Safe film coating composition that does not use titanium oxide and food and pharmaceutical preparations coated with the same

Abstract

The present invention relates to a film coating composition that does not use titanium oxide and is therefore safe from genotoxicity, and to foods and pharmaceutical preparations coated with the same.

Description

[Technical Field]

[0001] The present invention relates to a film coating composition for coating foods and pharmaceutical preparations, and to foods and pharmaceutical preparations coated with the same. In particular, the present invention can provide a film coating composition that is safe from genotoxicity because it does not use titanium oxide, which is an opacifying agent. [Background technology]

[0002] Titanium dioxide (Titanium dioxide) is a white compound obtained by reacting titanium, a transition metal element, with oxygen. Due to its low reactivity, it is chemically very stable. For this reason, it is widely used as an additive in paints, dyes, foods, and pharmaceuticals, as well as a component of UV-blocking agents. When added to film coating compositions, titanium dioxide exhibits a high whiteness index (ΔL), making it an important component for identifying pharmaceuticals based on their color, which is crucial for their safe use. Furthermore, due to its high light-blocking ability, titanium dioxide also plays a role in maintaining the stability of pharmaceuticals from external light.

[0003] In 2017, the French National Institute for Agricultural Research (NIAR) conducted research on titanium dioxide, and the results of the research raised questions about its safety. The NIAR study reported that titanium dioxide increases the incidence of early colon cancer in 40% of animals. For this reason, the European Food Safety Authority (EFSA) announced that it was withdrawing its approval for titanium dioxide as a food additive. The EFSA cited titanium dioxide's carcinogenic potential due to its genotoxicity and noted that, despite its low absorption rate, titanium dioxide particles may accumulate in the body after oral ingestion. Taking into account the scientific research results and data, the EFSA concluded that titanium dioxide is no longer considered safe as a food additive. (https: / / www.efsa.europa.eu / en / news / titanium-dioxide-e171-no-longer-considered-safe-when-used-food-additive)

[0004] However, titanium oxide is widely used not only in food products but also in pharmaceuticals as a coloring agent for film coating bases. However, the European Union (EU) is concerned that a ban on titanium oxide use could lead to a shortage of medicines, and has announced that it will postpone the ban on titanium oxide use in pharmaceuticals, with a decision on whether to ban its use three years from now (https: / www.ema.europa.eu / en / documents / report / final-feedback-european-medicine-agency-ema-eu-commission-request-evaluate-impact-removal-titanium_en.pdf).

[0005] As such, concerns about the carcinogenicity of titanium oxide due to genotoxicity, which is widely used in the fields of food and pharmaceuticals, continue to be raised, and there is a current need to invent substances and compositions that can replace titanium oxide. [Prior art documents] [Non-patent literature]

[0006] [Non-Patent Document 1] https: / www.efsa.europa.eu / en / news / titanium-dioxide-e171-no-longer-considered-safe-when-used-food-additive [Non-patent document 2] https: / www.ema.europa.eu / en / documents / report / final-feedback-european-medicine-agency-ema-eu-commission-request-evaluate-impact-removal-titanium_en.pdf Summary of the Invention [Problem to be solved by the invention]

[0007] The problem to be solved by the present invention is to provide a film coating composition for coating films of food and pharmaceutical preparations that exhibits high whiteness (ΔL) and light blocking ability, which are the main functions of titanium oxide, without using titanium oxide, which is a genotoxic substance, and a pharmaceutical preparation and a food preparation to which the film coating composition is applied.

[0008] In particular, the film coating composition for food and pharmaceutical preparations of the present invention does not use titanium oxide, and therefore does not have the problem of genotoxicity that titanium oxide has. Furthermore, it has the characteristic of not affecting the disintegration of plain tablets while exhibiting a whiteness (ΔL) and light-blocking degree that are approximately the same as those of titanium oxide. [Means for solving the problem]

[0009] The inventors of the present invention have discovered that silicon dioxide metal salts are an additive that can be used in food and pharmaceutical preparations, can be added as a component to a film coating composition to smoothly form a film, can mask the color of the plain tablet with a high whiteness (ΔL), and not only has a high light-blocking effect but also does not significantly affect the disintegration of the plain tablet.

[0010] Conventionally, silicon dioxide metal salts have been widely used as additives in food and pharmaceutical preparations, primarily for the purposes of improving the flowability of powders and increasing lubricity. However, there have been no reports of their use as a substitute for titanium oxide when added to film coating compositions, and no reports have been made yet about the carcinogenicity of silicon dioxide metal salts.

[0011] Film coating compositions containing such silicon dioxide metal salts as a substitute for titanium oxide can have high whiteness (ΔL) and light blocking properties, even though titanium oxide is not used in the composition, and do not further delay the disintegration time of plain tablets compared to titanium oxide.

[0012] In most embodiments of the present invention, the film coating composition of the present invention exhibits a whiteness (ΔL) sufficient to replace titanium oxide, and after coating a tablet with a film, the film coating composition of the present invention exhibits storage stability that is even improved over titanium oxide.

[0013] In one embodiment of the present invention, there is provided a film coating composition comprising a coating polymer, a silicon dioxide metal salt, a plasticizer, and a solvent, but not containing titanium oxide, and may also contain a surfactant or a pigment depending on the purpose. [Effects of the Invention]

[0014] The present invention can provide a film coating composition for food and pharmaceutical preparations that does not use titanium oxide and is therefore safe from genotoxicity, and that has the main properties of titanium oxide, namely high whiteness (ΔL) and light blocking ability when coating a preparation with a film.

[0015] The effects of the present invention are not limited to those described above, and a wide variety of effects can be incorporated within a range that is obvious to a person skilled in the art from the content described below.

[0016] The accompanying drawings illustrate only preferred embodiments and should not be construed as limiting the scope of the invention to the details set forth in the drawings. [Brief explanation of the drawings]

[0017] [Figure 1] 1 is a graph showing an evaluation of the light transmittance of the film coating composition of Comparative Example 2, which contains 20% by weight of titanium oxide, and the film coating compositions of Examples 4 and 6, which contain 20% by weight of silicon dioxide metal salt. [Figure 2] The results show the results of an accelerated stability evaluation conducted under accelerated conditions (temperature: 40±2°C, relative humidity: 75±5%) for 30 days. DETAILED DESCRIPTION OF THE INVENTION

[0018] This specification will be explained in more detail below.

[0019] This will be explained in detail as follows. The terms used in this specification have been selected as widely used as possible, taking into consideration the functions of the present invention. However, these may change depending on the intentions of engineers in the field, legal precedents, the emergence of new technologies, etc. In addition, in certain cases, the applicant may have arbitrarily selected terms, and in such cases, the meanings of these terms will be described in detail in the relevant section of the description of the invention. Therefore, the terms used in this specification should not be simply defined by their names, but should be defined in light of the meanings of the terms and the overall content of the present invention.

[0020] Furthermore, unless otherwise specified herein or clearly contradictory to the context, all terms used in this disclosure, including technical and scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the art to which this invention belongs. In addition, commonly used terms and dictionary-defined terms should be interpreted as meanings consistent with the meanings they have in the context of the relevant art, and should not be interpreted as idealized or overly formalized unless clearly defined in this application.

[0021] Numerical ranges are inclusive of the numerical values ​​defined in the range. Every maximum numerical limitation given throughout this specification includes every lower numerical limitation, as if such lower numerical limitation were expressly written. Every minimum numerical limitation given throughout this specification includes every higher numerical limitation, as if such higher numerical limitations were expressly written. Every numerical limitation given throughout this specification is intended to include every finer numerical range within the broader numerical range, as if such narrower numerical limitations were expressly written.

[0022] Each description and embodiment disclosed in the present invention can be applied to other descriptions and embodiments. That is, any combination of various elements disclosed in the present invention falls within the scope of the present invention. It should be noted that the scope of the present invention is not limited by the specific descriptions set forth below.

[0023] As used herein, terms such as "comprises," "has," "includes," and "comprises" should be construed as open-ended terms that include the possibility of including other embodiments, unless otherwise indicated.

[0024] The inventors of the present invention screened for substances that are widely used as additives in foods and pharmaceuticals in order to replace titanium oxide, and found that metal silicon dioxide salts can have high whiteness (ΔL) and light blocking properties, and do not further delay the disintegration time of plain tablets compared to titanium oxide. As a result, they confirmed that even after film coating of tablets, they exhibit improved storage stability compared to titanium oxide, which led to the completion of the present invention.

[0025] The present invention will be described in detail below.

[0026] Unless otherwise specified, the term "wt. %" refers to the mass ratio of a particular component to the overall film coating composition into which it is incorporated.

[0027] Film coating composition

[0028] In order to solve the above problems, the present invention discloses the following means.

[0029] In one aspect, the present invention discloses a film coating composition comprising a coating polymer, a silicon dioxide metal salt, and a plasticizer, and is free of titanium oxide.

[0030] In the present invention, the content of the coating polymer may be 30 to 90 wt % based on the total weight of the entire film coating composition, specifically 50 to 75 wt %, but is not limited thereto. If the content of the coating polymer is less than 30 wt %, there is a problem that the coating polymer is insufficient to form a film, while if it exceeds 90 wt %, there is a problem that the content of the plasticizer is low, resulting in poor elasticity of the film layer and causing the film layer to break.

[0031] In the present invention, the content of the silicon dioxide metal salt may be 5 to 50 wt % based on the total weight of the entire film coating composition, specifically 5 to 30 wt %, but is not limited thereto. If the content of the silicon dioxide metal salt is less than 5 wt %, there is a problem that the film cannot be formed due to insufficient light-shielding power or whiteness, and if the content of the silicon dioxide metal salt is more than 50 wt %, there is a problem that the coating polymer is insufficient.

[0032] In the present invention, the content of the plasticizer may be 5 to 40 wt % based on the total weight of the entire film coating composition, specifically 5 to 30 wt %, but is not limited thereto. If the content of the plasticizer is less than 5 wt %, the elasticity of the film layer is poor, resulting in the problem of the film layer breaking. If the content of the plasticizer is more than 40 wt %, the elasticity of the film layer is too high, resulting in poor adhesion to the tablet, and the problem of film formation being difficult.

[0033] In the present invention, the film coating composition may be in the form of a solid powder, but is not limited thereto.

[0034] In the present invention, the film coating composition may be mixed with a solvent so that the content of the film coating composition in the final film coating solution is 5 to 30 wt %, but is not limited thereto. Specifically, the content of the film coating composition relative to the total amount of the solvent and film coating composition used to dissolve the film coating composition in the solvent may be 5 to 30 wt % (w / w), specifically, 10 to 25 wt % (w / w), but is not limited thereto. If the content of the film coating composition is less than 5 wt %, the content of the film coating composition in the solvent is too low, resulting in a long film coating process. On the other hand, if the content of the film coating composition is more than 30 wt %, the content of the film coating composition in the solvent is too high, resulting in a high viscosity of the coating polymer, which makes it difficult to smoothly spray the coating solution from the coating device.

[0035] In the present invention, the solvent may be selected from the group consisting of purified water, ethanol, and mixtures thereof, but is not limited thereto.

[0036] In the present invention, the coating polymer may be either a pH-independent polymer or a pH-dependent polymer, but is not limited thereto.

[0037] In the present invention, the term "non-pH dependent polymer" refers to a polymer whose dissolution does not change significantly with changes in pH. Specifically, the non-pH dependent polymer may be at least one selected from the group consisting of hydroxypropylmethyl cellulose, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol, and hydroxypropyl cellulose, but is not limited thereto.

[0038] In the present invention, the term "pH-dependent polymer" refers to a polymer whose dissolution behavior changes depending on the pH. Specifically, the pH-dependent polymer may be at least one selected from the group consisting of polyvinyl acetate phthalate, hydroxypropylmethyl cellulose acetate succinate, hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, and methacrylic acid copolymer, but is not limited thereto.

[0039] In the present invention, the term "metallic silicon dioxide salt" refers to an opacifying agent that has the function of replacing titanium oxide, and an opacifying agent refers to an agent that is added to food or pharmaceutical products for the purpose of reducing their transparency. Specifically, the silicon dioxide metal salt may be at least one selected from the group consisting of calcium silicate, calcium silicate hydrate, sodium silicate, magnesium silicate, magnesium trisilicate, aluminum silicate, magnesium aluminum metasilicate, potassium aluminum disilicate, and sodium aluminum silicate. In a preferred embodiment of the present invention, the silicon dioxide metal salt used as a substitute for titanium oxide is calcium silicate, calcium silicate hydrate, sodium silicate, magnesium silicate, aluminum silicate, and magnesium aluminum metasilicate. The material may be any one or more selected from the group consisting of aluminometasilicate, but is not limited thereto.

[0040] In the present invention, the film coating composition may further contain, in addition to the coating polymer and the silicon dioxide metal salt, a plasticizer for imparting elasticity to the film layer, a dye for imparting color to the film layer, and a surfactant for increasing the wettability of the film layer.

[0041] The plasticizer, pigment, and surfactant are described below. The film coating composition contains a plasticizer as an essential component, and may contain a pigment and a surfactant depending on the purpose (necessity).

[0042] In the present invention, the plasticizer may be at least one selected from the group consisting of triethyl citrate, tributyl citrate, glyceryl triacetate, acetyl triethyl citrate, dibutyl sebacate, diethyl phthalate, polyethylene glycol having a molecular weight of 200 to 20,000, castor oil, and a copolymer of propylene oxide and ethylene oxide. In a preferred embodiment of the present invention, the plasticizer used is triethyl citrate, tributyl citrate, glyceryl triacetate, acetyl triethyl citrate, diethyl phthalate. The polyisocyanate may be any one or more selected from the group consisting of polyethylene glycol having a molecular weight in the range of 200 to 20,000, and is not limited thereto.

[0043] In the present invention, the pigment may include a colored pigment such as an aluminum lake pigment, but is not limited thereto.

[0044] In the present invention, the surfactant may be, but is not limited to, polysorbate, sodium lauryl sulfate, etc.

[0045] In the present invention, the content of the dye and surfactant may be 0 to 15 wt %, preferably 0 to 10 wt %, based on the total weight of the entire film coating composition, but is not limited thereto. Here, 0 wt % means that they are not included in the film coating composition, and can be expressed as a lower limit of 0 wt %. That is, as described above, in the present invention, the content of the dye and surfactant being 0 wt % means that they can be selectively used as needed.

[0046] In the present invention, the film coating composition may be a film coating composition applied to pharmaceutical preparations, but is not limited thereto.

[0047] In the present invention, the film coating composition may be a film coating composition applied to food preparations, but is not limited thereto.

[0048] Pharmaceutical preparations

[0049] In another aspect, the present invention discloses a pharmaceutical formulation in which the film coating composition is coated on a pharmaceutical.

[0050] Specifically, the film coating composition comprises a pharmaceutical formulation that is applied to the surface of the pharmaceutical to form a film coating. In this case, the film coating composition can be applied to the pharmaceutical dosage form using a conventional process such as pan coating or as part of a spray coating process. The applied coating amount of the film coating composition is 1 to 30% (w / w), preferably 2 to 20% (w / w), and more preferably 2 to 10% (w / w), based on the weight of the uncoated pharmaceutical dosage form. In coatings applied to dosage forms containing multiple particles (e.g., pellets or microparticles of the active ingredient itself), the large surface area of ​​the dosage form requires a substantially higher weight percentage of the coating composition. In such cases, the coating amount of the film coating composition is 5 to 50% (w / w), preferably 10 to 40% (w / w), based on the weight of the uncoated pharmaceutical dosage form.

[0051] The above-mentioned contents regarding the film coating composition are all applicable to pharmaceutical preparations in which the film coating composition is coated on a pharmaceutical product, unless they are inconsistent with each other.

[0052] Food Preparations

[0053] In yet another aspect, the present invention discloses a food preparation in which the film coating composition is coated on a food product.

[0054] Specifically, the film coating composition comprises a food formulation that is applied to the surface of the food to form a film coating. In this case, the film coating composition can be applied to the food formulation using a conventional process as part of a pan coating or spray coating process. The amount of coating of the applied film coating composition is 1 to 30% (w / w), preferably 2 to 20% (w / w), and more preferably 2 to 10% (w / w), based on the weight of the uncoated food formulation.

[0055] The above-mentioned contents regarding the film coating composition are all applicable to food preparations in which the film coating composition is coated on a food product, unless they are inconsistent with each other.

[0056] The present invention will be described in detail below with reference to examples. However, the following examples are merely for the purpose of illustrating the present invention, and the scope of the present invention is not limited thereto.

[0057] Examples and Comparative Examples Comparative Examples 1 and 2: Film coating compositions A film coating composition of Comparative Example 1, which does not contain titanium oxide or a titanium oxide substitute, and a film coating composition of Comparative Example 2, which contains titanium oxide, were prepared according to the compositions and contents shown in Table 1 below.

[0058] Specifically, a film coating composition according to Comparative Example 1 was prepared by mixing a coating base (hydroxypropyl methylcellulose) and a plasticizer (polyethylene glycol 400), and a film coating composition according to Comparative Example 2 was prepared by mixing a coating base (hydroxypropyl methylcellulose), a plasticizer (polyethylene glycol 400), and an opacifying agent (titanium oxide).

[0059] [Table 1]

[0060] (In Table 1 above, the % content means % by weight.)

[0061] Example Examples 1 to 6: Film coating compositions containing calcium silicate A film coating composition containing calcium silicate, a silicon dioxide metal salt, was prepared according to the composition and content shown in Table 2 below.

[0062] Specifically, the film coating compositions according to Examples 1 to 6 were prepared by thoroughly mixing a coating base (hydroxypropylmethylcellulose), a plasticizer (polyethylene glycol 400 or polyethylene glycol 6000), and an opacifying agent (calcium silicate).

[0063] [Table 2]

[0064] (In Table 2 above, the % content means % by weight.)

[0065] Examples 7 to 13. Film coating compositions containing various pH-independent coating bases, silicon dioxide metal salts, and plasticizers. Non-pH dependent film coating compositions containing metal silicon dioxide salts, calcium silicate, sodium silicate, magnesium silicate or magnesium aluminum metasilicate, were prepared in the compositions and amounts shown in Table 3 below.

[0066] Specifically, the film coating compositions according to Examples 7 to 13 were prepared by thoroughly mixing a non-pH-dependent coating base (hydroxypropyl methylcellulose, polyvinyl alcohol or polyvinyl alcohol / polyethylene glycol polymer), a plasticizer (polyethylene glycol 6000, triethyl citrate or glyceryl triacetate) and an opacifying agent (calcium silicate, sodium silicate, magnesium silicate or magnesium aluminum metasilicate).

[0067] [Table 3]

[0068] (In Table 3 above, the % content means % by weight.)

[0069] Examples 14 to 16. Film coating compositions containing various pH-dependent coating bases, calcium silicate, and plasticizers A pH-dependent film coating composition containing calcium silicate, a silicon dioxide metal salt, was prepared according to the composition and content shown in Table 4 below.

[0070] Specifically, a pH-dependent coating base (hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, or polyvinyl acetate phthalate), a plasticizer (triethyl citrate), and an opacifying agent (calcium silicate) were thoroughly mixed to prepare pH-dependent film coating compositions according to Examples 14 to 16.

[0071] [Table 4]

[0072] (In Table 4 above, the % content means % by weight.)

[0073] The present invention will be described in detail below based on experimental examples. However, the following experimental examples are merely for the purpose of illustrating the present invention, and the scope of the present invention is not limited thereto.

[0074] Manufacturing example Manufacturing of uncoated tablets Red tablets containing a red pigment were prepared according to the composition shown in Table 5 below for the evaluation of whiteness (ΔL), disintegration, and stability described below.

[0075] Specifically, microcrystalline cellulose, lactose hydrate, and crospovidone were mixed. Povidone was dissolved in purified water, red iron oxide was dispersed, and the mixture was then added to the above mixture and kneaded. The kneaded mixture was dried and then sieved. Magnesium stearate was added to the sieved product and finally mixed. The final mixture was compressed into red plain tablets using an 8 mm round punch in a rotary tablet press.

[0076] [Table 5]

[0077] (In Table 5 above, the % content means % by weight.)

[0078] Coating conditions In the following experimental examples, the coating conditions for coating the prepared plain tablets using the film coating compositions according to the comparative examples and examples are as follows.

[0079] (1) Coating conditions using purified water as a solvent (Examples 1 to 13) Intake air temperature: 55~60℃ Exhaust temperature: 40~45℃ Coating pan rotation speed: 5-10 rpm Film coating solution: The film coating compositions of Examples 1 to 13 are dissolved or dispersed in purified water to give a film coating solution concentration of 10% (w / w).

[0080] (2) Coating conditions using 80% aqueous ethanol solution (v / v) as a solvent (Examples 14 to 16) Intake air temperature: 45~50℃ Exhaust temperature: 35~40℃ Coating pan rotation speed: 5-10 rpm Film coating solution: The film coating compositions of Examples 14 to 16 were dissolved or dispersed in an 80% aqueous ethanol solution (v / v) to give a film coating solution concentration of 10% (w / w).

[0081] Experimental example Experimental Example 1: Evaluation of carcinogenicity Evaluation method To evaluate the genotoxicity and carcinogenicity of calcium silicate, a representative of the wide variety of silicon dioxide metal salts, in accordance with the ICH M7 guideline, which evaluates DNA-reactive substances that may directly damage DNA and cause mutations, thereby potentially inducing cancer, genotoxicity was evaluated using the computer programs Dreck Ver. 6.2.1 and Sarah Ver. 3.2.1 based on quantitative structure-activity relationship (Q)SAR, and carcinogenicity was evaluated using a literature search. The results are shown in Table 6.

[0082] When searching for literature, references 1 to 3 were used as references.

[0083] Reference 1:Safety assessment of titanium dioxide (E171) as a food additive. EFSA journal 2021

[0084] Reference 2: European chemical substrate information system

[0085] Reference 3: Re-evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) as food additives. EFSA journal 2018

[0086] Evaluation results Referring to Table 6, although genotoxicity was not confirmed in titanium oxide and calcium silicate, which is a representative of silicon dioxide metal salts, through (Q)SAR evaluation, the carcinogenicity of titanium oxide has been reported in literature, whereas the carcinogenicity of calcium silicate has not been confirmed through literature reports.

[0087] [Table 6]

[0088] (In Table 6 above, 1) refers to Reference 1, 2) refers to Reference 2, and 3) refers to Reference 3.)

[0089] Experimental Example 2: Evaluation of whiteness (ΔL) Evaluation method Using the film coating compositions of Comparative Examples 1 to 2 and Examples 2 to 6, red plain tablets prepared according to the above manufacturing examples were coated by adjusting the coating amount relative to the weight of the plain tablets. (Here, the coating amount (w / w) of the film coating composition relative to the weight of the plain tablets was set to 0%, 3%, 5%, and 10%. Here, 0% is understood to mean the plain tablets themselves.)

[0090] Specifically, the whiteness (ΔL) of tablets coated with a white film coating composition using a red plain tablet was evaluated using a color difference meter, and the whiteness (ΔL), which is the degree to which the whiteness is different from the standard whiteness, was evaluated. In the case of whiteness (ΔL), a difference of 10 compared to the standard whiteness is a difference that cannot be easily discerned visually, and this was used as a standard for judgment, and the results are shown in Table 7.

[0091] Evaluation results Referring to Table 7, compared to Comparative Example 1, a clear shift in color from red to white was observed in the film coating compositions of Examples 2 to 6 containing silicon dioxide metal salt.

[0092] Furthermore, compared to the titanium oxide-containing film coating composition (Comparative Example 2), which is prohibited for use in foods due to genotoxicity issues, the film coating compositions of Examples 2 to 6, which contain silicon dioxide metal salt coated at approximately 3 to 10% (w / w) based on the weight of the plain tablet, were found to achieve a whiteness (ΔL) at approximately the same level as the titanium oxide-containing film coating composition (composition of Comparative Example 2) coated at 3% (w / w) based on the weight of the plain tablet, thereby confirming the suitability of the film coating compositions of Examples 2 to 6 as white film coating compositions.

[0093] [Table 7]

[0094] (In Table 7 above, the unit (%) of the amount of opacifying agent used means % by weight.)

[0095] Experimental Example 3: Evaluation of light blocking rate (transmittance) Evaluation method The film coating compositions of Comparative Example 2, Example 4, and Example 6 were used to evaluate the light blocking rate (transmittance).

[0096] Specifically, to evaluate the light blocking degree (transmittance), the film coating compositions of Comparative Example 2, Example 4, and Example 6 were coated onto a quartz cell of an absorbance measuring device. The light blocking degree (transmittance) of the film layer was evaluated by measuring the degree of transmittance according to wavelength, and the results are shown in Table 8 and Figure 1. (In Table 8, the coating amount (%, w / w) was set by converting the thickness of the film layer obtained in Example 1 above. That is, the thickness of the film layer was set based on the weight of the film layer coated on the plain tablet. For example, when a plain tablet is coated at 3 wt %, the thickness of the film layer formed on the quartz cell is measured, and the measured thickness is taken as 100. When a 1.5 wt % coating is applied, the thickness of the film layer formed by coating the quartz cell so that it is half the thickness of the film layer coated at 3 wt % is taken as 50. This means that the coating is considered to be performed.)

[0097] Evaluation results 1, it was confirmed that the film coating compositions of Examples 4 and 6 according to the present invention exhibited a transmittance of less than 0.5% even at a coating amount of less than 2% (w / w) relative to the weight of the plain tablet, compared to the film coating composition of Comparative Example 2 in which titanium oxide was used. This confirmed that a sufficient degree of light blocking (transmittance) could be obtained by applying the film coating compositions of Examples 4 and 6 according to the present invention.

[0098] [Table 8]

[0099] Experimental Example 4: Evaluation of the degree of collapse Evaluation method The film coating compositions of Comparative Example 2, Example 4, and Example 6 were used to evaluate the degree of disintegration.

[0100] Specifically, to evaluate the disintegration degree, the coating amount (the coating amount (w / w) of the film coating composition relative to the weight of the plain tablet was set to 0%, 3%, 5%, and 10%. 0% is considered to mean the plain tablet itself) relative to the weight of the plain tablet prepared according to the above manufacturing example was evaluated for delay in disintegration time in accordance with the disintegration test method in the general test methods of the Korean Pharmacopoeia, and the results are shown in Table 9.

[0101] Evaluation results Referring to Table 9, the evaluation showed that the disintegration time of the plain tablets was approximately 3.5 minutes, and the difference was between a minimum of 1.5 minutes and a maximum of 2.5 minutes, which was approximately the same as the disintegration time of the comparative example.

[0102] [Table 9]

[0103] (In Table 9 above, the unit (%) of the amount of opacifying agent used means % by weight.)

[0104] Experimental Example 5. Evaluation of storage stability Evaluation method The film coating compositions of Examples 2 and 5 were used to evaluate the accelerated stability.

[0105] Specifically, to test the stability of tablets prepared according to the above manufacturing example, which were coated with the film coating compositions of Examples 2 and 5 at coating amounts (w / w) of 5% (w / w) and 10% (w / w) of the weight of the plain tablet, respectively (see the above description for the coating method), the prepared tablets were placed in a stability chamber and evaluated for accelerated stability for 30 days under accelerated conditions (temperature: 40±2°C, relative humidity: 75±5%), and the results are shown in Figure 2.

[0106] Evaluation results Referring to FIG. 2, the evaluation showed that the coating on the surface of the plain tablet was not damaged after 30 days from the start of the test when the coating amount of the film coating composition according to Example 2 and Example 5 relative to the weight of the plain tablet prepared according to the above manufacturing example was 5% (w / w) and 10% (w / w). This confirmed that the film coating composition according to the present invention has excellent storage stability.

[0107] Although specific parts of the present invention have been described in detail above, it will be apparent to those skilled in the art that such specific descriptions are merely preferred embodiments and do not limit the scope of the present invention.

[0108] Therefore, the true scope of the invention is to be defined by the appended claims and their equivalents.

Claims

1. A coating polymer, a silicon dioxide metal salt, and a plasticizer are included. A film coating composition characterized by not containing titanium oxide.

2. 10. The film coating composition according to claim 1, wherein the content of the coating polymer is 30 to 90 wt % based on the total weight of the entire film coating composition.

3. 10. The film coating composition according to claim 1, wherein the content of the silicon dioxide metal salt is 5 to 50 wt % based on the total weight of the entire film coating composition.

4. 10. The film coating composition according to claim 1, wherein the content of the plasticizer is 5 to 40 wt % based on the total weight of the entire film coating composition.

5. The film coating composition according to claim 1, wherein the film coating composition is in the form of a solid powder.

6. 10. The film coating composition according to claim 1, wherein the film coating composition is mixed with a solvent so that the content of the film coating composition is 5 to 30 wt % based on the final film coating liquid.

7. The film coating composition according to claim 1, wherein the coating polymer is either a pH-independent polymer or a pH-dependent polymer.

8. 8. The film coating composition of claim 7, wherein the non-pH dependent polymer is at least one selected from the group consisting of hydroxypropylmethyl cellulose, polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol polymer, and hydroxypropyl cellulose.

9. 8. The film coating composition of claim 7, wherein the pH-dependent polymer is at least one selected from the group consisting of polyvinyl acetate phthalate, hydroxypropylmethyl cellulose acetate succinate, hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, and methacrylic acid copolymers.

10. 2. The film coating composition according to claim 1, wherein the metal silicon dioxide salt is at least one selected from the group consisting of calcium silicate, calcium silicate hydrate, sodium silicate, magnesium silicate, magnesium trisilicate, aluminum silicate, magnesium aluminum metasilicate, potassium aluminum disilicate, and sodium aluminum silicate.

11. 10. The film coating composition of claim 1, wherein the plasticizer is at least one selected from the group consisting of triethyl citrate, tributyl citrate, glyceryl triacetate, acetyl triethyl citrate, dibutyl sebacate, diethyl phthalate, polyethylene glycol having a molecular weight of 200 to 20,000, castor oil, and a copolymer of propylene oxide and ethylene oxide.

12. The film coating composition according to claim 1, wherein the film coating composition is for use in film coating applied to pharmaceutical preparations.

13. The film coating composition according to claim 1, wherein the film coating composition is for film coating applied to food preparations.

14. A pharmaceutical preparation, wherein the film coating composition according to claim 1 is coated on the pharmaceutical.

15. A food preparation, wherein the film coating composition according to claim 1 is coated on a food product.

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