KR100855566B1 - Orally comsumable films - Google Patents

Abstract

The present invention relates to an oral consumable film containing a functional raw material, and more particularly, to improve the physical and chemical stability of the functional raw material contained in the film, and to improve the storage stability of the film, and also to the functional raw material And / or relates to an oral consumable film that can improve the capacity to accept a pharmaceutical.

The oral consumption film of the present invention comprises a film former, sorbitol fatty acid ester, and polysorbet, wherein the film former consists of a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3.

As a result, the present invention improves the physical and chemical stability of the functional raw materials and / or pharmaceuticals included in the film, and has an effect of improving the storage safety of the film. In addition, the present invention has the effect of improving the capacity to accommodate functional raw materials and / or pharmaceuticals.

Oral, Consumption, Film, Capacity, Functionality, Raw Materials

Description

Oral Consumable Film {ORALLY COMSUMABLE FILMS}

The present invention relates to an oral consumable film containing a functional raw material, and more particularly, to improve the physical and chemical stability of the functional raw material contained in the film, and to improve the storage stability of the film, and also to the functional raw material And / or relates to an oral consumable film that can improve the capacity to accept a pharmaceutical.

Oral consumption film is applied to food or medicine for oral cleanliness such as gum, lozenge, toothpaste, gargle and spray, etc., and various products have been disclosed that have improved the convenience of use by overcoming constraints such as time and place. It is.

For example, U.S. Patent No. 6,596,298 discloses a composition comprising a film made of pullulan and a functional raw material such as an antimicrobial agent (such as thymol, methyl salicylate, eucalyptol, menthol, etc.) and saliva stimulant (citric acid, malic acid, etc.). In addition, it discloses also about the film which added various pharmaceutical agents, such as a pharmaceutical active agent, etc. in general.

On the other hand, pullulan used as the main raw material of the film has a disadvantage of high price, import dependency and low physical properties in handling of the distribution, in order to cope with this, there are a number of methods of manufacturing the film with various natural polysaccharides such as alginic acid and starch. Published in the literature. For example, Korean Patent Laid-Open Publication No. 2005-48056 (hereinafter referred to as 'first application') discloses an oral consumption film including a film former mixed with starch and alginate at a predetermined ratio.

The above-mentioned application is not self-adhesive due to the properties of starch and alginate, and it dissolves rapidly when used orally, and its physical properties such as strength or softness are improved, so that it can be used as a pharmaceutical agent such as antihistamine, analgesic and anti-inflammatory agent as well as oral cleansing effect. Has been presented.

However, these conventional films have a limitation in their ability to accommodate functional ingredients and / or pharmaceuticals, and thus have limitations in the efficacy or effects expressed upon actual ingestion.

On the other hand, oral consumption film containing a functional raw material and / or a pharmaceutical agent is not only physical properties such as strength and softness in order to be used as a health functional food and / pharmaceuticals that are ingested in the human body to help the human body, Chemical properties such as stability and reactivity of the pharmaceutical, physical properties such as crystalline and phase separation are very important factors.

Accordingly, the oral consumption film has been required to consider the physical properties of the film as well as the physical and chemical properties of the film considering the compatibility.

In addition, various conditions such as the reactivity of the film-forming agent with the functional ingredient and / or pharmaceutical agent, oral dosage, daily recommended amount, film formation, storage stability, etc. should be considered.

The present invention has been made in view of the above, and provides an oral consumption film that can improve the storage safety of the film while improving the physical and chemical stability of the functional raw materials and / or pharmaceuticals included in the film. Its purpose is to.

It is also an object of the present invention to provide an oral consumable film capable of improving the capacity to accommodate functional raw materials and / or pharmaceuticals.

Oral consumption film according to the first embodiment of the present invention for achieving the above object comprises a film former, sorbitol fatty acid ester, and polysorbet, the film former is 1: 2.4 to 1: It consists of a mixture of starch: alginate with 3 weight ratios.

Oral consumption film according to a second embodiment of the present invention comprises a film former, vitamin C, and vitamin E, the film former comprises a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3. .

Oral consumption film according to a third embodiment of the present invention comprises a film former, anhydrous caffeine, and vitamin B3, the film former comprises a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3. .

Oral consumption film according to a fourth embodiment of the present invention comprises a film former, trehalose, and tadalafil, the film former comprises a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3.

Hereinafter, preferred embodiments of the present invention will be described in detail.

The film of the present invention includes a film forming agent, an antimicrobial agent, a fragrance, a filler, a softener, a stabilizer, a saliva stimulant and a sweetener, and the like, and various kinds of functional raw materials may be added.

Preferably, the film former comprises starch: alginate having a weight ratio of 1: 2.4 to 1: 3.

The present invention improves the physical properties of the film, particularly strength (tensile strength) and ductility (elongation), etc. by mixing starch: alginate in a weight ratio of 1: 2.4 to 1: 3 as a film forming agent, and thus antimicrobial agents, perfumes and bad breath removers. It can accommodate various types of functional raw materials such as vitamins, caffeine, Noni, tadalafil, etc., and in the case of functional raw materials having good compatibility or reactivity with films, it can accommodate up to 1/3 ratio of film weight. There is a feature to do. (The above composition ratios (1: 2.4 to 1: 3) require a wide range of functional ingredients to be widely accepted and critical significance of their capacity , and experimental data on them. If there is no proof of this, there is a high probability that it will be rejected later.)

On the other hand, the mixing ratio of starch and alginate is selected in consideration of hygroscopicity, hydrophilicity / hydrophobicity, solubility and crystallinity of the functional raw materials to be added, but the mixing ratio of starch: alginate is 1: 2.4 to 1: 3 The physical properties of the film, in particular, the strength (tensile strength) and ductility (elongation) can be kept stable.

Starch as a film-forming agent can impart the stability of the film structure appearing in the high molecular weight polysaccharide through gelatinization at a temperature above 60 ℃ in addition to the structurally flexible inherent properties. On the other hand, other polysaccharides used as film-forming agents, such as pullulan, gelatin, etc., are advantageous in the production of films of functional raw materials having high hygroscopicity, hydrophilicity, water solubility, and solubility due to lower moisture hygroscopicity, but the film has low strength. There is a limit in maintaining the form and the resolution is difficult during the coating process is difficult to manage. In contrast, alginate may give strength to the film by forming a dense structure during film formation due to structurally strong bonds such as hydrogen bonds. Due to the strength of alginate, it is advantageous to manufacture a film of a functional raw material having high hydrophobicity, poor solubility, and high crystallinity, which is difficult to be commercialized with a water-soluble film. However, since it has high strength, it is an acidic polysaccharide containing a carboxyl group in a repeatable unit, and thus, vitamin C and The same acidic functional raw material makes film formation difficult. When prepared using the starch: alginate mixing ratio of 1: 2.4 to 1: 3 weight ratio of the present invention, the physical properties (such as ductility and strength) are not only improved (see Example 1), but also film forming ability and added functionality. A functional oral consumption film with stable and evenly distributed raw materials could be prepared.

 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 octenylsuccinateated starch or dodecylsuccinate. Take starch, for 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 the 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.

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, diphenylpy 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, dex tromethorphan 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.

Film compositions to which the pharmaceutically active agent is added may be used as triglycerides such as corn oil, sunflower oil, peanut oil, oli

Vegetable oils such as bromine oil, canola oil, soybean oil, mixtures thereof, and may also include preservatives such as 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)

Add 70.70 g of distilled water to the container, add 0.58 g of crystal cellulose slowly, stir thoroughly, and add 1.10 g of sorbitol, 1.10 g of glycerol, and 0.20 g of propylene glycol, and stir. After a while, 0.22 g of carrageenan, 0.18 g of locust bean gum, 0.11 g of xanthan gum, 0.06 g of acesulfame potassium, 0.42 g of aspartame, 0.09 g of sucralose, 0.21 g of citric acid, and 0.31 g of malic acid were slowly added to the container and stirred for 1 hour. Warm the solution temperature to 70 ~ 90 ℃, add 4.71g of starch and 14.13g of sodium alginate and stir for 1 hour more. After cooling to 40 ~ 60 ℃, 0.61g sucrose fatty acid ester, menthol 1.48g, peppermint flavor 1.00g, citrus flavor 1.28g, spearmint powder flavor 0.65g, peppermint cotton flavor 0.67g, cooling flavor 0.15g, methyl salicylate Add 0.03 g and stir for about 30 minutes, and dissolve Blue No. 1 in water in a small amount, add and mix. The sufficiently mixed solution was defoamed overnight and then coated using a film molding machine and then dried using a tunneled convection oven. The coated film was made into a final size by slitting and cutting to a constant size.

 Table 1

Furtherance Example  One Comparative Example  1-1 Comparative Example  1-2 Comparative Example  1-3 Sorbitol 1.10 1.10 1.10 1.10 glycerin 1.10 1.10 1.10 1.10 Propylene glycol 0.20 0.20 0.20 0.20 Citric acid 0.21 0.21 0.21 0.21 Malic acid 0.31 0.31 0.31 0.31 Locust bean gum 0.18 0.18 0.18 0.18 Xanthan Gum 0.11 0.11 0.11 0.11 Carrageenan 0.22 0.22 0.22 0.22 Aspartame 0.42 0.42 0.42 0.42 Acesulfame Potassium 0.06 0.06 0.06 0.06 Sucralose 0.09 0.09 0.09 0.09 Sucrose Fatty Acid Ester 0.61 0.61 0.61 0.61 Crystalline cellulose 0.58 0.58 0.58 0.58 Starch 4.71 5.54 5.24 4.96 Sodium alginate 14.13 13.30 13.61 13.90 Blue No. 1 0.01 0.01 0.01 0.01 Peppermint flavor 1.00 1.00 1.00 1.00 Citrus flavor 1.28 1.28 1.28 1.28 Spearmint Powder Fragrance 0.65 0.65 0.65 0.65 Mint cotton flavor 0.67 0.67 0.67 0.67 menthol 1.48 1.48 1.48 1.48 Cooling scent 0.15 0.15 0.15 0.15 Methylsalicylate 0.03 0.03 0.03 0.03 Distilled water 70.70 70.70 70.70 70.70 Sum 100.17 100.17 100.18 100.19 Starch: Alginate 1: 3 1: 2.4 1: 2.6 1: 2.8 The tensile strength( MPa ) 29.871 25.314 27.015 27.947 Elongation (%) 7.814 9.541 9.102 8.612

Tensile strength (TS) and elongation (E) of the film were used by modifying the ASTM D882-02 standard test method for oral consumption film. The test method was sampled at 22mm (W) × 32mm (L), aged for 3 days in a constant temperature and humidity chamber set at 30 ° C and 70% RH, and then Texture Analyzer (TX-HD, Stable Micro System, UK). The average value was obtained by measuring 9 times in total. The measured tensile strength was expressed in MPa and the elongation was expressed in%.

As shown in Table 1, the weight ratio of starch: alginate showed stable tensile strength and elongation in the range of 1: 2.4 to 1: 3.0, and the weight ratio of the film was closer to 1: 3 (Example 1). As the structure became harder, the tensile strength increased, and as it approached 1: 2.4 (Comparative Example 1-1), the film became flexible and the elongation rate increased.

(Example 2)

Using the composition shown in Table 2 below, the film was prepared by adding sorbitol fatty acid ester and polysorbate, and then working similarly to the method of Example 1, and exhibiting change with time.

The change over time was measured by observing the degree of self-sticking and breaking (breaking). In order to measure the influence on the high temperature and humidity external environment, the temperature of the constant temperature and humidity bath was set at 35 ° C. and the humidity was set at 90% RH, and the film was stored for 3 days and then checked for self-adhesion. In addition, in order to measure the effect of the low temperature dry external environment, the temperature of the constant temperature and humidity bath was set to 25 ℃, the humidity to 50% RH and then put the film and stored for 3 days to check whether or not broken.

Table 2

Ingredients Example  2 Comparative Example  2-1 Comparative Example  2-2 Comparative Example  2-3 Comparative Example  2-4 Comparative Example  2-5 Comparative Example  2-6 Sorbitol 1.07 1.08 1.09 1.08 1.08 1.08 1.08 glycerin 1.07 1.08 1.09 1.08 1.08 1.08 1.08 Propylene glycol 0.19 0.20 0.20 0.20 0.20 0.20 0.20 Citric acid 0.20 0.21 0.21 0.21 0.21 0.21 0.21 Malic acid 0.30 0.30 0.31 0.31 0.31 0.31 0.31 Locust bean gum 0.17 0.18 0.18 0.18 0.18 0.18 0.18 Xanthan Gum 0.11 0.11 0.11 0.11 0.11 0.11 0.11 Carrageenan 0.21 0.22 0.22 0.22 0.22 0.22 0.22 Aspartame 0.41 0.41 0.42 0.41 0.41 0.41 0.41 Acesulfame Potassium 0.06 0.06 0.06 0.06 0.06 0.06 0.06 Sucralose 0.09 0.09 0.09 0.09 0.09 0.09 0.09 Sucrose Fatty Acid Ester 0.59 0.60 0.60 0.60 0.60 0.60 0.60 Sorbitol Fatty Acid Ester 1.76 1.12 0.60 1.76 0.00 1.76 1.76 Polysorbate 1.76 1.12 0.60 0.00 1.76 0.60 1.12 Crystalline cellulose 0.56 0.57 0.57 0.57 0.57 0.57 0.57 Starch 4.57 4.62 4.66 4.64 4.64 4.64 4.64 Sodium alginate 13.71 13.85 13.99 13.92 13.92 13.92 13.92 Blue 1 0.01 0.01 0.01 0.01 0.01 0.01 0.01 Peppermint flavor 0.97 0.98 0.99 0.99 0.99 0.99 0.99 Citrus flavor 1.24 1.25 1.27 1.26 1.26 1.26 1.26 Spearmint Powder Fragrance 0.63 0.64 0.64 0.64 0.64 0.64 0.64 Mint cotton flavor 0.65 0.66 0.66 0.66 0.66 0.66 0.66 menthol 1.44 1.45 1.47 1.46 1.46 1.46 1.46 Cooling scent 0.15 0.15 0.15 0.15 0.15 0.15 0.15 Methylsalicylate 0.03 0.03 0.03 0.03 0.03 0.03 0.03 Distilled water 68.58 69.28 70.02 69.64 69.64 69.64 69.64 Sum 100.68 100.40 100.40 100.42 100.42 101.02 101.54 Self-adhesion × × ○ × ○ × × Broken × × ○ ○ × ○ ×

As shown in Table 2, as the ratio of sorbitol fatty acid ester increases, self-adhesion does not occur in the aging change of high temperature and high humidity conditions, and as the ratio of polysorbate increases, the phenomena of crushing change in the aging change of low temperature dry conditions are alleviated. . As in Example 2 and Comparative Example 2-1, when sorbitol fatty acid ester and polysorbate are added at 1.12% or more, it shows good performance on self-adhesion and breakage with time.

(Example 3)

Each component of Table 3 below was used in the same manner as in Example 1 to prepare a vitamin C film.

Table 3

Example 3 Comparative Example 3-1 Comparative Example 3-2 Comparative Example 3-3 Comparative Example 3-4 Comparative Example 3-5 Sorbitol 0.54 0.57 0.57 0.57 0.59 0.55 glycerin 0.54 0.57 0.57 0.57 0.59 0.55 Propylene glycol 0.27 0.29 0.29 0.28 0.29 0.28 Sodium citrate 0.16 0.17 0.17 0.17 0.18 0.17 Citric acid 0.22 0.23 0.23 0.23 0.24 0.22 Malic acid 0.32 0.34 0.34 0.34 0.35 0.33 Locust bean gum 0.16 0.17 0.17 0.17 0.18 0.17 Xanthan Gum 0.11 0.11 0.11 0.11 0.12 0.11 Carrageenan 0.22 0.23 0.23 0.23 0.24 0.22 Aspartame 0.22 0.23 0.23 0.23 0.24 0.22 Acesulfame Potassium 0.10 0.10 0.10 0.10 0.11 0.10 Sucralose 0.10 0.10 0.10 0.10 0.11 0.10 Trehalose 0.54 0.57 0.57 0.57 0.59 0.55 Sucrose Fatty Acid Ester 0.32 0.34 0.34 0.34 0.35 0.33 Crystalline cellulose 0.16 0.17 0.17 0.17 0.18 0.17 Starch 4.33 4.58 4.56 4.54 4.70 4.41 Sodium alginate 12.98 13.74 13.69 13.61 14.10 13.24 Red 40 0.01 0.01 0.01 0.01 0.01 0.01 Yellow 4 0.01 0.01 0.01 0.01 0.01 0.01 Orange flavor 2.16 2.29 2.28 2.27 2.35 2.21 Vitamin C 10.57 6.21 6.19 6.15 3.65 8.98 Vitamin E 1.05 0.29 0.41 0.61 0.36 0.89 Distilled water 64.91 68.68 68.45 68.03 70.50 66.20 Sum  100    100    100  100  100 100 Film Formation ○ × × ○ ○ ○ content( mg Of sheet ) 18 10 10 10 5 15

(Example 4)

Each component of Table 4 was used in the same manner as in Example 1 to prepare a caffeine film.

Table 4

Example 4 Comparative Example 4-1 Comparative Example 4-2 Comparative Example 4-3 Comparative Example 4-4 Comparative Example 4-5 Comparative Example 4-6 Comparative Example 4-7 Sorbitol 1.61 1.71 1.70 1.69 1.67 1.75 1.72 1.64 glycerin 1.61 1.71 1.70 1.69 1.67 1.75 1.72 1.64 Propylene glycol 0.25 0.27 0.27 0.26 0.26 0.27 0.27 0.26 Sodium citrate 0.27 0.28 0.28 0.28 0.28 0.29 0.29 0.27 Citric acid 0.16 0.17 0.17 0.17 0.17 0.17 0.17 0.16 Locust bean gum 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 Xanthan Gum 0.13 0.14 0.14 0.14 0.14 0.15 0.14 0.14 Carrageenan 0.11 0.11 0.11 0.11 0.11 0.12 0.11 0.11 Aspartame 0.26 0.27 0.27 0.27 0.27 0.28 0.27 0.26 Acesulfame Potassium 0.06 0.07 0.07 0.07 0.07 0.07 0.07 0.07 Sucralose 0.14 0.15 0.15 0.15 0.14 0.15 0.15 0.14 Trehalose 0.88 0.94 0.93 0.93 0.92 0.96 0.94 0.90 Sucrose Fatty Acid Ester 0.54 0.57 0.57 0.56 0.56 0.58 0.57 0.55 Crystalline cellulose 0.27 0.28 0.28 0.28 0.28 0.29 0.29 0.27 Starch 3.21 3.42 3.39 3.37 3.34 3.49 3.43 3.28 Sodium alginate 12.32 13.09 13.01 12.93 12.81 13.40 13.15 12.58 Blue 1 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 Peppermint flavor 2.14 2.28 2.26 2.25 2.23 2.33 2.29 2.19 menthol 0.80 0.85 0.85 0.84 0.84 0.87 0.86 0.82 Cooling scent   0.27 0.28 0.28 0.28 0.28 0.29 0.29 0.27 Caffeine Anhydrous 7.33 4.98 4.95 4.92 4.88 1.91 3.13 5.99 Vitamin B3 3.30 0.62 1.23 2.19 0.86 1.41 2.70 Distilled water 64.25 68.31 67.89 67.47 66.81 69.90 68.63 65.66 Sum 100  100   100 100 100 100 100 100 Film Formation ○ × × × ○ ○ ○ ○ content( mg Of sheet ) 12.5 8 8 8 8 3 5 10

(Example 5)

Each component of the following Table 5 was used similarly to the method of Example 1 to prepare a tadalafil film.

Table 5

Example 5 Comparative Example 5-1 Comparative Example 5-2 Comparative Example 5-3 Comparative Example 5-4 Comparative Example 5-5 Comparative Example 5-6 Sorbitol 1.06 1.12 1.11 1.11 1.10 1.15 1.09 glycerin 1.06 1.12 1.11 1.11 1.10 1.15 1.09 Propylene glycol 0.27 0.28 0.28 0.28 0.28 0.29 0.27 Sodium citrate 0.00 0.00 0.00 0.00 0.00 0.00 0.00 Citric acid 0.08 0.09 0.09 0.09 0.09 0.09 0.09 Malic acid 0.13 0.13 0.13 0.13 0.13 0.14 0.13 Locust bean gum 0.16 0.17 0.17 0.17 0.17 0.17 0.16 Xanthan Gum 0.11 0.11 0.11 0.11 0.11 0.12 0.11 Carrageenan 0.21 0.22 0.22 0.22 0.22 0.23 0.22 Aspartame 0.27 0.28 0.28 0.28 0.28 0.29 0.27 Acesulfame Potassium 0.05 0.06 0.06 0.06 0.06 0.06 0.05 Sucralose 0.08 0.08 0.08 0.08 0.08 0.09 0.08 Trehalose 1.06 0.00 0.28 0.55 1.16 1.15 1.09 Sucrose Fatty Acid Ester 0.32 0.33 0.33 0.33 0.33 0.35 0.33 Crystalline cellulose 0.16 0.17 0.17 0.17 0.17 0.17 0.16 Starch 4.25 4.46 4.45 4.44 4.41 4.62 4.35 Sodium alginate 12.74 13.39 13.35 13.32 13.24 13.85 13.05 Yellow 4 0.01 0.01 0.01 0.01 0.01 0.01 0.01 Peppermint flavor 0.53 0.56 0.56 0.55 0.55 0.58 0.54 Citrus flavor 0.64 0.67 0.67 0.67 0.66 0.69 0.65 Spearmint Powder Fragrance 0.27 0.28 0.28 0.28 0.28 0.29 0.27 Mint cotton flavor 0.27 0.28 0.28 0.28 0.28 0.29 0.27 menthol 0.53 0.56 0.56 0.55 0.55 0.58 0.54 Cooling scent 0.05 0.06 0.06 0.06 0.06 0.06 0.05 Tadalafil 12.03 8.63 8.61 8.58 8.53 4.36 9.86 Distilled water 63.68 66.95 66.77 66.58 66.18 69.24 65.25 sum 100.000 100.000 100.000 100.000 100.000 100.000 100.000 Film Formation ○ × × × ○ ○ ○ content( mg Of sheet ) 15 10 10 10 10 5 12

The present invention as described above, while improving the physical and chemical stability of the functional raw materials and / or pharmaceuticals contained in the film, there is an effect to improve the storage safety of the film.

In addition, the present invention has the effect of improving the capacity to accommodate functional raw materials and / or pharmaceuticals.

It is apparent to those skilled in the art that the present invention is not limited to the described embodiments, and that various modifications and changes can be made without departing from the spirit and scope of the present invention. Therefore, such modifications or variations will have to be belong to the claims of the present invention.

Claims (4)

In the oral consumption film containing the film-forming agent, antimicrobial agent, fragrance, filler, emollient, stabilizer, saliva stimulant and sweetener and sorbitol fatty acid ester and polysorbet, The film forming agent oral consumption film, characterized in that consisting of a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3. In the oral consumption film comprising a film former, antimicrobial agent, fragrance, filler, softener, stabilizer, saliva stimulant and sweetener and vitamin C and vitamin E, The film forming agent oral consumption film, characterized in that consisting of a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3. In the oral consumption film containing a film forming agent, an antimicrobial agent, a fragrance, a filler, an emollient, a stabilizer, a saliva stimulant and a sweetener and an anhydrous caffeine, and vitamin B3, The film forming agent oral consumption film, characterized in that consisting of a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3. In the oral consumption film comprising a film forming agent, antimicrobial agent, fragrance, filler, softener, stabilizer, saliva stimulant and sweetener, Including film formers, trehalose, and tadalafil, The film forming agent oral consumption film, characterized in that consisting of a mixture of starch: alginate having a weight ratio of 1: 2.4 to 1: 3.