KR102619728B1 - Heat-stable oral disintegrating film comprising S-allyl-L-cysteine from fermented black garlic and manufacturing method thereof - Google Patents

Abstract

Sulfur-containing fermented black garlic (SAC) orally dispersible film is vulnerable to heat and has the characteristic of producing bubbles when dried at high temperatures, making it difficult to manufacture. The present invention relates to an orally dispersible film of sulfur-containing fermented black garlic (SAC) with improved thermal stability. The orally dispersible film formulation according to one aspect contains titanium dioxide and has excellent thermal stability even when dried at a high temperature of 80°C or higher. It has excellent release properties and flexibility, including improved bubble generation and hardness.

Description

Heat-stable orally disintegrating film comprising S-allyl-L-cysteine from fermented black garlic and manufacturing method thereof}

It relates to an orally dispersible film with improved thermal stability and a method of manufacturing the same.

Recently, Oral Destructive Tablet (ODT) or Oral Disintegrating Film (ODF) formulations in which solid substances disintegrate or dissolve in the oral cavity have been developed. Among these, the orally dispersible film formulation can be taken without water, so it is very useful not only for the elderly who have difficulty taking tablets or capsules, but also for children, the disabled, and patients lying in bed. It is evaluated as an improved formulation compared to any other formulation. In addition to the health-vulnerable population, it is also in the spotlight as a form of health functional food for busy modern people due to its convenience in carrying and taking, and the advantages of rapidly disintegrating in the mouth, enabling rapid absorption of active ingredients.

However, orally disintegratable films cannot be manufactured above a certain weight because i) they must be thin enough to disintegrate quickly in the oral cavity; ii) they must be manufactured in a certain amount to mix well with the drug and maintain strength and plasticity suitable for film handling. Since the above polymer must be included in the film, the content of the active ingredient that can be included in the film is relatively low; iii) because the manufacturing method varies greatly depending on the form and content of the raw materials that can have the pharmacological effect of the main ingredient; The downside is that standardization is difficult. In the development of orally dispersible formulations, many studies are focusing on methods for developing formulations that match the raw material characteristics of the main ingredients.

Garlic ( Allium sativum L.) is a fruit vegetable belonging to the Allium genus of the Lilliaceae family and is widely used as a functional material due to its physiological activity. The main components that show the efficacy of garlic are sulfur compounds (organosulfur compounds). When garlic is processed, alliinase present in the cells is activated and decomposed into allicin, pyruvic acid, and ammonia, and allicin acts again with pyruvic acid to produce DAS, DADS, and DATS. By producing low-grade sulfur compounds and carbonyl compounds, it generates garlic's unique aroma and spicy taste. Among these, S-allyl-L-cysteine (SAC) is produced from GSAC by γ-glutamyl transpeptidase (γ-GTP, EC 2.3.2.2) during the storage, ripening and processing of garlic. SAC is considered to be a major functional ingredient of garlic as studies related to antioxidant, anti-cancer, blood glucose control, improvement of cardiovascular disease, improvement of blood cholesterol, improvement of brain disease, and improvement of cognitive function have been reported.

The present inventors began research on an orally dispersible film formulation based on the intake of useful components of garlic and its various physiological activity enhancement effects. However, since garlic contains sulfur as an active ingredient, it is vulnerable to heat, and when dried and molded using tunnel-type hot air drying and infrared irradiation (IR) at high temperatures according to commonly used film production methods, the phenomenon of bubble generation is observed. I came to recognize it. To solve this problem, research efforts were made to develop a sulfur-containing orally dispersible film formulation with improved thermal stability. In this, the present invention was completed by selecting the optimal film former, introducing titanium dioxide, and confirming the optimal amount of additives. I did it.

One aspect is a biologically active substance containing sulfur as an active ingredient; and an orally dispersible film formulation containing titanium dioxide.

Another aspect includes heating and dissolving a mixture of a bioactive substance containing sulfur and a solvent and then cooling;

Adding titanium dioxide and a film forming agent to the mixed solution and stirring to prepare a crude film solution; and

drying the film solution; It provides a method for manufacturing an orally dispersible film comprising.

One aspect is a biologically active substance containing sulfur as an active ingredient; and an orally dispersible film formulation containing titanium dioxide.

In this specification, the term “Oral Disintegrating Film (ODF)” has the meaning known in the art, and is also called “strip” and “orally dissolving film.” Specifically, it is a preparation that is absorbed into the capillaries through the mucous membrane of the oral cavity, and refers to a film dosage form that can be dissolved or finely dispersed in the oral cavity and taken. The film formulation dissolves on the tongue, but can also be ingested by attaching it to the palate, sublingual area, buccal area, oral mucosa, inner side of the cheek, and above the gums. The formulation preferably allows more than 80% of the total formulation to be dissolved, dispersed, or disintegrated within 1 minute or 1 minute after oral administration.

As used herein, the term "orally dispersible film formulation" refers to a mixture containing components for producing the orally dispersible film of the present invention, and limits the form of the mixture before the drying process for producing the orally dispersible film. Includes without.

As used herein, the term "biologically active substance" refers to a substance that has a special effect on the normal function or biological activity of the human body and thus contributes to or improves health or strengthens the function of maintaining and improving health. In the present invention, it specifically refers to sulfur (sulfur). ) may be strengthened by.

As used herein, “comprising sulfur” or “comprising sulfur” or “containing sulfur” are used interchangeably. Bioactive substances containing sulfur include, for example, three types of S-alkyl (alkenyl)-L-cysteine sulfoxides such as alline, isoaline, and methine, and γ-glutamyl-L-cysteine derivative peptides. Tamil-S-1-propenyl-cysteine (γ-glutamyl-S-1-propenyl-cysteine (GSPC), γ-glutamyl-S-allyl-cysteine (GSAC) and Their reaction products are S-allyl-L-cysteine (SAC), allicin, diallyl sulfide (DAS), diallyl disulfide (DADS), and diallyl trisulfide. (dially trisulfide, DATS), dithiin, ajoene, etc.

In one embodiment, the sulfur-containing physiologically active substance may be garlic extract or garlic extract concentrate powder obtained by drying and pulverizing the garlic extract. The garlic extract or concentrated garlic extract powder is 10 to 50% by weight, for example, 10 to 50% by weight, 10 to 40% by weight, 10 to 35% by weight, based on the total weight of the solid content of the orally dispersible film preparation of the present invention. 20 to 50% by weight, 20 to 40% by weight, 20 to 35% by weight, 30 to 40% by weight, 30 to 35% by weight, 30 to 33% by weight, 30 to 32% by weight, 31 to 35% by weight, 31 to It may be included at 33% by weight, 31 to 32% by weight.

In the present invention, titanium dioxide not only acts as a coloring agent or clarifying agent, but also acts as a tissue improving agent that improves oral feel, a disintegrant of the film of the present invention, and an agent that improves the thermal stability of the film of the present invention. During the film manufacturing process, when tunnel-type hot air drying or infrared irradiation drying at high temperature, inappropriate sensory characteristics such as a large amount of bubbles, boiling, browning and discoloration may be observed depending on the raw material. By adding an appropriate amount of titanium dioxide, wettability, disintegration speed or It does not adversely affect oral feel and at the same time enhances thermal safety during the tunnel-type hot air drying and infrared irradiation drying process, thereby reducing the generation of bubbles and improving hardness.

The titanium dioxide is 0.01 to 5% by weight, for example, 0.01 to 5% by weight, 0.01 to 4% by weight, 0.01 to 3% by weight, 0.01 to 2% by weight, based on the total weight of the solid content of the orally dispersible film formulation of the present invention. 0.01 to 1.5% by weight, 0.01 to 1% by weight, 0.01 to 0.5% by weight, 0.01 to 0.4% by weight, 0.01 to 0.3% by weight, 0.01 to 0.2% by weight, 0.01 to 0.1% by weight, 0.05 to 4% by weight, 0.05 to 0.05% by weight 3% by weight, 0.05 to 2% by weight, 0.05 to 1% by weight, 0.05 to 0.5% by weight, 0.05 to 0.4% by weight, 0.05 to 0.3% by weight, 0.05 to 0.2% by weight, 0.05 to 0.1% by weight, 0.06 to 0.1% by weight %, 0.07 to 0.1% by weight, 0.08 to 0.1% by weight, and 0.09 to 0.1% by weight.

The orally dispersible film formulation of the present invention may contain a film-forming polymer for producing an orally dispersible film.

As used herein, the term "film-forming agent" or "film-forming polymer" refers to a water-soluble polymer that forms an orally dispersible film, including pullulan, gelatin, pectin, low-viscosity pectin, hydroxypropylmethylcellulose, low-viscosity Figure 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, elsinan, gluten, acacia gum, carrageenan, gum arabic, guar gum, locust bean gum, xanthan gum, gellan gum and agar. It may be one or more water-soluble polymers selected from the group consisting of

In this specification, the term "pullulan" is a substance obtained by separating and purifying polysaccharides produced from black yeast ( Aureobasidium pullulans ), and the main component is a neutral polysaccharide. It is highly soluble in water and insoluble in alcohol and oil. Although it has a lower viscosity than other gums, it is stable in acids, alkalis, and heat, and has strong adhesion in addition to film properties. Pullulan gives the product a soft feel and stabilizes the gel structure. Compared to gelatin or hydroxypropylmethylcellulose, pullulan has a non-animal origin and is a completely natural substance without any chemical modification. It has highly consistent production quality by controlling the fermentation process, and produces films with high homogeneity and transparency. It has advantages such as formation, very low oxygen permeability and low moisture content, making it useful for product storage, and high stability during storage.

In forming the orally dispersible film formulation of the present invention, the film forming agent may preferably be a water-soluble polymer consisting of pullulan, hydroxypropylmethylcellulose, or a combination of pullulan and hydroxypropylmethylcellulose.

In one embodiment, the film forming agent may be pullulan in an amount of 10.0 to 40.0% by weight based on the total weight of the solid content of the orally dispersible film formulation of the present invention. For example, 10 to 40% by weight, 20 to 40% by weight, 30 to 40% by weight, 33 to 40% by weight, 35 to 40% by weight, 37 to 40% by weight, 37 to 39% by weight, 37 to 38% by weight. It can be included as a percentage.

In one embodiment, the pullulan and hydroxypropylmethylcellulose may be included in the orally dispersible film formulation at a weight ratio of 1:1 to 10. For example, a weight ratio of 1:10, a weight ratio of 1:9, a weight ratio of 1:8, a weight ratio of 1:7, a weight ratio of 1:6, a weight ratio of 1:5, a weight ratio of 1:4, a weight ratio of 1:3. It may be included in a weight ratio of 1:2.

The orally dispersible film formulation of the present invention may contain appropriate excipients in a commonly used amount, if necessary. The excipients are substances added for the purpose of improving disintegration, solubility, moldability, tabletability, stability, flexibility, elasticity, etc., for example, plasticizers, complexing agents, disintegrants, stabilizers, surfactants. , pigments, coloring agents, etc., but are not limited thereto, and include all suitable forms that can be used in orally dispersible film preparations.

The excipients may be added singly or in combination.

In one embodiment, the plasticizer may be acetyl triethyl citrate, polyethylene glycol, propylene glycol, polypropylene glycol, glycerin, citrate ester, triacetin, or triethyl citrate. The plasticizer is present in an amount of 0.1 to 5% by weight, for example, 0.1 to 5% by weight, 0.1 to 4% by weight, 0.1 to 3% by weight, 0.1 to 2% by weight, based on the total weight of the solid content of the orally dispersible film formulation of the present invention. 0.1 to 1.5% by weight, 0.1 to 1% by weight, 0.1 to 0.7% by weight, 0.3 to 1.5% by weight, 0.3 to 1% by weight, 0.3 to 0.7% by weight, 0.5 to 1.5% by weight, 0.5 to 1% by weight, 0.5 to It may be included at 0.7% by weight.

In one embodiment, the complexing agent may be α-cyclodextrin, β-cyclodextrin, or γ-cyclodextrin, and is preferably β-cyclodextrin. The complexing agent is present in an amount of 2 to 10% by weight, for example, 2 to 10% by weight, 2 to 7% by weight, 2 to 5% by weight, 2 to 4% by weight, based on the total weight of the solid content of the orally dispersible film formulation of the present invention. It may be included in 2 to 3% by weight or 2 to 2.5% by weight.

In one embodiment, the disintegrant may be carboxymethylcellulose sodium (CMC-Na), carboxymethylcellulose calcium (CMC-Ca), or modified starch. Modified starch can be used as acid-treated modified starch, hydroxypropylated modified starch, alpha-modified starch, cross-linked modified starch, and modified starch made from starch decomposition products. It has the advantage of having good film-forming ability together with pullulan. there is. The disintegrant is present in an amount of 0.1 to 5% by weight, for example, 0.1 to 5% by weight, 0.1 to 3% by weight, 0.1 to 1% by weight, 0.3 to 1% by weight, based on the total weight of the solid content of the oral dispersible film formulation of the present invention. It may be included in 0.5 to 1% by weight, 0.7 to 1% by weight, or 0.9 to 1% by weight.

The orally dispersible film formulation of the present invention may contain appropriate additives in a commonly used amount as needed. The additives may be vitamins, nutritional fortifiers, minerals, sweeteners, acidulants, flavorings, flavor enhancers, anti-foaming agents, etc., but are not limited thereto, and include all suitable forms that can be used in orally dispersible film preparations. These additives are added for the purpose of shaping, stabilizing, improving taste, enhancing nutrition, etc., and can be added in an amount that does not adversely affect the disintegration time or hardness of the orally dispersible film preparation.

The above additives may be added alone or in combination.

In one embodiment, the vitamin is vitamin A or its esters (e.g., vitamin A acetate and vitamin A palmitate), vitamin E or its esters (e.g., vitamin E acetate), vitamin K (phytomenada ion), vitamin D3 (cholecalciferol), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin, niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxamine, pyridoxal) ), vitamin B7 (biotin), vitamin B9 (folic acid, folinic acid), vitamin B12 (cyanocobalamin, hydroxycobalamin, methylcobalamin), or vitamin C (ascorbic acid). The vitamins are present in an amount of 0.001 to 5% by weight, for example, 0.001 to 5% by weight, 0.01 to 5% by weight, 0.1 to 5% by weight, 0.001 to 1% by weight, based on the total weight of the solid content of the orally dispersible film preparation of the present invention. It may be included at 0.001 to 0.1% by weight, 0.001 to 0.01% by weight, 0.01 to 0.1% by weight, 0.1 to 0.2% by weight, and 0.15 to 0.2% by weight.

In one embodiment, the nutritional fortifier may be a free amino acid such as leucine, isoleucine, valine, glutamine, carnitine, taurine, saline taurine, or arginine.

In one embodiment, the minerals may be iron, zinc, calcium, selenium, copper, boron, iodine, manganese, chromium, molybdenum, arsenic, or cobalt.

In one embodiment, the acidulant may be citric acid, malic acid, or tartaric acid.

In one embodiment, the sweetener is sugars and sugar alcohols such as xylitol, erythritol, sorbitol, trehalose, glucose, and sucrose, aspartame, sucralose, saccharin and its salts, and dipotassium glycyrrhizinate. , thaumatin, stevia, etc. can be high-intensity sweeteners.

In one embodiment, the flavor enhancer includes beef flavor, natural flavor (guarana, orange, lemon, peppermint, cinnamon, menthol, peppermint oil, wintergreen mint, clove, butterscotch, maple, apricot, peach flavor, cherry flavor, anise). , strawberry, vanillin, citrus, pineapple, orange, licorice, root beer, gardenia, raspberry, walnut, chocolate, etc.) and synthetic fragrances.

In one embodiment, the antifoaming agent is used to suppress or remove air bubbles, and may be a natural antifoaming agent such as decanoic acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, or a mixture of olive oil. .

Another aspect includes heating and dissolving a mixture of a bioactive substance containing sulfur and a solvent and then cooling;

Adding titanium dioxide and a film forming agent to the mixed solution and stirring to prepare a crude film solution; and

drying the film solution; It provides a method for manufacturing an orally dispersible film comprising.

In one embodiment, the heating may be performed at 70 to 90°C, for example, 70 to 90°C, 70 to 80°C, or 70 to 75°C.

In one embodiment, the second step may additionally include adding excipients or additives and stirring.

The excipients or additives are as described above.

In one embodiment, the drying may be performed at 70 to 90°C, for example, 70 to 90°C, 70 to 80°C, or 80 to 90°C. The drying process may be a tunnel-type hot air drying process and/or an infrared irradiation (IR) drying process, but is not limited thereto.

In one embodiment, the drying may be performed for 10 to 30 minutes, for example, 10 to 25 minutes, 10 to 20 minutes, 15 to 30 minutes, 15 to 25 minutes, or 15 to 20 minutes.

The orally dispersible film formulation according to one aspect contains a bioactive ingredient containing sulfur as an active ingredient, but contains an appropriate amount of titanium dioxide, so it may vary during film production depending on the high-temperature hot air drying and infrared irradiation drying process. It has excellent release properties and sensory properties, including no sticking or tearing and improved stickiness. In addition, it has excellent thermal stability, such as no boiling or bubbling, and has physical properties suitable for orally dispersible film formulations.

Figure 1 is an image showing the manufacturing process of the orally dispersible film of the present invention.
Figure 2 is a photograph showing the manufacturing results of an orally dispersible film according to Example 1 of the present invention.
Figure 3 is a photograph showing the manufacturing results of an orally dispersible film according to Comparative Example 1 of the present invention.
Figure 4 is a photograph showing the manufacturing results of an orally dispersible film according to Comparative Example 2 of the present invention.

This will be described in more detail through examples below. However, these examples are intended to illustrate one or more embodiments and the scope of the present invention is not limited to these examples. Throughout the specification of the present invention, when a part is said to "include" a certain component, this means that it does not exclude other components but may further include other components, unless specifically stated to the contrary. .

Example 1. Preparation of sulfur-containing orally dispersible film.

Example 1 was prepared in the order shown in Figure 1 according to the prescription in Table 1 below.

Specifically, purified water, garlic extract (SAC1%) of phase A, and β-cyclodextrin were dissolved by heating at 75°C for 30 minutes, and then cooled. Afterwards, the raw materials of phase B were added in order and stirred at room temperature for 30 minutes. Afterwards, the raw materials of phase C were added in order and stirred at room temperature for 30 minutes. Finally, after adding the raw materials of phase D, the mixture was stirred at room temperature for 10 minutes and degassed at 2,000 RPM for 5 minutes. The crude solution prepared in this way was applied at 750 to 1,000 uM, dried by tunnel-type hot air drying and infrared irradiation at 80°C for 20 minutes, and then molded into 25 x 40 mm to finally prepare an orally dispersible film.

The components used to manufacture the film of the present invention and their standard amounts and ratios are shown in Table 1 below. The ratio was calculated as the weight of each ingredient compared to the total weight of solids excluding purified water, which is a solvent.

award Raw material name Reference amount (mg/strip) Solid content (%) Purified water 470.0000 - A Garlic Extract (SAC1%) 100.0000 31.250 β -cyclodextrin 8.0000 2.500 B
Anhydrous citric acid 5.0000 1.563 aspartame 5.0000 1.563 Ornithine hydrochloride 1.0000 0.313 propylene glycol 2.0000 0.625 Modified starch 2.0000 0.625 CMC-Ca 3.0000 0.938 Olive oil mixture 0.1000 0.031 titanium dioxide 0.30000 0.094 HPMC 27.0000 8.438 flurane 118.6726 37.085 C taurine 5.50000 1.719 pineapple powder 24.0000 7.500 glycerin 5.0000 1.563 Vitamin B1 Hydrochloride (100%) 5.0000 1.563 Vitamin B2 (98%) 0.50000 0.156 Vitamin B3 (niacin; 100%) 0.50000 0.156 Vitamin B6 (100%) 0.50000 0.156 Vitamin B9 (folic acid; 100%) 0.40000 0.125 Vitamin B12 (100%) 0.0024 0.001 Molybdenum (0.2%) 0.0250 0.008 Vitamin C 5.0000 1.563 D Drink scent 1.50000 0.469

Figure 2 is a photograph showing the manufacturing results of an orally dispersible film according to Example 1 of the present invention.

As shown in Figure 2, when manufacturing the film according to Example 1, it showed excellent release properties and sensory properties, such as no sticking or tearing, improved stickiness, and good taste sensation. In addition, the thermal stability was improved, with no boiling or bubbles occurring.

Comparative Examples 1 and 2. Preparation of sulfur-containing orally dispersible film.

Comparative Examples 1 and 2 were prepared in the order of Figure 1 according to the prescriptions in Table 2 below.

Comparative Examples 1 and 2 do not contain titanium dioxide, the proportions of pullulan and HPMC, which are film forming agents, are different from Example 1, and the solid content of β-cyclodextrin, which is a complexing agent, is different from Example 1. Except for this point, it was prepared according to the same recipe as Example 1.

In the step of applying and drying the film solution, Comparative Example 1 was dried by tunnel-type hot air drying and infrared irradiation at 80°C for 20 minutes, and Comparative Example 2 was dried only by hot air drying without using infrared irradiation at 60°C for 20 minutes. Except for this point, the specific manufacturing method is the same as Example 1.

award Raw material name Reference amount (mg/strip) Solid content (%) Purified water 420.0000 - A Garlic Extract (SAC1%) 100.0000 31.250 β -cyclodextrin 6.0000 1.875 B
Anhydrous citric acid 5.0000 1.562 aspartame 5.0000 1.562 Ornithine hydrochloride 1.0000 0.312 propylene glycol 2.0000 0.625 Modified starch 2.0000 0.625 CMC-Ca 3.0000 0.937 Olive oil mixture 0.1000 0.031 HPMC 10.0000 3.125 flurane 137.9910 43.120 C taurine 5.50000 1.719 pineapple powder 24.0000 7.500 glycerin 5.0000 1.562 Vitamin B1 Hydrochloride (100%) 5.0000 1.562 Vitamin B2 (98%) 0.50000 0.156 Vitamin B3 (niacin; 100%) 0.50000 0.156 Vitamin B6 (100%) 0.50000 0.156 Vitamin B9 (folic acid; 100%) 0.40000 0.125 Vitamin B12 (100%) 0.0024 0.001 Molybdenum (0.2%) 0.0250 0.008 Vitamin C 5.0000 1.562 D Drink scent 1.50000 0.469

Figures 3 and 4 are photographs showing the manufacturing results of orally dispersible films according to Comparative Examples 1 and 2 of the present invention.

As shown in Figure 3, when dried at high temperature according to Comparative Example 1, a large amount of bubbles were observed. In order to manufacture an orally dispersible film with a smooth surface without generating bubbles using the same raw materials, as shown in Figure 4, the drying temperature must be lowered to 60°C or lower without the use of infrared irradiation according to Comparative Example 2 to be suitable for the film. It was confirmed that it had physical properties. In contrast, Example 1 of the present invention maintained excellent release properties even when the film was manufactured using high-temperature tunnel hot air drying and infrared irradiation drying processes, and no boiling or bubbling phenomenon occurred.

The above results show that when titanium dioxide is added in an appropriate amount when manufacturing an orally dispersible film containing a bioactive substance containing sulfur as an active ingredient, an orally dispersible film has excellent thermal stability and physical properties that enable a high temperature drying process. This means that the preparation can be manufactured.

Claims (12)

Garlic extract or garlic extract concentrate powder containing S-allyl-L-cysteine (S-allyl-L-cysteine) as an active ingredient; and an orally dispersible film formulation containing titanium dioxide. delete delete In claim 1,
An orally dispersible film formulation wherein the garlic extract or concentrated garlic extract powder is contained in an amount of 10 to 50% by weight based on the total weight of the film solids. In claim 1,
An orally dispersible film formulation wherein the titanium dioxide is contained in an amount of 0.01 to 2% by weight based on the total weight of the solid content of the film. In claim 1,
The formulation further comprises a film forming agent,
An orally dispersible film formulation wherein the film forming agent is pullulan, hydroxypropylmethylcellulose, or a combination thereof. In claim 6,
An orally dispersible film formulation in which the pullulan is contained in an amount of 10 to 40% by weight based on the total weight of the solid content of the film. In claim 6,
The combination is an orally dispersible film formulation in which pullulan and hydroxypropylmethylcellulose are included in a weight ratio of 1:1 to 10 in the formulation. In claim 1,
The formulation is an orally dispersible film formulation characterized in that it additionally contains excipients or additives,
The excipient is at least one selected from the group consisting of plasticizers, complexing agents, disintegrants, stabilizers, surfactants, pigments, or coloring agents,
The orally dispersible film formulation wherein the additive is at least one selected from the group consisting of vitamins, nutritional fortifiers, minerals, sweeteners, acidulants, flavorings, flavor enhancers, or antifoaming agents. heating and dissolving a mixture of garlic extract or concentrated garlic extract powder and solvent containing S-allyl-L-cysteine and then cooling;
Adding titanium dioxide and a film forming agent to the mixed solution and stirring to prepare a crude film solution; and
drying the film solution; A method of manufacturing an orally dispersible film comprising. In claim 10,
The step of preparing the film crude solution additionally includes the step of adding excipients or additives and stirring,
The excipient is at least one selected from the group consisting of plasticizers, complexing agents, disintegrants, stabilizers, surfactants, pigments, or coloring agents,
The additive is any one or more selected from the group consisting of vitamins, nutritional fortifiers, minerals, sweeteners, acidulants, flavorings, flavor enhancers, or anti-foaming agents. In claim 10,
A method of producing an orally dispersible film, wherein the drying is performed at 70 to 90°C.