Composition for pearl-like film coating and coating method using the same

Abstract

The present invention provides a composition for a pearlescent film coating that exhibits excellent pearlescent properties with a single coating, and a method for coating a tablet using such a composition. When using the coating composition according to the present invention, an excellent pearlescent film layer can be formed with a single coating without the need for the conventional two-layer process, and the surface slippage and pearl residue issues that were problematic in the conventional method can be improved.

Description

Technology Field

[0001] The present disclosure relates to a composition for film coating of tablets, and in particular to a coating composition for forming a film layer that exhibits a pearlescent effect after coating. The present disclosure also relates to a method for coating an uncoated tablet using such a coating composition. Background Technology

[0003] Film-coated tablets that exhibit a pearlescent effect have been required to identify tablets or to enhance user satisfaction.

[0004] Conventionally, it has been thought that such a pearlescent film coating is difficult to form in a single coating. Therefore, a first coating that forms a conventional film layer is performed, and then a second coating that imparts a pearlescent effect is performed to form a pearlescent film coating layer.

[0005] However, this method required a lot of time and cost to form two layers, and since the second coating was performed on top of the first coating layer, there were quality issues such as surface slippage and pearl shedding. The problem to be solved

[0007] Therefore, the problem that the present invention aims to solve is to provide a composition for a pearlescent film coating that, unlike existing compositions for pearlescent coatings, makes it easy to form a pearlescent film coating layer with a single coating and improves various problems during coating.

[0008] Another problem that the present invention aims to solve is to provide a method for coating tablets using such a pearlescent-forming film coating composition. means of solving the problem

[0010] To solve the above problem, one aspect of the present disclosure provides a composition for a pearlescent film coating comprising a coating polymer, a potassium aluminum silicate / titanium oxide mixture (Silver Mica), polyethylene glycol, a pigment, and optionally talc.

[0011] Preferably, another aspect of the present invention provides a composition for a pearlescent film coating comprising polyvinyl alcohol, a potassium aluminum silicate / titanium oxide mixture (Silver Mica), polyethylene glycol, talc, and a pigment, using water as a coating solvent. Herein, a preferred aspect of the present invention provides a composition for a pearlescent film coating comprising, based on the total weight of a solvent-free powdered coating composition, 30-50 wt% polyvinyl alcohol, 17-30 wt% potassium aluminum silicate / titanium oxide mixture (Silver Mica), 15-25 wt% polyethylene glycol, 10-20 wt% talc, and 0.5-5 wt% pigment.

[0012] Preferably, another aspect of the present invention provides a composition for a pearlescent film coating comprising hypromellose, a potassium aluminum silicate / titanium oxide mixture (Silver Mica), polyethylene glycol, and a pigment, using ethanol or an aqueous ethanol solution as a coating solvent. Herein, a preferred aspect of the present invention provides a composition for a pearlescent film coating comprising 48-75% by weight of hypromellose, 17-37% by weight of a potassium aluminum silicate / titanium oxide mixture (Silver Mica), 4-10% by weight of polyethylene glycol, and 0.5-5% by weight of a pigment, based on the total weight of a solvent-free powdered coating composition.

[0013] In the present invention, the polyvinyl alcohol is preferably a polyvinyl alcohol having a viscosity of 4-6 mPas when measured as a 4 weight% aqueous solution at 20°C.

[0014] In the present invention, hypromellose 2910 is preferred as the hypromellose, and hypromellose having a viscosity of 3-20 mPas when measured as a 2 wt% aqueous solution at 20°C is more preferred for the purposes of the present invention. In particular, hypromellose with a viscosity of 3-10 mPas is more preferred, and hypromellose with a viscosity of 6 mPas is most preferred.

[0015] In the present invention, polyethylene glycol such as polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 4000, polyethylene glycol 6000, etc. may be used.

[0016] In the present invention, the pigments may include brilliant blue FCF aluminum lake (preferably 11-13%), indigo carmine aluminum lake (preferably 12-14%), quinoline yellow WS aluminum lake (preferably 18-24%), sunset yellow FCF aluminum lake (preferably 17-19%), tartrazine aluminum lake (preferably 14-16%), allura red AC aluminum lake (preferably 14-16%), red iron oxide, yellow iron oxide, black iron oxide, or a mixture thereof, but the present invention is not limited to these specific types of pigments.

[0017] The compositions for pearlescent film coating according to the present invention can form a film coating layer exhibiting excellent pearlescent properties as a single coating.

[0018] The film coating composition of the present invention may be provided in the form of a solid powder, or it may be provided in the form of a coating solution by mixing with a suitable solvent. When the composition of the present invention is provided as a coating solution, the content of each component is evaluated based on the total weight of the remaining dry materials excluding the coating solvent.

[0019] The coating solvent may preferably be selected from the group consisting of water, ethanol, and mixtures thereof.

[0020] Another aspect of the present invention also provides a method for coating a tablet using a film coating composition according to the present invention. This method is characterized by not additionally including any other coating in addition to the film coating composition according to the present invention.

[0021] The method of coating the coating solution onto the tablet is not particularly limited, and conventional methods in the relevant technical field for forming a coating film may be used. Examples include dip coating and spray coating. However, in terms of various aspects such as the uniformity of the coating film and the formation of a pearlescent effect, it is preferable to perform spray coating for a short period of time rather than using methods such as dip coating, which involves immersing the entire tablet in a solvent. Effects of the invention

[0023] The present invention provides a composition for a pearlescent film coating that exhibits excellent pearlescent properties with a single coating, and a method for coating a tablet using such a composition. Brief explanation of the drawing

[0025] Figure 1 is the result of photographing the surface of the coated tablets of samples 1 to 20. Specific details for implementing the invention

[0026] Hereinafter, the present invention will be described in detail with reference to examples and the like to aid in understanding the invention. However, the embodiments according to the present invention may be modified in various different forms, and the scope of the present invention should not be interpreted as being limited to the following embodiments. The embodiments of the present invention are provided to more completely explain the invention to those with average knowledge in the field to which the invention pertains.

[0028] Preparation of Samples 1 to 5, which are primary coating tablets

[0029] After preparing the coating composition of Table 1 below, the raw tablets were coated until the coating content increased by 3 wt% relative to the weight of the raw tablets. For the coating composition below, a coating solution (solid content 18 wt%) was prepared using water as a solvent, and subsequently, an inlet temperature of 75℃, a coating pan rotation speed of 15 rpm, a pump speed of 3.0 rpm, and an airflow of 170 m 3 Film coating was performed under conditions such as / hr. The coating machine used was the XENA-IV BTCIt was used. After coating, a photograph was taken and the results are shown in Figure 1.

[0030] Ingredient Name Example 1 Example 2 Example 3 Example 4 Example 5 Polyvinyl alcohol 40 40 40 40 40 titanium oxide 23 23 23 23 23 Polyethylene glycol 3350 20.2 20.2 20.2 20.2 20.2 Talc 14.8 14.8 14.8 14.8 14.8 Brilliant Blue 11-13% 2.0 0.3 Indigocarmine 12-14% 2.0 Quinoline Yellow 18-24% 2.0 1.7 Sunset Yellow 17-19% 2.0 Total 100 100 100 100 100

[0032] Preparation of secondary coating tablets Samples 6 to 10

[0033] A secondary coating was performed to form a pearl coating as in a previously known method. The primary coated tablets of Samples 1 to 5 were secondary coated with the composition of Table 2 below until the weight of the primary coated tablets increased by 0.5 wt%. For the coating composition below, a coating solution (solid content 5 wt%) was prepared using water as a solvent, and the tablets were coated in the same manner as Sample 1. Photographs were taken after coating and are summarized in Figure 1.

[0034] Ingredient Name Composition for secondary coating sodium carboxymethylcellulose 48.5 Maltodextrin 18.8 glucose 15.2 Potassium aluminum silicate / titanium oxide mixture (Silver Mica) 10.0 lecithin 7.5 Total 100

[0036] Preparation of samples 11 to 20 formed by a single pearl coating

[0037] We intended to form a pearl coating by performing the work only once, instead of the existing work that was divided into two steps.

[0038] First, the raw tablet was coated with the composition of Table 3 below and film-coated once alone until the weight of the raw tablet increased by 3% by weight. For the coating composition below, a coating solution (solid content 18% by weight) was prepared using water as a solvent, and the coating was performed in the same manner as Sample 1. Photographs were taken after coating and are summarized in Figure 1.

[0039] Ingredient Name Example 11 Example 12 Example 13 Example 14 Example 15 Polyvinyl alcohol 40 40 40 40 40 Potassium aluminum silicate / titanium oxide mixture (Silver Mica) 23 23 23 23 23 Polyethylene glycol 3350 20.2 20.2 20.2 20.2 20.2 Talc 14.8 14.8 14.8 14.8 14.8 Brilliant Blue 11-13% 2.0 0.3 Indigocarmine 12-14% 2.0 Quinoline Yellow 18-24% 2.0 1.7 Sunset Yellow 17-19% 2.0 Total 100 100 100 100 100

[0041] Next, the raw tablets were coated with the composition of Table 4 below and film-coated once alone until the weight of the raw tablets increased by 3 wt%. For the coating composition below, a coating solution (solid content 10 wt%) was prepared using 80 wt% ethanol as a solvent. Subsequently, the inlet temperature was set to 60℃, the coating pan rotation speed to 30 rpm, the pump speed to 5.0 rpm, and the airflow to 170 m 3Film coating was performed under conditions such as / hr. The coating machine used was the XENA-IV BTC It was used. After coating, a photograph was taken and the results are shown in Figure 1.

[0042] Ingredient Name Example 11 Example 12 Example 13 Example 14 Example 15 Hypromellose 6 mPas 62.5 62.5 62.5 62.5 62.5 Potassium aluminum silicate / titanium oxide mixture (Silver Mica) 30 30 30 30 30 Polyethylene glycol 400 6.25 6.25 6.25 6.25 6.25 Brilliant Blue 11-13% 1.25 0.25 Indigocarmine 12-14% 1.25 Quinoline Yellow 18-24% 1.25 1.0 Sunset Yellow 17-19% 1.25 Total 100 100 100 100 100

[0044] As shown in Figure 1, samples 11 to 20, which formed a pearl coating with a single coating, exhibited a pearlescent effect similar to samples 6 to 10, which formed a pearl coating with two coatings. In particular, work efficiency was greatly improved, and the surface slippage and pearl shedding issues that occurred during the conventional second coating were also significantly improved when proceeding with a single coating.

Claims

Claim 1 A composition for a pearlescent film coating comprising a coating polymer, a potassium aluminum silicate / titanium oxide mixture (Silver Mica), polyethylene glycol, a pigment, and optionally talc. Claim 2 A composition for a pearlescent film coating according to claim 1, wherein the composition comprises polyvinyl alcohol, a potassium aluminum silicate / titanium oxide mixture (Silver Mica), polyethylene glycol, talc, and a pigment, and uses water as a coating solvent. Claim 3 In paragraph 2, the composition is a composition for a pearlescent film coating comprising, based on the total weight of the solvent-free powder coating composition, 30-50 wt% polyvinyl alcohol, 17-30 wt% potassium aluminum silicate / titanium oxide mixture (Silver Mica), 15-25 wt% polyethylene glycol, 10-20 wt% talc, and 0.5-5 wt% pigment. Claim 4 A composition for a pearlescent film coating according to claim 1, wherein the composition comprises hypromellose, a potassium aluminum silicate / titanium oxide mixture (Silver Mica), polyethylene glycol, and a pigment, and uses ethanol or an aqueous ethanol solution as a coating solvent. Claim 5 In claim 4, the composition is a composition for a pearlescent film coating comprising 48-75% by weight of hypromellose, 17-37% by weight of a potassium aluminum silicate / titanium oxide mixture (Silver Mica), 4-10% by weight of polyethylene glycol, and 0.5-5% by weight of a pigment, based on the total weight of the solvent-free powdered coating composition. Claim 6 A composition for a pearlescent film coating, characterized in that, in any one of claims 1 to 5, the composition forms a pearlescent film coating layer by a single coating. Claim 7 A method for coating a tablet using a film coating composition according to any one of claims 1 to 5. Claim 8 A method for coating a tablet according to claim 7, characterized in that the method does not additionally include any other coating in addition to the film coating composition according to any one of claims 1 to 5.

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