KR20240012091A - Tablet film coating composition comprising partially hydrolyzed guar gum as a film coating base materials - Google Patents

Abstract

In one aspect, the present disclosure relates to a tablet film coating composition comprising partially hydrolyzed guar gum as a film coating base. The film coating composition of the present disclosure has film coating productivity and quality equivalent to or better than coating compositions using synthetic additives, thereby reducing the intake of synthetic additives by replacing coating compositions using synthetic additives, and providing an enteric coating that is harmless to the human body. Health functional foods and general foods can be provided.

Description

Tablet film coating composition comprising partially hydrolyzed guar gum as a film coating base {TABLET FILM COATING COMPOSITION COMPRISING PARTIALLY HYDROLYZED GUAR GUM AS A FILM COATING BASE MATERIALS}

The present disclosure relates to a tablet film coating composition comprising partially hydrolyzed guar gum as a film coating base.

In tablet-type health functional foods, general foods, and medicines, chemical polymers that are sugar or synthetic additives are used to improve tablet strength, surface condition, block unpleasant odors of tablet ingredients, protect active ingredients, chemical and physical protection, and improve swallowing. It has been commonly practiced to coat tablets with a film. It is desirable that the film coating of tablets prevents the penetration of moisture to maintain the stability of the tablet product and to ensure quality, while not delaying disintegration to ensure product efficacy. In addition, the film coating base applied to tablets is made up of a spraying process on the tablet inclined surface that rotates with a fan, so it must have suitable surface adhesion and viscosity, and in addition, it contains surfactants, plasticizers, solvents, colorants, etc.

Polymers used to form tablet coating films in health functional foods and general foods include hydroxypropyl methylcellulose, shellac, polyvinyl alcohol, polyethylene glycol, and polyvinyl. Pyrrolidone (Polyvinylpyrrolidone), etc. are all synthetic additives. Film coating bases using synthetic additives have excellent productivity and quality, but as the safety of synthetic additives has emerged and consumers' related knowledge has increased, antipathy toward synthetic additives has grown. Accordingly, consumers are increasingly demanding products using natural additives that exclude synthetic additives, and as a result, the marketability of products using natural additives is greatly increasing.

Meanwhile, enteric coating is a coating method that prevents tablets or capsules from being disintegrated by gastric acid before they reach the intestines. (1) It is applied to products that have a specific odor after taking, such as garlic, to prevent unpleasant odors, or (2) Applied to products that are decomposed by gastric acid, such as lactic acid bacteria, enzymes, nattocyase, etc., to stably deliver active ingredients to the intestines without being decomposed by gastric acid, or (3) to products that irritate the gastric mucosa, such as vitamin C. It has been applied to health functional foods to prevent heartburn. Regarding enteric coating, according to the Ministry of Food and Drug Safety Notice No. 2021-25 on the Standards and Specifications of Health Functional Foods, the additives that can be used in the enteric base are cellulose phthalate acetate, hydroxypropylmethylcellulose phthalate, and Eudragit. There are L and S, shellac, polyvinyl alcohol phthalate, polymers of styrene and maleic acid, Keratin, and Salol, and the enteric film coating base includes cellulose phthalate, hydroxypropylmethylcellulose phthalate, and styrene and maleic acid. There are polymers. In Korea, hydroxypropyl methyl cellulose phthalate (HPMCP) is generally used as an enteric coating base for health functional foods, but the raw material is not only a synthetic polymer additive, but is also classified as GRAS (Generally Recognized As Safe) in the United States. It is not registered in the list and is not permitted as a food ingredient by the European Food Safety Authority (EFSA), so it cannot be used as a coating for general foods. In addition, phthalate in hydroxypropylmethylcellulose phthalate (HPMCP) is one of the endocrine disruptors (environmental hormones) and accumulates in the body, causing adverse health effects.

In response to consumer demand for the use of natural additives, the use of natural materials as a film coating base and enteric base was considered, but it was difficult to adjust the viscosity of the coating composition with natural materials alone, so synthetic additives had to be added. Natural gums, which are natural polymers, have been mainly used as viscosity enhancers, but there is no known use of them as film formers in tablet film coating compositions without the addition of synthetic additives or excipients. Republic of Korea Patent Publication No. 10-2021-0008680 discloses a natural coating composition that adjusts the type and mixing ratio of natural gums, but since tamarind gum and maltodextrin are essential main ingredients, the use of maltodextrin as an excipient was unavoidable, and the use of maltodextrin as an excipient was inevitable. Guar gum, which may be contained in small amounts, is unsuitable as a coating solution due to its high viscosity, and is not easily soluble in water or alcohol, so a natural coating composition containing guar gum as a main ingredient has not been considered at all.

Meanwhile, Partially Hydrolyzed Guar Gum is hydrolyzed by heat treatment of guar gum and is used as a dietary fiber supplement with good digestion and absorption rate.

The inventors of the present disclosure surprisingly discovered that partially hydrolyzed guar gum as a film coating base for tablets provides film coating productivity and quality equivalent to or better than that of synthetic coating bases.

KR 10-2021-008680 A

The purpose of the present disclosure is to provide a tablet film coating composition containing partially hydrolyzed guar gum as a film coating base, so as to reduce the intake of synthetic additives and excipients and allow consumers to safely consume health functional foods and general foods.

Specifically, the purpose of the present disclosure is to replace coating compositions using synthetic polymer additives by providing a natural film coating that has film forming ability equivalent to or better than that of coating compositions using synthetic additives and has excellent physical strength and disintegrability.

In addition, the object of the present disclosure is to provide a tablet film coating that has an enteric film forming ability equivalent to or better than that of a coating composition using synthetic polymer additives as a coating base, reduces the use of synthetic additives, and provides enteric food without the risk of endocrine disruptors. The purpose is to provide a composition.

In order to solve the above problems, the inventor of the present disclosure tried to develop a natural coating base that can be used as a coating composition without containing synthetic additives and excipients. As a result, when partially hydrolyzed guar gum is used as a film coating base, it shows equal or better coating forming ability than coating compositions using existing synthetic additives even without using synthetic additives or excipients, and also partially hydrolyzed guar gum shows phthalic acid. The present disclosure was completed by confirming that an enteric tablet film coating without the influence of environmental hormones can be provided as a film coating composition when used in combination with sodium alginate as a substitute for hydroxypropylmethylcellulose (HPMCP).

One aspect or embodiment of the present disclosure is illustrated for the purpose of explaining the technical idea of the present disclosure. The scope of rights according to the present disclosure is not limited to aspects or embodiments or specific descriptions thereof presented below.

All technical terms and scientific terms used in this disclosure, unless otherwise defined, have meanings commonly understood by those skilled in the art to which this disclosure pertains. All terms used in this disclosure are selected for the purpose of more clearly explaining this disclosure and are not selected to limit the scope of rights according to this disclosure.

Expressions such as “comprising,” “comprising,” “having,” and the like used in the present disclosure are open terms that imply the possibility of including other embodiments, unless otherwise stated in the phrase or sentence containing the expression. It should be understood as (open-ended terms).

Expressions such as “consisting only of” the corresponding configuration used in the present disclosure should be understood as closed-ended terms that exclude the possibility of including other configurations other than the corresponding configuration.

The singular forms described in this disclosure may include plural forms unless otherwise stated, and this also applies to the singular forms recited in the claims.

In one aspect of the present disclosure, the term “about” is used with the intention of including errors in the manufacturing process included in specific values or slight numerical adjustments that fall within the scope of the technical idea of the present disclosure. For example, the term “about” means a range of ±10%, in one aspect ±5%, in another aspect ±2% of the value to which it refers. For the field of this disclosure, this level of approximation is appropriate unless values are specifically stated to require a narrower range.

Hereinafter, a partially hydrolyzed guar gum as a film coating base and a tablet film coating composition containing the same according to one aspect of the present disclosure will be described in detail.

One. Tablet Film Coating Base

In one aspect, the present disclosure may relate to the use of partially hydrolyzed guar gum as a tablet film coating base. In one aspect of the present disclosure, partially hydrolyzed guar gum can be used in place of synthetic polymers used to form tablet coating films.

In one aspect, the present disclosure may relate to a tablet film coating base containing partially hydrolyzed guar gum.

In the present disclosure, “partially hydrolyzed guar gum” is obtained by partially hydrolyzing guar gum through a heat treatment process, and is characterized by having low viscosity while maintaining the original dietary fiber content of guar gum. “Guar Gum” refers to a polysaccharide composed of galactomannan obtained by pulverizing the endosperm of legume guar (Cyamopsis tetragonolobus) seeds or extracting it with warm or hot water. It is used to improve the stickiness and viscosity of foods. It is used as a thickener and stabilizer because it increases emulsion stability and is a food additive to improve the physical properties and texture of food. Guar gum and partially hydrolyzed guar gum are the main ingredients of health functional foods, and are functional ingredients that can help improve blood cholesterol, suppress the rise in blood sugar after a meal, proliferate beneficial bacteria in the intestines, and help smooth bowel movements.

In the present disclosure, guar gum is not easily soluble in water or alcohol, and when used as a main component of a tablet film coating base, there is a problem that the ability to form a film coating is reduced due to its high viscosity, or the injection inlet can be blocked when spraying the composition for forming a film coating. there is. However, the tablet film coating base according to the present disclosure uses partially hydrolyzed guar gum, which has a lower viscosity than guar gum, excellent solubility, and the functionality of guar gum, such as dietary fiber content, to form a synthetic film coating without the use of unnecessary excipients. It may have film forming ability equal to or better than that of the base material.

In one aspect of the present disclosure, it may relate to the use of partially hydrolyzed guar gum and sodium alginate as a tablet film coating base, and specifically, it may relate to the use as an enteric base. In one aspect of the present disclosure, partially hydrolyzed guar gum and sodium alginate can be used in place of synthetic polymers that are at risk of endocrine disruptors used to form enteric tablet coating films.

In the present disclosure, sodium alginate is used as a food additive to improve the adhesion and viscosity, emulsion stability, physical properties and texture of food. It is viscous when dissolved in water and does not show a change in viscosity below 80°C. In addition, since it is insoluble in acidic conditions, it can form an enteric coating, but it lacks the ability to form a film on its own. However, in the present disclosure, sodium alginate is used together with partially hydrolyzed guar gum to form an enteric coating that is equivalent to or better than hydroxypropylmethylcellulose phthalate (HPMCP), which is a synthetic additive and is harmful to the human body.

In one aspect of the present disclosure, the tablet film coating base is a synthetic polymer such as hydroxypropyl methylcellulose (HPMC), shellac, polyvinyl alcohol, polyethylene glycol, polyvinylpyrrolidone, and hydroxypropylmethylcellulose phthalate (HPMCP). may not include.

2. Tablet film coating composition comprising a film coating base

In one aspect, the present disclosure may relate to a tablet film coating composition comprising partially hydrolyzed guar gum as a film coating base. The tablet film coating composition according to one aspect of the present disclosure may use partially hydrolyzed guar gum as a film coating base.

In one aspect, the present disclosure may relate to a tablet film coating composition including a film coating base and a solvent.

In one aspect of the present disclosure, the concentration of the film coating base in the tablet film coating composition is not limited as it can be appropriately adjusted as needed, but for example, the tablet film coating composition may be based on the total weight% of the composition. It may include from about 0.5% to about 3% by weight of the coating base and from about 85% to about 99% by weight of the solvent. At this time, the content of the film coating base may be about 0.5% by weight to about 2.5% by weight or about 1% by weight to about 2% by weight, and the content of the solvent is about 90% by weight to about 98% by weight, about 93% by weight. It may be from about 98% by weight or from about 95% by weight to about 98% by weight. If the content of the film coating base exceeds the above upper limit, the viscosity of the composition is high, which may cause problems with the spray inlet being clogged during spray coating. If the content is less than the above lower limit, the film coating may not be formed smoothly or the adhesion to the tablet may be reduced. .

In one aspect of the present disclosure, the solvent included in the tablet film coating composition may be a water-soluble solvent, and may specifically be purified water, alcohol, or a combination thereof.

In one aspect of the present disclosure, when the tablet film coating composition includes purified water and alcohol as solvents, the alcohol is present in an amount of about 0.5% to about 15% by weight, about 1% to about 15% by weight based on the total weight% of the composition. %, it may be included in about 5% by weight to about 15% by weight. In the present disclosure, alcohol is alcohol (ethanol) produced by alcohol fermentation that ultimately produces ethanol and carbon dioxide from sugars or polysaccharides, and corresponds to a natural solvent. When alcohol and purified water are used together, partially hydrolyzed guar gum is mixed with purified water. It can be easily dissolved.

In one aspect of the present disclosure, when the tablet film coating composition of the present disclosure uses partially hydrolyzed guar gum and sodium alginate as a film coating base, the partially hydrolyzed guar gum is 0.5% by weight to 0.5% by weight based on the total weight% of the composition. It may include 2% by weight, 3% to 7% by weight of sodium alginate, and 85% to 96.5% by weight of solvent. If the sodium alginate content is less than the above lower limit, the film-coated tablet disintegrates in the stomach, making it difficult to deliver the active ingredients of the tablet to the intestines, or unusual odor or heartburn cannot be prevented. If the sodium alginate content is more than the above upper limit, the tablet The film coating may not form well.

In one aspect of the disclosure, the tablet film coating composition comprises partially hydrolyzed guar gum and sodium alginate in a ratio of about 1:1 to about 1:10, or in a ratio of about 1:1 to about 1:5, or in a ratio of about 1:1 to about 1:10. It may be included in a ratio of :1 to about 1:3.

The tablet film coating composition according to one aspect of the present disclosure may be an enteric coating composition. The tablet coated with the enteric coating composition of the present disclosure prevents the tablet from being disintegrated by stomach acid in the stomach before it reaches the intestines, thereby preventing unpleasant odor of the tablet, safely delivering the active ingredient to the intestine, and solving the problem of heartburn in the stomach. It can be prevented. In addition, in the case of general foods, hydroxypropylmethylcellulose phthalate (HPMCP), which is mainly used as an enteric base, cannot be used, but the tablet film coating composition of the present disclosure provides enteric tablets as general foods as well as health functional foods. possible.

In one aspect of the present disclosure, the tablet film coating composition contains natural excipients of sugars, sugar alcohols, starch, calcium preparations, magnesium preparations, and/or natural gums, such as tamarind gum and Arabic gum. Gum), xanthan gum, carrageenan, etc. may be additionally included, and natural excipients and/or natural gums are contained in an amount of about 10% by weight or less and about 5% by weight or less based on the total weight% of the composition. , may or may not be included in about 2% by weight or less or about 1% by weight or less.

In one aspect, the present disclosure may relate to a tablet coated with a tablet film coating composition according to an aspect of the present disclosure. The type of tablet of the present disclosure is not limited, and the tablet film coating composition of the present disclosure may be selected so that the formed coating has appropriate transparency and gloss depending on the raw materials and physical properties of the tablet.

In one aspect of the present disclosure, tablets coated with the tablet film coating composition according to one aspect of the present disclosure may have a coating amount, for example, from about 0.5% by weight to about 2% by weight, based on the total weight% of the tablet. there is.

In one aspect of the present disclosure, the tablet film coating composition may further include at least one selected from the group consisting of colorants, brighteners, plasticizers, defoamers, and surfactants.

In one aspect of the present disclosure, the tablet film coating composition according to one aspect of the present disclosure can be sprayed and coated on tablets using a conventional tablet coater.

In one aspect of the present disclosure, the tablet to which the tablet film coating composition can be applied contains the main active ingredient, an excipient, a binder, a disintegrant, a lubricant, etc., and preferably does not contain synthetic additives, but the quality of the tablet If film coating is required for this, it may be included without limitation. In the present disclosure, the tablet may additionally contain sugars, sugar alcohols, sugars, calcium preparations, magnesium preparations, etc. as excipients and binders. In addition, in the present disclosure, the tablet may contain carnauba wax, stearic acid, rice magnesium, etc. as an additive to overcome friction between the tablet and the die during the tableting process and as a lubricant, which is a necessary ingredient for discharging the tablet. there is.

The film coating base and tablet film coating composition according to one aspect of the present disclosure have a film forming ability equal to or better than that of a coating composition using a synthetic additive, despite using partially hydrolyzed guar gum, which is a natural additive, and have physical strength and shelf life. A film coating with excellent decomposability can be provided.

Due to this effect, the tablet film coating composition of the present disclosure can replace synthetic additives, reduce the intake of synthetic additives, and allow consumers to safely consume tablet-type foods containing this tablet film coating composition.

In addition, the film coating base according to one aspect of the present disclosure and the tablet film coating composition containing the same replace the previously used hydroxypropylmethylcellulose phthalate (HPMCP), reduce the use of synthetic additives, and have enteric properties without the risk of environmental hormones. Coating can be provided, and enteric coating can be applied to general foods as well as health functional foods.

Figure 1 A) compares the transparency of guar gum (right) and partially hydrolyzed guar gum (left), and B) compares the flowability of guar gum (right) and partially hydrolyzed guar gum (left). will be.
Figure 2 shows uncoated tablets of Reference Examples 1 to 5, tablets coated with the coating composition of Examples 2-1 to 2-5 using partially hydrolyzed guar gum, and Comparative Examples 2-1 to 2-5 using HPMC. The properties of tablets coated with the coating composition were compared.
Figure 3 compares the properties of uncoated tablets (control group), tablets coated with the coating composition of Comparative Example 3-1 using guar gum, and tablets coated with the coating composition of Example 3-1 using partially hydrolyzed guar gum.

Hereinafter, the configuration and effects of the present disclosure will be described in more detail through examples and test examples. However, these examples and test examples are provided only for illustrative purposes to aid understanding of the present disclosure, and the scope and scope of the present disclosure are not limited by the examples below.

[Reference example] Confirmation of the difference in physical properties between guar gum and partially hydrolyzed guar gum

An experiment was conducted to determine the difference in solubility properties between regular guar gum and partially hydrolyzed guar gum.

To confirm the difference in solubility properties, guar gum and partially hydrolyzed guar gum were mixed with purified water at 25°C and stirred at 600 RPM for 30 minutes to prepare a 0.1% by weight coating solution. The results of comparing the transparency of guar gum and partially hydrolyzed guar gum coating solution with the naked eye are shown in Figure 1. A). In addition, in order to compare the flowability of guar gum and partially hydrolyzed guar gum, the amount of liquid sieved was compared when 100 g of coating liquid was passed through a 60 mesh sieve for 1 minute. In the case of guar gum, only 47% of the coating liquid was sieved for 1 minute, but partial In the case of hydrolyzed guar gum, it was confirmed that 98% of the coating solution was sieved in 1 minute (Figure 1. B). Finally, the viscosity of guar gum and partially hydrolyzed guar gum coating solution was measured using an 18 spindle at 22 RPM. As a result, the viscosity of guar gum was 57.6 cP, while the viscosity of partially hydrolyzed guar gum was 7.68 cP.

From this, partially hydrolyzed guar gum and guar gum are substances with completely different physical properties. Unlike guar gum, partially hydrolyzed guar gum has a low viscosity and excellent water solubility, so there is a risk of blocking the spray nozzle when forming a film coating on tablets. It can be seen that it is finely sprayed and adhered to the tablet surface.

[Experimental Example 1] Comparison of coating compositions using guar gum and coating compositions using partially hydrolyzed guar gum

Guar gum and partially hydrolyzed guar gum were mixed with purified water at 25°C and stirred to prepare a coating composition containing 0.5% by weight, 1.0% by weight, 1.5% by weight, and 2.0% by weight of guar gum and partially hydrolyzed guar gum, respectively. The viscosity and coating film productivity of the coating compositions were compared and shown in Tables 2 and 3, respectively.

Viscosity was measured at 25°C, 22rpm, 18 spindles using BROOKFIELD's DV2T machine, and productivity of the coating film was determined by spraying the coating composition on a bare tablet using a coater and determining whether a film coating was formed.

Comparative Example 1-1 Comparative Example 1-2 Comparative Example 1-3 Comparative Example 1-4 Guar Gum 0.5% by weight 1.0% by weight 1.5% by weight 2.0% by weight Example 1-1 Example 1-2 Example 1-3 Example 1-4 Partially hydrolyzed guar gum 0.5% by weight 1.0% by weight 1.5% by weight 2.0% by weight

Comparative Example 1-1 Comparative Example 1-2 Comparative Example 1-3 Comparative Example 1-4 viscosity 189.10 cP 1504.00 cP not measurable not measurable Example 1-1 Example 1-2 Example 1-3 Example 1-4 viscosity 2.91 cP 11.64 cP 43.64 cP 104.7 cP

Comparative Example 1-1 Comparative Example 1-2 Comparative Example 1-3 Comparative Example 1-4 Whether film is formed or not X No spraying possible No spraying possible No spraying possible Example 1-1 Example 1-2 Example 1-3 Example 1-4 Whether film is formed or not O O O O

From this, the tablet film coating composition according to the content of partially hydrolyzed guar gum has a lower viscosity than the coating composition using guar gum, and does not block the coating nozzle, so the coating composition can be sprayed finely on the uncoated tablet through the nozzle, so film coating is possible. I was able to confirm what was possible. On the other hand, the coating composition using guar gum had a high viscosity, so it was difficult to measure the viscosity of Comparative Examples 1-3 and 1-4, which had a guar gum content of 1.5% by weight or more, and it was difficult to dissolve in purified water due to the high viscosity, so they were coated through a coating nozzle. Spraying the composition was also difficult. In Comparative Example 1-1, where the guar gum content was 0.5% by weight, no film coating was formed, and in Comparative Example 1-2, where the guar gum content was 1.0% by weight, the coating composition had high viscosity and was sticky, so the nozzle of the coater was clogged and the spray was sprayed. was not possible, and as a result, a film coating could not be formed.

[Experimental Example 2] Comparison of a coating composition containing hydroxypropyl methylcellulose (HPMC) and a coating composition using partially hydrolyzed guar gum

For comparison with natural coating compositions, a coating composition containing hydroxypropyl methylcellulose (HPMC), a synthetic additive used as a conventional tablet coating base, and a coating composition using partially hydrolyzed guar gum according to one aspect of the present disclosure were used. A film coating was formed on the bare tablet, and the film forming ability was evaluated.

Uncoated tablets (tablets) for forming a film coating are made mainly of natural products and do not contain synthetic additives, and contain natural excipients (calcium preparation, Superior Powders Ltd; dextrin, Samyang Co., Ltd.) and lubricants (carnauba wax, It was compressed into tablets with the composition shown in Table 4 below to include Pontes Indestria).

Raw material name Composition (% by weight) tablet 1 tablet 2 tablet 3 tablet 4 tablet 5 Natural Product A (Garcinia Cambogia Extract) - 50.00 - - - Natural product B (chlorophyll powder) - - 20.00 - - Natural product C (Banaba alcohol extract) - - - 70.00 - Natural product D (green tea extract) - - - - 70.00 excipient 97.00 46.00 75.00 25.00 25.00 lubricant 3.00 4.00 5.00 5.00 5.00 Sum 100.00 100.00 100.00 100.00 100.00

For tablets 1 to 5, coating compositions prepared according to the compositions in Tables 5 and 6 below were respectively put into a spray-type coater to form a film coating on the tablets according to the set conditions of the coater (PKC-60F, manufactured by Pharmatech Korea). The set coating machine conditions were Inlet Damper 65℃, Outlet Damper 50℃, Inlet Blow 50%, Outlet Blow 50%, Pan RPM 10, Spray RPM 8, and spraying time of 30 minutes.

Comparison of properties of uncoated tablets 1 to 5 without a film coating (Reference Examples 1 to 5) and coated tablets with a film coating according to Examples 2-1 to 2-5 and Comparative Examples 2-1 to 2-5 This is shown in Figure 2.

Raw material name Composition (% by weight) Example 2-1 Example 2-2 Example 2-3 Example 2-4 Example 2-5 refine tablet 1 tablet 2 tablet 3 tablet 4 tablet 5 Partially hydrolyzed guar gum 0.50 1.00 1.50 1.00 2.00 Alcohol (95% fermented alcohol) 5.00 5.00 7.00 5.00 10.00 Purified water 94.50 94.00 91.50 94.00 88.00 Sum 100.00 100.00 100.00 100.00 100.00

Raw material name Composition (% by weight) Comparative Example 2-1 Comparative Example 2-2 Comparative Example 2-3 Comparative Example 2-4 Comparative Example 2-5 refine tablet 1 tablet 2 tablet 3 tablet 4 tablet 5 Hydroxypropylmethylcellulose (HPMC) 5.00 5.00 5.00 5.00 5.00 Glycerin fatty acid ester 0.50 0.50 0.50 0.50 0.50 Alcohol (95% fermented alcohol) 75.60 75.60 75.60 75.60 75.60 Purified water 8.90 8.90 8.90 8.90 8.90 Sum 100 100 100 100 100

The film coating-forming ability of the coating composition using partially hydrolyzed guar gum and the coating composition containing HPMC was confirmed by evaluating gloss, flowability, disintegration, and friability, and compared with uncoated tablets on which no film coating was formed.

(One) Glossiness

Glossiness was measured using the 5-point method by observing the surface of the tablet with the naked eye, and the results are shown in Table 7 below. The higher the gloss number, the more glossy it is. When a tablet is coated with a film, the surface becomes smooth and glossy, so the presence of film formation was determined by checking the glossiness.

Najeong Reference example 1 Reference example 2 Reference example 3 Reference example 4 Reference example 5 Glossiness 3 3 One 2 2 coated tablet Partially hydrolyzed guar gum Example 2-1 Example 2-2 Example 2-3 Example 2-4 Example 2-5 Glossiness 4 5 3 5 5 HPMC Comparative Example 2-1 Comparative Example 2-2 Comparative Example 2-3 Comparative Example 2-4 Comparative Example 2-5 Glossiness 4 5 3 5 4

In the case of Examples 2-1 to 2-5 using the coating composition according to one aspect of the present disclosure, the glossiness was improved compared to the bare tablets of Reference Examples 1 to 5 without forming a film coating, and when using HPMC, a synthetic additive, It can be confirmed that it has a glossiness equal to or better than that of Comparative Examples 2-1 to 2-5 and that a film coating can be formed smoothly.

(2) flowability

Tablets with a film coating have reduced friction due to the smooth surface, which increases the moving distance on an inclined acrylic plate. Therefore, the moving distance can be used to determine whether the film coating has been well formed on the tablet surface or whether the tablet surface has been improved to be smooth by the film coating. can do. When the tablet was placed on a 30 cm acrylic plate inclined at 30° to determine flowability, the distance the tablet moved was measured five times, and the average moving distance was calculated and listed in Table 8 below.

Najeong Reference example 1 Reference example 2 Reference example 3 Reference example 4 Reference example 5 Moving distance (cm) 13 14 6 8 8 coated tablet Partially hydrolyzed guar gum Example 2-1 Example 2-2 Example 2-3 Example 2-4 Example 2-5 Moving distance (cm) 22 25 18 26 27 HPMC Comparative Example 2-1 Comparative Example 2-2 Comparative Example 2-3 Comparative Example 2-4 Comparative Example 2-5 Moving distance (cm) 23 24 19 27 22

In the case of Examples 2-1 to 2-5 using the coating composition according to one aspect of the present disclosure, the moving distance was longer and flowability was improved compared to the bare tablets of Reference Examples 1 to 5 without forming a film coating, and the synthetic additive It can be confirmed that it has flowability equivalent to or better than that of Comparative Examples 2-1 to 2-5 using phosphorus HPMC and that a film coating can be formed smoothly.

(3) Disintegration

There may be a problem in that the disintegration of the tablet is delayed by the film coating formed to protect the tablet, preventing proper absorption of the active ingredient. Therefore, the disintegration is not delayed by the film coating formed through disintegration comparison, making it suitable as a coating composition. Checked if it can be used. In accordance with the disintegration test method of the standards and specifications for health functional foods (「Chapter 4, 2. General test methods, 2-1 disintegration test method, 4.2.2. Tablet products coated with a suitable coating agent」), the film is not coated. The uncoated tablets of Reference Examples 1 to 5 and the coated tablets of Examples 2-1 to 2-5 and Comparative Examples 2-1 to 2-5 were placed in water at 37°C and moved up and down to measure the time for the tablets to disintegrate. The results are shown in Table 9 below. The time taken for the tablet to disintegrate was measured as the time taken until there was a film, a soft substance, a spongy substance, or a small amount of needle-like substance, even if there was no residue of the sample in the glass tube.

Najeong Reference example 1 Reference example 2 Reference example 3 Reference example 4 Reference example 5 Disintegration time (minutes) 20 14 One 35 17 coated tablet Partially hydrolyzed guar gum Example 2-1 Example 2-2 Example 2-3 Example 2-4 Example 2-5 Disintegration time (minutes) 20 16 3 36 18 HPMC Comparative Example 2-1 Comparative Example 2-2 Comparative Example 2-3 Comparative Example 2-4 Comparative Example 2-5 Disintegration time (minutes) 22 18 4 40 20

The disintegration time of the film-coated tablets was delayed compared to the uncoated tablets of Reference Examples 1 to 5 without a film coating. The disintegration time of Comparative Examples 2-1 to 2-5 using synthetic additives was delayed by about 2 to 5 minutes compared to Reference Examples 1 to 5, while Examples 2-1 to 2 using the coating composition according to one aspect of the present disclosure For -5 there was a delay of about 1 to 2 minutes. It was confirmed that when the coating composition according to one aspect of the present disclosure was used, the disintegration degree was superior to that when a conventional synthetic additive was used.

(4) Masondo

Friability is measured to confirm the physical stability of the tablet. Friability is generally measured before tablet film coating to determine whether the tablet will break or crack due to physical damage. In this experiment, friability was measured to determine whether physical strength was increased by forming a film coating on the tablet. It was measured once according to the friability test method described in the Korean Pharmacopoeia. If the result was difficult to determine or if the mass loss was greater than the standard, the test was repeated two additional times and the average value of a total of three test results was obtained. was obtained. Friability was measured using ERWEKA's TAR-120 device under conditions of 25 rpm and 100 rotations, and the results are shown in Table 10 below.

Najeong Reference example 1 Reference example 2 Reference example 3 Reference example 4 Reference example 5 Friability (%) 0.1 0.5 0.5 0.2 0.3 coated tablet Partially hydrolyzed guar gum Example 2-1 Example 2-2 Example 2-3 Example 2-4 Example 2-5 Friability (%) 0.02 0.15 0.2 0.03 0.1 HPMC Comparative Example 2-1 Comparative Example 2-2 Comparative Example 2-3 Comparative Example 2-4 Comparative Example 2-5 Friability (%) 0.02 0.18 0.2 0.04 0.13

In the case of Examples 2-1 to 2-5 using the coating composition according to one aspect of the present disclosure, the friability was reduced compared to the bare tablets of Reference Examples 1 to 5 without forming a film coating, thereby improving the physical strength of the tablet by film coating. It can be confirmed that the strength was improved, and the friability was equivalent to or reduced compared to Comparative Examples 2-1 to 2-5 using HPMC, a synthetic additive, so that a film coating with excellent strength could be formed.

[Experimental Example 3] Formation of enteric film coating using partially hydrolyzed guar gum and sodium alginate

A tablet film coating composition using guar gum or partially hydrolyzed guar gum and sodium alginate was prepared according to the composition in Table 11 to form a film coating on the tablet, and the film forming ability and disintegration were evaluated and are shown in Table 11 below. Purified water and alcohol were used as solvents, and alcohol was used in an amount of approximately 5% by weight.

Disintegration is used to determine whether the film coating formed on the tablet is enteric-coated or not, and is determined in Chapter 4, 2. General Test Methods, 2-1 Disintegration Test Method, 4.2.6.2 of the Standards and Specifications for Health Functional Foods. It was evaluated by the “Test method for enteric-coated products other than granule products or capsules filled in granular form.” Specifically, as the first solution, a test solution of pH 1.2 made by dissolving 2.0 g of sodium chloride with 7.0 ml of hydrochloric acid and water to make 1 L was used and moved up and down for 120 minutes. When observed, the release of contents among the 6 samples was 1. It is suitable if there is less than 0.2 mol/L or no release of contents. As a second solution, a test solution of pH 6.8 made by adding 118 mL of 0.2 mol/L sodium hydroxide solution and water to 250 mL of 0.2 mol/L potassium dihydrogen phosphate solution to make 1 L. , insert the auxiliary plate, move it up and down for 60 minutes, and then observe. Even if there is no sample residue in the glass tube, it is suitable if there is a small amount of film, spongy material, or soft material.

Comparative Example 3-1 Comparative Example 3-2 Comparative Example 3-3 Example 3-1 Example 3-2 Example 3-3 composition
(weight%) Guar Gum 0.5 1.0 1.5 - - - Partially hydrolyzed guar gum - - - 0.5 1.0 1.5 Sodium alginate 5.0 5.0 5.0 5.0 5.0 5.0 menstruum 94.5 94.0 93.5 94.5 94.0 93.5 Coating formation ability Whether film is formed or not X Spraying not possible Insoluble O O O stickiness O - - X X △ Disintegration 1st liquid incongruity incongruity incongruity fitness fitness fitness 2nd liquid incongruity incongruity incongruity fitness fitness fitness

The properties of the uncoated tablet without a film coating (control group) and the tablets to which the coating compositions of Comparative Example 3-1 and Example 3-1 were applied are shown in Figure 3. The coating composition of Comparative Example 3-1 could be sprayed through a coating nozzle, but could not form a film coating, and the coating solution remained very sticky on the tablet surface due to its high viscosity.

In the case of Examples 3-1 to 3-3 using the tablet film coating composition according to one aspect of the present disclosure, a film could be formed smoothly, and the disintegration test in the first and second liquid test solutions was judged to be suitable. It can be confirmed that an enteric film coating can be formed. On the other hand, in the case of Comparative Examples 3-1 to 3-3 using guar gum, no film was formed, and when the content of guar gum increases, it can be confirmed that the spray nozzle of the coating machine is clogged or does not dissolve in purified water due to high viscosity during coating. there was.

The tablet film coating composition according to one aspect of the present disclosure forms an enteric film coating, thereby safely delivering the active ingredient to the intestines without being decomposed in the stomach and preventing heartburn or unusual odor of the product by not irritating the gastric mucosa. can do.

From the above description, those skilled in the art will be able to understand that the present disclosure can be implemented in other specific forms without changing its technical idea or essential features. In this regard, the embodiments described above should be understood in all respects as illustrative and not restrictive. The scope of the present disclosure should be construed as including the meaning and scope of the patent claims described below rather than the detailed description above, and all changes or modified forms derived from the equivalent concept thereof are included in the scope of the present disclosure.

Claims (9)

A tablet film coating composition comprising partially hydrolyzed guar gum as a film coating base. The tablet film coating composition of claim 1, further comprising a solvent. The tablet film coating composition according to claim 1 or 2, comprising 0.5% to 3% by weight of the film coating base and 85% to 99% by weight of the solvent. The tablet film coating composition of claim 3, wherein the solvent is purified water, alcohol, or a combination thereof. A tablet film coating composition comprising partially hydrolyzed guar gum and sodium alginate as a film coating base. The tablet film coating composition of claim 5, further comprising a solvent. 7. A tablet film coating composition according to claim 5 or 6, comprising 0.5% to 2% by weight of partially hydrolyzed guar gum, 3% to 7% by weight of sodium alginate and 85% to 96.5% by weight of solvent. The tablet film coating composition according to claim 5 or 6, wherein the solvent is purified water, alcohol, or a combination thereof. The tablet film coating composition according to claim 5 or 6, which is an enteric coating composition.