White film coating compositions without titanium dioxide and processes for their preparation and methods of use

Abstract

The present application provides a film coating composition free of titanium dioxide comprising a combination of a water-soluble cellulose ether, a water-soluble anionic cellulose ether, calcium carbonate, and a plasticizer. The present application also provides a method of making a film coating composition and a method of coating a solid substrate with such a coating composition.

Description

[0001] This invention patent application is a divisional application of the invention patent application filed on September 5, 2020, with application number 202080080562.5 and invention title "White film coating composition without titanium dioxide and its preparation process and application method" (based on PCT international application No. PCT / US2020 / 052724). Technical Field

[0002] This application relates to coating compositions, and more specifically, to white film coating compositions that do not contain titanium dioxide, methods for their preparation, and methods for coating solid substrates. Background Technology

[0003] Coatings play a vital role in many industrial sectors, including pharmaceuticals, veterinary medicine, agriculture, nutrition, automotive, biochemistry, chemicals, computers, consumer goods, food, electronics, materials, and healthcare. The widespread use of coatings is due to the broad range of functions they provide, such as protection (e.g., preventing water absorption, preventing UV damage), separation (e.g., chemical incompatibility), alteration of active ingredient release (e.g., immediate release, prolonged release, delayed release, controlled release), and changes in sensory perception (e.g., smoothness / roughness, taste, color).

[0004] For various reasons, titanium dioxide (TiO2) has become an unpopular colorant globally, making the search for new or alternative components and ingredients that can replace titanium dioxide for various needs and purposes crucial for coatings in many industrial sectors. Specifically, this new and alternative component of titanium dioxide aims to enhance the visual appeal, whiteness, and brightness of a substrate or substance (e.g., tablets, capsules, granules, lozenges, candies, or seeds) carrying active ingredients, such as those found in agricultural, nutritional, and / or pharmaceutical applications.

[0005] U.S. Patent No. 4,931,286 (assigned to Aqualon) discloses a high-gloss pharmaceutical tablet having an outer coating of sodium carboxymethyl cellulose and polyethylene glycol at a weight of 0.1% to 5.0% per tablet.

[0006] U.S. Patent No. 10,159,650 (assigned to Sensient Colors LLC) discloses a film coating composition comprising hydroxypropyl methylcellulose (HPMC), a cellulose polymer, precipitated calcium carbonate, a light-blocking agent, and a fatty acid.

[0007] However, it has been observed that existing coating compositions containing sodium carboxymethyl cellulose (NaCMC) or precipitated calcium carbonate (CaCO3) do not effectively provide good opacity, and the resulting coated products or substrates exhibit a dull and gray appearance.

[0008] Therefore, there is a need in the art for an effective, whiter, and brighter titanium dioxide-free film coating composition suitable for coating solid substrates (e.g., tablets, granules, lozenges, candies, or seeds) carrying active ingredients, including but not limited to agricultural, nutritional, and / or pharmaceutical active substances.

[0009] Unexpectedly or by chance, we discovered a titanium dioxide-free film coating composition that provides (i) improved gloss and a brighter appearance; and (ii) improved whiteness when coated on a solid substrate. Summary of the Invention

[0010] Improvements to film coatings have been discovered that enable the final product or finished product to have better performance than existing technologies. These coatings contain (i) water-soluble cellulose ethers, (ii) water-soluble anionic cellulose ethers, (iii) calcium carbonate (CaCO3), and (iv) plasticizers.

[0011] In one aspect of the invention, a titanium dioxide-free white film coating composition is provided, comprising: (i) 20% to 50% by weight of hydroxypropyl methylcellulose (HPMC), a water-soluble cellulose ether; (ii) 5% to 15% by weight of carboxymethyl cellulose (CMC), a water-soluble anionic cellulose ether; (iii) 10% to 60% by weight of calcium carbonate (CaCO3); and (iv) 0.0% to 5% by weight of a plasticizer.

[0012] According to another aspect of this application, a white film coating composition is provided, having a total solids content of about 10% to about 25% by weight of the total composition.

[0013] In another aspect, a colorant coating composition is disclosed, wherein the composition further comprises from 0.001% by weight to 25% by weight of an optional secondary pigment, including but not limited to red iron oxide, black iron oxide, or combinations thereof.

[0014] In another aspect, a method for preparing a white film-coated substrate is disclosed, the method comprising the steps of: (a) preparing a coating suspension comprising the above-described white film coating composition, (b) applying the coating suspension of step (a) to the surface of a solid substrate to form a coating, (c) simultaneously and / or subsequently drying the coating to form a dried coating on the surface of the solid substrate, and (d) obtaining the final film-coated solid substrate.

[0015] According to another aspect, a white film-coated solid product is disclosed, which is produced by a method comprising the following steps: (a) preparing a coating suspension comprising the above-described white film coating composition, (b) applying the coating suspension of step (a) to the surface of the solid product to form a coating, (c) simultaneously and / or subsequently drying the coating to form a dried coating on the surface of the solid product, and (d) obtaining the desired final film-coated solid product. Attached Figure Description

[0016] The objects, features, and advantages of the present invention will become apparent after reading the following description in conjunction with the accompanying drawings / figures, wherein: Figure 1 Comparative tablets coated with hydroxypropyl methylcellulose (HPMC) and hydroxypropyl cellulose (HPC) were depicted, showing poor opacity and a dull appearance.

[0017] Figure 2 The images show a comparison between existing paint and the applicant's paint, which is whiter and brighter.

[0018] Figure 3 It is a front view of the tablet whiteness, showing a comparison image of the prior art coating (light gray and dull appearance) and the applicant's coating (whiter and brighter).

[0019] Figure 4 It is a front view comparing the whiteness of the tablets, showing an image of the applicant's coated tablets and a standard tablet.

[0020] Figure 5 It is an image showing the opacity of the applicant's membrane coating and the standard membrane coating.

[0021] Figure 6 It is a diagram showing the gloss and surface roughness parameters of the applicant's film coating and the standard film coating.

[0022] Figure 7 These are scanning electron microscope images showing the effect of calcium carbonate particle size on the opacity of the coating.

[0023] Figure 8 The image shows coated tablets, illustrating the effect of calcium carbonate particle size on coating whiteness. Detailed Implementation

[0024] Although this specification concludes with claims that specifically point out and explicitly claim protection as the subject of this invention, it is anticipated that the invention will be more readily understood by reading the following detailed description of the invention and studying the included embodiments.

[0025] As used in accordance with this disclosure, unless otherwise stated, the following terms shall be understood to have the following meanings.

[0026] Unless otherwise defined herein, technical terms used in conjunction with the disclosed and / or claimed inventive concepts shall have the meaning commonly understood by one of ordinary skill in the art. Furthermore, unless the context requires otherwise, singular terms shall include plural forms, and plural terms shall include singular forms.

[0027] The singular indefinite articles (“a”, “an”) and definite articles (“the”) include the plural referent unless the context explicitly specifies otherwise or the cited context clearly implies the opposite meaning. As used herein, the words “comprising” (and any form of inclusion, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of inclusion, such as “includes” and “include”), or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unlisted elements or steps of action.

[0028] For the purposes of the following detailed description, except in any operational instance or where otherwise specified, figures (representing the amount of an ingredient as used, for example, in the specification and claims) should be understood to be modified in all cases by the term “about”. The numerical parameters described in the specification and appended claims are approximate values ​​and may vary depending on the desired characteristics obtained in practicing the invention.

[0029] Unless otherwise stated, all percentages, parts, proportions and ratios used herein are by weight of the total composition. All such weights relating to the listed ingredients are based on activity levels, and therefore, solvents or byproducts that may be included in commercially available materials are not included unless otherwise stated.

[0030] All publications, articles, papers, patents, patent publications and other references cited in this article are incorporated in their entirety for all purposes and to the extent consistent with the information disclosed herein.

[0031] As used herein, the terms “applicant’s coating,” “test sample,” and “coating of the present invention” are interchangeable and refer to the coating composition currently claimed. Similarly, the terms “solid substrate” and “solid substance” are interchangeable in this application.

[0032] As used in this article, the term "HPC" refers to hydroxypropyl cellulose.

[0033] As used in this article, the term "HPMC" refers to hydroxypropyl methylcellulose.

[0034] As used in this article, the term "MCT" refers to medium-chain triglycerides.

[0035] As used in this article, the term "PEG" refers to polyethylene glycol.

[0036] As used in this article, the term "NaCMC" refers to sodium carboxymethyl cellulose.

[0037] As used herein, the terms “solid substrate” or “solid substance” or “solid product” refer to, but are not limited to, tablets, granules, lozenges, candies, seeds, etc.

[0038] This application specifically describes a white film coating and products coated therewith, which offer unique advantages or properties not found in the prior art. The coating is based on a combination of water-soluble cellulose polymers, water-soluble anionic cellulose polymers, calcium carbonate, plasticizers, and other optional ingredients. Compared to existing coatings, these coatings provide an improved film coating with a whiter, brighter, and glossier appearance.

[0039] In one embodiment, this application provides a titanium dioxide-free white film coating composition comprising: (i) 20% to 50% by weight of hydroxypropyl methylcellulose (HPMC), a water-soluble cellulose ether; (ii) 5% to 15% by weight of carboxymethyl cellulose (CMC), a water-soluble anionic cellulose ether; (iii) 10% to 60% by weight of calcium carbonate; and (iv) 5% to 25% by weight of a plasticizer.

[0040] In addition, the white film coating composition contains 0.0% to 5% by weight of medium-chain triglycerides (MCT) and 0.0% to 2% by weight of citric acid monohydrate.

[0041] In another embodiment of this application, the total solids content of the white film coating composition is from about 10% by weight to about 25% by weight of the total composition. In a non-limiting embodiment of this application, other possible ranges of solids content include, but are not limited to, from about 10% by weight to about 15% by weight of the total composition, from about 15% by weight to about 20% by weight of the total composition, or from about 20% by weight to about 25% by weight of the total composition.

[0042] In another embodiment, the water-soluble cellulose ether has the following general structure: Each of R1, R2, R3, R4, R5, and R6 is independently substituted to form a cellulose ether derivative with a suitable functional moiety. Examples of such derivatives include, but are not limited to, carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), and methyl cellulose (MC). These cellulose ethers differ in the variety of R functional groups, the degree of substitution of the hydroxyl groups, and their molecular weight range.

[0043] Hydroxypropyl methylcellulose is also known by its acronym HPMC, and pharmaceutical grade is known by its common chemical name, hydroxypropyl methylcellulose (Hypromellose). HPMC is a partially O-methylated and O-(2-hydroxypropylated) cellulose, where R1, R2, R4, and R5 are OH, OCH3, and / or O[CH3CH(OH)CH2]. y ; and R3 and R6 are CH2OH, CH2OCH3 and / or CH2O[CH3CH(OH)CH2] y The subscript "y" indicates the number of hydroxypropyl monomer units. For the purposes of this invention, commercially available HPMCs are readily available from Dow Chemical (Methocel™ grades E3, E5, E6, E15, E50, E4M, E10M, F50, K3, K100, K4M, K15M, K100M), Shin-Etsu Chemical Company (Pharmacoat grades 603, 606, 615, 904) and Hercules Inc. (Benecel® MP 843, 814, and 844). Hydroxypropyl methylcellulose (HPMC) HPMC is present in an amount of 20% to 50%, preferably 20% to 45%, more preferably 25% to 45% by weight, based on the total weight of the coating composition. Two or more different grades of HPMC may be present.

[0044] Hydroxypropyl cellulose (HPC) is a partially substituted poly(hydroxyethyl) ether of cellulose, wherein R1, R2, R4, and R5 are OH and / or O [CH2CH(CH3)O]. y H; and R3 and R6 are CH2OH or CH2O[CH2CH(CH3)O] y H, where the subscript "y" represents the number of hydroxypropyl monomer units. HPC grades manufactured by Ashland LLC. include Klucel® EF, LF, HF, JF, LF, MF, and GF; Hydroxypropyl cellulose (HPC) Sodium carboxymethyl cellulose (NaCMC) is a water-soluble anionic cellulose polymer. Sodium carboxymethyl cellulose is the sodium salt of a polycarboxymethyl ether of cellulose, wherein R1, R2, R4, and R5 are OH; and R3 and R6 are CH2OCH2COONa. Commercially available NaCMC includes, but is not limited to, NaCMC from Hercules Inc. under the trade names Aqualon® and Blanose®. The chemical and physical properties of NaCMC have broader applications in food, pharmaceuticals, and personal care. Carboxymethyl cellulose has the following structure: Carboxymethyl cellulose (CMC) CMC is present in an amount of 5% to 15%, 5% to 10%, or 10% to 15% by weight based on the total weight of the coating composition. Two or more different grades of CMC may be present.

[0045] Calcium carbonate (CaCO3) used herein can be obtained from natural sediments, which are then finely ground or obtained through chemical precipitation and drying of the precipitate. Calcium carbonate is used as a filler material in painting, rubber, paper, food, pharmaceuticals, plastics, etc. Calcium carbonate is an opacifier and is provided herein for film coatings exhibiting excellent brightness, whiteness, and / or opacity without the use of compounds containing heavy metals. The morphology of precipitated calcium carbonate provides an increased surface area and more uniform dispersion in aqueous media. The morphology and particle size of calcium carbonate affect the whiteness and opacity of the film coating. The morphology of calcium carbonate includes prismatic and triangular structures. The particle size of calcium carbonate used in this coating composition is selected from 0.5 micrometers to 20 micrometers. Therefore, the particle size range of calcium carbonate can be from 0.5 micrometers to about 5 micrometers, from 5 micrometers to 10 micrometers, from 10 micrometers to 15 micrometers, and from 15 micrometers to 20 micrometers. More preferably, this application uses calcium carbonate with an average particle size of 1.8 micrometers to 2.0 micrometers and a triangular morphology. Calcium carbonate is present in an amount of 10% to 60%, preferably 15% to 55%, more preferably 20% to 50% by weight of the composition. Blends with different particle sizes and morphologies are being considered.

[0046] The plasticizer is present in quantities ranging from about 5% by weight to about 30% by weight to increase plasticity or flowability. Plasticizers enhance the plastic properties of the polymerized composition, for example, by lowering the glass transition temperature (Tg) of the composition, thereby increasing flexibility and / or durability. Some plasticizers have been approved for direct or indirect human use in some end-user products. Examples of such plasticizers include citrates selected from acetylacetonate tributyl citrate, acetylacetonate triethyl citrate, tributyl citrate, and triethyl citrate; diols selected from polyethylene glycol (PEG), propylene glycol, and glycerol; phthalates selected from dibutyl phthalate, diethyl phthalate, and dimethyl phthalate; stearates selected from glyceryl monostearate; and triacetylglycerol. In one or more embodiments, the coating composition includes PEG selected from, but not limited to, the group consisting of: PEG 200, PEG 300, PEG 400, PEG 600, PEG 1000, PEG 1500, PEG 4000, PEG 3350, PEG 6000, and PEG 8000. In another non-limiting embodiment of this application, other possible ranges of the plasticizer include, but are not limited to, about 5% to about 10% by weight, about 10% to about 15% by weight, about 15% to about 20% by weight, about 20% to about 25% by weight, or about 25% to about 30% by weight.

[0047] In another embodiment, this application provides medium-chain triglycerides (MCTs) derived from glycerol and three fatty acids with chain lengths of 8 to 12 carbon atoms. Suitable fatty acid components are caprylic acid, capric acid, and lauric acid. Medium-chain fatty acids having 8 carbon atoms may be referred to herein as C8 fatty acids or C8. Medium-chain fatty acids having 10 carbon atoms may be referred herein as C10 fatty acids or C10. MCTs have been used in various applications, such as food additives, treatment of neurological disorders, etc. White film coating compositions typically contain 0.0% to 5% by weight of medium-chain triglycerides (MCTs).

[0048] In another embodiment, this application also provides citric acid in monohydrate or anhydrous form. Citric acid is widely used in pharmaceutical preparations and food as an acidifying agent, antioxidant, buffer, chelating agent, or flavoring agent. Citric acid monohydrate loses moisture when crystallized in dry air or heated to about 40°C. The film coating composition of the present invention may contain 0.0% to 2.0% by weight of citric acid monohydrate.

[0049] Suitable pigments include colorants, dyes, and lakes, including but not limited to iron oxide, dyes such as FD&C lake, carmine lake, FD&C Blue 1, FD&C Blue 2, FD&C Red 3, FD&C Red 40, FD&C Yellow 5, FD&C Yellow 6, FD&C Green 3, red iron oxide, black iron oxide, alumina talc, turmeric oil resin, cochineal extract, gardenia yellow, gardenia blue, beet powder, etc. The pigments present in the film coating composition of the present invention can range from 0.001% by weight to 25% by weight, preferably from 0.01% by weight to 10% by weight, and can be selected from the group including but not limited to red iron oxide, black iron oxide, or combinations thereof.

[0050] In another embodiment, this application provides a coating formulation in which the components are dry-mixed using a commercial-grade mixer, including a high-shear mixer. Solid components such as polyethylene glycol (PEG) and medium-chain triglycerides (MCT) can be used as plasticizers.

[0051] In another embodiment, this application provides a method for preparing a white film-coated solid substrate, the method comprising the steps of: (a) preparing a coating suspension comprising the white film coating composition described herein, (b) applying the coating suspension of step (a) to the surface of the solid substrate to form a coating, (c) simultaneously or subsequently drying the coating to form a dried coating on the surface of the solid substrate, and (d) obtaining a final coated solid product or substrate.

[0052] In another embodiment, the solid substrate to which this application is coated is an agricultural product, nutritional product, or pharmaceutical product.

[0053] In another embodiment, this application provides a coated pharmaceutical product or substrate formulated into an oral solid dosage form selected from tablets, mini tablets, pills, capsules, granules, lozenges, multigranules, etc.

[0054] In yet another embodiment, this application provides a white film-coated solid product manufactured by a method comprising the steps of: (a) preparing a coating suspension comprising the white film coating composition described herein, (b) applying the coating suspension of step (a) to the surface of the solid product to form a coating, (c) simultaneously and / or subsequently drying the coating to form a dried coating on the surface of the solid product, and (d) obtaining the final film-coated solid product.

[0055] In another embodiment, this application provides a white film-coated solid product or substrate, wherein the solid product or substrate is a coated agricultural product, a coated nutritional product, or a coated pharmaceutical product. In a preferred embodiment, the white film-coated pharmaceutical product is formulated into an oral solid dosage form. Such forms include, but are not limited to, tablets, mini tablets, pills, capsules, granules, lozenges, and multi-granule dosage forms.

[0056] In another embodiment, this application provides a titanium dioxide-free coating system with improved properties such as gloss, surface roughness, opacity, and color, thereby maximizing product quality and improving processing efficiency.

[0057] gloss For illustrative and not limiting purposes, the gloss of the tablets was measured using a gloss meter / surface analysis system. Acceptable edges are well-defined. Unacceptable edges are not defined. The current gloss value for the titanium dioxide-free film coating system is 80 gloss units (glu), while the gloss value for the standard is 60 glu. Results are as follows: Figure 6 As shown, this indicates that the applicant's coating composition has a high gloss value.

[0058] Surface roughness For illustrative and not limiting purposes, roughness images were analyzed and corrected for surface curvature before determining surface roughness, where the shape of the removed form should match the general shape of the tablet. The roughness report for the sample set is the average of the roughness values ​​of 16 tablets in the sample. Results are as follows: Figure 6 As shown, the roughness is approximately 2.5 square micrometers, while the standard sample shows a roughness of 3 square micrometers, indicating that the current coating composition reduces surface roughness.

[0059] color For illustrative and not limiting purposes, the product's color was determined through reflectance measurements. Visual analysis of color variations has been performed, and the results are as follows: Figure 3 As shown, the applicant's film coating is whiter and brighter, while its weight increases by 5%. The color change has been experimentally verified by measuring reflectance using a data color spectrophotometer, as shown in the results. Figure 4 As shown, the applicant's coating has a reflectance value of 0.63, close to the standard coating's reflectance of 1.42. When applied to black tablets, the applicant's primary TF (titanium-free) coating caused it to whiten, while increasing the weight by 5%. Experimental results are as follows... Figure 5 As shown.

[0060] Opacity and whiteness coverage For illustrative and not limiting purposes, opacity was measured using scanning electron microscopy (SEM), where higher light reflectance indicates greater opacity and imparts more whiteness to the coated substrate. Results are as follows: Figure 7 and Figure 8 As shown.

[0061] In yet another embodiment of this application, it has been found that the combination of cellulose ethers, calcium carbonate, plasticizers, and other components of this application unexpectedly increases the surface area capable of angular reflection, increases gloss, provides high opacity, brightness, and whiteness, and reduces the surface roughness of the coated substrate or product. These coating parameters for white film coatings and standard coatings are provided in Table 9. Such film coatings can be processed more advantageously than those skilled in the art would typically expect, particularly compared to other types of coatings in the relevant art. Whiteness and brightness are increased compared to conventional HPC-based coating systems known to those skilled in the art. Other benefits of these coating compositions are also provided in the examples.

[0062] The following examples are intended to illustrate the compositions and methods according to the present invention, but do not limit the scope of the invention in any way.

[0063] Example Example 1: Coating Formulation - A A coating formulation with a solids concentration range of 10% to 15% was developed, containing the following ingredients: hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), citric acid monohydrate, and polyethylene glycol.

[0064] Table 1: Coating Formulation A Example 2: Coating Formulation - B Coating formulations with solid concentrations ranging from 15% to 20% were developed, containing the following ingredients: three different components of hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), citric acid monohydrate, medium-chain triglycerides, and polyethylene glycol.

[0065] Table 2: Coating Formulation B Example 3: Coating Formulation C A coating formulation was developed containing the following ingredients: two different grades of hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), calcium carbonate, citric acid monohydrate, polyethylene glycol, and medium-chain triglycerides.

[0066] Table 3: Coating Formulation C Example 4: Coating Formulation - D A coating formulation has been developed containing the following ingredients: hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), calcium carbonate, citric acid monohydrate, polyethylene glycol, and medium-chain triglycerides.

[0067] Table 4: Coating Formulation D Example 5: Coating Formulation - E A coating formulation was developed containing two different grades of hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), calcium carbonate, and polyethylene glycol.

[0068] Table 5: Coating Formulation E Example 6: Coating Formulation - F A coating formulation has been developed containing the following ingredients: hydroxypropyl methylcellulose (HPMC), hydroxyethyl cellulose (HEC), carboxymethyl cellulose (CMC), calcium carbonate, citric acid monohydrate, polyethylene glycol, and medium-chain triglycerides.

[0069] Table 6: Coating Formulation F Example 7: Coating Formulation - G Coating formulations with solid concentrations ranging from 15% to 20% were developed, containing three different grades of hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), calcium carbonate, red iron oxide, black iron oxide, citric acid monohydrate, medium-chain triglycerides, and polyethylene glycol.

[0070] Table 7: Coating Formulation G Example 8: Improvement of color uniformity Placebo tablets were coated at a high speed with 25% solids. When the tablets were coated with the white film coating compositions formulated in Examples 1 to 8, improved color uniformity was observed. Tablets using the applicant's coating were whiter and brighter, as shown in the image. Figure 1 and Figure 2 As shown.

[0071] Example 9: Comparative coating formulation using hydroxypropyl cellulose A coating formulation was developed comprising the following ingredients: hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), calcium carbonate, yellow iron oxide, citric acid monohydrate, medium-chain triglycerides, and polyethylene glycol. Tablets coated with HPC exhibited poor opacity and edge chipping. Results are as follows... Figure 3 As shown.

[0072] Table 8: Coating Formulations Using HPC Example 10: Better opacity and better whiteness coverage The opacity of white film coatings is typically caused by the use of titanium dioxide, as powdered titanium dioxide provides the whitest and most opaque film with a high refractive index. The applicant's coating formulation was developed using combinations of calcium carbonate and cellulose ethers with different particle sizes to achieve the same opacity as when using titanium dioxide. 0.7 μm prismatic particles and 1.8 μm and 2.0 μm triangular-faceted calcium carbonate particles were tested. Smaller particles provided better coverage; however, the applicant's coating, which used calcium carbonate with a larger average particle size of 1.8 μm to 2.0 μm and a triangular-faceted structure, showed better opacity and better whiteness coverage compared to 0.7 μm prismatic calcium carbonate. Results are as follows... Figure 7 and Figure 8 As shown.

[0073] Example 11: Coating Properties Table 9: Coating Parameters While the compositions and methods of the disclosed and / or claimed inventive concepts have been described in detail, it will be apparent to those skilled in the art that modifications may be made to the compositions and / or methods, as well as the steps or sequence of steps of the methods described herein, without departing from the concept, spirit, and scope of the disclosed and / or claimed inventive concepts. All such similar substitutions and modifications that are apparent to those skilled in the art are considered to be within the spirit, scope, and concept of the disclosed and / or claimed inventive concepts.

Claims

1. A white film coating composition that does not contain titanium dioxide, comprising: (i) 20% to 50% by weight of hydroxypropyl methylcellulose (HPMC), a water-soluble cellulose ether; (ii) 5% to 15% by weight of carboxymethyl cellulose (CMC), a water-soluble anionic cellulose ether; (iii) 10% to 60% by weight calcium carbonate (CaCO3) having an average particle size of 0.5 micrometers to 20 micrometers; and (iv) 5% to 25% by weight of plasticizer; in, The total solids content of the composition ranges from about 10% by weight to about 25% by weight.

2. The white film coating composition according to claim 1, wherein, The composition also contains 0.0% to 5% by weight of medium-chain triglycerides (MCT) and 0.0% to 2% by weight of citric acid monohydrate.

3. The white film coating composition according to claim 1, wherein, The plasticizer is polyethylene glycol (PEG).

4. A method for preparing a substrate coated with a white film, the method comprising: (a) Manufacturing a coating suspension comprising the white film coating composition of claim 1 or 2; (b) Apply the coating suspension of step (a) to the surface of a solid substrate to form a coating; (c) Dry the coating simultaneously and / or subsequently to form a dry coating on the surface of the solid substrate; as well as (d) Obtain the final white film-coated solid substrate.

5. The method according to claim 4, wherein, The solid substrate is an agricultural product, nutritional product, or pharmaceutical.

6. A white film-coated solid product, produced by a method comprising the following steps: (a) Manufacturing a coating suspension comprising the white film coating composition of claim 1 or 2; (b) Apply the coating suspension of step (a) to the surface of the solid product to form a coating; (c) Dry the coating simultaneously and / or subsequently to form a dry coating on the surface of the solid product; as well as (d) Obtain the final film-coated solid product.

7. The solid product coated with a white film according to claim 6, wherein, The coated products are coated agricultural products, coated nutritional products, or coated pharmaceuticals.

8. The solid substrate coated with a white film according to claim 7, wherein, The coated medicine is formulated into an oral solid dosage form.

9. The solid substrate coated with a white film according to claim 8, wherein, The oral solid dosage form is selected from tablets, capsules, granules, lozenges, candies, and seeds.

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