CN112843014A - 骨化二醇软胶囊 - Google Patents

骨化二醇软胶囊 Download PDF

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Publication number
CN112843014A
CN112843014A CN202110038958.XA CN202110038958A CN112843014A CN 112843014 A CN112843014 A CN 112843014A CN 202110038958 A CN202110038958 A CN 202110038958A CN 112843014 A CN112843014 A CN 112843014A
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Prior art keywords
soft capsule
pharmaceutically acceptable
calcifediol
acid
group
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Pending
Application number
CN202110038958.XA
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English (en)
Chinese (zh)
Inventor
约瑟普·马里亚·苏涅·内格雷
伊格纳西奥·奥尔特加·阿斯皮塔特
佩帕·德尔阿雷纳尔·巴里奥斯
贡萨洛·埃尔南德斯·埃雷罗
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Faes Farma SA
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Faes Farma SA
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Application filed by Faes Farma SA filed Critical Faes Farma SA
Publication of CN112843014A publication Critical patent/CN112843014A/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5939,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/662Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
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    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

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  • Health & Medical Sciences (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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Paints Or Removers (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Lubricants (AREA)
  • Carbon And Carbon Compounds (AREA)
CN202110038958.XA 2015-02-06 2016-02-05 骨化二醇软胶囊 Pending CN112843014A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15382042.8 2015-02-06
EP15382042.8A EP3053598A1 (en) 2015-02-06 2015-02-06 Calcifediol soft capsules
CN201680004162.XA CN106999441B (zh) 2015-02-06 2016-02-05 骨化二醇软胶囊

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201680004162.XA Division CN106999441B (zh) 2015-02-06 2016-02-05 骨化二醇软胶囊

Publications (1)

Publication Number Publication Date
CN112843014A true CN112843014A (zh) 2021-05-28

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CN202110038958.XA Pending CN112843014A (zh) 2015-02-06 2016-02-05 骨化二醇软胶囊
CN201680004162.XA Active CN106999441B (zh) 2015-02-06 2016-02-05 骨化二醇软胶囊

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US (1) US10525018B2 (enExample)
EP (3) EP3053598A1 (enExample)
JP (2) JP6427270B2 (enExample)
KR (1) KR101971384B1 (enExample)
CN (2) CN112843014A (enExample)
AU (1) AU2016214336B2 (enExample)
BR (1) BR112017010657B1 (enExample)
CA (1) CA2967170C (enExample)
CL (1) CL2017001335A1 (enExample)
CO (1) CO2017004545A2 (enExample)
CY (1) CY1122976T1 (enExample)
DK (2) DK3204047T3 (enExample)
EA (1) EA034821B1 (enExample)
ES (2) ES2738642T3 (enExample)
HR (1) HRP20200859T1 (enExample)
HU (1) HUE050133T2 (enExample)
LT (1) LT3204047T (enExample)
MA (2) MA52507A (enExample)
MD (1) MD3204047T2 (enExample)
ME (1) ME03739B (enExample)
MX (1) MX367999B (enExample)
MY (2) MY199862A (enExample)
PE (1) PE20170911A1 (enExample)
PH (1) PH12017501350A1 (enExample)
PL (1) PL3204047T3 (enExample)
PT (1) PT3204047T (enExample)
RS (2) RS64166B1 (enExample)
SI (1) SI3204047T1 (enExample)
SM (1) SMT202000278T1 (enExample)
WO (1) WO2016124724A1 (enExample)
ZA (1) ZA201703444B (enExample)

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EP3053598A1 (en) 2015-02-06 2016-08-10 Faes Farma, S.A. Calcifediol soft capsules
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CN109662953B (zh) * 2019-02-18 2022-05-10 威海金思力生物科技股份有限公司 一种维生素d软胶囊及其制作方法
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CN113559079B (zh) * 2020-04-28 2023-10-20 江苏恒瑞医药股份有限公司 一种软胶囊及其制备方法和用途
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CN114159402A (zh) * 2021-12-21 2022-03-11 湖州展望天明药业有限公司 一种不透明植物胶囊及其制备方法
CN116350598A (zh) * 2021-12-28 2023-06-30 人福普克药业(武汉)有限公司 一种用于维生素d类药物的成膜组合物及其药物制剂和制备方法
CN114712505B (zh) * 2022-03-10 2023-09-05 南方医科大学南方医院 维生素d受体激动剂在制备预防和/或治疗炎症性骨丢失的药物中的应用
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JP2018184458A (ja) 2018-11-22
MA52507A (fr) 2021-03-10
MX367999B (es) 2019-09-12
ES2738642T3 (es) 2020-11-06
CN106999441B (zh) 2020-11-24
RS60467B1 (sr) 2020-07-31
ME03739B (me) 2021-01-20
EP3053598A1 (en) 2016-08-10
CL2017001335A1 (es) 2018-01-19
JP6697779B2 (ja) 2020-05-27
PE20170911A1 (es) 2017-07-12
KR20170093123A (ko) 2017-08-14
EA034821B1 (ru) 2020-03-25
CO2017004545A2 (es) 2017-08-31
RS64166B1 (sr) 2023-05-31
MX2017006272A (es) 2017-08-14
SI3204047T1 (sl) 2020-07-31
EA201791097A1 (ru) 2017-08-31
US10525018B2 (en) 2020-01-07
LT3204047T (lt) 2020-07-10
BR112017010657B1 (pt) 2022-10-11
WO2016124724A1 (en) 2016-08-11
SMT202000278T1 (it) 2020-07-08
US20170348249A1 (en) 2017-12-07
MD3204047T2 (ro) 2020-06-30
CA2967170A1 (en) 2016-08-11
JP6427270B2 (ja) 2018-11-21
AU2016214336B2 (en) 2017-10-19
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MA41058B1 (fr) 2020-05-29
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HUE050133T2 (hu) 2020-11-30
BR112017010657A2 (pt) 2018-02-14
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CN106999441A (zh) 2017-08-01
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