WO2011034274A3 - 비스포스포네이트 유도체 및 고용량의 콜레칼시페롤을 포함하는 약학 조성물 - Google Patents

비스포스포네이트 유도체 및 고용량의 콜레칼시페롤을 포함하는 약학 조성물 Download PDF

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Publication number
WO2011034274A3
WO2011034274A3 PCT/KR2010/003920 KR2010003920W WO2011034274A3 WO 2011034274 A3 WO2011034274 A3 WO 2011034274A3 KR 2010003920 W KR2010003920 W KR 2010003920W WO 2011034274 A3 WO2011034274 A3 WO 2011034274A3
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Prior art keywords
cholecalciferol
pharmaceutical compositions
salts
acids
dose
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PCT/KR2010/003920
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English (en)
French (fr)
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WO2011034274A2 (ko
Inventor
김진선
이근혁
최병선
김재신
박진하
오미진
김은미
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한림제약(주)
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Application filed by 한림제약(주) filed Critical 한림제약(주)
Priority to BR112012003907A priority Critical patent/BR112012003907A2/pt
Priority to RU2012109614/15A priority patent/RU2533230C2/ru
Priority to CN201080041701.XA priority patent/CN102497867B/zh
Priority to EP10817343.6A priority patent/EP2478909B1/en
Priority to MX2012002786A priority patent/MX343184B/es
Publication of WO2011034274A2 publication Critical patent/WO2011034274A2/ko
Publication of WO2011034274A3 publication Critical patent/WO2011034274A3/ko
Priority to MA34780A priority patent/MA33676B1/fr

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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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • 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
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

본 발명은 리세드론산 혹은 그의 염 또는 이반드론산 혹은 그의 염 등의 비스포스포네이트 계열의 화합물과 고용량의 콜레칼시페롤을 포함하는 매월 1회(once a month) 투여되는, 골다공증 예방 또는 치료용 약학 조성물을 제공한다. 본 발명은 또한, (a) 에탄올 또는 에탄올 수용액 중에 (i) 24,000∼50,000 IU 해당량의 콜레칼시페롤; (ii) 초산토코페롤, 부틸하이드록시톨루엔, 및 부틸하이드록시아니솔로부터 1 종 이상 선택된 제1 안정화제; 및 (iii) 결합제를 용해시켜 얻어진 용액을 미결정 셀룰로오스에 흡착시켜 얻어진 콜레칼시페롤-함유 과립, (b) 제2 안정화제로서 만니톨, 및 (c) 리세드론산 혹은 그의 염 또는 이반드론산 혹은 그의 염을 포함하는, 매월 1회(once a month) 투여되는, 골다공증 예방 또는 치료용 약학 조성물을 제공한다.
PCT/KR2010/003920 2009-09-18 2010-06-17 비스포스포네이트 유도체 및 고용량의 콜레칼시페롤을 포함하는 약학 조성물 WO2011034274A2 (ko)

Priority Applications (6)

Application Number Priority Date Filing Date Title
BR112012003907A BR112012003907A2 (pt) 2009-09-18 2010-06-17 composições farmacêuticas para prevenção ou tratamento da osteoporose, a ser adminstrada uma vez por mês
RU2012109614/15A RU2533230C2 (ru) 2009-09-18 2010-06-17 Фармацевтические композиции, содержащие производные бисфосфоната и высокие дозы холекальциферола
CN201080041701.XA CN102497867B (zh) 2009-09-18 2010-06-17 含有双膦酸盐衍生物和高剂量胆钙化醇的药物组合物
EP10817343.6A EP2478909B1 (en) 2009-09-18 2010-06-17 Pharmaceutical compositions comprising bisphosphonate derivatives and high-dose cholecalciferol
MX2012002786A MX343184B (es) 2009-09-18 2010-06-17 Composiciones farmacéuticas que comprenden derivados bisfosfonato y colecalciferol en alta dosis.
MA34780A MA33676B1 (fr) 2009-09-18 2012-04-16 Compositions pharmaceutiques comprenant des dérivés de bisphosphonate et du cholécalciférol à dose élevée

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020090088480A KR101102364B1 (ko) 2009-09-18 2009-09-18 비스포스포네이트 유도체 및 고용량의 콜레칼시페롤을 포함하는 약학 조성물
KR10-2009-0088480 2009-09-18

Publications (2)

Publication Number Publication Date
WO2011034274A2 WO2011034274A2 (ko) 2011-03-24
WO2011034274A3 true WO2011034274A3 (ko) 2011-05-19

Family

ID=43759131

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2010/003920 WO2011034274A2 (ko) 2009-09-18 2010-06-17 비스포스포네이트 유도체 및 고용량의 콜레칼시페롤을 포함하는 약학 조성물

Country Status (8)

Country Link
EP (1) EP2478909B1 (ko)
KR (1) KR101102364B1 (ko)
CN (2) CN102497867B (ko)
BR (1) BR112012003907A2 (ko)
MA (1) MA33676B1 (ko)
MX (1) MX343184B (ko)
RU (1) RU2533230C2 (ko)
WO (1) WO2011034274A2 (ko)

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KR101230178B1 (ko) * 2010-06-10 2013-02-06 주식회사 네비팜 골다공증 예방 또는 치료용 조성물 및 이의 제조방법
ITMI20120393A1 (it) * 2012-03-14 2013-09-15 Tiberio Bruzzese Formulazioni acquose di bisfosfonati, vitamina d e alcol benzilico adatte all'uso intramuscolare o sottocutaneo
MX350569B (es) 2012-12-03 2017-09-11 Landsteiner Scient S A De C V Composicion farmaceutica estable para el tratamiento de osteoporosis.
KR101847947B1 (ko) 2013-03-15 2018-05-28 옵코 아이피 홀딩스 Ⅱ 인코포레이티드 안정화되고 변형된 비타민 ｄ 방출 제형
KR20160144663A (ko) 2015-06-09 2016-12-19 최숙 제제 및 이의 제조방법
IT201600123773A1 (it) * 2016-12-06 2018-06-06 Abiogen Pharma Spa Composizione per il trattamento dell’osteoartrosi
CN108420797B (zh) * 2018-05-09 2022-05-03 南京海融制药有限公司 维生素d类似物制剂及其制备方法
KR102158375B1 (ko) 2018-10-25 2020-09-21 단국대학교 천안캠퍼스 산학협력단 비타민 d 에멀젼 및 비스포스포네이트를 포함하는 복합 액상 제형 및 이의 골다공증 예방 또는 치료 용도
KR102211287B1 (ko) * 2018-12-21 2021-02-03 (주)휴온스 비타민 d 또는 이의 유도체를 포함하는 안정성이 개선된 액상 제제

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Also Published As

Publication number Publication date
BR112012003907A2 (pt) 2016-03-22
MA33676B1 (fr) 2012-10-01
WO2011034274A2 (ko) 2011-03-24
CN103191138A (zh) 2013-07-10
MX343184B (es) 2016-10-26
KR101102364B1 (ko) 2012-01-03
EP2478909A2 (en) 2012-07-25
MX2012002786A (es) 2012-06-25
CN102497867A (zh) 2012-06-13
EP2478909B1 (en) 2018-04-25
KR20110030852A (ko) 2011-03-24
RU2533230C2 (ru) 2014-11-20
EP2478909A4 (en) 2014-02-26
RU2012109614A (ru) 2013-10-27
CN102497867B (zh) 2015-04-29

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