WO2020106007A1 - Film-coated tablet having excellent moisture-proof property - Google Patents

Film-coated tablet having excellent moisture-proof property

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Publication number
WO2020106007A1
WO2020106007A1 PCT/KR2019/015824 KR2019015824W WO2020106007A1 WO 2020106007 A1 WO2020106007 A1 WO 2020106007A1 KR 2019015824 W KR2019015824 W KR 2019015824W WO 2020106007 A1 WO2020106007 A1 WO 2020106007A1
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WIPO (PCT)
Prior art keywords
film
weight
film coating
coating layer
coating
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PCT/KR2019/015824
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French (fr)
Korean (ko)
Inventor
이경호
Original Assignee
주식회사 코피텍
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Publication of WO2020106007A1 publication Critical patent/WO2020106007A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin

Definitions

  • the present invention relates to a film coating composition having a high moisture-proof ability and a film coated tablet coated with such a film coating composition.
  • the present invention relates to a film coating composition for coating uncoated tablets, which has high property stability and has high expandability after moisture absorption and / or moisture absorption, and a film coated tablet coated with such a film coating composition.
  • the tablet often absorbs the coating solvent and the shape changes frequently.
  • the problem to be solved by the present invention is to provide a moisture-proof film coating composition having a good moisture-proofing property even with a conventional coating amount, and a coating film easily coated with such a composition.
  • the present invention is (a) 50-60% by weight of hypromellose, 30-40% by weight of stearic acid, 4-13% by weight of plasticizer, polyvinyl compared to the total weight of the primary film coating layer formed on the tablet.
  • Primary film coating layer comprising 0.4-2% by weight of pyrrolidone and 0.4-2% by weight of ethyl cellulose, and (b) 40-50% by weight of polyvinyl alcohol compared to the total weight of the secondary film coating layer formed on the primary film coating layer , 20-30% by weight of titanium oxide, 15-25% by weight of talc, and a secondary film coating layer comprising 0.4-5% by weight of a plasticizer.
  • the primary and secondary coatings are used as a coating composition having the above components and content ratios, stability of the film-coated tablet, particularly moisture-proof stability, may be secured even if the components contained in the tablet have high deliquescent properties.
  • the primary film coating layer of the film-coated tablet according to the present invention uses stearic acid, polyvinylpyrrolidone and ethylcellulose to increase the moisture-proofing ability, in particular, it contains polyvinylpyrrolidone to prevent the viscosity of the coating solution from increasing and to increase the moisture-proofing ability, It is thought that the moisture content can be increased without affecting disintegration due to the proper content of ethyl cellulose, but the present invention is not limited to this theoretical mechanism.
  • the plasticizer included in the primary film coating layer is preferably at least one selected from the group consisting of propylene glycol, triethyl citrate, polyethylene glycol, and lecithin, particularly the plasticizer included in the primary film coating layer It is more preferable that it contains lecithin, and further comprises any one or more of triethyl citrate and polyethylene glycol.
  • the polyethylene glycol used as the plasticizer is preferably polyethylene glycol 4000, polyethylene glycol 6000, and the like, and particularly, for various purposes of the present invention, polyethylene glycol 6000 is more preferable.
  • hypromellose 2910 is preferred, and when measuring viscosity with a 2% by weight aqueous solution at 20 ° C, hypromellose having a viscosity of 10-20 mPas is an object of the present invention in terms of moisture resistance and coating ease. It is more preferable.
  • polyvinylpyrrolidone K-15, K-17, K-25, K-30, etc. are preferable, and in particular, K-25 is more preferable in terms of the moisture-proof purpose and the ease of coating of the present invention. Do.
  • the ethyl cellulose is preferably ethyl cellulose having a viscosity of 5-15 mPas when measuring a viscosity by preparing a 5% by weight solution using a mixed solvent of toluene and ethanol 80:20 (toluene: ethanol) by volume.
  • any one or more selected from the group consisting of propylene glycol, triethyl citrate, polyethylene glycol, and lecithin can be used, the moisture-proof purpose of the present invention, ease of coating And lecithin is preferred in terms of coating efficiency.
  • the secondary film coating layer may optionally further include a pigment of 1-10% by weight relative to the total weight of the secondary film coating layer, such as iron oxide, aluminum lake-based pigment, riboflavin, curcumin, beta Natural colors such as carotene and spirulina may be used.
  • a pigment of 1-10% by weight relative to the total weight of the secondary film coating layer such as iron oxide, aluminum lake-based pigment, riboflavin, curcumin, beta Natural colors such as carotene and spirulina may be used.
  • the primary film-coated layer is coated with 1-4% by weight compared to the uncoated weight, and the secondary film-coated layer is coated with 2-6% by weight relative to the weight of the primary film-coated tablet.
  • the film-coated tablet according to the present invention exhibits high moisture resistance and stability despite this conventional coating amount.
  • the present invention provides a film coating composition characterized in that the secondary film coating composition according to the present invention does not contain xanthan gum and a film coated tablet coated with them.
  • the film coating layer of the present invention and the film-coated tablet having such a film coating layer are more useful when the uncoated tablet contains a high deliquescent component (mainly, a drug), and these high deliquescent components include choline alfoscerate, multi Vitamins, amoxicillin and clavulanate.
  • a high deliquescent component mainly, a drug
  • the film coating of the present invention is very useful for coating with high deliquescent choline alfoscerate tablets.
  • the method of coating the coating solution on the uncoated tablet or the primary film coated tablet is not particularly limited, and a conventional method in the art of forming a coating film may be used.
  • a conventional method in the art of forming a coating film may be used.
  • dip coating or spray coating it is preferable to perform spray coating for a short period of time rather than a method such as dip coating in which the entire tablet is immersed in a solvent.
  • the present invention provides a film coating composition excellent in moisture resistance and stability, an easy coating, and a film coated tablet coated with such a film coating composition.
  • the film coating layer of the present invention is useful as a film coating for choline alfoscerate tablets.
  • Example 1 is a stability evaluation picture of Example 1 according to the present invention.
  • Example 2 is a stability evaluation picture of Example 2 according to the present invention.
  • Comparative Example 3 is a stability evaluation picture of Comparative Example 3 for comparison with the film-coated tablet of the present invention.
  • Comparative Example 4 is a stability evaluation picture of Comparative Example 4 for comparison with the film-coated tablet of the present invention.
  • Comparative Example 5 is a stability evaluation picture of Comparative Example 5 for comparison with the film-coated tablet of the present invention.
  • the first film coating prescription according to the present invention was as follows.
  • the primary film coating composition, purified water and ethanol were mixed in a weight ratio of 30: 80: 320 (composition: purified water: ethanol) to first coat choline alfoscerate tablets.
  • the coating conditions were as shown in Table 2 below, and film coating was performed so as to be 3% by weight compared to the tablet weight. The first film coating took 20 minutes.
  • the secondary film coating formulation according to the present invention was shown in Table 3 below.
  • the secondary film coating composition and purified water were mixed in a weight ratio of 50: 228 (composition: purified water) to coat the primary film-coated tablet secondary.
  • the coating conditions were as shown in Table 4 below, and the film was coated so that the weight of the primary film coating tablet was 3% by weight. The second film coating took 30 minutes.
  • Fig. 1 shows the stability test results of the first coating with the Tap Shield MT prescription and the second coating with the Tap Shield M prescription, and the first coating with the Tap Shield MP prescription and the second coating with the Tap Shield M prescription.
  • the stability test results are shown in Fig. 2, respectively.
  • the results of the change in moisture content with a commercially available choline alfoscerate coated tablet (trade name: Gliatamin tablet) are shown in Table 5 below. Stability test was carried out in 40 °C, 75% RH, open dish conditions.
  • the choline alfoscerate film coated tablet according to the present invention was stable for more than 40 days even under the open condition of 40 ° C and 75% RH, and was much more stable than the existing product in the evaluation of moisture.
  • the prescription of the tap shield M-P using polyethylene glycol was more stable than the tap shield M-T using triethyl citrate.
  • a choline alfoscerate film coated tablet in the same manner as the above embodiments of the present invention, except that the composition of Table 6 below was used as a secondary film coating prescription.
  • a tap shield M-T Comparative Example 1
  • a tap shield M-P Comparative Example 2
  • Example 2 It was coated in a similar manner to Example 1, except that the coating according to Table 7 below.
  • the same choline alfoscerate tablets used in Example 1 were used and coated in the same amount.
  • Comparative Example 3 The stability results of Comparative Example 3 are shown in FIG. 3. As shown in Fig. 3, after 24 hours, tablets were broken because the tablets absorbed a lot of moisture.
  • Example 2 With the prescription of Table 8, the same choline alfoscerate tablets as in Example 1 were coated. The coating amount was 6% by weight relative to the tablet weight.
  • Raw material name 200F620010 Polyvinyl alcohol 35.00 Talc 23.88 Titanium oxide 16.46 Polyethylene glycol 3350 12.00 Yellow iron oxide 8.50 Methacrylic acid copolymer TPYE C 4.00 Sodium hydrogen carbonate 0.12 Black iron oxide 0.03 Red iron oxide 0.01 Sum 100
  • Comparative Example 4 The stability results of Comparative Example 4 are shown in FIG. 4. As shown in Fig. 4, after 24 hours, tablets were broken because the tablets absorbed a lot of moisture.
  • Comparative Example 5 The stability results of Comparative Example 5 are shown in FIG. 5. As shown in FIG. 5, after 3 days elapsed when the tap shield M-T was coated alone, the color of choline alfoscerate was cut out and the color changed to black.
  • the tablet expands after 7 days when stability is evaluated under the same conditions, and the coating film is broken.
  • Disintegration and dissolution properties of Examples 1 and 2 according to the present invention were evaluated. Disintegration properties were evaluated according to the Korean Pharmacopoeia disintegration test method, and dissolution properties were evaluated according to an existing choline alfoscerate tablet evaluation method.
  • the film coating according to the present invention does not affect disintegration and dissolution of the tablet.

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  • Inorganic Chemistry (AREA)
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Abstract

Provided in the present invention is a film-coated tablet having an excellent moisture-proof property and being easily coated. Particularly, the present invention is useful for film-coating of an ingredient having low stability due to high deliquescence, such as choline alfoscerate.

Description

높은 방습성을 가지는 필름코팅정Film coated tablets with high moisture resistance
본 발명은 높은 방습능을 가지는 필름코팅 조성물 및 이러한 필름코팅 조성물로 코팅된 필름코팅정에 관한 것이다. 특히, 나정의 조해성 및/또는 흡습 후 팽창성이 높아 성상 안정성이 문제되는 나정을 코팅하기 위한 필름코팅 조성물 및 이러한 필름코팅 조성물로 코팅된 필름코팅정에 관한 것이다.The present invention relates to a film coating composition having a high moisture-proof ability and a film coated tablet coated with such a film coating composition. In particular, the present invention relates to a film coating composition for coating uncoated tablets, which has high property stability and has high expandability after moisture absorption and / or moisture absorption, and a film coated tablet coated with such a film coating composition.
콜린알포세레이트와 같은, 조해성 및/또는 흡습 후 팽창성이 큰 약물들의 경우 보관 중 주변의 수분을 흡수해 성상이 파괴되는 문제점이 있다. In the case of drugs that are highly decomposable after deliquescent and / or hygroscopic, such as choline alfoscerate, there is a problem in that properties are destroyed by absorbing surrounding moisture during storage.
이러한 문제점을 해결하기 위하여 방습 코팅을 하는 것이 일반적이나, 코팅 후에도 완벽히 방습성이 확보되기 어렵다. 방습성을 높이기 위해 많은 양을 코팅할 경우 정제의 붕해 및 용출에 좋지 않은 영향을 미칠 뿐만 아니라, 제조에 오랜 시간이 걸려 제조단가가 상승한다는 문제가 있다. 따라서 통상적인 코팅량으로 좋은 방습성을 확보하는 것이 바람직하다. In order to solve this problem, it is common to apply a moisture-proof coating, but it is difficult to secure a completely moisture-proof after coating. When a large amount is coated to increase moisture resistance, it not only has a bad effect on disintegration and dissolution of tablets, but also takes a long time to manufacture, which increases the manufacturing cost. Therefore, it is desirable to secure good moisture resistance with a conventional coating amount.
또한 코팅 과정 중에도 나정이 코팅용매를 흡수하여 모양이 변하는 문제가 종종 생긴다. Also, during the coating process, the tablet often absorbs the coating solvent and the shape changes frequently.
따라서 본 발명이 해결하고자 하는 과제는 통상적인 코팅량으로도 좋은 방습성을 가지며, 코팅이 용이한 방습 필름코팅용 조성물 및 이러한 조성물로 코팅된 필름코팅정을 제공하는 것이다.Therefore, the problem to be solved by the present invention is to provide a moisture-proof film coating composition having a good moisture-proofing property even with a conventional coating amount, and a coating film easily coated with such a composition.
상기 과제를 해결하기 위하여, 본 발명은 (a) 나정 위에 형성된, 1차 필름코팅층 총 중량 대비 히프로멜로오스 50-60 중량%, 스테아린산 30-40 중량%, 가소제 4-13 중량%, 폴리비닐피롤리돈 0.4-2 중량% 및 에틸셀룰로오스 0.4-2 중량%를 포함하는 1차 필름코팅층, 및 (b) 1차 필름코팅층 위에 형성된, 2차 필름코팅층 총 중량 대비 폴리비닐알코올 40-50 중량%, 산화티탄 20-30 중량%, 탈크 15-25 중량%, 및 가소제 0.4-5 중량을 포함하는 2차 필름코팅층을 포함하는, 필름코팅정을 제공한다.In order to solve the above problems, the present invention is (a) 50-60% by weight of hypromellose, 30-40% by weight of stearic acid, 4-13% by weight of plasticizer, polyvinyl compared to the total weight of the primary film coating layer formed on the tablet. Primary film coating layer comprising 0.4-2% by weight of pyrrolidone and 0.4-2% by weight of ethyl cellulose, and (b) 40-50% by weight of polyvinyl alcohol compared to the total weight of the secondary film coating layer formed on the primary film coating layer , 20-30% by weight of titanium oxide, 15-25% by weight of talc, and a secondary film coating layer comprising 0.4-5% by weight of a plasticizer.
상기와 같은 성분 및 함량비를 가진 코팅용 조성물로 1차 및 2차 코팅 시, 나정에 포함된 성분들이 높은 조해성을 가지더라도 필름코팅정의 안정성, 특히 방습 안정성이 확보될 수 있다. When the primary and secondary coatings are used as a coating composition having the above components and content ratios, stability of the film-coated tablet, particularly moisture-proof stability, may be secured even if the components contained in the tablet have high deliquescent properties.
본 발명에 따른 필름코팅정의 1차 필름코팅층은 스테아린산, 폴리비닐피롤리돈 및 에틸셀룰로오스를 사용하여 방습력을 높이며, 특히 폴리비닐피롤리돈을 함유하여 코팅액의 점도 높아지는 것을 막으며 방습력 높이고, 에틸셀룰로오스가 적정량 함유됨으로 인해 붕해 영향을 주지 않고 방습력 높일 수 있다고 생각되나, 본 발명은 이러한 이론적 기전에 한정되는 것은 아니다. The primary film coating layer of the film-coated tablet according to the present invention uses stearic acid, polyvinylpyrrolidone and ethylcellulose to increase the moisture-proofing ability, in particular, it contains polyvinylpyrrolidone to prevent the viscosity of the coating solution from increasing and to increase the moisture-proofing ability, It is thought that the moisture content can be increased without affecting disintegration due to the proper content of ethyl cellulose, but the present invention is not limited to this theoretical mechanism.
본 발명에 다른, 상기 1차 필름코팅층에 포함된 가소제는 프로필렌글리콜, 트리에틸시트레이트, 폴리에틸렌글리콜, 및 레시틴으로 이루어진 군으로부터 선택된 어느 하나 이상이 바람직하며, 특히 상기 1차 필름코팅층에 포함된 가소제는 레시틴를 포함하고, 트리에틸시트레이트 및 폴리에틸렌글리콜 중 어느 하나 이상을 더 포함하는 것이 더욱 바람직하다. In accordance with the present invention, the plasticizer included in the primary film coating layer is preferably at least one selected from the group consisting of propylene glycol, triethyl citrate, polyethylene glycol, and lecithin, particularly the plasticizer included in the primary film coating layer It is more preferable that it contains lecithin, and further comprises any one or more of triethyl citrate and polyethylene glycol.
상기 가소제로 사용되는 폴리에틸렌글리콜로는 폴리에틸렌글리콜4000, 폴리에틸렌글리콜6000 등이 바람직하며, 특히 본 발명의 여러 목적상 폴리에틸렌글리콜6000이 더욱 바람직하다.The polyethylene glycol used as the plasticizer is preferably polyethylene glycol 4000, polyethylene glycol 6000, and the like, and particularly, for various purposes of the present invention, polyethylene glycol 6000 is more preferable.
상기 히프로멜로오스로는 히프로멜로오스 2910이 바람직하며, 20℃에서 2 중량% 수용액으로 점도 측정 시 그 점도가 10-20 mPas인 히프로멜로오스가 본 발명의 목적인 방습성 및 코팅 용이성 측면에서 더욱 바람직하다.As the hypromellose, hypromellose 2910 is preferred, and when measuring viscosity with a 2% by weight aqueous solution at 20 ° C, hypromellose having a viscosity of 10-20 mPas is an object of the present invention in terms of moisture resistance and coating ease. It is more preferable.
상기 폴리비닐피롤리돈으로는 폴리비닐피롤리돈 K-15, K-17, K-25, K-30 등이 바람직하며, 특히 본 발명의 방습 목적 및 코팅 용이성 측면에서 K-25가 더욱 바람직하다.As the polyvinylpyrrolidone, polyvinylpyrrolidone K-15, K-17, K-25, K-30, etc. are preferable, and in particular, K-25 is more preferable in terms of the moisture-proof purpose and the ease of coating of the present invention. Do.
상기 에틸셀룰로오스는 톨루엔과 에탄올 80:20 (톨루엔:에탄올) 부피비 혼합용매를 이용하여, 5 중량% 용액을 제조하여 점도 측정 시 그 점도가 5-15 mPas인 에틸셀룰로오스가 바람직하다. The ethyl cellulose is preferably ethyl cellulose having a viscosity of 5-15 mPas when measuring a viscosity by preparing a 5% by weight solution using a mixed solvent of toluene and ethanol 80:20 (toluene: ethanol) by volume.
본 발명에 따른, 상기 2차 필름코팅층에 포함된 가소제로는 프로필렌글리콜, 트리에틸시트레이트, 폴리에틸렌글리콜, 및 레시틴으로 이루어진 군으로부터 선택된 어느 하나 이상이 사용될 수 있으며, 본 발명의 방습 목적, 코팅 용이성 및 코팅 효율 측면에서 레시틴이 바람직하다. According to the present invention, as the plasticizer included in the secondary film coating layer, any one or more selected from the group consisting of propylene glycol, triethyl citrate, polyethylene glycol, and lecithin can be used, the moisture-proof purpose of the present invention, ease of coating And lecithin is preferred in terms of coating efficiency.
본 발명에 따른, 상기 2차 필름코팅층은 선택적으로 2차 필름코팅층 총 중량 대비 1-10 중량%의 색소를 더 포함할 수 있으며, 이러한 색소로는 산화철, 알루미늄레이크계 색소, 리보플라빈, 커큐민, 베타카로틴, 스피루리나 등의 천연색소 등이 사용될 수 있다. According to the present invention, the secondary film coating layer may optionally further include a pigment of 1-10% by weight relative to the total weight of the secondary film coating layer, such as iron oxide, aluminum lake-based pigment, riboflavin, curcumin, beta Natural colors such as carotene and spirulina may be used.
본 발명에 따른 필름코팅정에 있어, 바람직하게, 상기 1차 필름코팅층은 나정 중량 대비 1-4 중량% 코팅되고, 2차 필름코팅층은 1차 필름코팅정 중량 대비 2-6 중량% 코팅된다. 본 발명에 따른 필름코팅정은 이러한 통상적인 코팅량에도 불구하고 높은 방습성 및 안정성을 나타낸다. In the film-coated tablet according to the present invention, preferably, the primary film-coated layer is coated with 1-4% by weight compared to the uncoated weight, and the secondary film-coated layer is coated with 2-6% by weight relative to the weight of the primary film-coated tablet. The film-coated tablet according to the present invention exhibits high moisture resistance and stability despite this conventional coating amount.
또한, 본 발명은 본 발명에 따른 상기 2차 필름코팅 조성물이 잔탄검을 포함하지 않는 것을 특징으로 하는 필름코팅 조성물 및 이들로 코팅된 필름코팅정을 제공한다.In addition, the present invention provides a film coating composition characterized in that the secondary film coating composition according to the present invention does not contain xanthan gum and a film coated tablet coated with them.
본 발명의 필름코팅층 및 이러한 필름코팅층을 가진 필름코팅정은 나정(uncoated tablet)이 조해성이 높은 성분(주로, 약물)을 포함하는 경우 더욱 유용하며, 이러한 조해성이 높은 성분으로는 콜린알포세레이트, 멀티비타민, 아목시실린과 클라뷸란산칼륨의 복합제 등이 있다. The film coating layer of the present invention and the film-coated tablet having such a film coating layer are more useful when the uncoated tablet contains a high deliquescent component (mainly, a drug), and these high deliquescent components include choline alfoscerate, multi Vitamins, amoxicillin and clavulanate.
특히 후술하는 실시예들에 나타나는 바와 같이, 본 발명의 필름코팅은 조해성이 높은 콜린알포세레이트 나정의 코팅에 매우 유용하다. In particular, as shown in the examples described below, the film coating of the present invention is very useful for coating with high deliquescent choline alfoscerate tablets.
나정 또는 1차 필름코팅정 상에 코팅액을 코팅하는 방법은, 특별히 제한되지 아니하고, 코팅막을 형성하는 당해 기술분야의 통상적인 방법을 사용할 수 있다. 예를 들어, 딥코팅이나 스프레이 코팅 등을 들 수 있다. 다만, 코팅막의 균일성 및 콜린알포세레이트의 조해성 문제를 해결하는 측면에서, 용매에 나정 전체를 담그는 딥코팅 등의 방법보다는 짧은 시간 동안 스프레이 코팅을 시행하는 것이 바람직하다.The method of coating the coating solution on the uncoated tablet or the primary film coated tablet is not particularly limited, and a conventional method in the art of forming a coating film may be used. For example, dip coating or spray coating. However, in view of solving the problem of uniformity of coating film and deliquescent property of choline alfoscerate, it is preferable to perform spray coating for a short period of time rather than a method such as dip coating in which the entire tablet is immersed in a solvent.
본 발명은 방습성 및 안정성이 뛰어나고, 코팅이 용이한 필름코팅 조성물 및 이러한 필름코팅 조성물로 코팅된 필름코팅정을 제공한다. 특히, 본 발명의 필름코팅층은 콜린알포세레이트 정제의 필름코팅으로 유용하다.The present invention provides a film coating composition excellent in moisture resistance and stability, an easy coating, and a film coated tablet coated with such a film coating composition. In particular, the film coating layer of the present invention is useful as a film coating for choline alfoscerate tablets.
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.The following drawings attached to this specification are intended to illustrate preferred embodiments of the present invention, and serve to further understand the technical idea of the present invention together with the contents of the above-described invention, so the present invention is limited to those described in those drawings. It should not be construed as limited.
도 1은 본 발명에 따른 실시예 1의 안정성 평가 사진이다.1 is a stability evaluation picture of Example 1 according to the present invention.
도 2는 본 발명에 따른 실시예 2의 안정성 평가 사진이다.2 is a stability evaluation picture of Example 2 according to the present invention.
도 3은 본 발명의 필름코팅정과 비교하기 위한, 비교예 3의 안정성 평가 사진이다. 3 is a stability evaluation picture of Comparative Example 3 for comparison with the film-coated tablet of the present invention.
도 4는 본 발명의 필름코팅정과 비교하기 위한, 비교예 4의 안정성 평가 사진이다.4 is a stability evaluation picture of Comparative Example 4 for comparison with the film-coated tablet of the present invention.
도 5는 본 발명의 필름코팅정과 비교하기 위한, 비교예 5의 안정성 평가 사진이다.5 is a stability evaluation picture of Comparative Example 5 for comparison with the film-coated tablet of the present invention.
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 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 interpreted as being limited to the following examples. The embodiments of the present invention are provided to more fully explain the present invention to those skilled in the art to which the present invention pertains.
실시예 1 및 2Examples 1 and 2
본 발명에 따른 1차 필름코팅 처방은 다음과 같았다. The first film coating prescription according to the present invention was as follows.
원료명Raw material name 탭쉴드M-TTap Shield M-T 원료명Raw material name 탭쉴드M-PTap Shield M-P
히프로멜로오스2910 15mPasHypromellose 2910 15 mPas 54.554.5 히프로멜로오스2910 15mPasHypromellose 2910 15 mPas 54.554.5
스테아르산Stearic acid 35.035.0 스테아르산Stearic acid 35.035.0
트리에틸시트레이트Triethyl citrate 5.05.0 폴리에틸렌글리콜6000Polyethylene glycol 6000 5.05.0
레시틴lecithin 3.53.5 레시틴lecithin 3.53.5
폴리비닐피롤리돈 K-25Polyvinylpyrrolidone K-25 1.01.0 폴리비닐피롤리돈 K-25Polyvinylpyrrolidone K-25 1.01.0
에틸셀룰로오스 10mPasEthyl cellulose 10 mPas 1.01.0 에틸셀룰로오스 10mPasEthyl cellulose 10 mPas 1.01.0
합계Sum 100100 합계Sum 10001000
상기 1차 필름코팅 조성물, 정제수 및 에탄올을 30 : 80 : 320 (조성물 : 정제수 : 에탄올)의 중량비로 혼합하여 콜린알포세레이트 나정을 1차 코팅하였다. 코팅 조건은 하기 표 2와 같았으며, 나정 중량 대비 3 중량%가 되도록 필름코팅 하였다. 1차 필름코팅에 20분이 소요되었다.The primary film coating composition, purified water and ethanol were mixed in a weight ratio of 30: 80: 320 (composition: purified water: ethanol) to first coat choline alfoscerate tablets. The coating conditions were as shown in Table 2 below, and film coating was performed so as to be 3% by weight compared to the tablet weight. The first film coating took 20 minutes.
항목 (평균)Items (average) 1차 필름코팅 조건Primary film coating conditions
Inlet temperatureInlet temperature 약 75℃About 75 ℃
Exhaust temperatureExhaust temperature 약 40℃About 40 ℃
Spray rateSpray rate 약 10.6 g/minAbout 10.6 g / min
Pump SpeedPump Speed 약 11.2 rpmAbout 11.2 rpm
Pan speedPan speed 약 16 rpmAbout 16 rpm
Atomizing air pressureAtomizing air pressure 약 0.4 barAbout 0.4 bar
Pattern Air pressurePattern Air pressure 약 0.4 barAbout 0.4 bar
Air flowAir flow 약 180 m 3/hrAbout 180 m 3 / hr
Coating weightCoating weight 24 mg (813 mg에서 837 mg으로 증량)24 mg (increase from 813 mg to 837 mg)
Coating Weight GainCoating Weight Gain 3 중량%3% by weight
본 발명에 따른 2차 필름코팅 처방은 하기 표 3과 같았다. The secondary film coating formulation according to the present invention was shown in Table 3 below.
원료명Raw material name 탭쉴드MTap Shield M
폴리비닐알콜Polyvinyl alcohol 45.5245.52
산화티탄Titanium oxide 25.5025.50
탈크Talc 20.4820.48
황색산화철Yellow iron oxide 6.506.50
레시틴lecithin 2.002.00
합계Sum 100100
상기 2차 필름코팅 조성물 및 정제수를 50 : 228 (조성물 : 정제수)의 중량비로 혼합하여 상기 1차 필름코팅정을 2차로 코팅하였다. 코팅 조건은 하기 표 4와 같았으며, 1차 필름코팅정 중량 대비 3 중량%가 되도록 필름코팅 하였다. 2차 필름코팅에 30분이 소요되었다.The secondary film coating composition and purified water were mixed in a weight ratio of 50: 228 (composition: purified water) to coat the primary film-coated tablet secondary. The coating conditions were as shown in Table 4 below, and the film was coated so that the weight of the primary film coating tablet was 3% by weight. The second film coating took 30 minutes.
항목 (평균)Items (average) 2차 필름코팅 조건Second film coating conditions
Inlet temperatureInlet temperature 약 82℃About 82 ℃
Exhaust temperatureExhaust temperature 약 42℃About 42 ℃
Spray rateSpray rate 약 4.5 g/minAbout 4.5 g / min
Pump SpeedPump Speed 약 5.0 rpmAbout 5.0 rpm
Pan speedPan speed 약 17 rpmAbout 17 rpm
Atomizing air pressureAtomizing air pressure 약 1 barAbout 1 bar
Pattern Air pressurePattern Air pressure 약 1 barAbout 1 bar
Air flowAir flow 약 180 m 3/hrAbout 180 m 3 / hr
Coating weightCoating weight 24 mg (837 mg에서 861 mg으로 증량)24 mg (increase from 837 mg to 861 mg)
Coating Weight GainCoating Weight Gain 3 중량%3% by weight
탭쉴드 M-T 처방으로 1차 코팅 후 탭쉴드 M 처방으로 2차 코팅한 필름코팅정의 안정성 실험결과를 도 1에, 탭쉴드 M-P 처방으로 1차 코팅 후 탭쉴드 M 처방으로 2차 코팅한 필름코팅정의 안정성 실험결과를 도 2에 각각 나타내었다. 또한 시판 중인 콜린알포세레이트 코팅정 (상품명: 글리아타민정)과의 함습도 변화 결과를 하기 표 5에 나타내었다. 안정성 시험은 40℃, 75%RH, open dish 조건으로 수행하였다.Fig. 1 shows the stability test results of the first coating with the Tap Shield MT prescription and the second coating with the Tap Shield M prescription, and the first coating with the Tap Shield MP prescription and the second coating with the Tap Shield M prescription. The stability test results are shown in Fig. 2, respectively. In addition, the results of the change in moisture content with a commercially available choline alfoscerate coated tablet (trade name: Gliatamin tablet) are shown in Table 5 below. Stability test was carried out in 40 ℃, 75% RH, open dish conditions.
함습도(%)Moisture humidity (%) 00 55 1010 1515 2020
탭쉴드 M-T 코팅 후 탭쉴드 M 코팅After tap shield M-T coating, tap shield M coating 0.00%0.00% 8.95%8.95% 13.28%13.28% 14.90%14.90% 16.42%16.42%
탭쉴드 M-P 코팅 후 탭쉴드 M 코팅After tap shield M-P coating, tap shield M coating 0.00%0.00% 7.78%7.78% 12.07%12.07% 13.76%13.76% 15.47%15.47%
글리아타민정Gliatamin Tablet 0.00%0.00% 11.95%11.95% 15.25%15.25% 16.34%16.34% 17.43%17.43%
상기 결과들에 나타나는 바와 같이, 본 발명에 따른 콜린알포세레이트 필름코팅정은 40℃, 75%RH의 개방 조건에서도 40일 이상 안정하였으며, 함습도 평가에서도 기존 제품 대비 훨씬 뛰어나게 안정하였다.As shown in the above results, the choline alfoscerate film coated tablet according to the present invention was stable for more than 40 days even under the open condition of 40 ° C and 75% RH, and was much more stable than the existing product in the evaluation of moisture.
함습도 평가에 있어서, 트리에틸시트레이트를 사용한 탭쉴드 M-T보다는 폴리에틸렌글리콜을 사용한 탭쉴드 M-P 처방이 더 안정하였다. In evaluating moisture content, the prescription of the tap shield M-P using polyethylene glycol was more stable than the tap shield M-T using triethyl citrate.
비교예 1 및 2Comparative Examples 1 and 2
2차 필름코팅 처방으로 하기 표 6의 조성물을 사용한 것을 제외하고는 상기 본 발명 실시예들과 동일한 방법으로 콜린알포세레이트 필름코팅정을 제조하고자 하였다. 1차 필름코팅 처방으로는 탭쉴드 M-T (비교예 1) 및 탭쉴드 M-P (비교예 2)를 각각 사용하였다.It was intended to prepare a choline alfoscerate film coated tablet in the same manner as the above embodiments of the present invention, except that the composition of Table 6 below was used as a secondary film coating prescription. As a primary film coating prescription, a tap shield M-T (Comparative Example 1) and a tap shield M-P (Comparative Example 2) were used, respectively.
원료명Raw material name 비교예 1 및 2Comparative Examples 1 and 2
폴리비닐알콜Polyvinyl alcohol 45.5245.52
산화티탄Titanium oxide 25.5025.50
탈크Talc 20.0020.00
황색산화철Yellow iron oxide 6.506.50
레시틴lecithin 2.002.00
잔탄검Xanthan gum 0.480.48
합계Sum 100100
비교예 1 및 2의 필름코팅정 또한 안정성은 어느 정도 확보되었다. 그러나, 본 발명 코팅 조성물과 동일한 조건으로 필름코팅 시 정제 간 스티킹이 너무 심하게 발생하여 기존 코팅조건보다 높은 온도와 적은 양의 분사로 코팅시간이 많이 걸렸고, 결과적으로 대량 생산에는 부적합하였다. The stability of the film-coated tablets of Comparative Examples 1 and 2 was also secured to some extent. However, sticking between tablets occurred too severely during film coating under the same conditions as the coating composition of the present invention, which took a lot of coating time with a higher temperature and less spray than the existing coating conditions, and as a result, was unsuitable for mass production.
비교예 3Comparative Example 3
하기 표 7에 따라 코팅한 것을 제외하고는 상기 실시예 1과 유사한 방법으로 코팅하였다. 실시예 1과 동일한 콜린알포세레이트 나정을 사용하였으며, 동일한 양으로 코팅하였다.It was coated in a similar manner to Example 1, except that the coating according to Table 7 below. The same choline alfoscerate tablets used in Example 1 were used and coated in the same amount.
원료명Raw material name 1차 필름코팅1st film coating
히프로멜로오스2910 6mPasHypromellose2910 6mPas 9090
폴리에틸렌글리콜3350Polyethylene glycol 3350 55
탈크Talc 33
에틸셀룰로오스 10mPasEthyl cellulose 10 mPas 1One
폴리비닐피롤리돈 K-30Polyvinylpyrrolidone K-30 1One
합계Sum 100100
원료명Raw material name 2차 필름코팅2nd film coating
폴리비닐알콜Polyvinyl alcohol 45.5245.52
산화티탄Titanium oxide 25.5025.50
탈크Talc 20.0020.00
황색산화철Yellow iron oxide 6.506.50
레시틴lecithin 2.002.00
잔탄검Xanthan gum 0.480.48
합계Sum 100100
비교예 3의 안정성 결과를 도 3에 나타내었다. 도 3에 나타나는 바와 같이, 24시간 경과 후에 나정이 수분을 많이 흡수하여 정제가 깨졌다. The stability results of Comparative Example 3 are shown in FIG. 3. As shown in Fig. 3, after 24 hours, tablets were broken because the tablets absorbed a lot of moisture.
비교예 4Comparative Example 4
하기 표 8의 처방으로, 실시예 1과 동일한 콜린알포세레이트 나정을 코팅하였다. 코팅량은 나정 중량 대비 6 중량%이었다. With the prescription of Table 8, the same choline alfoscerate tablets as in Example 1 were coated. The coating amount was 6% by weight relative to the tablet weight.
원료명Raw material name 200F620010200F620010
폴리비닐알콜Polyvinyl alcohol 35.0035.00
탈크Talc 23.8823.88
산화티탄Titanium oxide 16.4616.46
폴리에틸렌글리콜3350Polyethylene glycol 3350 12.0012.00
황색산화철Yellow iron oxide 8.508.50
메타아크릴산공중합체 TPYE CMethacrylic acid copolymer TPYE C 4.004.00
탄산수소나트륨Sodium hydrogen carbonate 0.120.12
흑색산화철Black iron oxide 0.030.03
적색산화철Red iron oxide 0.010.01
합계Sum 100100
비교예 4의 안정성 결과를 도 4에 나타내었다. 도 4에 나타나는 바와 같이, 24시간 경과 후에 나정이 수분을 많이 흡수하여 정제가 깨졌다. The stability results of Comparative Example 4 are shown in FIG. 4. As shown in Fig. 4, after 24 hours, tablets were broken because the tablets absorbed a lot of moisture.
비교예 5Comparative Example 5
상기 실시예 1의 탭쉴드 M-T로 1차 필름코팅만 수행하고, 2차 필름코팅은 수행하지 않았다. Only the first film coating was performed with the tap shield M-T of Example 1, and the second film coating was not performed.
비교예 5의 안정성 결과를 도 5에 나타내었다. 도 5에 나타나는 바와 같이, 탭쉴드 M-T 단독 코팅 시 3일 경과 후에, 콜린알포세레이트 성분이 베어 나와 색상이 까맣게 변하였다. The stability results of Comparative Example 5 are shown in FIG. 5. As shown in FIG. 5, after 3 days elapsed when the tap shield M-T was coated alone, the color of choline alfoscerate was cut out and the color changed to black.
비교예 6Comparative Example 6
시중에 유통 중인 콜린알포세레이트 코팅정 (제품명: 글리아타민정)을 동일한 방법으로 안정성 평가하였으며, 그 결과를 도 6에 나타내었다. The commercially available choline alfoscerate coated tablets (product name: gliaamine tablets) were evaluated for stability in the same way, and the results are shown in FIG. 6.
도 6에 나타나는 바와 같이, 동일한 조건에서 안정성 평가 시 7일 경과 후에 정제가 팽창하여 코팅막이 깨졌다. As shown in FIG. 6, the tablet expands after 7 days when stability is evaluated under the same conditions, and the coating film is broken.
붕해성 및 용출성의 평가Evaluation of disintegration and dissolution properties
본 발명에 따른 실시예 1 및 2의 붕해성 및 용출성을 평가하였다. 붕해성은 대한약전 붕해시험법에 따라 평가하였으며, 용출성은 기존 콜린알포세레이트 정제 평가 방법에 따라 평가하였다.Disintegration and dissolution properties of Examples 1 and 2 according to the present invention were evaluated. Disintegration properties were evaluated according to the Korean Pharmacopoeia disintegration test method, and dissolution properties were evaluated according to an existing choline alfoscerate tablet evaluation method.
시중에 유통 중인 콜린알포세레이트 코팅정 (제품명: 글리아타민정)의 경우 11~13분에 붕해되었으며, 본 발명에 따른 실시예들의 경우 11~12.5분에 붕해되어 붕해성에는 양자에 큰 차이가 없었다. 한편, 글리아타민정의 경우 15분에 75% 이상, 30분 85% 이상 용출되었으며, 본 발명에 따른 실시예들 또한 동일한 결과를 나타내어 양자가 용출에 있어서도 동일한 양상을 나타내었다.In the case of a commercially available choline alfoscerate coated tablet (product name: Gliatamin tablet), it disintegrated in 11 to 13 minutes, and in the case of the examples according to the present invention, it disintegrated in 11 to 12.5 minutes, and the disintegration property had a large difference in both. There was not. On the other hand, in case of gliatamin tablet, it eluted at least 75% at 15 minutes and at least 85% at 30 minutes, and the examples according to the present invention also showed the same results, and both exhibited the same pattern in elution.
이러한 결과들로부터, 본 발명에 따른 필름코팅은 정제의 붕해와 용출에 영향을 미치지 않음을 확인할 수 있었다. From these results, it was confirmed that the film coating according to the present invention does not affect disintegration and dissolution of the tablet.

Claims (9)

  1. 나정 위에 형성된, 1차 필름코팅층 총 중량 대비 히프로멜로오스 50-60 중량%, 스테아린산 30-40 중량%, 가소제 4-13 중량%, 폴리비닐피롤리돈 0.4-2 중량% 및 에틸셀룰로오스 0.4-2 중량%를 포함하는 1차 필름코팅층, 및50-60% by weight of hypromellose, 30-40% by weight of stearic acid, 4-13% by weight of plasticizer, 0.4-2% by weight of polyvinylpyrrolidone and 0.4% by weight of ethylcellulose, formed on the total weight of the primary film coating layer on the tablet. Primary film coating layer comprising 2% by weight, and
    1차 필름코팅층 위에 형성된, 2차 필름코팅층 총 중량 대비 폴리비닐알코올 40-50 중량%, 산화티탄 20-30 중량%, 탈크 15-25 중량%, 및 가소제 0.4-5 중량을 포함하는 2차 필름코팅층을 포함하는, 필름코팅정.Secondary film formed on the primary film coating layer, 40-50% by weight of polyvinyl alcohol, 20-30% by weight of titanium oxide, 15-25% by weight of talc, and 0.4-5% of plasticizer by total weight of the secondary film coating layer A film-coated tablet comprising a coating layer.
  2. 제1항에 있어서, 상기 1차 필름코팅층에 포함된 가소제는 트리에틸시트레이트, 폴리에틸렌글리콜, 및 레시틴으로 이루어진 군으로부터 선택된 어느 하나 이상인, 필름코팅정.The film-coated tablet of claim 1, wherein the plasticizer included in the primary film coating layer is at least one selected from the group consisting of triethyl citrate, polyethylene glycol, and lecithin.
  3. 제2항에 있어서, 상기 1차 필름코팅층에 포함된 가소제는 레시틴를 포함하고, 트리에틸시트레이트 및 폴리에틸렌글리콜 중 어느 하나 이상을 더 포함하는, 필름코팅정.The film coated tablet of claim 2, wherein the plasticizer included in the primary film coating layer contains lecithin, and further comprises any one or more of triethyl citrate and polyethylene glycol.
  4. 제1항에 있어서, 상기 2차 필름코팅층에 포함된 가소제는 레시틴인, 필름코팅정. The film-coated tablet of claim 1, wherein the plasticizer included in the secondary film coating layer is lecithin.
  5. 제1항에 있어서, 상기 2차 필름코팅층은 2차 필름코팅층 총 중량 대비 1-10 중량%의 색소를 더 포함하는, 필름코팅정.According to claim 1, The secondary film coating layer further comprises a pigment of 1-10% by weight relative to the total weight of the secondary film coating layer, the film coated tablet.
  6. 제1항에 있어서, 상기 1차 필름코팅층은 나정 중량 대비 1-4 중량% 코팅되고, 2차 필름코팅층은 1차 필름코팅정 중량 대비 2-6 중량% 코팅된, 필름코팅정. According to claim 1, The primary film coating layer is coated with 1-4% by weight compared to the weight of the tablet, and the secondary film coating layer is coated with 2-6% by weight of the weight of the primary film coating, the film coated tablet.
  7. 제1항에 있어서, 상기 2차 필름코팅층은 잔탄검을 포함하지 않는, 필름코팅정.The film-coated tablet of claim 1, wherein the secondary film coating layer does not include xanthan gum.
  8. 제1항에 있어서, 상기 나정은 조해성이 높은 약물을 포함하는, 필름코팅정.The film-coated tablet of claim 1, wherein the uncoated tablet contains a drug having high deliquescent property.
  9. 제8항에 있어서, 상기 조해성이 높은 약물은 콜린알포세레이트인, 필름코팅정.The film-coated tablet according to claim 8, wherein the drug having high deliquescent property is choline alfoscerate.
PCT/KR2019/015824 2018-11-20 2019-11-19 Film-coated tablet having excellent moisture-proof property WO2020106007A1 (en)

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