NO341573B1 - Faste formuleringer av ospemifen og fremgangsmåte for fremstilling av ospemifen - Google Patents

Faste formuleringer av ospemifen og fremgangsmåte for fremstilling av ospemifen

Info

Publication number
NO341573B1
NO341573B1 NO20064262A NO20064262A NO341573B1 NO 341573 B1 NO341573 B1 NO 341573B1 NO 20064262 A NO20064262 A NO 20064262A NO 20064262 A NO20064262 A NO 20064262A NO 341573 B1 NO341573 B1 NO 341573B1
Authority
NO
Norway
Prior art keywords
ospemifene
preparation
solid formulations
stereoisomer
metabolite
Prior art date
Application number
NO20064262A
Other languages
English (en)
Other versions
NO20064262L (no
Inventor
Veli-Matti Lehtola
Kaija Halonen
Original Assignee
Hormos Medical Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34861126&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO341573(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hormos Medical Corp filed Critical Hormos Medical Corp
Publication of NO20064262L publication Critical patent/NO20064262L/no
Publication of NO341573B1 publication Critical patent/NO341573B1/no

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/075Ethers or acetals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/075Ethers or acetals
    • A61K31/085Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • 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
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/32Antioestrogens

Landscapes

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

Abstract

Foreliggende oppfinnelse vedrører faste medikamentformuleringer omfattende granulater inneholdende ospemifen (også kjent som (deaminohydroksy)toremifen) som en terapeutisk aktiv forbindelse, eller en geometrisk isomer, en stereoisomer, et farmasøytisk akseptabelt salt, en ester derav eller en metabolitt derav, i kombinasjon med én eller flere intra-granulære eksepienser.
NO20064262A 2004-02-23 2006-09-20 Faste formuleringer av ospemifen og fremgangsmåte for fremstilling av ospemifen NO341573B1 (no)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/783,024 US8642079B2 (en) 2004-02-23 2004-02-23 Solid formulations of ospemifene
PCT/FI2005/000037 WO2005079777A1 (en) 2004-02-23 2005-01-19 Solid formulations of ospemifene

Publications (2)

Publication Number Publication Date
NO20064262L NO20064262L (no) 2006-09-20
NO341573B1 true NO341573B1 (no) 2017-12-04

Family

ID=34861126

Family Applications (1)

Application Number Title Priority Date Filing Date
NO20064262A NO341573B1 (no) 2004-02-23 2006-09-20 Faste formuleringer av ospemifen og fremgangsmåte for fremstilling av ospemifen

Country Status (19)

Country Link
US (2) US8642079B2 (no)
EP (2) EP1718288B1 (no)
JP (1) JP4993203B2 (no)
CN (1) CN1953741B (no)
AT (1) ATE506054T1 (no)
AU (1) AU2005215174B2 (no)
BR (1) BRPI0507897B8 (no)
CA (1) CA2554695C (no)
CY (1) CY1111689T1 (no)
DE (1) DE602005027540D1 (no)
DK (1) DK1718288T3 (no)
ES (1) ES2364970T3 (no)
MX (1) MXPA06009546A (no)
NO (1) NO341573B1 (no)
PL (1) PL1718288T3 (no)
PT (1) PT1718288E (no)
RU (2) RU2423113C2 (no)
SI (1) SI1718288T1 (no)
WO (1) WO2005079777A1 (no)

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US7867516B2 (en) 2001-01-29 2011-01-11 Shionogi & Co., Ltd. Medicinal preparation containing 5-methyl-1-phenyl-2-(1h)-pyridone as active ingredient
US8236861B2 (en) 2004-02-13 2012-08-07 Hormos Medical Corporation Method for enhancing the bioavailablity of ospemifene
US8642079B2 (en) 2004-02-23 2014-02-04 Hormos Medical Corporation Solid formulations of ospemifene
PT1742618E (pt) 2004-05-04 2012-10-11 Hormos Medical Ltd Formulações líquidas orais de ospemifeno
US8758821B2 (en) * 2004-05-04 2014-06-24 Hormos Medical Ltd. Oral formulations of ospemifene
NZ591443A (en) * 2005-09-22 2013-04-26 Intermune Inc Granule formation of pirfenidone and pharmaceutically acceptable excipients
KR20080075157A (ko) * 2005-11-09 2008-08-14 호르모스 메디칼 리미티드 피스페미펜 제제
CA2563690C (en) * 2006-10-12 2014-10-07 Pharmascience Inc. Pharmaceutical compositions comprising intra- and extra- granular fractions
US7504530B2 (en) 2007-02-14 2009-03-17 Hormos Medical Ltd. Methods for the preparation of fispemifene from ospemifene
JP5363344B2 (ja) 2007-02-14 2013-12-11 ホルモス メディカル リミテッド 治療に有用なトリフェニルブテン誘導体の調製方法
MX2010010383A (es) * 2008-04-01 2010-12-14 Ocean 1 806 Llc Formulaciones orodispersables de inhibidores de fosfodiesterasa-5 (pde-5).
WO2014060639A1 (en) 2012-10-19 2014-04-24 Fermion Oy A process for the preparation of ospemifene
CN104788300B (zh) * 2014-01-22 2017-01-11 南京华威医药科技开发有限公司 欧司哌米芬多晶型
US20160000732A1 (en) * 2014-07-02 2016-01-07 Cadila Healthcare Limited Oral pharmaceutical compositions of ospemifene
US20160022604A1 (en) * 2014-07-23 2016-01-28 Cadila Healthcare Limited Directly compressed ospemifene compositions
WO2016110805A1 (en) * 2015-01-09 2016-07-14 Glenmark Pharmaceuticals Limited Process for preparation of ospemifene
CN107529758B (zh) * 2015-03-10 2021-01-26 盐野义制药公司 固体分散体
CA2937365C (en) 2016-03-29 2018-09-18 F. Hoffmann-La Roche Ag Granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone and method of making the same
EP3573472A1 (en) * 2017-01-24 2019-12-04 Omnigen Research, L.L.C. Granulated feed supplement and methods for making and using
BR112022023307A2 (pt) 2020-05-18 2022-12-20 Orexo Ab Composição farmacêutica para entrega de fármacos
EP4236921A1 (en) 2021-11-25 2023-09-06 Orexo AB Pharmaceutical composition comprising adrenaline

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Also Published As

Publication number Publication date
BRPI0507897A (pt) 2007-07-24
CY1111689T1 (el) 2015-10-07
JP4993203B2 (ja) 2012-08-08
CN1953741B (zh) 2011-03-30
PT1718288E (pt) 2011-07-25
DE602005027540D1 (de) 2011-06-01
CN1953741A (zh) 2007-04-25
NO20064262L (no) 2006-09-20
RU2006133902A (ru) 2008-03-27
SI1718288T1 (sl) 2011-09-30
AU2005215174B2 (en) 2010-06-03
DK1718288T3 (da) 2011-08-01
EP1718288A1 (en) 2006-11-08
PL1718288T3 (pl) 2011-10-31
BRPI0507897B8 (pt) 2021-05-25
JP2007523210A (ja) 2007-08-16
EP1718288B1 (en) 2011-04-20
MXPA06009546A (es) 2007-04-10
US20050187301A1 (en) 2005-08-25
ATE506054T1 (de) 2011-05-15
WO2005079777A1 (en) 2005-09-01
CA2554695A1 (en) 2005-09-01
US20140220118A1 (en) 2014-08-07
RU2423113C2 (ru) 2011-07-10
BRPI0507897B1 (pt) 2018-10-09
EP2286806A1 (en) 2011-02-23
RU2675624C2 (ru) 2018-12-21
RU2011112362A (ru) 2012-10-10
US8642079B2 (en) 2014-02-04
CA2554695C (en) 2013-03-05
ES2364970T3 (es) 2011-09-19
AU2005215174A1 (en) 2005-09-01

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