase and the like; Peptic ulcer solvents such as omeprazole; Antitussive expectorants such as theophylline, glenbuterol and the like; Skin disease treatment agents such as finasteride and the like; Antiemetic agents such as ondansetron; Antidepressants such as fluoxetine and the like; Antihistamines such as fexofenadine hydrochloride; Antipyretic analgesic agents such as aspirin, ibuprofen, ketoprofen, meloxycam and the like; Hormonal agents such as testosterone and the like; Therapeutic agents for circulatory organs such as felodipine, atorvastatin, ammodidicamramic acid, doxazosin, simvastatin, lercanidipine and the like; Therapeutic agents for the digestive system such as famotidine, ranitidine, lansoprazole and the like; Cardiovascular agents such as amlodipine, nitroglycerin, and the like: mental neurological agents such as paroxetine and the like; Erectile dysfunction agents such as sildenafil, tadalafil, vardenafil and the like; Alzheimer's therapies, such as donepezil and the like: osteoporosis agents; Arthritis agents; Epilepsy treatments; Muscle relaxants; Brain function improvers; Schizophrenic agents; Immunosuppressants; Antibiotics such as ampicillin and amoxicillin; Anticancer agents; Anticancer adjuvant; Vaccines; Mouthwashes; Anemia treatment agents; Constipation therapy; Allergy treatment: anticoagulant: oral vaccine: melatonin: vitamin; Nutrients; Lactic acid bacteria preparations; Comprehensive cold medicine; Or health functional foods.

The pharmaceutically active ingredient is triclosan, cetyl pyridium chloride, domiphen bromide, quaternary ammonium salt, zinc compound, acid guinarin, fluoride, alexidine, octonidine, EDTA, aspirin, acetaminophen, ibuprofen, ketoprofen, Diflunisal, Phenopropenecalcium, Naproxen, Tolmethinine Sodium, Indomethacin, Benzonatate, Caramiphene, Edsylate, Menthol, Dextromerophane, Hydrobromide, Hydrochloride, Cropedanol, Diphenhydra Min, pseudoephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine sulfate, brompheniramine maleate, chlorpheniramine maleate, carbinoxamine maleate, clemastine fumarate, dexchlorpheniramine maleate, diphene Hydramine hydrochloride, diphenhydramine citrate, diphenylpyraline hydrochloride, doxylamine succinate, promethazine Drochloride, Pyrylamine Maleate, Tripelinamine Citrate, Triprolidine Hydrochloride, Acribastine, Loratadine, Bromfenyramine, Dexbromfenyramine, Guapefensin, Ifecac, Calcium Iodide , Terpinhydrate, loperamide, pamotidine, ranitidine, omeprazole, lansoprazole, aliphatic alcohol, nicotine, caffeine, strikinin, picrotoxin, pentylenetetrazole, phenyhydrantoin, phenobarbital, primidone, carr Bamzepine, Ethosuccimid, Metsuccimid, Pensuccimid, Trimmethadione, Diazepam, Benzodiazepines, Penacemide, Penethuride, Acetazolamide Sultiam, Bromydrevodopa, Amantadine, Morphine, Heroin, Hydromortin , Methopone, oxymorphone, levorpanone, codeine, hydrocondon, gycodone, nalnorphine, naloxone, naltrexone, salicylate. Phenylbutyrate, indomethacin, phenacetin, chlorpromazine, methotreeprazine, haloperidon, clozapine, reserpin, imiprazine, tranilcip, lomine, phenelzin, iridium, apomorphine, sildenafil, One selected from the group consisting of tadanafil, vardenafil, zolpidem tartrate, bambuterol hydrochloride, galantamine chloride, galcarmine dipine, paroxetine hydrochloride, meloxycamp, tolteridine tartarate and doxazosin mesylate The above components may be used.

The active ingredient may contain 0.1 to 30% by weight, preferably 10 to 20% by weight, based on the total weight of the flux film.

The filler serves to reduce the slippery properties of the film in the oral cavity and to impart a backbone to the film. It also reduces the sticking properties of the films, and can control the sticking and dissolution rate of the film in the oral cavity and the dissolution rate of the drug. The filler may be added in an amount of 1 to 15% by weight based on the total weight of the flux film.

In one embodiment, the filler may be one or more components selected from the group consisting of microcrystalline cellulose, cellulose polymers, magnesium carbonate, calcium carbonate, limestone powder, silicates, clays, talc, titanium dioxide and calcium phosphate.

The plasticizer can be used to adjust the flexibility of the film. The plasticizer may be added in an amount of 0.1 to 15 wt% based on the total weight of the flux film.

In one embodiment, the plasticizer is at least one selected from the group consisting of sorbitol, maltitol, xylitol, glycerin, polyethylene glycol, propylene glycol, hydrogenated syrup, syrup, glycerin, triacetin, glycerololate, sucrose fatty acid ester, and medium chain fatty acid. It may be a component.

The fastener film of the present invention may include a second sweetener. The second sweetener may be added 0.1 to 10% by weight based on the total weight of the edible film.

In one embodiment, the sweetener is selected from the group consisting of sugar, glucose, maltose, oligosaccharides, dextrin, invert sugar, fructose, lactose, galactose, syrup, sorbitol, maltitol, xylitol, erythritol, hydrogenated syrup, mannitol, and trehalose It may be one or more components.

The oral rapid release film of the present invention may also further comprise an acidulant. The acidulant, together with the sweetener, controls the taste and may play a role in stimulating the generation of saliva so that the edible film can be dissolved well. The acidulant may be added in an amount of 0.1 to 10% by weight based on the total weight of the flux film composition.

In one embodiment, the acidulant may be at least one component selected from the group consisting of citric acid, malic acid, fumaric acid, tartaric acid, ascorbic acid, succinic acid, adipic acid and lactic acid.

The oral rapid release film of the present invention may also contain a fragrance. Since the rapid-release film of the present invention is a product that is dissolved and absorbed in the oral cavity, it is necessary to add an appropriate scent. The flavor may be natural flavors, artificial flavors or mixtures thereof.

Natural flavors may be extracts from the leaves, flowers, fruits and the like of plants, oils of plants and the like. Plant oils include spearmint oil, cinnamon oil, peppermint oil, lemon oil, clove oil, bay oil, thyme oil, cedar leaf oil, nutmeg oil and sage ( sage) oil, almond oil, and the like. In addition, artificial flavors of fruits, such as lemons, oranges, grapes, limes, strawberries and artificial synthetic flavors such as vanilla, chocolate, coffee, cocoa, pine needles, ginseng, red ginseng, citrus may be used.

The amount of fragrance used depends on a number of factors such as the type, type, and desired strength of the fragrance that is commonly used, and may generally comprise 1 to 15% by weight relative to the total weight of the generic film.

Perfume in oil form may be used together with an emulsifier to make it compatible with water-soluble substances. The amount of the emulsifier may be adjusted according to the type and amount of the fragrance, and in general, 0.1 to 10% by weight based on the total weight of the film for the flux.

In one embodiment, the emulsifier may be at least one component selected from the group consisting of glycerin fatty acid ester, sucrose fatty acid ester, lecithin, enzyme treated lecithin, polysorbate, sorbitan fatty acid ester and propylene glycol.

In addition, the oral film for oral use of the present invention may contain a pigment suitable for the product. The pigment may be appropriately adjusted in its content as needed, and generally 0.01 to 10% by weight based on the total weight of the edible film. The pigment may be a natural or synthetic pigment.

The oral rapid release film of the present invention may also further comprise a freshener. The coolant may be, for example, but not limited to, WS3, WS23 or Questais-L. The freshener can be appropriately adjusted in its content as needed, and generally can be added in an amount of 0.01 to 5% by weight, based on the total weight of the film for fastening.

The present invention also provides a flux film comprising the oral flux film composition.

The oral rapid-release film of the present invention will preferably form a thin film that maintains an appropriate range of tensile strength and toughness in a very thin film state. As one embodiment, the thickness of the rapid-release film of this invention is 20 micrometers-200 micrometers, Preferably it is 40 micrometers-100 micrometers.

The present invention also provides a method for producing the oral flux film.

In one embodiment, the method for producing a rapid-release film of the present invention

(1) preparing a fast-acting film composition comprising the active ingredient, two kinds of high sweetener, and a water-soluble polymer;

(2) putting the edible film composition into a molding machine to mold the film at 50 to 80 ° C;

(3) may comprise aging the molded film at a relative humidity of 50 to 70% for 1 to 10 days.

The method for producing an edible film according to the present invention can be carried out through, for example, the following process.

(1) crude liquid process

a) First solution manufacturing process: Each of the water-soluble polymers is completely dissolved in boiling water.

b) 2nd solution manufacturing process: The 2nd solution which mixed additives, such as a pigment, a sweetener, an acidulant, and a filler, is prepared.

c) 3rd solution manufacturing process: The 3rd solution is prepared by mixing an active ingredient, menthol, a fragrance, and a freshener with an emulsifier.

d) 4th solution manufacturing process: The 4th solution is prepared by mixing the said 2nd solution and the said 3rd solution.

e) 5th solution manufacturing process: It raises the temperature to 60 degreeC or more, and mixes the said 1st solution and the said 4th solution, and manufactures a 5th solution.

(2) forming process

The fifth solution is filtered and then introduced into a molding machine to form a film. At this time, the temperature of the molding machine is 50 to 80 ℃ and manufactured in roll form through a belt drum dryer.

(3) Aging process

The molded film contains moisture suitable for slitting or cutting through a aging process of about 1 to 10 days at a relative humidity of 50 to 70%. At this time, the water content is appropriately 8 to 12%.

The following process may be further performed as a subsequent process of the manufacturing method.

(4) cutting process

The aged rolls are slits into small rolls, cut into appropriate sizes and filled into small containers or aluminum wrappers.

(5) Packing process

Filled small containers or aluminum bags are repackaged in small boxes or blistered into products.

By this method, in the present invention, regardless of whether or not the application of a special coating technology of the active ingredient, it is possible to produce a quick-release film shielding the unpleasant taste only by the addition of stevioside and stevioside derivatives.

In addition, the rapid-release film prepared by the method of the present invention is rapidly disintegrated and dissolved by saliva in the oral cavity without eating extra water, and thus can be easily administered to patients or elderly and children who have difficulty in swallowing tablets.

Hereinafter, the present invention will be described in more detail by the following examples. However, the following examples are only for illustrating the present invention, and the scope of the present invention is not limited thereto.

Meloxycam was added as a pharmaceutically active ingredient to prepare a film according to the composition shown in Table 1 below.

This was put in the mouth of six adult men and women, the time when the film was completely disintegrated by the saliva of the oral cavity and the sensory test was performed. Sensory tests were performed randomly, which is described in Table 2 below.

Table 1

As a result of performing the sensory test as described above, there was no significant difference in oral disintegration time between the composition (Comparative Examples 1, 2, 3) without the stevioside and derivatives thereof (Examples 1, 2, 3). However, the degree of masking bitterness was confirmed that the composition containing the stevioside was more excellent, which is described in Table 2 below.

Aspartame and starch oxide were used by Daesang Co., Ltd., Acesulfame potassium was manufactured by Nutrinova, Sucralose was produced by Tate & Lyle, Carrageenan was manufactured by MSC, and Polysorbate was manufactured by Ilshin Wells. The product, pullulan was used by Hayashibara, and peppermint oil and lemon by Borax.

TABLE 2

The type of water-soluble polymer was changed, and meloxycamp was added as an active ingredient to prepare a film according to the compositions of Tables 3 and 4.

This was put in the mouth of six adult men and women was measured the time that the film is completely disintegrated by the saliva of the oral cavity, and the sensory test was performed. Sensory tests were performed randomly and are described in Table 5 below.

TABLE 3

Table 4

As a result of performing the sensory test as described above, oral disintegration time according to the type of water-soluble polymer was not significantly different, it was confirmed that the degree of masking bitter taste is also excellent, which is described in Table 5 below.

Low viscosity pectin is CIPIKELCO's GENU pectin DSS, gelatin is Geltech's 100 Bloom product, hydroxypropylmethylcellulose is Demasa's demacol HE 5/6 BV, low viscosity alginic acid is MSC's login, hydroxypropyl starch Grain Processing Corp. used the product.

Table 5

Zolpidem tartrate, galantamine chloride bromide, tadalafil, lercanidipine, and donepezil were added as pharmaceutically active ingredients to prepare films according to the compositions shown in Table 6. The composition from which steviosides are removed is shown in Table 7.

Films were prepared according to the compositions described in Tables 6 and 7, and placed in the mouths of six adult men and women, the time at which the film completely disintegrated by the saliva of the oral cavity was measured, and the sensory test was performed. Sensory tests were performed randomly and are described in Table 8 below.

Table 6

TABLE 7

As a result of performing the sensory test as described above, there was no significant difference in oral disintegration time according to the type of active ingredient, it was confirmed that the degree of masking the aftertaste after 1 minute addition of stevioside was also excellent, which is shown in Table 8 below. Described.

Table 8

A comparative elution experiment was carried out on the granfran tablet of GlaxoSmithKline (GSK), a commercially available formulation containing ondansetron fast-acting film prepared according to Example 9 of the present invention, at pH 1.2, according to the Food and Drug Administration's notification. 1 is shown. As shown in the accompanying drawings, there was no dissolution difference between the two formulations, and in terms of dose compliance, the oral rapid-use film of the present invention effectively shielding unpleasant taste was better.

Oral quick-release film of the present invention is not only excellent in the unpleasant taste blocking effect, but also can be easily produced by a low cost and simplified recipe, so that oral cleansers, bad breath removers, nutritional supplements for oral cleanliness and oral and gastrointestinal tract It can be usefully used as a snow-soluble agent for the absorption of the drug.

Claims

An oral fast-acting film comprising at least one water-soluble polymer, at least one medically active ingredient, a stevioside-based sweetener as a tail enhancer, and at least one first sweetener as a taste blocker.

According to claim 1, wherein the stevioside-based sweetener is oral fast-use film, characterized in that at least one selected from the group consisting of steviosides, enzymatic decomposition steviosides, rebaudioside A and high content products thereof.

The method of claim 1, wherein the first sweetener is at least one selected from the group consisting of aspartame, acesulfame salt, neotime, sucralose, taumartin, saccharin, licorice extract, neohesperidine and monelin. Dragon film.

The method according to claim 1, wherein the stevioside-based sweetener and the first sweetener, each containing 0.1 to 10% by weight, and the stevioside-based sweetener and the first sweetener in a ratio of 1: 3 to 3: 1, based on the total weight of the rapid-release film. Oral fast-use film, characterized in that contained (w / w).

The method of claim 1, wherein the water-soluble polymer is pullulan, gelatin, pectin, low viscosity pectin, hydroxypropyl methyl cellulose, low viscosity hydroxypropyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, poly Vinyl alcohol, polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl polymer, polyethylene glycol, alginic acid, low viscosity alginic acid, sodium alginate, modified starch, casein, whey protein isolate, soy protein isolate, zein, levan, elcinan Oral, gluten, acacia gum, carrageenan, gum arabic, guar gum, locust bean gum, xanthan gum, gellan gum and agar for oral use, characterized in that at least one selected from the group consisting of agar.

The method of claim 5, wherein the water-soluble polymer is at least one selected from the group consisting of pullulan, gelatin, low viscosity pectin, low viscosity alginic acid, and low viscosity hydroxymethylcellulose.

According to claim 1, wherein the medical active ingredient is a diabetes treatment agent; Insomnia therapy; Urogenital therapy; Obesity treatment; Enzymes; Peptic ulcer solvents; Antitussive expectorants; Skin disease treatments; Antiemetic agent; Antidepressants; Antihistamines; Antipyretic analgesic agents; Hormonal preparations; Circulatory therapy; Treatments for the digestive system; Mental neurological agents; Erectile dysfunction treatment; Osteoporosis therapeutics; Arthritis agents; Epilepsy treatments; Muscle relaxants; Brain function improvers; Schizophrenic agents; Immunosuppressants; Antibiotic; Anticancer agents; Anticancer adjuvant; Vaccines; Mouthwashes; Anemia treatment agents; Constipation therapy; vitamin; Nutrients; Lactic acid bacteria preparations; Comprehensive cold medicine; And oral film for oral, characterized in that at least one selected from the group consisting of health functional food.

The method according to claim 7, wherein the active ingredient is triclosan, cetyl pyridium chloride, domiphen bromide, quaternary ammonium salt, zinc compound, acid guinarine, fluoride, alexidine, octonidine, EDTA, aspirin, acetaminophen, ibuprofen , Ketoprofen, diflunisal, phenopropene calcium, naproxen, tolmethine sodium, indomethacin, benzonatate, caramiphene, edylate, menthol, dextrose metropan, hydrobromide, hydrochloride, croissant Fedianol, diphenhydramine, pseudoephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine sulfate, bromfenyramine maleate, chlorpheniramine maleate, carbinoxamine maleate, clemastine fumarate, dexchlorphenir Amine Maleate, Diphenhydramine Hydrochloride, Diphenhydramine Citrate, Diphenylpyraline Hydrochloride, Doxylamine Succine , Promethazine Hydrochloride, Pyrylamine Maleate, Tripelinamine Citrate, Triprolidine Hydrochloride, Acribastine, Loratadine, Bromfenyramine, Dexbromfenyramine, Guapenesine, Ife Cock, calcium iodide, terpinhydrate, loperamide, pamotidine, ranitidine, omeprazole, lansoprazole, aliphatic alcohol, nicotine, caffeine, strikinin, picrotoxin, pentylenetetrazole, phenihidantoin, phenobarbital , Primidone, carbamazepine, ethosuccimid, metsuccimid, pensuccimid, trimmedadione, diazepam, benzodiazepines, phenacemid, peneturide, acetazolamidesultiam, bromidevodopa, amantadine, morphine, Heroin, hydromortin, methopone, oxymorphone, levorpanone, codeine, hydrocondon, gycodone, nalnorphine, naloxone, naltrexone, salicylate. Phenylbutyrate, indomethacin, phenacetin, chlorpromazine, methotreeprazine, haloperidon, clozapine, reserpin, imiprazine, tranilcip, lomine, phenelzin, iridium, apomorphine, sildenafil, One selected from the group consisting of tadanafil, vardenafil, zolpidem tartrate, bambuterine hydrochloride, galantamine chloride, galcarmine dipine, paroxetine hydrochloride, meloxycamp, tolteridine tartarate and doxazosin mesylate Oral rapid-use film, characterized in that above.

According to claim 1, wherein the rapid release film for oral use, characterized in that it further comprises one or more additives.

10. The method according to claim 9, wherein the additive is at least one component selected from the group consisting of a filler, a plasticizer, a second sweetener, an acidulant, a flavoring agent, an emulsifier, a coloring agent and a refreshing agent.

11. The method of claim 10, wherein said filler is at least one selected from the group consisting of microcrystalline cellulose, cellulose polymers, magnesium carbonate, calcium carbonate, limestone powder, silicates, clays, talc, titanium dioxide and calcium phosphate. Commercial film.

The method of claim 10, wherein the plasticizer is one selected from the group consisting of sorbitol, maltitol, xylitol, glycerin, polyethylene glycol, propylene glycol, hydrogenated syrup, starch syrup, glycerin, triacetin, glycerol oleate, sucrose fatty acid ester and medium chain fatty acid. Oral rapid-use film, characterized in that above.

The method of claim 10, wherein the second sweetener consists of sugar, glucose, maltose, oligosaccharides, dextrin, invert sugar, fructose, lactose, galactose, syrup, sorbitol, maltitol, xylitol, erythritol, hydrogenated syrup, mannitol, and trehalose Oral fast-use film, characterized in that at least one selected from the group.

11. The oral rapid-release film of claim 10, wherein the acidulant is at least one selected from the group consisting of citric acid, malic acid, fumaric acid, tartaric acid, ascorbic acid, succinic acid, adipic acid and lactic acid.

11. The method of claim 10 wherein the fragrance is a natural oral fragrance, artificial fragrance or a mixture thereof.

11. The method of claim 10, wherein the emulsifier is at least one selected from the group consisting of glycerin fatty acid esters, sucrose fatty acid esters, lecithin, enzymatically decomposed lecithin, polysorbate, sorbitan fatty acid esters and propylene glycol. film.