KR20050048056A - Composition for oral consumable film - Google Patents

Abstract

The present invention relates to oral consumption film compositions comprising a mixture of starch: alginate from 1: 2.5 to 1: 4. Such compositions further comprise antimicrobial agents, perfumes, fillers, emollients, stabilizers, saliva stimulants, sweeteners, pharmaceutical actives, and the like.

Description

Composition for oral consumable film

The present invention relates to oral consumption film compositions comprising starch: alginate in a ratio of 1: 2.5 to 1: 4. Films made from such compositions are excellent in strength and ductility and are particularly useful for delivering a variety of active agents.

Toothpaste and gargle among various types of formulations used for oral cleaning are limited in time and place to use such preparations. In the case of gum and lozenges, use in all spaces is not socially acceptable. In addition, the use of the spray method requires a container for spraying and can be used by the surrounding people.

Edible films using a variety of polymeric biopolymers have been manufactured to meet the needs of consumers who want to clean their mouths easily without time and place restrictions.

Pullulan is a typical polymer biopolymer used in the preparation of such edible films and there are a number of documents that disclose the use thereof. For example, US Pat. No. 6,596,298 describes a film with a mixed composition of pullulan and the antimicrobial agents thymol, methyl salicylate, eucalyptol and menthol. In addition, there are a number of documents describing films to which various agents are added while using furan as a film forming agent. However, since pullulan is not only expensive but also has to rely on imports, it is intended to replace the film to manufacture the film.

Thus, the oral consumption film using starch instead of pullulan has been produced, but it was difficult to handle and store the fragile, and the use of modified starch has been suggested to improve this. In addition, although cellulose was used to replace flulan, these substitutes lacked the desirable film properties, rapid dissolution, oral cleanliness, ease of manufacture, and the like of flulan, and new substitutes were required to remedy these shortcomings.

The inventors have found that a proportion of the mixture of starch and alginate exhibits physical properties, in particular strength and ductility, that are suitable for use as film formers in oral consumption films, have no self-adhesion, and dissolve rapidly when used orally, The present invention has been completed by revealing that it can include an agent such as a microbial agent / flavor and thus exhibits an excellent oral cleansing effect.

The present invention relates to oral consumption film composition, characterized in that it comprises a mixture of starch: alginate of 1: 2.5 to 1: 4.0 as a film forming agent.

Materials conventionally used as film formers include pullulan, alginate, starch, gelatin, various gums such as carrageenan, xanthan LBG, gellan and the like. These polymeric biopolymers are dissolved in water, cast, and dried to form a film.

It is possible to obtain better physical properties when using these materials as a film forming agent than when using them alone, and the present inventors use a starch: alginate mixture of 1: 2.5 to 1: 4.0 as a film forming agent. The film has excellent physical properties, especially strength (tensile strength) and ductility (elongation), and can contain a variety of agents, such as antimicrobial agents, fragrances, and bad breath removers. I found it appropriate.

The starch used in the film composition of the present invention includes all starches derived from natural sources, and starches derived from plants obtained by various breeding methods, such as crossbreeding, inversion, and transformation, can also be used. Do. Sources of starch are typically grains, tubers, roots, beans and fruits, and the like, including corn, potatoes, sweet potatoes, bananas, barley, wheat, rice, sago, amaranth, tapioca, rice, canna, sugar cane and the like. The starch used in the film composition of the present invention can be modified to meet the desired film properties, and should have sufficient stiffness, ductility and no shattering when forming the film, and should be self-adhesive while blocking and moisture resistant to prevent self-adhesion. If exposed to liquids, they must dissolve rapidly. To this end, physical, chemical and enzymatic modifications can be used to meet desired film properties by methods known in the art.

Physically modified starch can be exemplified by sheared starch or thermally inhibited starch, and chemically modified starch can be crosslinked derivatives, acetylated derivatives, organically esterified derivatives, hydroxyethylated derivatives, Hydroxypropylated derivatives, phosphorylated derivatives, inorganically esterified derivatives, cationic derivatives, anionic derivatives, amphoteric derivatives, succinate derivatives, substituted succinate derivatives and the like. Such modifications are well known in the art. Examples include Perfectamyl AC esterified potato starch, Kreation MB modified tapioca starch, Perfectamyl HT2X modified tapioca starch and the like.

Particularly suitable starches are hydroxyalkylated starch, for example hydroxypropylated starch or hydroxyethylated starch, succinateized starch, for example octenylsuccinateized starch or dodecylsuccinateized. Starch is an example. Of these, especially hydroxyalkylated starch is advantageously used to impart ductility to the film produced.

Starches having properties suitable for use in the present invention may be purified by methods known in the art to remove odors / colors inherently present in polysaccharides or occurring during processing.

Alginates used in combination with starch can be derived from a variety of sources, for example brown algae or microorganisms, and are also used as gel formers, coagulants, and dietary fibers due to their high affinity for divalent metals. It is also used as a stabilizer for foods with high viscosity such as syrup and red bean porridge, and has been used in the manufacture of adhesive adhesives, lubricants, films, fibers and the like. Alginates are usually used in the form of sodium alginate, and Manucol LB and the like can be exemplified.

When the mixing ratio of starch and alginate was less than 1: 2.5 or greater than 1: 4.0, the film forming ability was lowered. Specifically, when only the alginate is used as the film forming agent (Comparative Example 2), the strength is high, but the ductility is lowered, so that when fragrance and oil are contained, the fragrance is halved by the unique smell of alginate. The more fragrance you have, the more fragile your film will be. In addition, when only starch is used as the film forming agent (Comparative Example 1), the ductility is good, but the strength is low, the resolution is also lowered, and handling is difficult. Increasing the content of starch relative to alginate resembles a film using only starch.Increasing the content of alginate relative to starch, for example, more than four times increases its strength but lowers its ductility and reduces the content of fragrance and oil. It becomes easy to lose. When the starch: alginate is 1: 2.5 to 1: 4, the strength and ductility were excellent, and the contents of active agents such as perfumes and antimicrobials could be increased.

A particularly preferred mixing ratio of the starch and alginate mixture, which is a film forming agent included in the oral consumption film composition of the present invention, is 1: 3.0 to 1: 3.5. Films made of such compositions of the present invention are suitable for use as oral consumption films, in particular tensile strength (20 MPa or more, preferably 25 MPa or more), elongation (3% or more, preferably 5% or more), Solubility (within seconds) is shown.

Softeners or plasticizing agents may be added with the use of certain formulations of film formers as described above to impart physical properties suitable for use as an oral consumable film. Examples of emollients include polyols such as ethylene glycol, propylene glycol, sugar alcohols (e.g. sorbitol, mannitol, maltitol, lacticol, xylitol, etc.), mono-, di- and oligosaccharides (e.g. fructose, glucose, Sucrose, maltose, lactose and high content fructose corn syrup and ascorbic acid), polycarboxylic acids such as citric acid, maleic acid, succinic acid, polyacrylic acid and polymaleic acid, polyesters such as glycerin triacetate, Acetylated monoglycerides, diethyl phthalate, triethyl citrate, tributyl citrate, acetyl triethyl citrate, acetyltributyl citrate and the like. These components increase ductility and solubility, but reduce strength. These softeners are preferably mixed rather than used alone, and sorbitol, glycerin, propylene glycol and the like are preferably used together. Its content is about 0 to 20% by weight, preferably about 1 to 5% by weight, based on the total weight of the film composition. Sorbitol added to the film composition can also increase moisturizing power.

As used herein, "total weight of film composition" means the total amount of material used to prepare the oral consumption film of the present invention.

In order to increase the strength of the oral consumption film, other polymer biopolymers may be added as a stabilizer in addition to the film forming agent described above. Biopolymers used include, for example, carageenan, Locust bean gum, LBG, xanthan gum, locust bean gum, gellan and the like. These polymers increase the viscosity of the film composition and increase the tensile strength, thereby preventing the film from breaking when producing a film containing a large amount of fragrance and oil. Its content is about 0 to 5% by weight, preferably about 0.5 to 2% by weight, based on the total weight of the film composition.

The polymer film-forming agent used for film formation has an important effect on its molecular weight, and it is preferable to have a molecular weight of about 300,000 Da to about 150,000 Da (dalton). When the molecular weight is increased, physical properties are significantly lowered. On the contrary, when the molecular weight is decreased, the film itself is brittle, so it is difficult to handle during aging, slitting and cutting in the production process.

The composition of the present invention may further contain an edible grade bulk filler. These fillers not only reduce the stickiness but also provide the structure of the film. Such fillers may include microcrystalline cellulose, cellulose polymers, magnesium carbonate, calcium carbonate, polished limestone, silicates, clay talc, titanium dioxide, monocalcium phosphate, dicalcium phosphate, tricalcium phosphate, and the like. Preferably, microcrystalline cellulose, such as Avicel, may be used to evenly disperse the plurality of film formers to lower the viscosity and improve solubility. Its content is about 0 to 5% by weight, preferably about 0.1 to 1% by weight, based on the total weight of the film composition.

An antimicrobial agent / flavor is included when the composition as described above is used for an oral cleansing effect. Perfumes that can be used include natural and artificial flavors known to those skilled in the art and are selected from synthetic fragrance oils and fragrances, and / or oils, oleo resins and extracts from plants, leaves, flowers, fruits, and the like, and combinations thereof. Can be. Typical fragrance oils are spearmint oil, cinnamon oil, peppermint oil, clove oil, bay oil, thyme oil, cedar leaf oil, nutmeg oil and sage oil. And bitter almond oil and the like. In addition, artificial, natural or synthetic fruit flavors such as vanilla, chocolate, coffee, cocoa and citrus oils and apples, pears, peaches, strawberries, raspberries, cherries, plums, pineapples, including lemon, orange, grape, lime and grape fruit Fruit essences like apricots are useful. These perfumes can be used individually or in combination. Flavors commonly used include mints such as peppermint, artificial vanilla, cinnamon derivatives, and various fruit flavors, which are used alone or in combination. In addition, fragrances such as aldehydes and esters, including cinnamil acetate, cinnamic aldehyde, citral, diethylacetal, dihydrocarbyl acetate, eugenyl formate, p-methylanisole and the like can be used. Generally, perfumes or food additives may be used, such as those described in Chemicals Used in Food Processing, Publication 1274 by the National Academy of Sciences, pages 63-258. Further examples of aldehyde fragrances include acetaldehyde (apple); Benzaldehyde (cherry, almond); Cinnamic aldehyde (cinnamon); Citral, ie alpha citral (lemon, lime); Neral, ie, beta citral (lemon, lime); Decanal (orange, lemon); Ethyl vanillin (vanilla, cream); Heliotropin, ie piperonal (vanilla, cream); Vanillin (vanilla, cream); Alpha-amyl cinnamic aldehyde (spicy fruit flavor); Butyraldehyde (butter, cheese); Valeraldehyde (butter, cheese); Citronellal (modified, many forms); Decanal (citrus fruits); Aldehyde C-8 (citrus fruits); Aldehyde C-9 (citrus fruits); Aldehyde C-12 (citrus fruits); 2-ethyl butyraldehyde (berry fruit); Hexenal, ie trans-2 (berry fruit); Tosyl aldehydes (cherry, almond); Veratraldehyde (vanilla); 2,6-dimethyl-5-heptenal, ie melonal (melon); 2,6-dimethyloctanal (green fruit); And 2-dodecenal (citrus, mandarin); Cherry; grape; Mixtures thereof, and the like.

The fragrance has an oil type, including a water-soluble powder type, and anti-microbial properties in the case of menthol, peppermint and methyl salicylate in the oil type perfume. In the case of adding an oil-type perfume showing such antimicrobial properties, an emulsifier may be added for miscibility with water. The amount of fragrance used depends on a number of factors such as the type of fragrance commonly used, the individual fragrances, and the desired strength, and such changes can be determined within the skill of one of ordinary skill in the art without the need for unnecessary experimentation. Generally, the content thereof is about 0.1 to 20% by weight, preferably about 1 to 5% by weight, based on the total weight of the film composition.

In particular, fragrances exhibiting antimicrobial properties such as menthol, peppermint and methyl sarisilate are in the form of oils and therefore emulsifiers are used together to make them compatible with water-soluble substances. Emulsifiers include, for example, glycerin fatty acid esters, sucrose fatty acid esters, lecithin, and the like, in particular, sucrose fatty acid ester S-1670 having a high hydrophilic content, based on the total weight of the film composition, from about 0 to 5 wt% %, Preferably in an amount of about 0.1 to 2.0% by weight.

In addition to the antimicrobial agent described above, the composition of the present invention may include a sulfur precipitater to reduce oral odor. Sulfur precipitants bind to and inactivate volatile sulfur compounds that cause oral odors. Sulfur precipitants which can be used include metal salts such as copper salts and zinc salts, preferably copper gluconate, zinc citrate, zinc gluconate and the like.

In addition, the composition of the present invention may further comprise a sweetener. Sweeteners are water soluble sweeteners such as monosaccharides, disaccharides, polysaccharides, for example xylose, ribose, glucose, mannose, galactose, fructose, sucrose, maltose, converted sugars, portions Hydrolyzed starch, corn syrup solids, dihydrochalcone, monelin, stevioside and the like; Water-soluble artificial sweeteners such as water-soluble saccharin salts, ie sodium or potassium saccharin salts, cyclate salts, 3,4-dihydro-6-methyl-1,2,3-oxadiazin-4-one-2, Sodium, ammonium or calcium salt of 2-dioxide, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxadiazin-4-one-2,2-dioxide, free acid of saccharin, etc. ; Dipeptide described sweeteners such as L-aspartic acid derived sweeteners such as L-aspartyl-L-phenylalanine methyl ester (aspartame), L-alpha-aspartyl-N- (2,2,4, 4-tetramethyl-3-thietanyl) -D-alanineamide hydrate, methyl ester of L-aspartyl-L-phenylgrisyl and L-aspartyl-L-2,5-dihydrophenyl-glycine, L- Ascatyl-2,5-dihydro-L-phenylalanine, L-aspartyl-L- (1-cyclohexene) -alanine, etc .; Water soluble sweeteners derived from natural water soluble sweeteners, for example chlorinated derivatives of conventional sugars such as sucralose; Protein described sweeteners such as Taumatococcus danieli and the like. Generally, a synthetic sweetener with higher sweetness than natural sugar is used, and sucralose, acesulfame K, aspartame, stevioside are frequently used. Preferably, sucralose, acesulfame K, aspartame are used in combination and the content thereof is about 0.01 to 2.0% by weight, preferably about 0.2 to 1.0% by weight, based on the total weight of the film composition.

In addition, the composition of the present invention may further comprise an acidulant. Acidifiers can stimulate saliva and not only affect the taste of films made with the compositions of the present invention, but also contribute to the improvement of gel strength. Examples of such acidulants include various acids such as citric acid, lactic acid, malic acid, succinic acid, ascorbic acid, adipic acid, fumaric acid, tartaric acid, and citric acid and malic acid are preferably used. Its content is about 0 to 2.0% by weight, preferably about 0.1 to 1.0% by weight, based on the total weight of the film composition.

In addition, the compositions of the present invention may further comprise an amount of colorant suitable to obtain the desired color. Colorants include, for example, dyes suitable for the color and edible of natural foods. Such colorants are commonly known as FD & D dyes.

In addition to the additives described above, the compositions of the present invention may include stabilizers, emulsifiers, coolants, various therapeutic agents for medical use, and the therapeutic agents may have multiple effects when used with the antimicrobial agents described above for oral cleanliness. have.

In addition, the compositions of the present invention may further comprise a pharmaceutically active agent. As used herein, "pharmaceutical active agent" means an agent other than food that enhances a structural or functional change in the body when administered. Such formulations must be physiologically acceptable and compatible with the film. Suitable pharmaceutically active agents include, but are not limited to: antimicrobial agents such as triclosan, cetyl pyridinium chloride, domiphene bromide, quaternary ammonium salts, zinc compounds, acid guinarin, fluoride, Alexidine, octonidine, EDTA and the like; Non-steroidal anti-inflammatory agents such as aspirin, acetaminophen, ibuprofen, ketoprofen, diflunisal, phenopropene calcium, naproxen, tolmetin sodium, indomethacin and the like; Antitussives such as benzonatate, caramifen edylate, menthol, dextromethorphan hydrobromide, clopedanol hydrochloride and the like; Decongestants such as pseudoephedrine hydrochloride, phenylephrine, phenylpropanolamine, pseudoephedrine sulfate and the like; Antihistamines such as brompheniramine maleate, chlorpheniramine maleate, carbinoxamine maleate, clemastine fumarate, dexchlorpheniramine maleate, diphenylhydramine hydrochloride, diphenylpi Raline hydrochloride, azatadine maleate, diphenylhydramine citrate, doxylamine succinate, promethazine hydrochloride, pyrilamine maleate, tripelinamine citrate, triprolidine hydrochloride, acrivastin, Loratadine, bromfenyramine, dexbromfenyramine and the like; Expectorants such as guaniphenesin, ifapec, potassium iodide, terpin hydrate and the like; Anticorrosive agents such as loperamide and the like; H2-antagonists such as famotidine, ranitidine and the like; Proton pump inhibitors such as omeprazole, lansoprazole and the like; Common non-selective CNS sedatives such as aliphatic alcohols, barbiturates and the like; General non-selective CNS stimulants such as caffeine, nicotine, strycnin, picrotoxin, pentylenetetrazole and the like; Drugs that selectively modify CNS function, such as phenylhydantoin, phenobarbital, pyrimidone, carbamepin, etosuccimid, metsuccimid, pensuccimid, trimetadione, diazepam, benzodiazepine, phenacetamide, Peneturide, acetazolamide, sultiam, bromide and the like; Anti-Parkinson's agents such as levodopa, amantadine and the like; Narcotic analgesics such as morphine, heroin, hydromorphone, oxymorphone, levorpanol, codeine, hydrocodone, gycodone, nallopine, naloxone, naltrexone and the like; Analgesic-antipyretics such as salicylate, phenylbutazone, indomethacin, phenacetin and the like; Psychopharmaceutical agents such as chlorchromazine, metotrimeprazine, haloperidol, clozapine, reserpin, imipramine, tranilcypromine, penelazine, lithium and the like.

Pharmaceutically active agents are preferably chlorpheniramine maleate, bromfenyramine maleate, dexchlorpheniramine, triprolidine hydrochloride, acribastine, azatadine maleate, loratidine, phenylephrine Hydrochloride, dextromethorphan hydrochloride, ketoprofen, sumatriptan succinate, zolmitriptan, loperamide, pamotidine, nicotine, caffeine, diphenhydramine hydrochloride, pseudoephedrine hydrochloride, and the like, may be used. Their amount per strip is well known in the art.

The film composition to which the pharmaceutically active agent is added may include vegetable oils such as triglycerides such as corn oil, sunflower oil, peanut oil, olive oil, canola oil, soybean oil, mixtures thereof, and also preservatives, eg Sodium benzoate and potassium sorbate; Polyethylene oxide compounds; Propylene glycol may be included, and the pharmaceutically active agent may be coated to obtain additional effects such as blocking its taste.

The film of the present invention prepared from the composition having the above composition has a tensile strength of 20 Mpa, preferably 25 Mpa or more and an elongation of 3%, preferably 5% or more, so that the film is easy to be manufactured and handled. And may contain larger amounts of fragrance / antimicrobial agents, which is effective for oral cleansing and delivery of additional drugs.

The present invention will be described in more detail with reference to the following examples, which are intended to illustrate the invention but the invention is not limited thereto.

Example 1:

71.891 g of water was placed in a container, 0.144 g of Avicel was added at room temperature, and then mixed uniformly for 20 minutes, 0.479 g of sucrose fatty acid ester S-1670 was added thereto, and then mixed again for 20 minutes. Subsequently, after adding 1.198 g of sorbitol, 1.198 g of glycerin and 0.240 g of propylene glycol, the temperature was adjusted to 80 ° C. When the temperature reached 80 ° C., the heating was stopped, 14.378 g of alginate (manucol LB), 0.288 g of carrageenan, 0.192 g of LBG, and 0.144 g of xanthan gum were added and mixed for 1 hour. Then, 4.793 g of HP-starch dissolved in cold water was added and mixed again for 1 hour. When mixing is completed, the temperature is lowered to 50 ° C., citric acid 0.096 g, malic acid 0.144 g, sucralose 0.479 g, menthol 1.246 g, peppermint cotton flavor 0.479 g, peppermint oil 1.150 g, citrus oil 0.958 g, spearmint powder 0.479 g , 0.014 g of methyl salicylate and 0.010 g of a dye were added in order and mixed. When mixing was completed, the filtrate was transferred to a storage tank and then defoamed overnight, and stirred again at low speed for 30 minutes before coating. The finished crude liquid was coated through a coater and then air dried. When the coating was complete, it was slipped to the desired size and the divided samples were aged for 3 days to 1 week. When aging is completed, the film was cut to a desired size.

Tensile strength (TS) and elongation (E) of the film were measured at 25 ℃ in a constant temperature and humidity chamber using a texture analyzer (TX-HD, Stable Micro Systems, UK) according to ASTM D 882-88. After 48 hours at 50% relative humidity, the equilibrium moisture content of the film was adjusted and measured. The size of the film was cut to 2.54 (W) cm * 10 (L) cm, the crosshead speed (500mm / min), the grip separation (grip separation) was 50mm. The average and standard deviation were calculated 9 times, and the measured tensile strength values were expressed in MPa and elongation was expressed in%.

Tensile strength of the prepared film was 28.230 Mpa, elongation (%) was 7.767%.

Comparative Example 1:

73.765 g of water was placed in a container, 0.221 g of Avicel was added at room temperature, then mixed uniformly for 20 minutes, and 0.738 g of sucrose fatty acid ester S-1670 was added thereto, followed by mixing for 20 minutes. Subsequently, after adding 1.844 g of sorbitol, 1.844 g of glycerin and 0.369 g of propylene glycol, the temperature was adjusted to 80 ° C. When the temperature reached 80 ° C, the heating was stopped, 0.443 g of carrageenan, 0.295 g of LBG, and 0.221 g of xanthan gum were added and mixed for 1 hour. Subsequently, 13.278 g of HP-starch dissolved in cold water was added and mixed for 1 hour. When the mixing was completed, the temperature was lowered to 50 ° C, citric acid 0.148 g, malic acid 0.221 g, sucralose 0.058 g, acesulfame K 0.058 g, aspartame 0.116 g, menthol 1.770 g, peppermint flavor 0.738 g, peppermint oil 1.623 g , 1.475 g of citrus oil, 0.738 g of spearmint powder, 0.022 g of methyl salicylate, and 0.015 g of a dye were added in order and mixed. When mixing was completed, the filtrate was transferred to a storage tank and then defoamed overnight, and stirred again at low speed for 30 minutes before coating. The finished crude liquid was coated through a coater and then air dried. When the coating was complete, it was slipped to the desired size and the divided samples were aged for 3 days to 1 week. When aging was completed, cut to package the desired size. The tensile strength of the prepared film measured according to the method described in Example 1 was 18.027 Mpa, and the elongation was 6.598%.

Comparative Example 2:

69.309 g of water was placed in a container, 0.160 g of Avicel was added at room temperature, then mixed uniformly for 20 minutes, and 0.533 g of sucrose fatty acid ester S-1670 was added thereto, followed by mixing for 20 minutes. Subsequently, 1.333 g of sorbitol, 1.333 g of glycerin and 0.267 g of propylene glycol were added, and then the temperature was adjusted to 80 ° C. When the temperature reached 80 ° C, the heating was stopped, 21.326 g of alginate (manucol LB), 0.320 g of carrageenan, 0.213 g of LBG, and 0.160 g of xanthan gum were added and mixed for 1 hour. When the mixing was completed, the temperature was lowered to 50 ° C, citric acid 0.107 g, malic acid 0.160 g, sucralose 0.042 g, acesulfame K 0.042 g, aspartame 0.084 g, menthol 1.280 g, peppermint cotton flavor 0.533 g, peppermint oil 1.173 g 1.066 g of citrus oil, 0.533 g of spearmint powder, 0.016 g of methyl salicylate, and 0.011 g of a dye were added in order and mixed. When mixing was completed, the filtrate was transferred to a storage tank and then defoamed overnight, and stirred again at low speed for 30 minutes before coating. The finished crude liquid was coated through a coater and then air dried. When the coating was complete, it was slipped to the desired size and the divided samples were aged for 3 days to 1 week. When aging is completed, the film was cut to a desired size. The tensile strength of the prepared film measured according to the method described in Example 1 was 25.642 Mpa, the percent elongation was 2.549%.

Comparative Example 3:

71.487 g of water was placed in a container, 1.054 g of Avicel was added at room temperature, followed by uniform mixing for 20 minutes, and 0.248 g of sucrose fatty acid ester S-1670 was added thereto, followed by mixing for 20 minutes. Subsequently, 1.162 g of sorbitol, 1.162 g of glycerin and 0.858 g of propylene glycol were added, and then the temperature was adjusted to 80 ° C. When the temperature reached 80 ° C., heating was stopped, 12.391 g of alginate (manucol LB), 0.087 g of carrageenan, 0.087 g of LBG, and 0.087 g of xanthan gum were added and mixed for 1 hour. Subsequently, 6.196 g of HP-starch dissolved in cold water was added thereto, followed by mixing for 1 hour. When the mixing was completed, the temperature was lowered to 50 ° C, citric acid 0.176 g, malic acid 0.217 g, sucralose 0.477 g, menthol 1.239 g, peppermint cotton flavor 0.477 g, peppermint oil 1.144 g, citrus oil 0.953 g, spearmint powder 0.477 g , 0.014 g of methyl salicylate and 0.010 g of a dye were added in order and mixed. When mixing was completed, the filtrate was transferred to a storage tank and then defoamed overnight, and stirred again at low speed for 30 minutes before coating. The finished crude liquid was coated through a coater and then air dried. When the coating was complete, it was slipped to the desired size and the divided samples were aged for 3 days to 1 week. When aging is completed, the film was cut to a desired size. The tensile strength of the prepared film measured according to the method described in Example 1 was 15.890 Mpa, and the percent elongation (%) was 4.941%.

Comparative Example 4:

71.560 g of water was placed in a container, 1.218 g of Avicel was added at room temperature, then mixed uniformly for 20 minutes, 0.506 g of sucrose fatty acid ester S-1670 was added thereto, and then mixed again for 20 minutes. Subsequently, 0.157 g of sorbitol, 0.354 g of glycerin and 1.982 g of propylene glycol were added, and then the temperature was adjusted to 80 ° C. When the temperature reached 80 ° C., the heating was stopped, 8.807 g of alginate (manucol LB) and 0.100 g of carrageenan, 0.100 g of LBG, 0.100 g of xanthan gum and 0.550 g of gellan were added and mixed for 1 hour. Subsequently, 8.807 g of HP-starch dissolved in cold water was added and mixed for 1 hour. When the mixing was completed, the temperature was lowered to 50 ° C., citric acid 0.204 g, malic acid 0.250 g, sucralose 1.431 g, menthol 0.550 g, peppermint cotton flavor 1.321 g, peppermint oil 1.101 g, citrus oil 0.550 g, spearmint powder 0.017 g , 0.010 g of methyl salicylate, and 0.323 g of a dye were sequentially added and mixed. When mixing was completed, the filtrate was transferred to a storage tank and then defoamed overnight, and stirred again at low speed for 30 minutes before coating. The finished crude liquid was coated through a coater and then air dried. When the coating was complete, it was slipped to the desired size and the divided samples were aged for 3 days to 1 week. When aging is completed, the film was cut to a desired size. The tensile strength of the prepared film, measured according to the method described in Example 1, was 12.020 Mpa and the elongation was 3.218%.

The compositions of Example 1 and Comparative Example and their tensile strength and elongation are shown in Table 1 below:

Ingredient (g) Example 1 Comparative Example 1 Comparative Example 2  Comparative Example 3 Comparative Example 4 SE 0.479 0.738 0.533 0.248 0.506 Avicel 0.144 0.221 0.160 1.054 1.218 Sorbitol 1.198 1.844 1.333 1.162 0.157 Citric acid 0.096 0.148 0.107 0.176 0.204 Malic acid 0.144 0.221 0.160 0.217 0.250 Xanthan Gum 0.144 0.221 0.160 0.087 0.100 LBG 0.192 0.295 0.213 0.087 0.100 Carrageenan 0.288 0.443 0.320 0.087 0.100 Gellan 0.000 0.000 0.000 0.000 0.550 Sucralose 0.479 0.058 0.042 0.477 1.431 Acesulfame K 0.000 0.058 0.042 0.000 0.000 Aspartame 0.000 0.116 0.084 0.000 0.000 menthol 1.246 1.770 1.280 1.239 0.550 Mint cotton flavor 0.479 0.738 0.533 0.477 1.321 Peppermint Oil 1.150 1.623 1.173 1.144 1.101 Citrus Oil 0.959 1.475 1.066 0.953 0.550 Spearmint Powder 0.479 0.738 0.533 0.477 0.017 Methylsalicylate 0.014 0.022 0.016 0.014 0.010 Pigment 0.010 0.015 0.011 0.010 0.323 glycerin 1.198 1.844 1.333 1.162 0.354 Propylene glycol 0.240 0.369 0.267 0.858 1.982 HP-starch 4.793 13.278 0.000 6.196 8.807 Alginate (manucol LB) 14.378 0.000 21.326 12.391 8.807 DW 71.891 73.765 69.309 71.487 71.560 synthesis 100.001 100.000 100.001 100.003 99.998 Tensile Strength (Mpa) 28.230 18.027 25.642 15.890 12.020 Elongation (%) 7.767 6.598 2.549 4.941 3.218

As shown in Table 1 above, when starch and alginate were mixed and used in a ratio of 1: 3 to 1: 3.5 as a film formation (Example 1), starch alone was used (Comparative Example 1), alginate alone was used. (Comparative Example 2) It showed excellent tensile strength and elongation compared to the mixed use of different ratios (Comparative Examples 3 to 4).

Examples 2-8:

Using the compositions shown in Table 2 below, films were prepared in a similar manner to Example 1, and the physical properties of these films are shown in Table 2 below:

Ingredient (g) Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Example 8 SE 0.481 0.462 0.483 0.458 0.462 0.480 0.462 Avicel 0.144 0.138 0.145 0.138 0.231 0.144 0.138 Sorbitol 1.202 1.385 0.724 1.375 1.387 1.200 1.385 Citric acid 0.096 0.092 0.097 0.092 0.000 0.096 0.092 Malic acid 0.144 0.138 0.145 0.138 0.092 0.144 0.138 Xanthan Gum 0.144 0.092 0.145 0.092 0.139 0.144 0.092 LBG 0.192 0.138 0.193 0.138 0.092 0.192 0.138 Carrageenan 0.288 0.185 0.000 0.183 0.139 0.288 0.185 Gellan 0.000 0.005 0.386 0.000 0.185 0.000 0.000 Sucralose 0.385 0.369 0.386 0.367 0.370 0.082 0.369 Acesulfame K 0.000 0.000 0.000 0.000 0.000 0.012 0.000 Aspartame 0.000 0.000 0.000 0.000 0.000 0.432 0.000 menthol 1.154 1.108 1.159 1.100 1.202 1.152 1.108 Mint cotton flavor 0.481 0.462 0.483 0.458 0.601 0.480 0.462 Pepper Oil 1.057 1.015 1.063 1.008 0.000 1.056 1.015 Cinnamon oil 0.000 0.000 0.000 0.000 1.202 0.000 0.000 Citrus Oil 0.961 0.923 0.966 0.917 0.555 0.960 0.923 Spearmint Powder 0.481 0.462 0.483 0.458 0.000 0.480 0.462 Methylsalicylate 0.014 0.014 0.014 0.014 0.005 0.014 0.014 Pigment 0.010 0.009 0.010 0.009 0.009 0.010 0.009 glycerin 1.202 1.385 0.724 1.375 1.387 1.200 1.385 cooking oil 0.000 0.000 0.483 0.000 0.000 0.000 0.000 gelatin 0.000 0.000 0.000 0.688 0.000 0.000 0.000 Propylene glycol 0.240 0.231 0.241 0.229 0.231 0.240 0.231 HP-starch 4.807 5.539 4.830 5.501 5.550 4.800 5.539 Alginate (manucol LB) 14.420 16.616 14.489 16.502 16.649 14.400 16.617 DW 72.098 69.233 72.446 68.760 69.371 71.998 69.236 synthesis 100.001 100.001 99.999 100.000 99.998 100.004 100.000 Tensile Strength (Mpa) 31.430 31.130 30.000 28.060 33.190 30.660 28.440 Elongation (%) 6.610 7.195 5.937 7.467 8.057 6.698 8.120

As a film forming agent, starch and alginate were mixed in a ratio of 1: 3 to 1: 3.5, and thus, in addition to starch and alginate in the above-mentioned ratios, as in Example 1, which shows excellent strength and elongation of the film, Films made from the compositions of Examples 2-8, which included also exhibited excellent tensile strength and elongation.

Example 9:

Films were prepared in a similar manner to the method of Example 1 above using the compositions of Table 3 containing specific therapeutically active agents:

Ingredient (g) Example 9 Example 10 Example 11 Example 12 Example 13 SE 0.46 0.47 0.46 0.47 0.48 Avicel  0.14 0.14 0.14 0.14 0.14 Sorbitol 1.14 1.17 1.16 1.17 1.19 Citric acid  0.09 0.09 0.09 0.09 0.10 Malic acid 0.14 0.14 0.14 0.14 0.14 Xanthan Gum 0.14 0.14 0.14 0.14 0.14 LBG 0.18 0.19 0.19 0.19 0.19 Carrageenan  0.27 0.28 0.28 0.28 0.29 Sucralose  0.10 0.11 0.11 0.11 0.11 Acesulfame K  0.07 0.07 0.07 0.07 0.07 Aspartame 0.19 0.20 0.20 0.20 0.20 menthol  1.09 1.12 1.12 1.12 1.15 Mint Powder 0.46 0.47 0.46 0.47 0.48 Peppermint 1.00 1.03 1.02 1.03 1.05 Citrus Spice Mint  0.91 0.94 0.93 0.94 0.95 Spearmint Powder 0.46 0.47 0.46 0.47 0.48 Methylsalicylate 0.01 0.01 0.01 0.01 0.01 Pigment  0.01 0.01 0.01 0.01 0.01 glycerin  1.14 1.17 1.16 1.17 1.19 Propylene glycol  0.23 0.23 0.23 0.23 0.24 Caffeine Anhydrous  5.20 0.00 0.00 2.60 0.00 Akrivastin 0.00 2.60 0.00 0.00 0.00 Loratadine 0.00 0.00 3.25 0.00 0.00 nicotine 0.00 0.00 0.00 0.00 0.65 HP-starch 4.56 4.68 4.65 4.68 4.77 Alginate (manucol LB) 13.67 14.04 13.95 14.04 14.32 DW 68.34 70.22 69.75 70.22 71.62

Example 10:

With the exception of using 2.60 g of acrivastin as the therapeutically active agent, a film was prepared in a similar manner to the method of Example 1 using the composition shown in Table 3 above.

Example 11:

With the exception of using 3.25 g of loratadine as the therapeutically active agent, a film was prepared in a similar manner to the method of Example 1 using the composition shown in Table 3 above.

Example 12:

With the exception of using 2.60 g of anhydrous caffeine as the therapeutically active agent, a film was prepared in a similar manner to the method of Example 1 using the composition shown in Table 3 above.

Example 13:

With the exception of using 0.65 g of nicotine as the therapeutically active agent, a film was prepared in a similar manner to the method of Example 1 using the composition shown in Table 3 above.

The composition of the present invention contains starch and alginate in a ratio of 1: 2.5 to 1: 4, so that the film produced using the same exhibits excellent tensile strength and elongation, and may contain a larger amount of fragrance / antimicrobial agent. And for the delivery of additional drugs.

Claims (16)

Oral consumption film composition comprising a mixture of 1: 2.5 to 1: 4 starch: alginate. The composition of claim 1 wherein the mixing ratio of starch and alginate is from 1: 3 to 1: 3.5. The composition of claim 1 further comprising an antimicrobial agent, a perfume or a combination thereof. 4. The composition of claim 3 wherein the antimicrobial agent is selected from the group consisting of menthol, methylsalicylate, eucalyptol, thymol and peppermin. The composition of claim 1 further comprising a filler. The composition of claim 5 wherein the filler is selected from the group consisting of microcrystalline cellulose, cellulose polymers, magnesium carbonate, calcium carbonate, limestone flour, silicates, clays, talc, titanium dioxide, calcium phosphate and combinations thereof. The composition of claim 1 further comprising an emollient. 8. The composition of claim 7, wherein the softener is selected from the group consisting of polyols, polycarboxylic acids, polyesters, glycerol and glycols. The composition of claim 1 further comprising a stabilizer. 10. The composition of claim 9, wherein the stabilizer is selected from the group consisting of carrageenan, LBG, xanthan gum and mixtures thereof. The composition of claim 1 further comprising a saliva stimulant. The composition of claim 11 wherein the saliva stimulant is selected from the group consisting of citric acid, lactic acid, malic acid, succinic acid, ascorbic acid, adipic acid, fumaric acid and tartaric acid. The composition of claim 1 further comprising a sweetener. The composition of claim 13, wherein the sweetener is selected from the group consisting of sucralose, acesulfame, and aspartame. The composition of claim 1 further comprising a therapeutically active agent. 16. The therapeutically active agent of claim 15 wherein the therapeutically active agent is chlorpheniramine maleate, bromfenyramine maleate, dexchlorpheniramine, triprolidine hydrochloride, acribastine, azatadine maleate, loratidine, phenyl Among the group consisting of lephrine hydrochloride, dextromethorphan hydrochloride, ketoprofen, sumatriptan succinate, zolmitriptan, loperamide, pamotidine, nicotine, caffeine, diphenhydramine hydrochloride and pseudoephedrine hydrochloride Composition selected.