AU2005215174B2 - Solid formulations of ospemifene - Google Patents

Solid formulations of ospemifene Download PDF

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Publication number
AU2005215174B2
AU2005215174B2 AU2005215174A AU2005215174A AU2005215174B2 AU 2005215174 B2 AU2005215174 B2 AU 2005215174B2 AU 2005215174 A AU2005215174 A AU 2005215174A AU 2005215174 A AU2005215174 A AU 2005215174A AU 2005215174 B2 AU2005215174 B2 AU 2005215174B2
Authority
AU
Australia
Prior art keywords
drug formulation
formulation according
granular
granulates
ospemifene
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2005215174A
Other languages
English (en)
Other versions
AU2005215174A1 (en
Inventor
Kaija Halonen
Veli-Matti Lehtola
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hormos Medical Ltd
Original Assignee
Hormos Medical Ltd
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=AU2005215174(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hormos Medical Ltd filed Critical Hormos Medical Ltd
Publication of AU2005215174A1 publication Critical patent/AU2005215174A1/en
Application granted granted Critical
Publication of AU2005215174B2 publication Critical patent/AU2005215174B2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61K9/14Particulate 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
    • A61K9/1605Excipients; 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
    • 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)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2005215174A 2004-02-23 2005-01-19 Solid formulations of ospemifene Ceased AU2005215174B2 (en)

Applications Claiming Priority (3)

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

Publications (2)

Publication Number Publication Date
AU2005215174A1 AU2005215174A1 (en) 2005-09-01
AU2005215174B2 true AU2005215174B2 (en) 2010-06-03

Family

ID=34861126

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2005215174A Ceased AU2005215174B2 (en) 2004-02-23 2005-01-19 Solid formulations of ospemifene

Country Status (19)

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

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ATE452637T1 (de) 2001-01-29 2010-01-15 Shionogi & Co Arzneipräparat, das als wirkstoff 5-methyl-1- phenyl-2-(1h)-pyridon enthält
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
ES2391626T3 (es) 2004-05-04 2012-11-28 Hormos Medical Ltd. Nuevas composiciones orales 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
CN101304738A (zh) * 2005-11-09 2008-11-12 霍尔莫斯医疗有限公司 非培米芬的制剂
CA2563690C (en) * 2006-10-12 2014-10-07 Pharmascience Inc. Pharmaceutical compositions comprising intra- and extra- granular fractions
WO2008099060A2 (en) 2007-02-14 2008-08-21 Hormos Medical Ltd Methods for the preparation of fispemifene from ospemifene
SI2518039T1 (sl) 2007-02-14 2015-02-27 Forendo Pharma Ltd. Postopek za pripravo terapevtsko dragocenih derivatov trifenilbutena
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
US10138190B2 (en) 2015-01-09 2018-11-27 Glenmark Pharmaceuticals Limited Process for preparation of ospemifene
AU2016229086B2 (en) * 2015-03-10 2018-12-06 Shionogi Inc. Solid dispersions
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
DK3573472T3 (da) * 2017-01-24 2025-01-27 Omnigen Res L L C Granuleret kosttilskud og fremgangsmåder til fremstilling og anvendelse deraf
HRP20221361T1 (hr) 2020-05-18 2023-01-06 Orexo Ab Novi farmaceutski sastav za davanje lijeka
WO2023094826A1 (en) 2021-11-25 2023-06-01 Orexo Ab Pharmaceutical composition comprising adrenaline
GB202117016D0 (en) 2021-11-25 2022-01-12 Orexo Ab New pharmaceutical device

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US6245352B1 (en) * 1999-04-27 2001-06-12 Eli Lilly And Company Pharmaceutical formulation
US6525084B2 (en) * 1998-07-23 2003-02-25 Novo Nordisk A/S Stable pharmaceutical formulation
CA2458452A1 (en) * 2001-08-10 2003-02-27 Takeda Chemical Industries, Ltd. Gnrh agonist combination drugs

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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
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WO1996007402A1 (en) * 1994-09-07 1996-03-14 Orion-Yhtymä Oy Triphenylethylenes for the prevention and treatment of osteoporosis
US6525084B2 (en) * 1998-07-23 2003-02-25 Novo Nordisk A/S Stable pharmaceutical formulation
US6245352B1 (en) * 1999-04-27 2001-06-12 Eli Lilly And Company Pharmaceutical formulation
CA2458452A1 (en) * 2001-08-10 2003-02-27 Takeda Chemical Industries, Ltd. Gnrh agonist combination drugs

Also Published As

Publication number Publication date
RU2675624C2 (ru) 2018-12-21
JP2007523210A (ja) 2007-08-16
BRPI0507897A (pt) 2007-07-24
RU2011112362A (ru) 2012-10-10
CA2554695A1 (en) 2005-09-01
CA2554695C (en) 2013-03-05
DE602005027540D1 (de) 2011-06-01
EP1718288A1 (en) 2006-11-08
EP2286806A1 (en) 2011-02-23
NO20064262L (no) 2006-09-20
RU2006133902A (ru) 2008-03-27
RU2423113C2 (ru) 2011-07-10
CN1953741B (zh) 2011-03-30
NO341573B1 (no) 2017-12-04
US8642079B2 (en) 2014-02-04
BRPI0507897B8 (pt) 2021-05-25
CN1953741A (zh) 2007-04-25
ATE506054T1 (de) 2011-05-15
CY1111689T1 (el) 2015-10-07
BRPI0507897B1 (pt) 2018-10-09
PL1718288T3 (pl) 2011-10-31
US20140220118A1 (en) 2014-08-07
PT1718288E (pt) 2011-07-25
WO2005079777A1 (en) 2005-09-01
SI1718288T1 (sl) 2011-09-30
JP4993203B2 (ja) 2012-08-08
ES2364970T3 (es) 2011-09-19
DK1718288T3 (da) 2011-08-01
MXPA06009546A (es) 2007-04-10
US20050187301A1 (en) 2005-08-25
AU2005215174A1 (en) 2005-09-01
EP1718288B1 (en) 2011-04-20

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FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired