KR20100072317A - Film-coated preparation - Google Patents

Film-coated preparation Download PDF

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KR20100072317A
KR20100072317A KR1020107009312A KR20107009312A KR20100072317A KR 20100072317 A KR20100072317 A KR 20100072317A KR 1020107009312 A KR1020107009312 A KR 1020107009312A KR 20107009312 A KR20107009312 A KR 20107009312A KR 20100072317 A KR20100072317 A KR 20100072317A
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film coating
polyvinyl alcohol
film
coating formulation
formulation
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다케시 하마우라
스스무 하세가와
이쿠마사 오노
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다이이찌 산쿄 가부시키가이샤
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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Epidemiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract

Disclosed is a film-coated preparation, in which the odor of a medicinal agent contained therein can be reduced. Specifically disclosed is a film-coated preparation which contains olmesartan medoxomil in its formulation, and which contains polyvinyl alcohol or a vinyl alcohol-containing copolymer in its film layer.

Description

필름 코팅 제제 {FILM-COATED PREPARATION}Film Coating Formulation {FILM-COATED PREPARATION}

본 발명은 필름 코팅 제제에 관한 것이다.The present invention relates to film coating formulations.

의약품 중에는, 복용자가 불쾌감을 느끼는 악취를 갖는 약제가 있는 것으로 알려져 있고, 이들을 함유하는 제제는 복용자의 컴플라이언스의 저하를 초래하게 되어, 상품 가치에도 영향을 주고 있다.Some medicines are known to have odorous drugs in which the doser feels unpleasant, and preparations containing them cause a decrease in the compliance of the doser and affect the product value.

종래 기술에서는, 예를 들어 당의정(糖衣錠)으로 하여 악취를 마스킹할 수 있었는데, 당의정에서는 정제가 대형화되어 복용하기 어려워지는 결점이 있었다. 또, 하이드록시프로필메틸셀룰로오스를 배합한 필름층으로 코팅된 필름 코팅정이 약제의 불쾌한 악취를 마스킹하는 것은 알려져 있지만 (일본 공개특허공보 2003-300883호), 악취 억제의 효과는 불충분하였다.In the prior art, for example, a malodor could be masked as a dragee. However, in the dragee, there is a drawback that the tablet is enlarged and difficult to take. Moreover, although it is known that the film-coated tablet coated with the film layer which mix | blended hydroxypropyl methylcellulose masks unpleasant odor of a chemical | medical agent (Japanese Unexamined-Japanese-Patent No. 2003-300883), the effect of odor suppression was inadequate.

(특허 문헌 1) 일본 공개특허공보 2003-300883호(Patent Document 1) Japanese Unexamined Patent Publication No. 2003-300883

본 발명의 목적은 약제가 갖는 악취를 저감시킬 수 있는 필름 코팅 제제를 제공하는 것에 있다.An object of the present invention is to provide a film coating formulation capable of reducing the odor of the drug.

본 발명자들은 상기 목적을 달성하기 위해 예의 검토한 결과, 놀랍게도, 폴리비닐알코올 또는 비닐알코올계 공중합체를 배합한 필름층에 의해 코팅하면 처방의 악취를 저감시킬 수 있는 것을 알아내어, 본 발명을 완성시켰다.MEANS TO SOLVE THE PROBLEM As a result of earnestly examining in order to achieve the said objective, the present inventors surprisingly discovered that coating with the film layer which mix | blended polyvinyl alcohol or a vinyl alcohol type copolymer can reduce the odor of a prescription, and completes this invention. I was.

즉, 본 발명은,That is, the present invention,

(1) 처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올 및 비닐알코올계 공중합체에서 선택되는 화합물의 1 종 또는 2 종 이상을 함유하는 필름 코팅 제제,(1) a film coating formulation containing olmesartan medoxomil in the formulation and containing one or two or more of the compounds selected from polyvinyl alcohol and vinyl alcohol copolymers in the film layer,

(2) 처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올, 폴리비닐알코올-폴리에틸렌글리콜 그래프트 코폴리머, 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머에서 선택되는 화합물의 1 종 또는 2 종 이상을 함유하는 필름 코팅 제제,(2) One kind of a compound containing olmesartan medoxyl wheat in the formulation, and selected from polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft copolymer, polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer in the film layer Or film coating formulations containing two or more species,

(3) 처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올을 함유하는 필름 코팅 제제,(3) a film coating formulation containing olmesartan medoxomil in the formulation and polyvinyl alcohol in the film layer,

(4) 처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머를 함유하는 필름 코팅 제제,(4) a film coating formulation containing olmesartan medoxomil in the formulation and a polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer in the film layer;

(5) 필름층 중에, 추가로 코팅 기제 또는 부형제를 함유하는 제 1 항 내지 제 4 항 중 어느 한 항에 기재된 필름 코팅 제제,(5) The film coating formulation according to any one of claims 1 to 4, further comprising a coating base or an excipient in the film layer,

(6) 처방 중에 올메사르탄 메독소밀 및 타 약제를 동시에 함유하는 제 1 항 내지 제 5 항 중 어느 한 항에 기재된 필름 코팅 제제,(6) the film coating formulation according to any one of claims 1 to 5, which simultaneously contains olmesartan medoxomil and other drugs in the prescription;

(7) 제제가 정제인 제 1 항 내지 제 6 항 중 어느 한 항에 기재된 필름 코팅 제제,(7) The film coating formulation according to any one of items 1 to 6, wherein the formulation is a tablet,

(8) 필름층이 처방 중량에 대해 1 % (w/w) 이상인 제 1 항 내지 제 7 항 중 어느 한 항에 기재된 필름 코팅 제제,(8) the film coating formulation according to any one of claims 1 to 7, wherein the film layer is 1% (w / w) or more based on the prescription weight;

(9) 필름층의 막두께가 1 ㎛ 이상인 제 1 항 내지 제 8 항 중 어느 한 항에 기재된 필름 코팅 제제,(9) The film coating formulation as described in any one of Claims 1-8 whose film thickness of a film layer is 1 micrometer or more,

(10) 악취의 발생이 저감된 제 1 항 내지 제 9 항 중 어느 한 항에 기재된 필름 코팅 제제,(10) The film coating formulation according to any one of claims 1 to 9, wherein occurrence of odor is reduced;

(11) 발생이 저감된 악취가 불쾌한 악취인 제 10 항에 기재된 필름 코팅 제제,(11) The film-coated preparation according to claim 10, wherein the malodor having reduced occurrence is an unpleasant malodor,

(12) 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제에 의한 악취 발생의 저감 방법,(12) a method for reducing odor generation by the film coating formulation according to (1) to (9);

(13) 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제에 의한 불쾌취 발생의 저감 방법,(13) a method for reducing unpleasant occurrence by the film coating formulation according to (1) to (9);

(14) 악취 발생을 저감화시킨 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제의 제조 방법,(14) The manufacturing method of the film coating formulation of Claims 1-9 which reduced odor generation | occurrence | production,

(15) 불쾌취 발생을 저감화시킨 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제의 제조 방법,(15) The manufacturing method of the film coating formulation of Claims 1-9 which reduced generation | occurrence | production of the unpleasantness,

(16) 올메사르탄 메독소밀 함유 제제 제조를 위한 폴리비닐알코올 및/또는 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머의 사용.(16) Use of polyvinyl alcohol and / or polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer for the preparation of olmesartan medoxomil containing formulations.

(17) 악취 저감화 올메사르탄 메독소밀 함유 제제 제조를 위한 폴리비닐알코올 및/또는 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머의 사용,(17) the use of polyvinyl alcohol and / or polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer for the preparation of malodor reducing olmesartan medoxomill-containing formulations;

(18) 악취 저감화 올메사르탄 메독소밀 함유 제제 제조를 위한 폴리비닐알코올 및/또는 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머 함유 코팅제의 사용 등을 제공하는 것이다. (18) Odor reduction The use of a polyvinyl alcohol and / or polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer-containing coating agent for the preparation of olmesartan medoxomil-containing formulations and the like.

본 발명에 의하면, 실질적으로 불쾌취가 없는, 상품성이 우수한 필름 코팅 제제를 제공할 수 있게 된다. ADVANTAGE OF THE INVENTION According to this invention, it becomes possible to provide the film coating formulation which is excellent in a commercial property which is substantially unpleasant.

본 발명에서의 필름 코팅 제제에서는, 필름층 중에 폴리비닐알코올 및 비닐 알코올계 공중합체에서 선택되는 화합물의 1 종 또는 2 종 이상을 함유한다. 이로써, 약제가 갖는 악취를 효과적으로 저감시킬 수 있고, 또한 시간 경과적으로도 안정적인 필름 코팅 제제가 얻어진다. 그러한 폴리비닐알코올 및 비닐알코올계 공중합체로서는, 예를 들어, 폴리비닐알코올 (니혼 고세이 화학 주식회사 제조 고세놀, 니혼 사쿠비·포발 주식회사 제조 포발, 덴키 화학 공업 주식회사 제조 덴카포발, 주식회사 쿠라레 제조 쿠라레 포발 등), 폴리비닐알코올-폴리에틸렌글리콜그래프트 코폴리머 (BASF 사 제조 코리코트 IR 등), 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머 (다이도 화성 공업사 제조 POVACOAT (등록상표) 등) 이고, 바람직하게는 폴리비닐알코올이다. 폴리비닐알코올은 폴리비닐알코올을 함유하는 코팅 기재 (칼라콘사 제조 OPADRY AMB, OPADRY II 85F18422 등) 로서 사용할 수 있다. 본 발명에서는, 이들을 단독으로 사용할 수도 있고, 또는 2 종 이상을 조합하여 사용할 수도 있다.In the film coating formulation in this invention, the film layer contains 1 type, or 2 or more types of compound chosen from a polyvinyl alcohol and a vinyl alcohol type copolymer. Thereby, the odor which a chemical | medical agent has can be reduced effectively, and the film coating formulation which is stable also with time is obtained. As such a polyvinyl alcohol and a vinyl alcohol type copolymer, For example, polyvinyl alcohol (Gosenol by Nippon Kosei Chemical Co., Ltd., Fobal, Nippon Sakubi Foam Co., Ltd. make, Denka Chemical, Co., Ltd. Kurare foam, etc.), polyvinyl alcohol- polyethyleneglycol copolymer (Corricoat IR by BASF Corporation, etc.), polyvinyl alcohol- acrylic acid-methyl methacrylate copolymer (POVACOAT (trademark) etc. by Dido Chemical Co., Ltd.), etc.); And preferably polyvinyl alcohol. Polyvinyl alcohol can be used as a coating base material (OPADRY AMB by Colorcon, OPADRY II 85F18422, etc.) containing polyvinyl alcohol. In this invention, these may be used independently or may be used in combination of 2 or more type.

필름층 중의 폴리비닐알코올 및/또는 비닐 알코올계 공중합체의 함유량은 통상적인 하한은 20 % (w/w) 이상이고, 바람직하게는 30 % (w/w) 이상이고, 더욱 바람직하게는 40 % (w/w) 이상이고, 상한은 90 % (w/w) 이하이고, 바람직하게는 80 % (w/w) 이하이고, 더욱 바람직하게는 70 % (w/w) 이하이다.The lower limit of the content of the polyvinyl alcohol and / or vinyl alcohol-based copolymer in the film layer is usually 20% (w / w) or more, preferably 30% (w / w) or more, and more preferably 40%. (w / w) or more, and an upper limit is 90% (w / w) or less, Preferably it is 80% (w / w) or less, More preferably, it is 70% (w / w) or less.

필름층 중에는, 필요에 따라 다른 코팅 기제 또는 부형제를 배합할 수 있다. 코팅 기제 또는 부형제의 종류는 특별히 한정되지 않고, 당업자가 적절히 선택할 수 있다. 그러한 코팅 기제 또는 부형제로서, 예를 들어, 폴리비닐피롤리돈 (PVP), 카르복시메틸셀룰로오스나트륨 (CMC-Na), 메틸셀룰로오스, 에틸셀룰로오스, 하이드록시프로필셀룰로오스 (HPC), 하이드록시프로필메틸셀룰로오스 (HPMC), 덱스트린, 말토덱스트린, 유당, D-만니톨, 폴리비닐알코올 폴리머, 메타크릴산 코폴리머, 아미노알킬메타크릴레이트 코폴리머 및 아크릴산에틸·메타크릴산메틸 코폴리머 등을 들 수 있다.In the film layer, other coating bases or excipients may be blended as necessary. The type of coating base or excipient is not particularly limited and can be appropriately selected by those skilled in the art. As such coating bases or excipients, for example, polyvinylpyrrolidone (PVP), sodium carboxymethylcellulose (CMC-Na), methylcellulose, ethylcellulose, hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose ( HPMC), dextrin, maltodextrin, lactose, D-mannitol, polyvinyl alcohol polymer, methacrylic acid copolymer, aminoalkyl methacrylate copolymer, ethyl acrylate methyl methacrylate copolymer, and the like.

또한 필요에 따라, 코팅 조성물 중에 통상적으로 사용되는 양의 가소제, 부형제, 활택제, 은폐제, 착색제 및 방부제 등의 1 개 또는 그 이상의 첨가제를 포함할 수 있다.It may also include one or more additives, such as plasticizers, excipients, glidants, masking agents, colorants and preservatives, in amounts conventionally used in the coating composition, as needed.

본 발명에 사용할 수 있는 가소제의 종류는 특별히 한정되지 않아, 당업자가 적절히 선택할 수 있다. 그러한 가소제로서는, 예를 들어, 매크로골 6000, 프로필렌글리콜, 폴리에틸렌글리콜, 폴리프로필렌글리콜, 글리세린 및 소르비톨, 글리세린트리아세테이트, 프탈산디에틸 및 시트르산트리에틸, 라우르산, 자당, 덱스트로오스, 소르비톨, 트리아세틴, 아세틸트리에틸티트레이트, 트리에틸티트레이트, 트리부틸티트레이트, 아세틸트리부틸티트레이트 등을 들 수 있다.The kind of plasticizer which can be used for this invention is not specifically limited, A person skilled in the art can select suitably. Such plasticizers include, for example, macrogol 6000, propylene glycol, polyethylene glycol, polypropylene glycol, glycerin and sorbitol, glycerin triacetate, diethyl phthalate and triethyl citrate, lauric acid, sucrose, dextrose, sorbitol, Triacetin, acetyl triethyl titrate, triethyl titrate, tributyl titrate, acetyl tributyl titrate, etc. are mentioned.

본 발명에 사용할 수 있는 부형제로서는, 예를 들어, 유당, 만니톨, 결정 셀룰로오스, 덱스트로오스, 말토덱스트린 등을 들 수 있다.As an excipient which can be used for this invention, lactose, mannitol, crystalline cellulose, dextrose, maltodextrin, etc. are mentioned, for example.

본 발명에 사용할 수 있는 활택제로서는, 예를 들어, 탤크, 스테아르산마그네슘, 스테아르산칼슘, 스테아르산 등을 들 수 있다.Examples of the lubricant that can be used in the present invention include talc, magnesium stearate, calcium stearate, stearic acid, and the like.

본 발명에 사용할 수 있는 은폐제로서는, 예를 들어, 산화티탄 등을 들 수 있다.As a concealment agent which can be used for this invention, a titanium oxide etc. are mentioned, for example.

본 발명에 사용할 수 있는 착색제로서는, 예를 들어, 산화티탄, 산화철, 삼이산화철, 황색삼이산화철, 황색5호알루미늄레이크, 탤크 등을 들 수 있다.As a coloring agent which can be used for this invention, a titanium oxide, iron oxide, iron trioxide, yellow trioxide, yellow No. 5 aluminum lake, talc, etc. are mentioned, for example.

본 발명에 사용할 수 있는 방부제로서는, 예를 들어, 파라벤 등을 들 수 있다.As a preservative which can be used for this invention, a paraben etc. are mentioned, for example.

본 발명에서, 필름 코팅 제제에 함유되는 유효 성분으로서는, 악취를 갖는 약물이면 그 구조, 정도 등에 의해 한정되는 것이 아니고, 예를 들어, 올메사르탄 메독소밀, 2-아미노-5-이소부틸-4-{2-[5-(N,N'-비스((S)-1-에톡시카르보닐)에틸)포스폰아미드]푸라닐}티아졸, (5-메틸-2-옥소-1,3-디옥소렌-4-일)메틸(5R,6S)-6-[(R)-1-히드록시에틸]-2-[(R)-2-테트라하이드로푸릴]페넴-3-카르복시레이트, 2-에톡시-1-{[2'-(5-옥소-4,5-디하이드로-1,2,4-옥사디아졸-3-일)비페닐-4-일]메틸}-1H-벤즈이미다졸-7-카르복실산(5-메틸-2-옥소-1,3-디옥솔-4-일)메틸 또는 그 염 (이하, 「아질사르탄 메독소밀」이라고 칭하는 경우가 있다), 2-에톡시-1-{[2'-(5-옥소-2,5-디하이드로-1,2,4-옥사디아졸-3-일)비페닐-4-일]메틸}-1H-벤즈이미다졸-7-카르복실산(5-메틸-2-옥소-1,3-디옥솔-4-일)메틸 또는 그 염 (이하, 「아질사르탄카 메독소밀」이라고 칭하는 경우가 있다), 2-시클로프로필-1-{[2'-(5-옥소-4,5-디하이드로-1,2,4-옥사디아졸-3-일)비페닐-4-일]메틸}-1H-벤즈이미다졸-7-카르복실산(5-메틸-2-옥소-1,3-디옥솔-4-일)메틸 또는 그 염, 2-시클로프로필-1-{[2'-(5-옥소-2,5-디하이드로-1,2,4-옥사디아졸-3-일)비페닐-4-일]메틸}-1H-벤즈이미다졸-7-카르복실산(5-메틸-2-옥소-1,3-디옥솔-4-일)메틸 또는 그 염 등을 들 수 있다. 바람직하게는 올메사르탄 메독소밀, 2-아미노-5-이소부틸-4-{2-[5-(N,N'-비스((S)-1-에톡시카르보닐)에틸)포스폰아미드]푸라닐}티아졸 또는 (5-메틸-2-옥소-1,3-디옥소렌-4-일)메틸(5R,6S)-6-[(R)-1-히드록시에틸]-2-[(R)-2-테트라하이드로푸릴]페넴-3-카르복시레이트이고, 특히 바람직하게는 올메사르탄 메독소밀이다. 또한, 올메사르탄 메독소밀은 고혈압증 또는 고혈압증에서 유래하는 질환 (보다 구체적으로는, 고혈압증, 심장 질환 [협심증, 심근경색, 부정맥, 심부전 혹은 심장 비대], 신장 질환 [당뇨병성 신증, 사구체신염 혹은 신장 경화증] 또는 뇌혈관성 질환 [뇌경색 혹은 뇌출혈]) 의 예방 또는 치료에 유효하고, 일본특허공보 제2082519호 (미국특허공보 제5,616,599호) 등에 기재된 방법에 따라 용이하게 제조할 수 있다. 2-아미노-5-이소부틸-4-{2-[5-(N,N'-비스((S)-1-에톡시카르보닐)에틸)포스폰아미드]푸라닐}티아졸은 당뇨병, 고혈당증, 내당능 부전, 비만증, 당뇨병 합병증 등의 예방 또는 치료에 유효하고 (바람직하게는 당뇨병의 예방 또는 치료), 국제공개 제2001/047935호 팸플릿 등에 기재된 방법에 따라 용이하게 제조할 수 있다. 또, (5-메틸-2-옥소-1,3-디옥소렌-4-일)메틸(5R,6S)-6-[(R)-1-히드록시에틸]-2-[(R)-2-테트라하이드로푸릴]페넴-3-카르복실레이트는 항균제로서 기대되고 있는 페넴 화합물이고, 국제공개 제1992/003442호 팸플릿 등에 기재된 방법에 따라 용이하게 제조할 수 있다. 또한 아질사르탄 메독소밀, 아질사르탄카 메독소밀, 2-시클로프로필-1-{[2'-(5-옥소-4,5-디하이드로-1,2,4-옥사디아졸-3-일)비페닐-4-일]메틸}-1H-벤즈이미다졸-7-카르복실산(5-메틸-2-옥소-1,3-디옥솔-4-일)메틸 또는 그 염 그리고 2-시클로프로필-1-{[2'-(5-옥소-2,5-디하이드로-1,2,4-옥사디아졸-3-일)비페닐-4-일]메틸}-1H-벤즈이미다졸-7-카르복실산(5-메틸-2-옥소-1,3-디옥솔-4-일)메틸 또는 그 염은 고혈압증 등의 치료약으로서 유망시되어 있고, 국제공개 제2005/080384호 팸플릿 혹은 국제공개 제2006/107062호 팸플릿 등에 개시된 방법 또는 그것에 준한 방법 등에 의해 제조할 수 있다.In the present invention, the active ingredient contained in the film coating formulation is not limited by its structure, degree, etc. as long as it has a malodorous drug. For example, olmesartan medoxomil, 2-amino-5-isobutyl-4 -{2- [5- (N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole, (5-methyl-2-oxo-1,3 -Dioxoren-4-yl) methyl (5R, 6S) -6-[(R) -1-hydroxyethyl] -2-[(R) -2-tetrahydrofuryl] phenem-3-carboxylate, 2-ethoxy-1-{[2 '-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1H- Benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl or its salt (hereinafter may be referred to as "azylsartan medoxomill"), 2-ethoxy-1-{[2 '-(5-oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1H- Benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl or its salt (hereinafter referred to as `` azyl Sartanka medoxomil ”), 2-cyclopropyl-1-{[2 '-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl) Biphenyl-4-yl] methyl} -1H-benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-diosol-4-yl) methyl or a salt thereof, 2-cyclopropyl -1-{[2 '-(5-oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1 H-benzimidazole- 7-carboxylic acid (5-methyl-2-oxo-1, 3-dioxol-4-yl) methyl, or its salt etc. are mentioned. Preferably olmesartan medoxomil, 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamide ] Furanyl} thiazole or (5-methyl-2-oxo-1,3-dioxoren-4-yl) methyl (5R, 6S) -6-[(R) -1-hydroxyethyl] -2 -[(R) -2-tetrahydrofuryl] phenem-3-carboxylate, and particularly preferably olmesartan medoxomil. In addition, olmesartan medoxyl wheat is a disease originating from hypertension or hypertension (more specifically, hypertension, heart disease [angina, myocardial infarction, arrhythmia, heart failure or cardiac hypertrophy], kidney disease [diabetic nephropathy, glomerulonephritis or kidney] Sclerosis] or cerebrovascular disease [cerebral infarction or cerebral hemorrhage]), and can be easily produced according to the method described in Japanese Patent Publication No. 2082519 (US Patent No. 5,616, 599) and the like. 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole is used for diabetes, It is effective for the prevention or treatment of hyperglycemia, impaired glucose tolerance, obesity, diabetes complications (preferably prevention or treatment of diabetes), and can be easily prepared according to the method described in International Publication No. 2001/047935 pamphlet or the like. In addition, (5-methyl-2-oxo-1,3-dioxoren-4-yl) methyl (5R, 6S) -6-[(R) -1-hydroxyethyl] -2-[(R) The 2-tetrahydrofuryl] phenem-3-carboxylate is a penem compound expected as an antibacterial agent, and can be easily produced according to the method described in International Publication No. 1992/003442 pamphlet or the like. In addition, azylsartan medoxomil, azilsartanca medoxomil, 2-cyclopropyl-1-{[2 '-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl ) Biphenyl-4-yl] methyl} -1H-benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-diosol-4-yl) methyl or a salt thereof and 2-cyclo Propyl-1-{[2 '-(5-oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1H-benzimidazole -7-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl or its salt is promising as a therapeutic drug for hypertension and the like, and published in International Publication No. 2005/080384 pamphlet or It can manufacture by the method disclosed in international publication 2006/107062 pamphlet etc., or the method according to it.

또, 본 발명에서의 필름 코팅 제제는 필요에 따라 그 밖의 유효 성분을 함유하고 있어도 된다. 그 유효 성분으로서는, 예를 들어, 트리클로르메티아지드 (Trichloromethiazide), 하이드로클로로티아지드 (Hydrochlorothiazide), 벤질하이드로클로로티아지드 (Benzylhydrochlorothiazide) 와 같은 이뇨제 ; 아젤니디핀 (Azelnidipine), 암로디핀 (Amlodipine), 베니디핀 (Benidipine), 니트렌디핀 (Nitrendipine), 마니디핀 (Manidipine), 니카르디핀 (Nicardipine), 니페디핀 (Nifedipine), 실니디핀 (Cilnidipine), 에포니디핀 (Efonidipine), 바니디핀 (Barnidipine), 펠로디핀 (Felodipine) 과 같은 칼슘 길항제 ; 피오글리타존 (Pioglitazone), 로시글리타존 (Rosiglitazone), 리보글리타존 (Rivoglitazone), MCC-555, NN-2344, BMS-298585, AZ-242, LY-519818, TAK-559 와 같은 인슐린 저항성 개선제 ; 프라바스타틴 (Pravastatin), 심바스타틴 (Simvastatin), 아토르바스타틴 (Atorvastatin), 로스바스타틴 (Rosuvastatin), 세리바스타틴 (Cerivastatin), 피타바스타틴 (Pitavastatin), 플루바스타틴 (Fluvastatin) 과 같은 HMG-CoA 환원 효소 저해제 ; SMP-797, 팩티마이브 (Pactimibe) 와 같은 ACAT 저해제 등을 들 수 있는데, 이들에 한정되는 것은 아니다. 이들 유효 성분의 양은 특별히 한정 되는 것이 아니고, 통상적으로 제제에 사용되는 양을 사용하면 된다.Moreover, the film coating formulation in this invention may contain another active ingredient as needed. As the active ingredient, for example, diuretics such as Trichloromethiazide, Hydrochlorothiazide, Benzylhydrochlorothiazide; Azelnidipine, Amlodipine, Benidipine, Benidipine, Nitrendipine, Manidipine, Nicardipine, Nifedipine, Cilnidipine, Calcium antagonists such as ponidipine, barnidipine, and pelodipine; Insulin resistance improving agents such as Pioglitazone, Rosiglitazone, Riboglitazone, Riboglitazone, MCC-555, NN-2344, BMS-298585, AZ-242, LY-519818, and TAK-559; HMG-CoA reductase enzymes such as Pravastatin, Simvastatin, Atorvastatin, Rovavastatin, Cerivastatin, Pitavastatin, Fluvastatin ; ACAT inhibitors, such as SMP-797 and Pactimibe, etc. are mentioned, It is not limited to these. The quantity of these active ingredients is not specifically limited, Usually, the quantity used for a formulation may be used.

본 발명에서의 필름 코팅 제제로서는, 예를 들어, 정제, 캡슐제, 산제, 세립제, 과립제, 트로키제 등을 들 수 있고, 바람직하게는 정제이다.As a film coating formulation in this invention, a tablet, a capsule, a powder, a granule, a granule, a troche, etc. are mentioned, for example, Preferably it is a tablet.

본 발명에서의 필름 코팅 제제의 제조 방법으로서는, Powder Technology and Pharmaceutical Processes (D.Chulia 외, Elsevier Science Pub Co (December 1, 1993)) 와 같은 간행물에 기재되어 있는 일반적인 방법을 사용하여 제조하면 되고, 특별한 제한은 두지 않는다.As a manufacturing method of the film coating formulation in this invention, what is necessary is just to manufacture using the general method described in the publication, such as Powder Technology and Pharmaceutical Processes (D.Chulia et al., Elsevier Science Pub Co (December 1, 1993)), There is no special restriction.

본 법으로 조정되는 필름 코팅 제제는 폴리비닐알코올 및/또는 비닐알코올계 공중합체를 코팅 기제로서 함유하는 필름 코팅액을, 정제, 원약 등의 피복되어야 하는 대상물에 분무함으로써 얻을 수 있다. 그 피복되어야 하는 대상물은 원하는 바에 따라 서브 코팅되어 있어도 된다. 그 필름 코트액은 폴리비닐알코올 및/또는 비닐알코올계 공중합체, 및 원하는 바에 따라 배합되는 상기 첨가제를 수중에 현탁, 용해시켜 얻어진다. 필름 코팅액의 분무는 시판된 필름 코팅기를 사용하는 등의 공지된 방법에 의해 실시하면 된다. 이들 제조 조건은 통상적인 필름 코팅 제제의 제조에서의 조건을 채용하면 된다.The film coating formulation adjusted by this method can be obtained by spraying the film coating liquid containing a polyvinyl alcohol and / or a vinyl alcohol-type copolymer as a coating base to the object to be coated, such as a tablet and a raw medicine. The object to be coated may be sub-coated as desired. The film coating liquid is obtained by suspending and dissolving a polyvinyl alcohol and / or a vinyl alcohol-based copolymer and the above-mentioned additives blended as desired in water. Spraying of a film coating liquid may be performed by a well-known method, such as using a commercially available film coating machine. These manufacturing conditions should just employ | adopt the conditions in manufacture of a conventional film coating formulation.

필름 코팅의 양으로서는, 약제가 갖는 악취를 효과적으로 저감시킬 수 있는 양이면 특별히 제한은 없는데, 통상적으로 하한은 처방 중량에 대해 1 % (w/w) 이상, 바람직하게는 3 % (w/w) 이상, 더욱 바람직하게는 6 % (w/w) 이상이고, 상한은 처방 중량에 대해 50 % (w/w) 이하, 바람직하게는 20 % (w/w) 이하, 더욱 바람직하게는 10 % (w/w) 이하가 되도록 실시한다.The amount of the film coating is not particularly limited as long as it is an amount that can effectively reduce the odor of the drug. The lower limit is usually 1% (w / w) or more, preferably 3% (w / w), based on the prescription weight. Or more, more preferably 6% (w / w) or more, and the upper limit is 50% (w / w) or less, preferably 20% (w / w) or less, more preferably 10% (relative to the prescription weight). w / w) or less.

필름층의 막두께는 약제가 갖는 악취를 효과적으로 저감시킬 수 있는 두께이면 특별히 제한은 없는데, 통상적으로 하한은 1 ㎛ 이상, 바람직하게는 5 ㎛ 이상, 더욱 바람직하게는 10 ㎛ 이상, 특히 바람직하게는 20 ㎛ 이상이고, 상한은 1000 ㎛ 이하, 바람직하게는 500 ㎛ 이하, 더욱 바람직하게는 200 ㎛ 이하, 특히 바람직하게는 100 ㎛ 이하이다.The film thickness of the film layer is not particularly limited as long as it is a thickness capable of effectively reducing the odor of the drug, but usually the lower limit is 1 µm or more, preferably 5 µm or more, more preferably 10 µm or more, particularly preferably It is 20 micrometers or more, and an upper limit is 1000 micrometers or less, Preferably it is 500 micrometers or less, More preferably, it is 200 micrometers or less, Especially preferably, it is 100 micrometers or less.

필름층의 막두께는 초심도 컬러 3D 형상 측정 현미경 VK-9500 ((주) 키엔스) 으로 측정할 수 있다.The film thickness of a film layer can be measured with a super depth color 3D shape measurement microscope VK-9500 (Keyence Co., Ltd.).

이렇게 하여 얻어지는 본 발명의 필름 코팅 제제는 통상적인 제제와 동일하게 투여하면 된다.What is necessary is just to administer the film coating formulation of this invention obtained in this way like a normal formulation.

실시예Example

이하, 실시예 등에 의해 본 발명을 더욱 상세하게 설명하는데, 본 발명은 이것에 한정되는 것은 아니다.Hereinafter, although an Example etc. demonstrate this invention further in detail, this invention is not limited to this.

(실시예 1) (Example 1)

올메사르탄 메독소밀 1200 g, 결정 셀룰로오스 600 g, 유당 3996 g, 저치환도 하이드록시프로필셀룰로오스 1200 g, 하이드록시프로필셀룰로오스 150 g 을 고속 교반 조립(造粒)기 (VG-50, 파우레크) 에서 혼합 후, 조립기 내에 정제수 3500 g 을 첨가하여 조립을 실시하고, 유동층 건조기 (GPCG-15, 파우레크) 로 건조시켰다. 건조시킨 과립을 정립(整粒)기 (코밀 QC-194, 파우레크) 를 사용하여 정립시킨 후, 스테아르산마그네슘 54 g 을 첨가하여 혼합기 (V 형 혼합기, 토쿠쥬 공작소) 에서 혼합하여 타정용 과립을 얻었다. 이 타정용 과립을 직경 7 ㎜ 의 절구, 곡률 반경 8 ㎜ 의 R 공이를 사용하고, 1 정당 질량 120 mg 이 되도록 제정하여 나정(裸錠)을 얻었다. 1200 g of olmesartan medoxomil, 600 g of crystalline cellulose, 3996 g of lactose, 1200 g of low-substituted hydroxypropyl cellulose, 150 g of hydroxypropyl cellulose (VG-50, Paurek) After mixing, 3500 g of purified water was added to the granulator, and granulation was carried out and dried with a fluid bed dryer (GPCG-15, Faurek). The dried granules are sized using a sizing machine (comyl QC-194, Faurek), and then 54 g of magnesium stearate is added and mixed in a mixer (type V mixer, Tokuju Works) for tableting granules. Got. The tableting granules were milled using a mortar having a diameter of 7 mm and an R ball with a radius of curvature of 8 mm to have a mass of 1 mg per tablet to obtain uncoated tablets.

얻어진 정제 1,000 g 에, 폴리비닐알코올을 함유하는 코팅 기재인 OPADRY II 85F18422 등 (카라콘사 제조) 을 소정 중량에 대해 약 3 % (w/w) 코팅하고 (코팅기 (하이코터 HCT-30, 플로인트 산업) 를 사용), 필름 코팅정 (A) 을 얻었다.1,000 g of the obtained tablet was coated with OPADRY II 85F18422, etc. (manufactured by Caracon Co., Ltd.), which is a coating base material containing polyvinyl alcohol, to about 3% (w / w) with respect to a predetermined weight (coating machine (High Coater HCT-30, Float) Industry)) and a film coated tablet (A) were obtained.

(비교예 1) (Comparative Example 1)

실시예 1 에서 얻어진 정제 1,000 g 에, 히프로메로오스 2910, 산화티탄, 탤크, 폴리에틸렌글리콜을 정제수에 현탁시킨 코팅액을 사용하고, 코팅기 (하이코터) 로 소정 중량에 대해 약 3 % (w/w) 코팅하여 필름 코팅정 (B) 을 얻었다.To 1,000 g of the tablet obtained in Example 1, using a coating solution in which hypromellose 2910, titanium oxide, talc, and polyethylene glycol were suspended in purified water, about 3% (w / w) to a predetermined weight with a coating machine (high coater). It coated and the film coating tablet (B) was obtained.

(시험예 1) (Test Example 1)

유리병에, 실시예 1 에서 제조한 나정 및 필름 코팅정 (A), 비교예 1 에서 제조한 필름 코팅정 (B) 각 1 정을 넣고, 실온에서 1 주간 보존하였다. 이 유리병을 열어, 피험자 9 명에 의해 하기 평가 기준으로 악취의 관능 시험을 실시하였다. 결과를 표 1 에 나타낸다.In the glass bottle, each of the uncoated tablets prepared in Example 1, the film coated tablets (A) and each of the film coated tablets (B) prepared in Comparative Example 1 was placed, and stored at room temperature for 1 week. This vial was opened and the sensory test of odor was carried out by nine subjects by the following evaluation criteria. The results are shown in Table 1.

(관능 평가 기준) (Sensory evaluation criteria)

<평점> <내용> <Rating> <contents>

0 : 악취가 나지 않는다 0: no smell

1 : 약간 악취가 난다1: Smells a little

2 : 악취가 난다 2: smells bad

3 : 매우 악취가 난다3: very bad smell

정제의 악취 평가Odor evaluation of tablets 피험자Subject 3층정 (소정)3-story tablet (prescribed) 필름 코팅정 (B)Film coated tablet (B) 필름 코팅정 (A)Film coated tablet (A) AA 33 1One 1One BB 33 22 00 CC 33 33 1One DD 33 22 1One EE 33 22 22 FF 33 33 22 GG 33 22 22 HH 33 33 33 II 33 22 1One 합계Sum 2727 2020 1313 평균Average 3.03.0 2.22.2 1.41.4

산업상 이용가능성Industrial availability

본 발명에 의하면, 실질적으로 불쾌취가 없는, 상품성이 우수한 필름 코팅 제제가 얻어진다.According to this invention, the film coating formulation which is excellent in a commercial property which is substantially unpleasant is obtained.

Claims (18)

처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올 및 비닐알코올계 공중합체에서 선택되는 화합물의 1 종 또는 2 종 이상을 함유하는 필름 코팅 제제.A film coating formulation containing olmesartan medoxomil in the formulation and containing one or two or more of compounds selected from polyvinyl alcohol and vinyl alcohol copolymers in the film layer. 처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올, 폴리비닐알코올-폴리에틸렌글리콜그래프트 코폴리머, 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머에서 선택되는 화합물의 1 종 또는 2 종 이상을 함유하는 필름 코팅 제제.1 type or 2 types of the compound which contains olmesartan medoxomil in the prescription, and is selected from polyvinyl alcohol, polyvinyl alcohol- polyethyleneglycol copolymer, and polyvinyl alcohol-acrylic-methyl methacrylate copolymer in a film layer Film coating formulation containing the above. 처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올을 함유하는 필름 코팅 제제.A film coating formulation containing olmesartan medoxomil in the formulation and polyvinyl alcohol in the film layer. 처방 중에 올메사르탄 메독소밀을 함유하고, 필름층 중에 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머를 함유하는 필름 코팅 제제.A film coating formulation containing olmesartan medoxomil in the formulation and a polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer in the film layer. 제 1 항 내지 제 4 항 중 어느 한 항에 있어서,
필름층 중에, 추가로 코팅 기제 또는 부형제를 함유하는 필름 코팅 제제.The method according to any one of claims 1 to 4,
The film coating formulation which contains a coating base or excipient further in a film layer. 제 1 항 내지 제 5 항 중 어느 한 항에 있어서,
처방 중에 올메사르탄 메독소밀 및 타 약제를 동시에 함유하는 필름 코팅 제제.6. The method according to any one of claims 1 to 5,
Film coating formulations containing olmesartan medoxomil and other agents simultaneously in the formulation. 제 1 항 내지 제 6 항 중 어느 한 항에 있어서,
제제가 정제인 필름 코팅 제제.The method according to any one of claims 1 to 6,
A film coating formulation wherein the formulation is a tablet. 제 1 항 내지 제 7 항 중 어느 한 항에 있어서,
필름층이 처방 중량에 대해 1 % (w/w) 이상인 필름 코팅 제제.The method according to any one of claims 1 to 7,
A film coating formulation wherein the film layer is at least 1% (w / w) based on the prescription weight. 제 1 항 내지 제 8 항 중 어느 한 항에 있어서,
필름층의 막두께가 1 ㎛ 이상인 필름 코팅 제제.The method according to any one of claims 1 to 8,
The film coating formulation whose film thickness of a film layer is 1 micrometer or more. 제 1 항 내지 제 9 항 중 어느 한 항에 있어서,
악취의 발생이 저감된 필름 코팅 제제.The method according to any one of claims 1 to 9,
Film coating formulations with reduced occurrence of odors. 제 10 항에 있어서,
발생이 저감된 악취가 불쾌한 악취인 필름 코팅 제제.The method of claim 10,
The film coating formulation whose odor which reduced occurrence is an unpleasant odor. 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제에 의한 악취 발생의 저감 방법.The method for reducing odor generation by the film coating formulation according to claim 1. 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제에 의한 불쾌취 발생의 저감 방법.A method for reducing unpleasant occurrence by the film coating formulation according to claim 1. 악취 발생을 저감화시킨 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제의 제조 방법.The manufacturing method of the film coating formulation of Claims 1-9 which reduced odor generation | occurrence | production. 불쾌취 발생을 저감화시킨 제 1 항 내지 제 9 항에 기재된 필름 코팅 제제의 제조 방법.The manufacturing method of the film coating formulation of Claims 1-9 which reduced the generation of unpleasant odor. 올메사르탄 메독소밀 함유 제제 제조를 위한 폴리비닐알코올 및/또는 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머의 사용.Use of polyvinyl alcohol and / or polyvinyl alcohol-acrylic acid-methyl methacrylate copolymers for the preparation of olmesartan medoxomil containing formulations. 악취 저감화 올메사르탄 메독소밀 함유 제제 제조를 위한 폴리비닐알코올 및/또는 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머의 사용.Use of polyvinyl alcohol and / or polyvinyl alcohol-acrylic acid-methyl methacrylate copolymers for the preparation of malodor reducing olmesartan medoxomil containing formulations. 악취 저감화 올메사르탄 메독소밀 함유 제제 제조를 위한 폴리비닐알코올 및/또는 폴리비닐알코올-아크릴산-메타크릴산메틸 코폴리머 함유 코팅제의 사용.Use of polyvinyl alcohol and / or polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer-containing coatings for the preparation of malodor reducing olmesartan medoxomil containing formulations.
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JP5730205B2 (en) * 2009-08-31 2015-06-03 日新化成株式会社 Coating composition
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