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

Fast dissolving film for oral administration which prevents unpleasant taste effectively Download PDF

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Publication number
WO2010150930A1
WO2010150930A1 PCT/KR2009/003451 KR2009003451W WO2010150930A1 WO 2010150930 A1 WO2010150930 A1 WO 2010150930A1 KR 2009003451 W KR2009003451 W KR 2009003451W WO 2010150930 A1 WO2010150930 A1 WO 2010150930A1
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WO
WIPO (PCT)
Prior art keywords
film
oral
sweetener
acid
group
Prior art date
Application number
PCT/KR2009/003451
Other languages
French (fr)
Korean (ko)
Inventor
박진규
양원석
정경태
Original Assignee
(주)벡스코아
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Publication date
Application filed by (주)벡스코아 filed Critical (주)벡스코아
Priority to PCT/KR2009/003451 priority Critical patent/WO2010150930A1/en
Publication of WO2010150930A1 publication Critical patent/WO2010150930A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/30—Artificial sweetening agents
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/30—Artificial sweetening agents
    • A23L27/33—Artificial sweetening agents containing sugars or derivatives
    • A23L27/36—Terpene glycosides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/70—Fixation, conservation, or encapsulation of flavouring agents
    • A23L27/79—Fixation, conservation, or encapsulation of flavouring agents in the form of films
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

Definitions

  • 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 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.
  • 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.
  • 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.
  • WO 2003/070227 masks the taste by containing a carbon dioxide forming material such as sodium bicarbonate.
  • a carbon dioxide forming material such as sodium bicarbonate.
  • sodium bicarbonate a drug with a strong bitter taste has a limit on concealment.
  • 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.
  • 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
  • the unpleasant taste can be effectively shielded without a separate coating process, and completed the present invention.
  • 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.
  • Example 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).
  • the sweetness expression rate is slow in the order of acesulfame potassium (ACK), aspartame (AST), stevioside (STS).
  • ACK acesulfame potassium
  • AST aspartame
  • STS stevioside
  • 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.
  • pharmaceutically acceptable additives such as saliva stimulants, thickeners, fillers, plasticizers, second sweeteners, acidulants, flavors, emulsifiers, surfactants, binders, preservatives, colorants, coolants and the like.
  • 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.
  • 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.
  • stevioside examples 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.
  • 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.
  • 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.
  • 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.
  • 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 fexofen
  • 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, diphen
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the method for producing a rapid-release film of the present invention is a rapid-release film of the present invention.
  • (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.
  • 2nd solution manufacturing process The 2nd solution which mixed additives, such as a pigment, a sweetener, an acidulant, and a filler, is prepared.
  • 3rd solution manufacturing process The 3rd solution is prepared by mixing an active ingredient, menthol, a fragrance, and a freshener with an emulsifier.
  • 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.
  • the fifth solution is filtered and then introduced into a molding machine to form a film.
  • the temperature of the molding machine is 50 to 80 °C and manufactured in roll form through a belt drum dryer.
  • 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.
  • the aged rolls are slits into small rolls, cut into appropriate sizes and filled into small containers or aluminum wrappers.
  • Filled small containers or aluminum bags are repackaged in small boxes or blistered into products.
  • 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.
  • Meloxycam was added as a pharmaceutically active ingredient to prepare a film according to the composition shown in Table 1 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.
  • 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.
  • 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.
  • 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.

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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

[규칙 제26조에 의한 보정 22.07.2009]　불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름[Revision 22.07.2009] by Rule 26 Oral generic film effectively concealing unpleasant taste
본 발명은 불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름에 관한 것으로, 더욱 상세하게는 스테비오사이드계 감미료와 고감미 감미료가 1:3~3:1의 비율(w/w)로 함유되어 있어, 약물의 불쾌한 맛을 효과적으로 차폐하고, 물 없이도 구강 내에서 빠르게 녹여 먹을 수 있는 후미개선 효과, 즉 환자의 복용 순응도를 높인 경구용 속용 필름에 관한 것이다.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.
최근 수명 연장으로 고령 인구의 사회적 구성비율이 증가하고 있는데, 이들 고령자들은 약물 동태학적인 변화 뿐만 아니라, 시력, 청력, 기억력 및 육체적 능력이 퇴보된 상태이기 때문에, 적절한 약물치료가 필요하다. 특히, 일반 정제나 캅셀제를 복용하는 데에 어려움을 격고 있으며, 이러한 관점에서 고령자들을 위한 경구투여제의 대체 제제가 요구된다. 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.
구강내에서 쉽게 붕해 또는 용해되는 속용필름은 물이 없이도 복용할 수 있으므로, 정제나 캅셀제를 복용하기에 어려움을 겪는 노인 뿐만 아니라, 어린이 장애자, 침대에 누워 있는 환자, 그리고 바쁜 현대인들에게도 매우 유용한 제제이다. 노인과 어린이에게 정제 또는 캅셀제의 대용으로 액제 처방이 가능하지만, 액상 제제는 안정성이 떨어지고, 용량이 정확하지 않다는 단점이 있다.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.
특히, 약물이 구강점막으로 흡수될 경우 간초회통과도 회피할 수 있으므로, 속용필름은 소화관으로부터 흡수되는 약물들 중에서, 간 대사를 많이 받는 약물들에 대해서도 적용할 수 있다.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.
그러나, 구강 내에서 쉽게 용해되는 필름 제제는 구강 점막을 통해 약물이 흡수되므로, 약물의 흡수시 고미 및 불쾌미를 차폐하는 방안이 요구된다.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.
국제공개특허 WO 2001/70194는 맛 차단제로 이온교환수지에 활성성분을 흡착시켜 속용성의 경구소모 필름을 제조하였다. 그러나, 이온교환수지가 수용성 고분자에 포함되어, 성형시 스크래취가 발생할 우려가 있고 작업이 복잡하다.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.
국제공개특허 WO 2003/070227은 탄산수소 나트륨과 같은 이산화탄소 형성물질을 함유시켜 맛을 마스킹하고 있다. 탄산수소 나트륨의 경우 쓴맛이 강한 약물에는 은폐에 한계가 있다.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.
국제공개특허 WO 2008/040534는 구강 점막에 부착되지 않고 붕해되어 위로 삼켜지는 필름 제형을 개시하고 있다. 그러나, 이 경우 구강점막의 흡수를 최대한 방지하는 제법을 사용하기 때문에 제조방법이 복잡하고, 구강흡수를 통한 위장관보호 등의 효과를 얻을 수 없다.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.
미국공개특허 US 2008/0044454는 다양한 코팅 기술을 이용하여 활성물질을 코팅하고, 이를 필름 형성제에 투입하여 균일한 필름을 제조하고 있다. 이 또한 코팅 공정이 제조를 번거롭게 한다.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.
본 발명자들은 상기 단점을 해결하기 위해 노력한 결과, 아스파탐, 아세설팜칼륨, 슈크랄로스,네오타임 중의 하나와 스테비오사이드 및 이의 유도체를 병용해 사용함으로써 제조방법의 큰 변화없이 쓴맛 및 불쾌한 맛을 차폐할 수 있었다. 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.
즉, 본 발명자들은 상기 종래기술의 문제점을 해결하고, 가장 바람직한 형태인 활성성분 함유 구강 속용 필름을 개발하고자 연구를 거듭한 결과, 고감미 감미료중 후감미가 특히 높은 스테비오사이드 및 이의 유도체를 기지의 고감미 감미료와 병용투여함으로써, 별도의 코팅공정 없이 불쾌한 맛을 효과적으로 차폐할 수 있다는 것을 발견하고, 본 발명을 완성하였다.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.
따라서, 본 발명의 목적은 치료학적 유효량의 의학적 활성성분, 스테비오사이드 및 스테비오사이드 유도체와 1종 이상의 고감미 감미료, 필름 형성제 및 하나 이상의 약제학적으로 허용 가능한 첨가제를 함유하는 경구용 속용 필름을 제공하는 것이다.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.
본 발명의 다른 목적은 치료학적 유효량의 의학적 활성성분의 불쾌한 맛을 효과적으로 차폐시키고, 구강 내에서 신속하게 용해되는 구강 속용 필름을 제공하는 것이다.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.
본 발명은 상기의 목적을 달성하기 위하여 안출된 것으로, 1종 이상의 수용성 고분자, 1종 이상의 의학적 활성성분, 후미 개선제로서 스테비오사이드계 감미료, 및 맛 차단제로서 1종 이상의 고감미 감미료(제1 감미제)를 포함하는 경구용 속용 필름을 제공한다.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.
본 발명의 경구용 속용필름은 불쾌한 맛 차단 효과가 뛰어날 뿐만 아니라, 저비용 및 단순화된 제법으로 쉽게 제조할 수 있으므로, 구강 내의 청결을 위한 구강 청정제, 구취 제거제, 영양보충물 전달제 그리고 구강 및 위장관 내에서의 약물의 흡수를 위한 설상 용해성 제제로서 유용하게 사용될 수 있다.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.
도 1은 pH 1.2에서 실시예 9에 따라 제조된 경구용 속용 필름과 대조약 (글락소스미스클라인사의 조프란정,8mg)의 비교용출 실험결과를 나타낸 도면이다.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).
도 2는 본원발명의 일 실시예에 따른 고감미 감미료(제1 감미료)의 종류별 감미 프로파일이다. 도 2에 의하면, 아세설팜 칼륨(ACK), 아스파탐(AST), 스테비오사이드(STS)의 순서대로 감미 발현속도가 늦어 진다.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).
본 발명은 의약적 활성성분을 함유하면서 불쾌한 맛을 효과적으로 차폐시키고 구강 내에서 신속하게 용해되는 구강 속용필름 조성물에 관한 것이다.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.
본 발명에 따른 바람직한 속용 필름은 제약학적 활성제, 스테비오사이드 및/또는 스테비오사이드 유도체와, 1종 이상의 고감미 감미료(제1 감미제), 필름 형성제 및 1종 이상의 하기 추가성분을 포함한다.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.
상기 추가 성분으로는 타액 자극제, 증점제, 충전제, 가소제, 제2 감미제, 산미제, 향료, 유화제, 계면활성제, 결합제, 보전제, 착색제, 냉각제 등의 약학적으로 허용가능한 첨가제로 구성된다. 상기 성분들을 자세히 설명하면 다음과 같다.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.
본 발명에서는 불쾌한 맛을 나타내는 약물과 고감미 감미료(제1 감미제)와 후미를 개선해 주는 스테비오사이드 및 이의 유도체를 물이나 오일에 용해시키고 유화시켜 수용성 고분자및 기타 첨가제와 혼합하여 속용 필름을 성형한다.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.
본 발명의 속용 필름은 고감미 감미료인 제1 감미제를 포함한다.The fast-drying film of this invention contains the 1st sweetener which is a high sweetness sweetener.
일 일실시예에서, 상기 고감미 감미료(제1 감미제)는 아스파탐, 아세설팜염, 슈크랄로스, 사카린염, 네오타임, 사이클라메이트염, 타우마틴, 나한과 추출물, 감초 추출물로 이루어진 군에서 선택되는 하나 이상의 고감미 감미료일 수 있다. 더욱 바람직하게는 아스파탐, 슈크랄로스, 네오타임, 아세설팜 염에서 선택되는 하나이상의 고감미 감미료일 수 있다. 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.
불쾌한 맛이 강한 약품의 경우에는 후미에서 특히 고미 및 불쾌한 맛이 강하게 느껴지므로, 전체중량 대비 0.1 내지 10 중량%의 스테비오사이드계 감미료 즉, 스테비오사이드 및/또는 이의 유도체를 병용하면 고미 및 불쾌한 맛을 차폐할 수 있다.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.
스테비오사이드의 구체적인 예로는 (주)대평에서 생산되는 스텐비텐라이트(스테비오사이드 98%이상), 스텐비텐 리치 (효소처리 스테비아 100%), 스테비아추출물 REB-A73%(레바우디오사이드A 73% 이상) 등을 들 수 있다.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.
상기에서, 효소처리 스테비아는 당전이 효소를 사용하여, 스테비아 추출물에 글루코스를 부가한 제품으로, 스테비오사이드의 고유한 쓴 맛을 줄이고, 용해성을 높인 미질 개선품이다. 또한, 스테비아 추출물 REB-A 73%는 스테비아의 감미성분 7가지 중 가장 감미도가 높고, 감미질이 우수한 성분으로서, 스테비아에서 별도의 분리조작을 통해 생산된다.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.
고감미 감미료의 경시 최대 감미는 도 2에서 알 수 있듯이, 아세설팜 칼륨이 제일먼저 발현이 되고, 아스파탐, 슈크랄로스, 스테비오사이드의 순으로 최대 감미가 발현된다. 따라서 약물이 구강에서 흡수되고 남았을때 느껴지는 불쾌한 맛의 제어에는 감미가 늦게 발현되는 스테비오사이드가 바람직하다.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.
본 발명의 경구용 속용 필름은 수용성 고분자를 포함한다.Oral rapid-release film of the present invention contains a water-soluble polymer.
상기 수용성 고분자는 풀루란, 젤라틴, 펙틴, 저점도 펙틴, 하이드록시프로필메틸셀룰로오스, 저점도 하이드록시프로필메틸셀룰로오스, 하이드록시에틸셀룰로오스, 하이드록시프로필 셀룰로오스, 카르복시메틸셀룰로오스, 폴리비닐알콜, 폴리아크릴산, 메틸메타크릴레이트 공중합체, 카르복시비닐 중합체, 폴리에틸렌글리콜, 알긴산, 저점도 알긴산, 알긴산 나트륨, 카라기난, 변성 전분, 카제인, 유장단백분리물, 콩단백분리물, 제인, 레반, 엘시난, 글루텐, 아카시아검, 카라기난, 아라비아 검, 구아 검, 로커스트빈 검, 잔탄 검, 겔란 검 및 아가로 이루어진 군으로부터 선택되는 하나 이상의 수용성 고분자일 수 있다. 바람직하게는, 상기 수용성 고분자는 풀루란, 젤라틴, 펙틴, 저점도 펙틴, 저점도 알긴산, 하이드록시프로필메틸셀룰로오스 및 변성 전분으로 이루어진 군으로부터 선택되는 하나 이상의 수용성 고분자일 수 있다.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.
상기 수용성 고분자는 속용 필름 전체중량 대비, 50~90 중량%, 바람직하게는 60~80 중량%, 보다 바람직하게는 60~70 중량%를 함유할 수 있다.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.
본 발명의 속용 필름에 사용되는 의약적 활성성분은 경구투여되는 약리학적 활성성분이면 가능하나, 특히 빠른 용해를 나타냄으로써, 약효를 신속히 나타낼 수 있는 약물이 바람직하다. 예를 들어, 글리메피리드, 피오글리타존 등과 같은 당뇨병 치료제; 졸피뎀, 에스조피클론 등과 같은 불면증 치료제; 톨테로딘, 트로스피움 등과 같은 비뇨생식기 치료제; 시부트라민 등과 같은 비만 치료제; 스트렙토키나제 등과 같은 효소제; 오메프라졸 등과 같은 소화성궤양용제; 테오필린, 글렌부테롤 등과 같은 진해거담제; 피나스테리드 등과 같은 피부질환치료제; 온단세트론 등과 같은 항구토제; 플루옥세틴 등과 같은 항우울제; 염산펙소페나딘 등과 같은 항히스타민제; 아스피린, 이부프로펜, 케토프로펜, 멜록시캄 등과 같은 해열진통소염제; 테스토스테론 등과 같은 호르몬제제; 펠로디핀, 아토르바스타틴, 캄실산암로디핀, 독사조신, 심바스타틴, 레르카니디핀 등과 같은 순환기용치료제; 파모티딘, 라니티딘, 란소프라졸 등과 같은 소화기관용 치료제; 암로디핀, 니트로글리세린 등과 같은 심장혈관제: 파록세틴 등과 같은 정신신경용제; 실데나필, 타다라필, 바데나필 등과 같은 발기부전치료제; 도네피질 등과 같은 알츠하이머치료제: 골다공증치료제; 관절염치료제; 간질치료제; 근육이완제; 뇌기능개선제; 정신분열증치료제; 면역억제제; 암피실린, 아목시실린 등의 항생제; 항암제; 항암치료 보조제; 백신제; 구강청결제; 빈혈치료제; 변비치료제; 알레르기치료제: 혈액응고방지제: 경구용 백신: 멜라토닌: 비타민; 영양제; 유산균제제; 종합감기약; 또는 건강기능식품 등을 포함할 수 있다.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.
상기 의약적 활성성분은 트리클로산, 세틸 피리듐클로라이드, 도미펜 브로마이드, 4차암모늄염, 아연화합물, 산귀나린, 플루오라이드, 알렉시딘, 옥토니딘, EDTA, 아스피린, 아세트아미노펜, 이부프로펜, 케토프로펜, 디플루니살, 페노프로펜칼슘, 나프록센, 톨메틴나트륨, 인도메타신, 벤조나테이트, 카라미펜, 에디실레이트, 멘톨, 덱스트로메트로판, 히드로브로마이드, 히드로클로라이드, 크로페디아놀, 디펜히드라민, 슈도에페드린, 페닐에페린, 페닐프로판올아민, 슈도에페드린설페이트, 브롬페니르아민말레이트, 클로르페니르아민말레이트, 카르비녹사민말레이트, 클레마스틴푸마레이트, 덱스클로르페니르아민말레이트, 디펜히드라민히드로크로라이드, 디펜히드라민시트레이트, 디페닐피랄린히드로클로라이드, 독실아민숙시네이트, 프로메타진히드로클로라이드, 피릴아민말레이트, 트리펠렌아민시트레이트, 트리프롤리딘히드로클로라이드, 아크리바스틴, 로라타딘, 브롬페니르아민, 덱스브롬페니르아민, 구아이페네신, 이페칵, 칼슘요다이드, 테르핀히드레이트, 로페르아미드, 파모티딘, 라니티딘, 오메프라졸, 란소프라졸, 지방족알콜, 니코틴, 카페인, 스트리키닌, 피크로톡신, 펜틸렌테트라졸, 페니히단토인, 페노바르비탈, 프리미돈, 카르밤아제핀, 에토숙시미드, 메트숙시미드, 펜숙시미드, 트림메타디온, 디아제팜, 벤조디아제핀, 펜아세미드, 펜에투리드, 아세타졸아미드술티암, 브로마이드레보도파, 아만타딘, 몰핀, 헤로인, 히드로모르틴, 메토폰, 옥시모르폰, 레보르판온, 코데인, 히드로콘돈, 자이코돈, 날노르핀, 날록손, 날트렉손, 살리실레이트. 페닐부타적, 인도메타신, 펜아세틴, 클로르프로마진, 메토트리메프라진, 할로페리동, 클로자핀, 레세르핀, 이미프라진, 트라닐시프, 로민, 페넬진, 리듐, 아포모르핀,실데나필, 타다나필, 바데나필, 졸피뎀타르타레이트, 염산밤부테롤, 갈란타민염화브로마이드, 염산르카르니디핀, 염산파록세틴, 멜록시캄, 톨테리딘타르타레이트 및 독사조신메실레이트로 이루어진 군으로부터 선택되는 하나 이상의 성분일 수 있다.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.
상기 활성성분은 속용 필름 전체중량 대비, 0.1~30 중량%, 바람직하게는 10~20 중량%를 함유할 수 있다.  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.
상기 충전제는 구강에서 필름이 미끈거리는 특성을 감소시키고, 필름에 골격을 부여하는 역할을 한다. 또한 필름끼리 점착되는 성질도 감소시키며, 끈적거림과 구강에서의 필름의 분해속도와 약물의 용출속도를 조절할 수 있다. 상기 충전제는 속용 필름 전체중량 대비, 1 내지 15 중량% 첨가될 수 있다.  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.
한 구체예로서, 상기 충전제는 미세결정 셀룰로오스, 셀룰로스 중합체, 탄산마그네슘, 탄산칼슘, 석회석 가루, 실리케이트, 점토, 활석, 이산화티타늄 및 인산칼슘으로 이루어진 군으로부터 선택되는 하나 이상의 성분일 수 있다.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.
상기 가소제는 필름의 유연성을 조절할 때 사용될 수 있다. 가소제는 속용 필름 전체중량 대비, 0.1 내지 15 중량% 첨가될 수 있다.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.
한 구체예로서, 상기 가소제는 솔비톨, 말티톨, 자일리톨, 글리세린, 폴리에틸렌글리콜, 프로필렌글리콜, 수첨 물엿, 물엿, 글리세린, 트리아세틴, 글리세롤올레이트, 자당 지방산에스테르 및 중쇄 지방산으로 이루어진 군으로부터 선택되는 하나 이상의 성분일 수 있다.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.
본 발명의 속용 필름은 제2 감미제를 포함할 수 있다. 상기 제2 감미제는 식용 필름 전체중량 대비, 0.1~10 중량% 첨가될 수 있다.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.
한 구체예로서, 상기 감미제는 설탕, 포도당, 말토스, 올리고당, 덱스트린, 전화당, 과당, 락토스, 갈락토스, 물엿, 솔비톨, 말티톨, 자일리톨, 에리스리톨, 수첨물엿, 만니톨, 및 트레할로스로 이루어진 군으로부터 선택되는 하나 이상의 성분일 수 있다.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.
본 발명의 경구용 속용 필름은 또한 산미제를 추가로 포함할 수 있다. 산미제는 감미제와 함께 맛을 조절하며, 식용 필름이 잘 용해될 수 있도록 침의 발생을 자극하는 역할을 할 수 있다. 상기 산미제는 속용 필름 조성물 전체중량 대비, 0.1 내지 10 중량% 첨가될 수 있다.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.
한 구체예로서, 상기 산미제는 구연산, 사과산, 푸말산, 타르타르산, 아스코르브산, 숙신산, 아디핀산 및 락트산으로 이루어진 군으로부터 선택되는 하나 이상의 성분일 수 있다.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.
본 발명의 경구용 속용 필름은 또한 향료를 포함할 수 있다. 본 발명의 속용 필름은 구강 내에서 용해시켜 흡수 되는 제품이므로 적절한 향을 가할 필요가 있다. 상기 향료는 천연 향료, 인공향료 또는 이들의 혼합물일 수 있다.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.
천연 향료는 식물의 잎, 꽃, 열매 등으로부터의 추출물, 식물의 오일 등일 수 있다. 식물의 오일은 스피어민트 오일, 계피오일, 페퍼민트 오일, 레몬 오일, 정향(clove) 오일, 베이(bay) 오일, 백리향(thyme) 오일, 삼나무잎(cedar leaf) 오일, 육두구(nutmeg) 오일, 세이지(sage) 오일 및 아몬드(almond) 오일 등을 포함한다. 또한 인공 향료로는 레몬, 오렌지, 포도, 라임, 딸기 등의 과일의 인공합성 과일향 및 바닐라, 초코렛, 커피, 코코아, 솔잎, 인삼, 홍삼, 시트러스와 같은 인공 합성향이 사용될 수 있다.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.
향료의 사용량은 통상 사용되는 향료의 형태, 종류 및 원하는 강도와 같은 다수의 인자에 따라 달라지며, 일반적으로 속용 필름 전체중량 대비, 1 내지 15 중량% 포함할 수 있다.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.
오일 형태의 향료는 수용성 물질들과 혼화되도록 하기 위해 유화제를 함께 사용할 수 있다. 유화제는 향료의 종류 및 양에 따라 그 함량이 조절될 수 있으며, 일반적으로 속용 필름 전체중량 대비, 0.1 내지 10 중량% 첨가될 수 있다.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.
한 구체예로서, 상기 유화제는 글리세린지방산에스테르, 슈크로스지방산에스테르, 레시틴, 효소처리레시틴, 폴리솔르베이트, 솔비탄지방산 에스테르 및 프로필렌글리콜로 이루어진 군으로부터 선택되는 하나 이상의 성분일 수 있다.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.
또한, 본 발명의 경구용 속용 필름은 제품에 알맞은 색소를 포함할 수 있다. 색소는 필요에 따라 그 함량을 적절히 조절할 수 있으며, 일반적으로 식용 필름 전체중량 대비, 0.01 내지 10 중량% 첨가될 수 있다. 상기 색소는 천연 또는 합성 색소일 수 있다.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.
본 발명의 경구용 속용 필름은 또한 청량제를 추가로 포함할 수 있다. 청량제는 이에 제한되는 것은 아니나, 예를 들어, WS3, WS23 또는 퀘스타이스-엘 일 수 있다. 청량제는 필요에 따라 그 함량을 적절히 조절할 수 있으며, 일반적으로 속용 필름 전체중량 대비, 0.01 내지 5 중량% 첨가될 수 있다.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.
본 발명은 또한 상기 경구용 속용 필름 조성물을 포함하는 속용 필름을 제공한다.The present invention also provides a flux film comprising the oral flux film composition.
본 발명의 경구용 속용 필름은 매우 얇은 막 상태에서, 적절한 범위의 인장 강도와 강인성을 유지하는 박막 필름을 형성하는 것이 바람직할 것이다. 한 구체예로서, 본 발명의 속용 필름의 두께는 20㎛ 내지 200㎛이고, 바람직하게는 40㎛ 내지 100㎛이다.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.
본 발명은 또한 경구용 속용 필름의 제조 방법을 제공한다.The present invention also provides a method for producing the oral flux film.
한 구체예로서, 본 발명의 속용 필름의 제조 방법은In one embodiment, the method for producing a rapid-release film of the present invention
(1) 활성성분, 고감미 감미료 2종, 수용성 고분자를 포함하는 속용 필름 조성물을 제조하고;(1) preparing a fast-acting film composition comprising the active ingredient, two kinds of high sweetener, and a water-soluble polymer;
(2) 상기 식용 필름 조성물을 성형기에 투입하여 50 내지 80℃에서 필름을 성형하고;(2) putting the edible film composition into a molding machine to mold the film at 50 to 80 ° C;
(3) 상기 성형된 필름을 상대 습도 50 내지 70%에서 1일 내지 10일 동안 숙성시키는 것을 포함할 수 있다.(3) may comprise aging the molded film at a relative humidity of 50 to 70% for 1 to 10 days.
본 발명에 따른 식용 필름의 제조 방법은, 예를 들어 다음과 같은 공정을 통해 수행될 수 있다.The method for producing an edible film according to the present invention can be carried out through, for example, the following process.
(1) 조액 공정(1) crude liquid process
a) 제1용액 제조공정 : 수용성 고분자를 각각 끓는 물에 넣어 완전히 용해시킨다.a) First solution manufacturing process: Each of the water-soluble polymers is completely dissolved in boiling water.
b) 제2용액 제조공정 : 색소, 감미제, 산미제, 충전제 등의 첨가제를 혼합한 제2용액을 제조한다.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) 제3용액 제조공정 : 활성성분, 멘톨, 향료, 청량제를 유화제와 혼합하여 제3용액을 제조한다.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) 제4용액 제조공정 : 상기 제2용액과 상기 제3용액을 섞어 제4용액을 제조한다.d) 4th solution manufacturing process: The 4th solution is prepared by mixing the said 2nd solution and the said 3rd solution.
e) 제5용액 제조공정 : 온도를 60℃ 이상으로 올리고 상기 제1용액과 상기 제4용액을 섞어 제5용액을 제조한다.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) 성형공정(2) forming process
상기 제5용액을 여과 후 성형기에 투입하여 필름을 성형한다. 이 때 상기 성형기의 온도는 50 내지 80℃ 이고 벨트드럼 드라이어를 통해 롤 형태로 제조된다.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) 숙성공정(3) Aging process
성형된 필름은 상대습도 50 내지 70%에서 1일 내지 10일 정도의 숙성공정을 거쳐 슬리팅이나 절단하기에 적절한 수분을 함유하게 된다. 이때의 수분함량은 8 내지 12%가 적당하다.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%.
상기 제조 방법의 후속 공정으로서 하기의 공정이 추가로 수행될 수 있다.The following process may be further performed as a subsequent process of the manufacturing method.
(4) 컷팅공정(4) cutting process
숙성된 롤은 작은 롤로 슬릿팅하고, 적당한 크기로 절단하여 작은 용기 또는 알루미늄 포장지에 충진한다.The aged rolls are slits into small rolls, cut into appropriate sizes and filled into small containers or aluminum wrappers.
(5) 포장공정(5) Packing process
충진된 작은 용기 또는 알루미늄포장지의 제품은 소박스에 재포장하거나 블리스터를 거쳐 제품화된다.Filled small containers or aluminum bags are repackaged in small boxes or blistered into products.
이러한 방법에 의해 본 발명에서는 활성성분의 특수한 코팅기술 적용 유무에 관계없이, 스테비오사이드 및 스테비오사이드 유도체의 첨가만으로 불쾌한 맛이 차폐된 속용필름을 제조할 수 있다.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.
또한 본 발명의 방법에 의해 제조된 속용 필름은 별도의 물을 먹지 않고도 구강내 타액에 의해 빠르게 붕해 및 용해되므로, 정제를 삼키기 어려운 환자나 노인 및 소아에게 용이하게 투여할 수 있다.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.
이하, 본발명을 하기 실시예에 의하여 더울 상세하게 설명하고자 한다. 다만, 하기 실시예는 본발 명을 예시하기 위한 것일 뿐, 본 발명의 범위가 이들 만으로 한정되는 것은 아니다.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.
<실시예 1-3 내지 비교예 1-3><Examples 1-3 to Comparative Examples 1-3>
의약 활성성분으로 멜록시캄을 첨가하여 하기 표 1의 조성대로 필름을 제조하였다.Meloxycam was added as a pharmaceutically active ingredient to prepare a film according to the composition shown in Table 1 below.
이를 성인남녀 6명의 입안에 넣고, 필름이 구강의 타액에 의해 완전히 붕해되는 시간을 측정하고 관능시험을 수행하였다. 관능시험은 무작위로 수행하였고, 이를 하기 표 2에 기술하였다.  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.
표 1
Figure PCTKR2009003451-appb-T000001
 Table 1
Figure PCTKR2009003451-appb-T000001
상기와 같이 관능시험을 수행한 결과, 스테비오사이드 및 이의 유도체를 넣지 않은 조성물 (비교예 1, 2, 3)과 넣은 조성물 (실시예 1, 2, 3)의 구강 붕해시간은 유의적인 차이가 없었으나, 쓴맛을 차폐하는 정도는 스테비오사이드를 넣은 조성물이 보다 우수함을 확인할 수 있었으며, 이를 하기 표 2에 기술하였다.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.
아스파탐, 산화전분은 대상(주)의 제품을 사용하였으며, 아세설팜 칼륨은 뉴트리노바의 제품을, 슈크랄로스는 테잇앤라일의 제품을, 카라기난은 MSC의 제품을, 폴리솔베이트는 일신웰스의 제품을, 풀루란은 하야시바라의 제품을, 페퍼민트오일 및 레몬향은 보락의 제품을 사용하였다.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.
표 2
Figure PCTKR2009003451-appb-T000002
 TABLE 2
Figure PCTKR2009003451-appb-T000002
<실시예 4-8 내지 비교예 4-8><Example 4-8 to Comparative Example 4-8>
수용성 고분자의 종류를 변경하고, 활성성분으로 멜록시캄을 첨가하여 표 3 및 표 4의 조성대로 필름을 제조하였다.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.
이를 성인남녀 6명의 입안에 넣고 필름이 구강의 타액에 의해 완전히 붕해되는 시간을 측정하고, 관능시험을 수행하였다. 관능시험은 무작위로 수행하였고, 이를 하기 표 5에 기술하였다.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.
표 3
Figure PCTKR2009003451-appb-T000003
 TABLE 3
Figure PCTKR2009003451-appb-T000003
표 4 Table 4
상기와 같이 관능시험을 수행한 결과, 수용성 고분자의 종류에 따른 구강 붕해시간은 유의적인 차이가 없었고, 쓴맛을 차폐하는 정도도 우수함을 확인할 수 있었으며, 이를 하기 표 5에 기술하였다. 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.
저점도 펙틴은 씨피켈코의 GENU pectin DSS를, 젤라틴은 젤텍의 100 Bloom 제품을, 하이드록시프로필메틸셀룰로스는 Demasa의 demacol HE 5/6 BV를, 저점도 알긴산은 MSC의 login을, 하이드록시프로필전분은 Grain Processing Corp.의 제품을 사용하였다. 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.
표 5
Figure PCTKR2009003451-appb-T000005
 Table 5
Figure PCTKR2009003451-appb-T000005
<실시예 9-13 내지 비교예 9-13><Example 9-13 to Comparative Example 9-13>
의약 활성성분으로 졸피뎀 타르타레이트, 갈란타민 염화브로마이드, 타다라필, 레르카니디핀, 도네피질을 첨가하여 표 6의 조성대로 필름을 제조하였다. 스테비오사이드가 제거된 조성을 표 7에 표시하였다. 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.
표 6과 표 7에 기술된 조성에 따라 필름을 제조하고, 이를 성인남녀 6명의 입안에 넣고, 필름이 구강의 타액에 의해 완전히 붕해되는 시간을 측정하고, 관능시험을 수행하였다. 관능시험은 무작위로 수행하였고, 이를 하기 표 8에 기술하였다.   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.
표 6
Figure PCTKR2009003451-appb-T000006
 Table 6
Figure PCTKR2009003451-appb-T000006
표 7
Figure PCTKR2009003451-appb-T000007
 TABLE 7
Figure PCTKR2009003451-appb-T000007
상기와 같이 관능시험을 수행한 결과, 활성성분의 종류에 따른 구강 붕해시간은 유의적인 차이가 없었고, 스테비오사이드 첨가시 1분 후의 후미를 차폐하는 정도도 우수함을 확인할 수 있었으며, 이를 하기 표 8에 기술하였다.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.
표 8
Figure PCTKR2009003451-appb-T000008
 Table 8
Figure PCTKR2009003451-appb-T000008
<실시예 14><Example 14>
본발명의 실시예 9에 따라 제조된 온단세트론 속용필름과 온단세트론을 함유한 일반 시판 제제인 글락소스미스 클라인(GSK)사의 조프란정을 pH 1.2에서 식품의약품 안정청 고시에 따라 비교 용출실험을 실시하였으며, 이를 도 1에 도시하였다. 첨부 도면에 도시된 바와 같이, 양 제제 간에 용출차는 없었으며, 복용순응도 면에 있어서는 불쾌한 맛을 효과적으로 차폐한 본 발명의 경구용 속용 필름이 보다 우수하였다.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.
본 발명의 경구용 속용필름은 불쾌한 맛 차단효과가 뛰어날 뿐만 아니라, 저비용 및 단순화된 제법으로 쉽게 제조할 수 있으므로 구강 내의 청결을 위한 구강 청정제, 구취 제거제, 영양보충물 전달제 그리고 구강 및 위장관 내에서의 약물의 흡수를 위한 설상 용해성 제제로서 유용하게 사용할 수 있다. 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 (16)

1종 이상의 수용성 고분자, 1종 이상의 의학적 활성성분, 후미 개선제로서 스테비오사이드계 감미료, 및 맛 차단제로서 1종 이상의 제1 감미제를 포함하는 경구용 속용 필름. 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.
제 1항에 있어서, 상기 스테비오사이드계 감미료는 스테비오사이드, 효소분해스테비오사이드, 레바우디오사이드A 및 이의 고함량 제품으로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름.  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.
제 1항에 있어서, 상기 제1 감미제는 아스파탐, 아세설팜염, 네오타임, 슈크랄로스, 타우마틴, 사카린, 감초 추출물, 네오헤스페리딘 및 모넬린으로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름. 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.
제 1항에 있어서, 상기 속용 필름의 전체중량 대비, 스테비오사이드계 감미료 및 제1 감미료를 각각 0.1~10 중량 함유하고, 상기 스테비오사이드계 감미료 및 제1 감미료는 1:3~3:1의 비율(w/w)로 함유되는 것을 특징으로 하는 경구용 속용 필름.       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).
제 1항에 있어서, 상기 수용성 고분자는 풀루란, 젤라틴, 펙틴, 저점도 펙틴, 하이드록시프로필메틸셀룰로오스, 저점도 하이드록시프로필메틸셀룰로오스, 하이드록시에틸셀룰로오스, 하이드록시프로필 셀룰로오스, 카르복시메틸셀룰로오스, 폴리비닐알콜, 폴리아크릴산, 메틸메타크릴레이트 공중합체, 카르복시비닐 중합체, 폴리에틸렌글리콜, 알긴산, 저점도 알긴산, 알긴산 나트륨, 변성 전분, 카제인, 유장단백분리물, 콩단백분리물, 제인, 레반, 엘시난, 글루텐, 아카시아검, 카라기난, 아라비아 검, 구아 검, 로커스트빈 검, 잔탄 검, 겔란 검 및 아가로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름. 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.
제 5항에 있어서, 상기 수용성 고분자는 풀루란, 젤라틴, 저점도 펙틴, 저점도 알긴산, 및 저점도 하이드록시메틸셀룰로오스로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름. 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.
제 1항에 있어서, 상기 의학적 활성성분은 당뇨병치료제; 불면증치료제; 비뇨생식기치료제; 비만치료제; 효소제; 소화성궤양용제; 진해거담제; 피부질환치료제; 항구토제; 항우울제; 항히스타민제; 해열진통소염제; 호르몬제제; 순환기용치료제; 소화기관용치료제; 정신신경용제; 발기부전치료제; 골다공증치료제; 관절염치료제; 간질치료제; 근육이완제; 뇌기능개선제; 정신분열증치료제; 면역억제제; 항생제; 항암제; 항암치료보조제; 백신제; 구강청결제; 빈혈치료제; 변비치료제; 비타민; 영양제; 유산균제제; 종합감기약; 및 건강기능식품으로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름. 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.
제 7항에 있어서, 상기 의학적 활성성분은 트리클로산, 세틸 피리듐클로라이드, 도미펜 브로마이드, 4차암모늄염, 아연화합물, 산귀나린, 플루오라이드, 알렉시딘, 옥토니딘, EDTA, 아스피린, 아세트아미노펜, 이부프로펜, 케토프로펜, 디플루니살, 페노프로펜칼슘, 나프록센, 톨메틴나트륨, 인도메타신, 벤조나테이트, 카라미펜, 에디실레이트, 멘톨, 덱스트로메트로판, 히드로브로마이드, 히드로클로라이드, 크로페디아놀, 디펜히드라민, 슈도에페드린, 페닐에페린, 페닐프로판올아민, 슈도에페드린설페이트, 브롬페니르아민말레이트, 클로르페니르아민말레이트, 카르비녹사민말레이트, 클레마스틴푸마레이트, 덱스클로르페니르아민말레이트, 디펜히드라민히드로크로라이드, 디펜히드라민시트레이트, 디페닐피랄린히드로클로라이드, 독실아민숙시네이트, 프로메타진히드로클로라이드, 피릴아민말레이트, 트리펠렌아민시트레이트, 트리프롤리딘히드로클로라이드, 아크리바스틴, 로라타딘, 브롬페니르아민, 덱스브롬페니르아민, 구아이페네신, 이페칵, 칼슘요다이드, 테르핀히드레이트, 로페르아미드, 파모티딘, 라니티딘, 오메프라졸, 란소프라졸, 지방족알콜, 니코틴, 카페인, 스트리키닌, 피크로톡신, 펜틸렌테트라졸, 페니히단토인, 페노바르비탈, 프리미돈, 카르밤아제핀, 에토숙시미드, 메트숙시미드, 펜숙시미드, 트림메타디온, 디아제팜, 벤조디아제핀, 펜아세미드, 펜에투리드, 아세타졸아미드술티암, 브로마이드레보도파, 아만타딘, 몰핀, 헤로인, 히드로모르틴, 메토폰, 옥시모르폰, 레보르판온, 코데인, 히드로콘돈, 자이코돈, 날노르핀, 날록손, 날트렉손, 살리실레이트. 페닐부타적, 인도메타신, 펜아세틴, 클로르프로마진, 메토트리메프라진, 할로페리동, 클로자핀, 레세르핀, 이미프라진, 트라닐시프, 로민, 페넬진, 리듐, 아포모르핀,실데나필, 타다나필, 바데나필, 졸피뎀타르타레이트, 염산밤부테롤, 갈란타민염화브로마이드, 염산르카르니디핀, 염산파록세틴, 멜록시캄, 톨테리딘타르타레이트 및 독사조신메실레이트로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름. 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.
제 1항에 있어서, 상기 속용필름은 하나 이상의 첨가제를 추가적으로 포함하는 것을 특징으로 하는 경구용 속용 필름. According to claim 1, wherein the rapid release film for oral use, characterized in that it further comprises one or more additives.
제 9항에 있어서, 상기 첨가제는 충전제, 가소제, 제2 감미제, 산미제, 향료, 유화제, 색소 및 청량제로 이루어진 군으로부터 선택되는 하나 이상의 성분인 것을 특징으로 하는 경구용 속용 필름.  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.
제 10항에 있어서, 상기 충전제는 미세결정 셀룰로오스, 셀룰로스 중합체, 탄산마그네슘, 탄산칼슘, 석회석 가루, 실리케이트, 점토, 활석, 이산화티타늄 및 인산칼슘으로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름. 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.
제 10항에 있어서, 상기 가소제는 솔비톨, 말티톨, 자일리톨, 글리세린, 폴리에틸렌글리콜, 프로필렌글리콜, 수첨물엿, 물엿, 글리세린, 트리아세틴, 글리세롤올레이트, 자당지방산 에스테르 및 중쇄 지방산으로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름.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.
제 10항에 있어서, 상기 제2 감미제는 설탕, 포도당, 말토스, 올리고당, 덱스트린, 전화당, 과당, 락토스, 갈락토스, 물엿, 솔비톨, 말티톨, 자일리톨, 에리스리톨, 수첨물엿, 만니톨, 및 트레할로스로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름.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.
제 10항에 있어서, 상기 산미제는 구연산, 사과산, 푸말산, 타르타르산, 아스코르브산, 숙신산, 아디핀산 및 락트산으로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름.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.
제 10항에 있어서, 상기 향료는 천연 향료, 인공향료 또는 이들의 혼합물인 것을 특징으로 하는 경구용 속용 필름. 11. The method of claim 10 wherein the fragrance is a natural oral fragrance, artificial fragrance or a mixture thereof.
제 10항에 있어서, 상기 유화제는 글리세린 지방산에스테르, 슈크로스 지방산에스테르, 레시틴, 효소분해 레시틴, 폴리솔르베이트, 솔비탄 지방산 에스테르 및 프로필렌글리콜로 이루어진 군으로부터 선택되는 하나 이상인 것을 특징으로 하는 경구용 속용 필름.  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.
PCT/KR2009/003451 2009-06-25 2009-06-25 Fast dissolving film for oral administration which prevents unpleasant taste effectively WO2010150930A1 (en)

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