KR102265977B1 - Composition for film-coating having improved damp-proof property and tablet coated with the composition - Google Patents
Composition for film-coating having improved damp-proof property and tablet coated with the composition Download PDFInfo
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- C—CHEMISTRY; METALLURGY
- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
- C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
- C09D129/00—Coating compositions based on homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal, or ketal radical; Coating compositions based on hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Coating compositions based on derivatives of such polymers
- C09D129/02—Homopolymers or copolymers of unsaturated alcohols
- C09D129/04—Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
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- C08L33/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
- C08L33/04—Homopolymers or copolymers of esters
- C08L33/06—Homopolymers or copolymers of esters of esters containing only carbon, hydrogen and oxygen, which oxygen atoms are present only as part of the carboxyl radical
- C08L33/10—Homopolymers or copolymers of methacrylic acid esters
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- C08L39/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions of derivatives of such polymers
- C08L39/04—Homopolymers or copolymers of monomers containing heterocyclic rings having nitrogen as ring member
- C08L39/06—Homopolymers or copolymers of N-vinyl-pyrrolidones
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- C09D7/00—Features of coating compositions, not provided for in group C09D5/00; Processes for incorporating ingredients in coating compositions
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- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
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- C09D7/00—Features of coating compositions, not provided for in group C09D5/00; Processes for incorporating ingredients in coating compositions
- C09D7/40—Additives
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- C09D7/61—Additives non-macromolecular inorganic
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Abstract
본 발명은 빠른 코팅이 가능하며, 코팅된 나정(uncoated tablet)의 안정성 확보에 유리하고, 갈라짐 등의 코팅 층 외관 안정성이 개선된 필름코팅용 조성물 및 이러한 필름코팅용 조성물로 코팅된 정제에 관한 것이다. 특히, 본 발명의 필름코팅용 조성물은 흡습 방지에 더욱 효과적이다.The present invention relates to a composition for film coating capable of rapid coating, which is advantageous for securing stability of a coated tablet, and improved stability of the appearance of the coating layer such as cracking, and a tablet coated with the composition for film coating . In particular, the composition for film coating of the present invention is more effective in preventing moisture absorption.
Description
본 발명은 정제를 필름 코팅하기 위한 조성물 및 이러한 필름 코팅 조성물로 코팅된 정제에 관한 것이다. 특히, 본 발명은 빠른 속도로 코팅 가능하여 코팅에 소요되는 시간을 획기적으로 줄일 수 있으며, 코팅이 뛰어난 방습력을 갖는 필름 코팅용 조성물 및 이러한 조성물로 코팅된 정제에 관한 것이다.The present invention relates to compositions for film coating tablets and tablets coated with such film coating compositions. In particular, the present invention relates to a film coating composition and tablets coated with the composition, which can be coated at a high speed, which can dramatically reduce the time required for coating, and the coating has excellent moisture resistance.
최근 코팅제로 수용성 고분자를 이용한 수성 필름코팅이 나정을 보호하고, 안정성, 외관 등을 개선할 목적으로 종종 행해지고 있다. 이러한 필름코팅의 목적상 필름 코팅 조성물이 코팅된 정제의 안정성 확보에 바람직한 영향을 미쳐야 한다.Recently, aqueous film coating using a water-soluble polymer as a coating agent is often performed for the purpose of protecting the uncoated tablet and improving stability and appearance. For the purpose of such film coating, the film coating composition should have a desirable effect on securing the stability of the coated tablet.
한편, 코팅되는 필름이 두꺼울 경우 코팅 공정을 완료하는데 너무 많은 시간이 소요되어 비경제적이며, 이러한 코팅 공정 자체는 나정의 성상 및 안정성에 좋지 않은 영향을 미칠 수 있어 코팅 공정을 단축하는 것은 큰 경제적 가치를 가진다.On the other hand, if the film to be coated is thick, it takes too much time to complete the coating process, which is uneconomical, and this coating process itself may adversely affect the properties and stability of the uncoated tablet, so shortening the coating process is of great economic value have
특히, 수분에 불안정한 약물들이 많이 있으므로, 만약 필름 코팅이 뛰어난 방습력을 가진다면 매우 큰 장점이 된다. 그러나, 뛰어난 방습력과 코팅 속도는 종종 배치되어, 코팅 공정을 단축하면서 동시에 뛰어난 방습력을 갖도록 하는 것은 어렵다.In particular, since there are many drugs that are unstable to moisture, it is a very big advantage if the film coating has excellent moisture resistance. However, excellent moisture resistance and coating speed are often arranged, so it is difficult to shorten the coating process and at the same time have excellent moisture resistance.
따라서 본 발명이 해결하고자 하는 과제는 빠른 코팅이 가능하며, 코팅된 나정(uncoated tablet)의 안정성 확보에 유리하고, 갈라짐 등의 코팅 층 외관 안정성이 개선된 필름코팅용 조성물을 제공하는 것이다. Therefore, the problem to be solved by the present invention is to provide a composition for film coating that enables rapid coating, is advantageous in securing stability of a coated uncoated tablet, and has improved stability of the appearance of the coating layer such as cracking.
특히, 본 발명은 빠른 코팅이 가능하면서도 뛰어난 방습력을 제공할 수 있는 필름코팅용 조성물을 제공하는 것이다. In particular, the present invention is to provide a film coating composition capable of providing excellent moisture-proof ability while allowing rapid coating.
본 발명이 해결하고자 하는 추가적인 과제는 이러한 필름코팅용 조성물로 코팅된 정제를 제공하는 것이다.An additional problem to be solved by the present invention is to provide a tablet coated with such a composition for film coating.
상기 과제를 해결하기 위하여, 본 출원은 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자를 포함하고, 상기 코팅용 고분자는 폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체이며, 상기 폴리비닐피롤리돈 및 메타아크릴산공중합체의 함량은 각각 폴리비닐알콜 함량 대비 0.35 내지 0.65 중량부인 것을 특징으로 하는 필름코팅용 조성물, 바람직하게는 정제 필름코팅용 조성물을 제공한다. 바람직하게, 상기 조성물에 있어 조성물 내 폴리비닐피롤리돈 및 메타아크릴산공중합체의 함량은 각각 폴리비닐알콜 함량 대비 0.4 내지 0.6 중량부이다. 더욱 바람직하게, 코팅용 고분자로 2:0.9-1.1:0.9-1.1 (폴리비닐알콜:폴리비닐피롤리돈:메타아크릴산공중합체) 중량부로 폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체이 사용된다.In order to solve the above problems, the present application contains a polymer for coating of 35-55% by weight based on the total weight of the composition, and the polymer for coating is polyvinyl alcohol, polyvinylpyrrolidone and a methacrylic acid copolymer, and the poly The content of the vinyl pyrrolidone and the methacrylic acid copolymer is 0.35 to 0.65 parts by weight relative to the polyvinyl alcohol content, respectively. A composition for film coating, preferably a tablet film coating composition, is provided. Preferably, in the composition, the content of polyvinylpyrrolidone and methacrylic acid copolymer in the composition is 0.4 to 0.6 parts by weight relative to the content of polyvinyl alcohol, respectively. More preferably, polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer are used in parts by weight of 2:0.9-1.1:0.9-1.1 (polyvinyl alcohol: polyvinyl pyrrolidone: methacrylic acid copolymer) as the coating polymer. do.
바람직하게, 본 발명의 필름코팅용 조성물에 있어 메타아크릴산공중합체로는 메타아크릴산공중합체 타입 C, 타입 B, 타입 A 또는 이들의 혼합물이 사용될 수 있으며, 본 발명의 상기 목적상 타입 C가 가장 바람직하다.Preferably, as the methacrylic acid copolymer in the film coating composition of the present invention, methacrylic acid copolymer type C, type B, type A, or a mixture thereof may be used, and type C is most preferred for the purpose of the present invention. .
상기 코포비돈(비닐피롤리돈-비닐아세테이트 공중합체) 등 폴리비닐알콜과 유사하다고 알려진 물질들이 많이 있으나, 이들의 경우 끈적거리는 성질이 있어 본 발명의 목적상 적합하지 않았고, 또 코팅 때 온도를 너무 많이 높여서 약물의 안정성에 문제를 야기할 가능성도 있으며, 방습력도 그다지 바람직하지 못하였다. There are many substances known to be similar to polyvinyl alcohol, such as copovidone (vinylpyrrolidone-vinyl acetate copolymer), but these are not suitable for the purpose of the present invention because they have a sticky property, and the temperature during coating is too high. There is a possibility of causing a problem in the stability of the drug by increasing it a lot, and the moisture-proof ability was not very desirable.
바람직하게, 본 출원은 상기 필름코팅용 조성물에 있어 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자(폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체), 13-33 중량%의 산화티탄, 15-30 중량%의 탈크 및 0.2-8 중량%의 가소제를 포함하는, 필름코팅용 조성물을 제공한다. Preferably, in the present application, in the composition for film coating, 35-55% by weight of the coating polymer (polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer), 13-33% by weight of oxidation based on the total weight of the composition Provided is a composition for film coating comprising titanium, 15-30% by weight of talc, and 0.2-8% by weight of a plasticizer.
바람직하게, 본 출원은 상기 필름코팅용 조성물에 있어 조성물 총 중량 대비 35-55 중량%의 코팅용 고분자(폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체), 13-33 중량%의 산화티탄, 15-30 중량%의 탈크, 0.2-8 중량%의 가소제, 및 잔량(예를 들어, 0.1-8 중량%)의 기타 첨가제 (색소, 레시틴 등으로 이루어진 군으로부터 선택된 어느 하나 이상)를 포함하는, 필름코팅용 조성물을 제공한다.Preferably, in the present application, in the composition for film coating, 35-55% by weight of the coating polymer (polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer), 13-33% by weight of oxidation based on the total weight of the composition Titanium, 15-30% by weight of talc, 0.2-8% by weight of a plasticizer, and the remaining amount (eg, 0.1-8% by weight) of other additives (any one or more selected from the group consisting of pigments, lecithin, etc.) It provides a composition for film coating.
본 발명에 따른 상기 필름코팅용 조성물은 코팅 시간을 단축할 목적으로, 또 좋은 필름 코팅층이 형성되도록 하기 위해 코팅액 내 조성물의 함량을 높일 수 있다. 바람직하게, 상기 조성물은 최종 코팅액 기준으로 25-35 중량%가 되도록 코팅용매와 혼합하여 사용한다. 보다 바람직하게, 상기 조성물은 최종 코팅액 기준으로 28-32 중량%가 되도록 코팅용매와 혼합하여 사용한다. 가장 바람직하게, 상기 조성물은 최종 코팅액을 기준으로 29-31 중량%가 되도록 코팅용매와 혼합하여 사용하다. The composition for film coating according to the present invention may increase the content of the composition in the coating solution for the purpose of shortening the coating time and to form a good film coating layer. Preferably, the composition is used by mixing with the coating solvent so as to be 25-35 wt% based on the final coating solution. More preferably, the composition is used by mixing with the coating solvent so as to be 28-32 wt% based on the final coating solution. Most preferably, the composition is used by mixing with a coating solvent so as to be 29-31 wt% based on the final coating solution.
본 발명에 따른 필름코팅용 조성물은 코팅용매로 물, 바람직하게는 정제수를 사용하여 코팅액을 제조하게 되며, 이때 코팅용매와 조성물의 혼합비는 앞서 언급한 바와 같다.For the film coating composition according to the present invention, a coating solution is prepared using water, preferably purified water, as a coating solvent, and the mixing ratio of the coating solvent and the composition is as described above.
본 발명자는 다양한 연구를 수행한 결과, 상기 필름코팅 조성물을 이용하여 필름코팅 시 필름코팅 속도를 획기적으로 올릴 수 있으며, 코팅된 정제의 안정성 및 외관 유지에도 큰 개선이 있음을 확인하여 본 발명을 완성하였다. 특히, 본 발명의 필름코팅용 조성물은 흡습 방지 효과가 탁월하다.As a result of conducting various studies, the present inventors completed the present invention by confirming that the film coating speed can be dramatically increased during film coating using the film coating composition, and there is a great improvement in maintaining the stability and appearance of the coated tablet. did. In particular, the composition for film coating of the present invention is excellent in preventing moisture absorption.
바람직하게, 본 발명에 따른 필름코팅용 조성물은 상기 기타 첨가제로 필름코팅 표면을 매끄럽게 하고, 필름을 유연하게 하는 역할을 하는 레시틴을 포함한다. Preferably, the composition for film coating according to the present invention contains lecithin, which serves to smooth the surface of the film coating with the other additives and to soften the film.
선택적으로, 본 발명의 필름코팅 조성물은 백색 계열의 착색제인 산화티탄 이외에 유색의 색소를 추가로 포함할 수 있다. 이러한 착색제로는 알루미늄레이크 계열의 색소들이 사용될 수 있다. Optionally, the film coating composition of the present invention may further include a colored pigment in addition to titanium oxide, which is a white-based colorant. As such a colorant, aluminum lake-based pigments may be used.
본 발명에 따른 필름코팅용 조성물에 있어, 가소제로는 폴리에틸렌글리콜, 트리에틸시트레이트, 프로필렌글리콜 등이 사용될 수 있다.In the composition for film coating according to the present invention, polyethylene glycol, triethyl citrate, propylene glycol, and the like may be used as the plasticizer.
본 발명에 따른 필름코팅용 조성물에 있어, 상기 폴리에틸렌글리콜로는 폴리에틸렌글리콜4000, 폴리에틸렌글리콜6000 등이 바람직하며, 특히 본 발명의 여러 목적상 폴리에틸렌글리콜6000이 더욱 바람직하다. 본 발명에 따른 필름코팅용 조성물에 있어, 상기 폴리비닐알콜로는 20℃에서 4 중량% 수용액으로 점도 측정 시 그 점도가 4-6 mPas인 폴리비닐알콜이 바람직하다. 본 발명에 따른 필름코팅용 조성물에 있어, 상기 폴리비닐피롤리돈으로는 폴리비닐피롤리돈 K-15, K-17, K-25, K-30 등이 바람직하다. 본 발명에 따른 필름코팅용 조성물에 있어, 상기 히프로멜로오스로는 히프로멜로오스 2910이 바람직하며, 20℃에서 2 중량% 수용액으로 점도 측정 시 그 점도가 10-20 mPas인 히프로멜로오스가 본 발명의 여러 목적상 더욱 바람직하다.In the film coating composition according to the present invention, the polyethylene glycol is preferably polyethylene glycol 4000, polyethylene glycol 6000, and the like, and particularly, polyethylene glycol 6000 is more preferred for various purposes of the present invention. In the composition for film coating according to the present invention, the polyvinyl alcohol is preferably polyvinyl alcohol having a viscosity of 4-6 mPas when the viscosity is measured with a 4 wt% aqueous solution at 20°C. In the film coating composition according to the present invention, the polyvinylpyrrolidone is preferably polyvinylpyrrolidone K-15, K-17, K-25, K-30, or the like. In the composition for film coating according to the present invention, the hypromellose is preferably hypromellose 2910, and the hypromellose has a viscosity of 10-20 mPas when measured with a 2 wt% aqueous solution at 20°C. is more preferred for several purposes of the present invention.
본 발명은 빠른 코팅이 가능하며, 코팅된 나정(uncoated tablet)의 안정성 확보에 유리하고, 갈라짐 등의 코팅 층 외관 안정성이 개선된 필름코팅용 조성물 및 이러한 필름코팅용 조성물로 코팅된 정제를 제공한다.The present invention provides a composition for film coating capable of rapid coating, which is advantageous for securing stability of a coated tablet, and improved stability of the appearance of the coating layer such as cracking, and a tablet coated with the composition for film coating .
본 명세서에 첨부되는 다음의 도면들은 본 발명의 바람직한 실시예를 예시하는 것이며, 전술한 발명의 내용과 함께 본 발명의 기술사상을 더욱 이해시키는 역할을 하는 것이므로, 본 발명은 그러한 도면에 기재된 사항에만 한정되어 해석되어서는 아니 된다.
도 1 내지 3은 실험예 1의 샘플 A 내지 E의 안정성 평가 결과이다. 도 1은 정제의 외부 변화를 촬영한 사진들이며, 도 2는 정제의 변색 정도를 측정한 결과이고, 도 3은 정제의 갈라짐 정도를 측정한 결과이다.
도 4 내지 6은 퀵 플러스 필름코팅용 조성물의 평가 결과이다. 도 4는 이들의 외부 변화를 촬영한 사진들이며, 도 5는 정제의 변색 측정 결과이고, 도 6은 이들의 흡습 정도를 평가한 결과이다.The following drawings attached to this specification illustrate preferred embodiments of the present invention, and serve to further understand the technical spirit of the present invention together with the above-described content of the present invention, so the present invention is limited to the matters described in those drawings It should not be construed as being limited.
1 to 3 are stability evaluation results of Samples A to E of Experimental Example 1. 1 is a photograph of the external change of the tablet, FIG. 2 is a result of measuring the degree of discoloration of the tablet, and FIG. 3 is a result of measuring the degree of cracking of the tablet.
4 to 6 are evaluation results of the composition for quick plus film coating. 4 is a photograph of their external changes, FIG. 5 is a measurement result of discoloration of the tablet, and FIG. 6 is a result of evaluating their moisture absorption.
이하, 본 발명의 이해를 돕기 위하여 실시예 등을 들어 상세하게 설명하기로 한다. 그러나, 본 발명에 따른 실시예들은 여러 가지 다른 형태로 변형될 수 있으며, 본 발명의 범위가 하기 실시예들에 한정되는 것으로 해석되어서는 안 된다. 본 발명의 실시예들은 본 발명이 속한 분야에서 평균적인 지식을 가진 자에게 본 발명을 보다 완전하게 설명하기 위해 제공되는 것이다.Hereinafter, examples and the like will be described in detail to help the understanding of the present invention. However, the embodiments according to the present invention may be modified in various other forms, and the scope of the present invention should not be construed as being limited to the following examples. The embodiments of the present invention are provided to more completely explain the present invention to those of ordinary skill in the art to which the present invention pertains.
하기 언급되는 점도는 BROOKFIFLD DVE 점도계 (스핀들 RV S02, 60 rpm)로 약 1분간 점도 측정하여 나온 용액의 점도임.The viscosity mentioned below is the viscosity of the solution obtained by measuring the viscosity for about 1 minute with a BROOKFIFLD DVE viscometer (spindle RV S02, 60 rpm).
비교예 1: 탭쉴드흰색 21W002Comparative Example 1: Tab Shield White 21W002
하기 표 1의 조성 및 함량으로 필름코팅용 조성물인 비교예 1을 제조하였다.Comparative Example 1, a composition for film coating, was prepared with the composition and content of Table 1 below.
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 25 중량% 이상 넘어갈 경우 점도가 높아져 분사가 어렵고, 분사되더라도 표면이 너무 거칠어져 필름코팅에 부적절하였다. 상기 비교예 1의 적당한 코팅액 농도는 코팅액 총 중량 대비 약 20 중량%이었으며, 그 때의 점도는 약 90 cp이었다.Film coating was attempted while mixing the composition with purified water to find a suitable coating solution concentration, and when the composition exceeds 25% by weight relative to the total weight of the coating solution, the viscosity increases and spraying is difficult. did. A suitable concentration of the coating solution of Comparative Example 1 was about 20% by weight based on the total weight of the coating solution, and the viscosity at that time was about 90 cp.
상기 코팅 조성물 50 중량부와 정제수 200 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 2와 같이 코팅하였다. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 200 parts by weight of purified water, and the sample tablets were coated as shown in Table 2 below using BGB-1 as a coating machine.
Coating weight는 10 mg이었으며, Coating Weight Gain은 2%이었고, 정제 중량은 527 mg에서 코팅 후 537 mg이었다. 총 코팅 시간은 15분이었고, 평균 분무 속도는 4.8 g/min이었다. 결과적으로 상기 조성물로 10 mg을 코팅하기 위하여 약 15분이 필요하였다. The coating weight was 10 mg, the coating weight gain was 2%, and the tablet weight was 537 mg after coating from 527 mg. The total coating time was 15 minutes and the average spray rate was 4.8 g/min. As a result, it took about 15 minutes to coat 10 mg with the composition.
비교예 2: 탭쉴드주황색 22O048Comparative Example 2: Tab Shield Orange 22O048
하기 표 3의 조성 및 함량으로 필름코팅용 조성물인 비교예 2를 제조하였다. Comparative Example 2, which is a composition for film coating, was prepared with the composition and content shown in Table 3 below.
상기 코팅 조성물 15 중량부와 정제수 35 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 4와 같이 코팅하였다. A coating solution was prepared by mixing 15 parts by weight of the coating composition and 35 parts by weight of purified water, and the sample tablets were coated as shown in Table 4 below using BGB-1 as a coating machine.
Coating weight는 36 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 714 mg에서 코팅 후 750 mg이었다. 총 코팅 시간은 35분이었고, 평균 분무 속도는 7.2 g/min이었다. 결과적으로 상기 조성물로 36 mg을 코팅하기 위하여 약 35분이 필요하였다. 코팅 과정 중에 스티킹(sticking) 현상이 많이 발생하여 코팅 공정을 세팅하기가 쉽지 않으며, 상대적으로 코팅에 많은 시간이 소요되었다. The coating weight was 36 mg, the coating weight gain was 5%, and the tablet weight was 750 mg after coating from 714 mg. The total coating time was 35 minutes and the average spray rate was 7.2 g/min. As a result, it took about 35 minutes to coat 36 mg with the composition. During the coating process, a lot of sticking occurs, so it is not easy to set the coating process, and it takes a relatively long time for coating.
실시예 1: 탭쉴드주황색 71O154Example 1: Tab Shield Orange 71O154
하기 표 5의 조성 및 함량으로 필름코팅용 조성물인 실시예 1을 제조하였다. Example 1, which is a composition for film coating, was prepared with the composition and content shown in Table 5 below.
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 약 30 중량%에서 필름코팅에 적절하였다. 상기 코팅액의 점도는 약 99 cp이었다.Film coating was attempted while mixing the composition with purified water to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight based on the total weight of the coating solution. The viscosity of the coating solution was about 99 cp.
상기 코팅 조성물 50 중량부와 정제수 116 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 6과 같이 코팅하였다. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water, and the sample tablets were coated as shown in Table 6 below using BGB-1 as a coating machine.
Coating weight는 35 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 9분이었고, 평균 분무 속도는 8.0 g/min이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다. The coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 742 mg after coating from 707 mg. The total coating time was 9 minutes and the average spray rate was 8.0 g/min. As a result, it took about 9 minutes to coat 35 mg with the composition.
실시예 2: 탭쉴드주황색 71O155Example 2: Tab Shield Orange 71O155
하기 표 7의 조성 및 함량으로 필름코팅용 조성물인 실시예 2를 제조하였다.Example 2, a composition for film coating, was prepared with the composition and content shown in Table 7 below.
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 약 30 중량%에서 필름코팅에 적절하였다. 상기 코팅액의 점도는 약 120 cp이었다.Film coating was attempted while mixing the composition with purified water to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight based on the total weight of the coating solution. The viscosity of the coating solution was about 120 cp.
상기 코팅 조성물 50 중량부와 정제수 116 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 8과 같이 코팅하였다. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water, and the sample tablets were coated as shown in Table 8 using BGB-1 as a coating machine.
Coating weight는 35 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 9분이었고, 평균 분무 속도는 8.0 g/min이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다. The coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 742 mg after coating from 707 mg. The total coating time was 9 minutes and the average spray rate was 8.0 g/min. As a result, it took about 9 minutes to coat 35 mg with the composition.
실시예 3: 탭쉴드주황색 71O156Example 3: Tab Shield Orange 71O156
하기 표 9의 조성 및 함량으로 필름코팅용 조성물인 실시예 3을 제조하였다. Example 3, which is a composition for film coating, was prepared with the composition and content shown in Table 9 below.
상기 조성물을 정제수와 혼합하면서 필름코팅을 시도하여 적당한 코팅액 농도를 찾고자 하였으며, 상기 조성물은 코팅액 총 중량 대비 약 30 중량%에서 필름코팅에 적절하였다. 상기 코팅액의 점도는 약 125 cp이었다.Film coating was attempted while mixing the composition with purified water to find a suitable coating solution concentration, and the composition was suitable for film coating at about 30% by weight based on the total weight of the coating solution. The viscosity of the coating solution was about 125 cp.
상기 코팅 조성물 50 중량부와 정제수 116 중량부를 혼합하여 코팅액을 제조하였으며, 코팅기로 BGB-1을 사용하여 샘플 정제를 하기 표 9와 같이 코팅하였다. A coating solution was prepared by mixing 50 parts by weight of the coating composition and 116 parts by weight of purified water, and the sample tablets were coated as shown in Table 9 using BGB-1 as a coater.
Coating weight는 35 mg이었으며, Coating Weight Gain은 5%이었고, 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 9분이었고, 평균 분무 속도는 8.0 g/min이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다. The coating weight was 35 mg, the coating weight gain was 5%, and the tablet weight was 742 mg after coating from 707 mg. The total coating time was about 9 minutes and the average spray rate was 8.0 g/min. As a result, it took about 9 minutes to coat 35 mg with the composition.
실험예 1: 폴리비닐피롤리돈의 혼합비(중량비)에 따른 영향 평가Experimental Example 1: Evaluation of the effect of polyvinylpyrrolidone mixing ratio (weight ratio)
비교예 1 처방에서 폴리비닐알콜의 일정 부분을 폴리비닐피롤리돈으로 치환하면서 비교예 1과 동일한 방법으로 나정 필름코팅을 수행하였다. 폴리비닐피롤리돈의 치환 비율을 하기 표 11과 같았다. Comparative Example 1 Uncoated tablet film coating was performed in the same manner as in Comparative Example 1 while replacing a certain portion of polyvinyl alcohol with polyvinylpyrrolidone in the prescription. The substitution ratio of polyvinylpyrrolidone was shown in Table 11 below.
(%)solute ratio
(%)
(cp)solution viscosity
(cp)
(%)Coating amount
(%)
(비교예 1)sample A
(Comparative Example 1)
이후, 항온항습기(모델명: YHS-250SC)에서 온도 40℃, 습도 75RH의 가혹한 조건으로 보관하면서 필름코팅정의 안정성을 평가하였다. 구체적으로 보관 시작 후 1시간, 2시간, 4시간, 6시간, 8시간, 및 24시간에 정제의 변색과 갈라짐을 관찰하였다. Thereafter, the stability of the film-coated tablet was evaluated while being stored in a thermo-hygrostat (model name: YHS-250SC) at a temperature of 40° C. and a humidity of 75 RH. Specifically, discoloration and cracking of the tablets were observed at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours after the start of storage.
그 결과를 도 1 내지 3에 나타내었다. 도 1은 정제의 외부 변화를 촬영한 사진들이며, 도 2는 정제의 변색 정도를 측정한 결과이고, 도 3은 정제의 갈라짐 정도를 측정한 결과이다. The results are shown in FIGS. 1 to 3 . 1 is a photograph of the external change of the tablet, FIG. 2 is a result of measuring the degree of discoloration of the tablet, and FIG. 3 is a result of measuring the degree of cracking of the tablet.
도 1 및 도 2의 결과로부터 알 수 있는 바와 같이, 폴리비닐피롤리돈은 변색에 다소 취약한 것으로 나타났다. 다만, 특이하게도 폴리비닐알콜과 폴리비닐피롤리돈의 함량이 유사한 비율로 혼합될 경우 변색 안정성이 상대적으로 양호하였다. As can be seen from the results of FIGS. 1 and 2 , polyvinylpyrrolidone was found to be somewhat vulnerable to discoloration. However, when the content of polyvinyl alcohol and polyvinylpyrrolidone were mixed in a similar ratio, discoloration stability was relatively good.
도 1 및 도 3에 나타나는 바와 같이, 샘플 A, B, 및 C는 갈라짐이 없었으며, 폴리비닐알콜보다 폴리비닐피롤리돈의 함량이 매우 높은 샘플 D 및 E에서만 코팅 기재가 녹아 내리고 갈라지는 현상을 보였다.As shown in FIGS. 1 and 3, samples A, B, and C did not crack, and the coating substrate melted and cracked only in samples D and E, which had a very high content of polyvinylpyrrolidone than polyvinyl alcohol. seemed
실험예 2: 탭쉴드 퀵 플러스 평가Experimental Example 2: Tab Shield Quick Plus Evaluation
하기 표 12와 같이 비교예 및 실시예들을 제조하였으며, 비교평가를 위해 나정은 동일한 나정(멀티비타민 제제인 임팩타민 프리미엄 정제의 나정을 이용함)을 사용하였다. 각각의 코팅 조성물은 표 13 (1차 코팅기재) 및 14 (2차 코팅기재)에 나타내었다. 조성물을 용해 또는 미세하게 현탁시키기 위한 코팅용매로는 물을 사용하였다. Comparative Examples and Examples were prepared as shown in Table 12 below, and for the comparative evaluation, the same uncoated tablets (unripe tablets of Impactamine premium tablets, a multivitamin preparation, were used) were used. Each coating composition is shown in Tables 13 (primary coating material) and 14 (secondary coating material). Water was used as a coating solvent for dissolving or finely suspending the composition.
코팅액 총중량 대비 탭쉴드클리어(71C152)는 8.5 중량%, 탭쉴드흰색은 20 중량%, 탭 쉴드 퀵은 30 중량%, 탭쉴드 퀵 플러스는 30 중량%가 되도록 물과 혼합하여 코팅액을 제조하였다. The coating solution was prepared by mixing with water so that the tab shield clear (71C152) was 8.5 wt%, tab shield white 20 wt%, tab shield quick 30 wt%, and tab shield quick plus 30 wt% relative to the total weight of the coating solution.
(11W001)tap shield white
(11W001)
(21W002)tap shield white
(21W002)
(22W005)tap shield white
(22W005)
각각의 코팅 조건은 하기 표 15와 같았다.Each coating condition was shown in Table 15 below.
(평균)Item
(Average)
(71C152)tap shield clear
(71C152)
탭쉴드흰색
(21W002)Tab Shield White (11W001)
tap shield white
(21W002)
(22W005)tap shield white
(22W005)
탭쉴드 퀵 플러스tap shield quick
Tap Shield Quick Plus
탭쉴드클리어(71C152)의 경우 정제 중량은 700 mg에서 코팅 후 707 mg이었다. 총 코팅 시간은 약 9분이었다. 결과적으로 상기 조성물로 7 mg을 코팅하기 위하여 약 9분이 필요하였다.In the case of Tab Shield Clear (71C152), the tablet weight was 707 mg after coating at 700 mg. The total coating time was about 9 minutes. As a result, about 9 minutes were required to coat 7 mg with the composition.
탭쉴드흰색(11W001)의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 40분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 40분이 필요하였다. 탭쉴드흰색(11W001) 코팅 조성물의 경우 코팅액 중 코팅조성물 함량이 12 중량%를 넘을 경우 분무가 잘 안되고 스티킹(sticking) 현상이 발생하였으며, 방습력도 현저히 좋지 않았다. For Tab Shield White (11W001), the tablet weight was 742 mg after coating at 707 mg. The total coating time was about 40 minutes. As a result, it took about 40 minutes to coat 35 mg with the composition. In the case of the tab shield white (11W001) coating composition, when the content of the coating composition in the coating solution exceeds 12% by weight, the spraying was not good and the sticking phenomenon occurred, and the moisture-proof ability was also not very good.
탭쉴드흰색(21W002)의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 20분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 20분이 필요하였다. 탭쉴드흰색(21W002) 코팅 조성물의 경우 코팅 시 스티킹(sticking) 현상이 발생하고, 코팅 질(quality)이 떨어져 분무 속도를 더 이상 높이기 어려웠다. For Tab Shield White (21W002), the tablet weight was 742 mg after coating at 707 mg. The total coating time was about 20 minutes. As a result, it took about 20 minutes to coat 35 mg with the composition. In the case of the tab shield white (21W002) coating composition, a sticking phenomenon occurred during coating, and it was difficult to further increase the spray rate due to poor coating quality.
탭쉴드흰색(22W005)의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 40분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 20분이 필요하였다. 탭쉴드흰색(22W005) 코팅 조성물의 경우 코팅 시 스티킹(sticking) 현상이 발생하고, 코팅 질(quality)이 떨어져 분무 속도를 더 이상 높이기 어려웠다.For Tab Shield White (22W005), the tablet weight was 742 mg after coating at 707 mg. The total coating time was about 40 minutes. As a result, it took about 20 minutes to coat 35 mg with the composition. In the case of the tab shield white (22W005) coating composition, a sticking phenomenon occurred during coating, and it was difficult to further increase the spray rate due to poor coating quality.
탭쉴드 퀵 및 탭쉴드 퀵 플러스의 경우 정제 중량은 707 mg에서 코팅 후 742 mg이었다. 총 코팅 시간은 약 9분이었다. 결과적으로 상기 조성물로 35 mg을 코팅하기 위하여 약 9분이 필요하였다.For TabShield Quick and TabShield Quick Plus, tablet weights ranged from 707 mg to 742 mg after coating. The total coating time was about 9 minutes. As a result, it took about 9 minutes to coat 35 mg with the composition.
상기 비교예 및 실시예 샘플들을 항온항습기(모델명: YHS-250SC)(40℃, 75RH)에서 보관하면서, 6시간, 12시간, 24시간, 48시간, 및 72시간에 정제의 변색과 흡습을 관찰하였다. 그 결과를 도 4 내지 6에 나타내었다. While the Comparative Examples and Examples samples were stored in a thermo-hygrostat (model name: YHS-250SC) (40° C., 75 RH), discoloration and moisture absorption of the tablets were observed at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours. did. The results are shown in FIGS. 4 to 6 .
도 4 내지 6에 나타나는 바와 같이, 본 발명에 따른 필름 코팅 조성물은 빠른 시간 내에 코팅이 가능하여 코팅 공정을 획기적으로 단축할 수 있으면서도 동시에 나정을 보호하는데 있어 뛰어난 안정성을 보여주었다.As shown in FIGS. 4 to 6 , the film coating composition according to the present invention can be coated within a short time, so that the coating process can be dramatically shortened, and at the same time, it shows excellent stability in protecting the uncoated tablet.
Claims (8)
상기 코팅용 고분자는 폴리비닐알콜, 폴리비닐피롤리돈 및 메타아크릴산공중합체이며,
상기 폴리비닐피롤리돈 및 메타아크릴산공중합체의 함량은 각각 폴리비닐알콜 함량 대비 0.35 내지 0.65 중량부인 것을 특징으로 하는, 정제의 방습 필름코팅용 조성물.Contains 35-55% by weight of the polymer for coating based on the total weight of the composition,
The coating polymer is polyvinyl alcohol, polyvinylpyrrolidone and methacrylic acid copolymer,
The content of the polyvinylpyrrolidone and the methacrylic acid copolymer is each 0.35 to 0.65 parts by weight relative to the content of polyvinyl alcohol, the composition for coating a moisture-proof film of the tablet.
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JP2001278780A (en) * | 2000-03-27 | 2001-10-10 | Basf Ag | Active ingredient-containing floating dosage form containing polyvinyl acetate and polyvinylpyrrolidone |
JP2014159480A (en) * | 2011-09-30 | 2014-09-04 | Astellas Pharma Inc | Pharmaceutical composition in particle form |
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