WO2012105767A3 - 피에이치 비의존적 용출양상을 갖는 부정맥치료제 제제 - Google Patents

피에이치 비의존적 용출양상을 갖는 부정맥치료제 제제 Download PDF

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Publication number
WO2012105767A3
WO2012105767A3 PCT/KR2012/000658 KR2012000658W WO2012105767A3 WO 2012105767 A3 WO2012105767 A3 WO 2012105767A3 KR 2012000658 W KR2012000658 W KR 2012000658W WO 2012105767 A3 WO2012105767 A3 WO 2012105767A3
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WO
WIPO (PCT)
Prior art keywords
dronedarone
solids
solid dispersions
liquids
drugs
Prior art date
Application number
PCT/KR2012/000658
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English (en)
French (fr)
Other versions
WO2012105767A2 (ko
Inventor
김정훈
장선우
한상덕
정상원
Original Assignee
동아제약 주식회사
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 동아제약 주식회사 filed Critical 동아제약 주식회사
Publication of WO2012105767A2 publication Critical patent/WO2012105767A2/ko
Publication of WO2012105767A3 publication Critical patent/WO2012105767A3/ko

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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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

본 발명은 부정맥 치료제인 드로네다론 함유 제제에 있어서, pH 비의존적인 용출양상을 갖게 하는 드로네다론 또는 약학적으로 허용 가능한 염을 함유하는 공침형태 고체분산체 또는 고체액체 및 이를 함유하는 제제에 관한 것이다. 본 발명에 따른 드로네다론 함유 고체분산체 또는 고체액체는 산성에서의 주성분 용출률을 극대화함으로써 pH가 낮은 공복상태(Fast-state)에서의 용출률을 높일 수 있고 산성에서 알칼리성 환경으로 변화시에도 아주 매우 작은 입자 혹은 용해상태로 드로네다론을 유지시키므로 해서 드론네다론 또는 이의 염의 낮은 생체이용률을 높여주거나 식전, 식후의 복용방법에 따라 생체이용률이 달라지는 식이효과(Food Effect)를 줄일 수 있게 한다. 따라서, 본 발명에 따른 드로네다론의 고체분산체 또는 고체액체를 함유하는 드로네다론 제제는 환자로 하여금 식전 및 식후 복용법에 관계없이 편하게 약물을 복용가능하게 하며, 복용케 하는 투여크기를 줄일 수 있어 복약 순응도를 높일 수 있다.
PCT/KR2012/000658 2011-02-01 2012-01-30 피에이치 비의존적 용출양상을 갖는 부정맥치료제 제제 WO2012105767A2 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2011-0010186 2011-02-01
KR1020110010186A KR20120094557A (ko) 2011-02-01 2011-02-01 피에이치 비의존적 용출양상을 갖는 부정맥치료제 제제

Publications (2)

Publication Number Publication Date
WO2012105767A2 WO2012105767A2 (ko) 2012-08-09
WO2012105767A3 true WO2012105767A3 (ko) 2012-10-26

Family

ID=46603189

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2012/000658 WO2012105767A2 (ko) 2011-02-01 2012-01-30 피에이치 비의존적 용출양상을 갖는 부정맥치료제 제제

Country Status (2)

Country Link
KR (1) KR20120094557A (ko)
WO (1) WO2012105767A2 (ko)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20010014098A (ko) * 1997-06-23 2001-02-26 고든 라이트 벤조푸란 유도체를 함유하는 고형 약제학적 조성물
KR20030060985A (ko) * 2000-12-11 2003-07-16 사노피-신델라보 비경구 투여용 드로네다론 제약 조성물

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20010014098A (ko) * 1997-06-23 2001-02-26 고든 라이트 벤조푸란 유도체를 함유하는 고형 약제학적 조성물
KR20030060985A (ko) * 2000-12-11 2003-07-16 사노피-신델라보 비경구 투여용 드로네다론 제약 조성물

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Publication number Publication date
KR20120094557A (ko) 2012-08-27
WO2012105767A2 (ko) 2012-08-09

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