BRPI0507897B8 - formulação de droga sólida - Google Patents

formulação de droga sólida

Info

Publication number
BRPI0507897B8
BRPI0507897B8 BRPI0507897A BRPI0507897A BRPI0507897B8 BR PI0507897 B8 BRPI0507897 B8 BR PI0507897B8 BR PI0507897 A BRPI0507897 A BR PI0507897A BR PI0507897 A BRPI0507897 A BR PI0507897A BR PI0507897 B8 BRPI0507897 B8 BR PI0507897B8
Authority
BR
Brazil
Prior art keywords
drug formulation
solid drug
deaminohydroxy
toremifene
stereoisomer
Prior art date
Application number
BRPI0507897A
Other languages
English (en)
Inventor
Halonen Kaija
Lehtola Veli-Matti
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=BRPI0507897(B8) "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 BRPI0507897A publication Critical patent/BRPI0507897A/pt
Publication of BRPI0507897B1 publication Critical patent/BRPI0507897B1/pt
Publication of BRPI0507897B8 publication Critical patent/BRPI0507897B8/pt

Links

Classifications

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K31/075—Ethers or acetals
    • 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
    • A61K31/075—Ethers or acetals
    • A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • 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
    • A61K9/1617—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
    • A61K9/1635—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
    • 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
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/32—Antioestrogens

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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Endocrinology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Reproductive Health (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)

Abstract

formulação de droga sólida a invenção refere-se a uma formulação de droga sólida, que compreende grânulos contendo ospemifeno (também conhecido como (deaminoidróxi) toremifeno) como um composto terapeuticamente ativo, ou um isômero geométrico, um estereoisômero, um sal farmaceuticamente aceitável, ou um éster do mesmo, ou um metabólito do mesmo, (i) em combinação com um ou mais excipientes intra-granulares.
BRPI0507897A 2004-02-23 2005-01-19 formulação de droga sólida BRPI0507897B8 (pt)

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 (3)

Publication Number Publication Date
BRPI0507897A BRPI0507897A (pt) 2007-07-24
BRPI0507897B1 BRPI0507897B1 (pt) 2018-10-09
BRPI0507897B8 true BRPI0507897B8 (pt) 2021-05-25

Family

ID=34861126

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0507897A BRPI0507897B8 (pt) 2004-02-23 2005-01-19 formulação de droga sólida

Country Status (19)

Country Link
US (2) US8642079B2 (pt)
EP (2) EP2286806A1 (pt)
JP (1) JP4993203B2 (pt)
CN (1) CN1953741B (pt)
AT (1) ATE506054T1 (pt)
AU (1) AU2005215174B2 (pt)
BR (1) BRPI0507897B8 (pt)
CA (1) CA2554695C (pt)
CY (1) CY1111689T1 (pt)
DE (1) DE602005027540D1 (pt)
DK (1) DK1718288T3 (pt)
ES (1) ES2364970T3 (pt)
MX (1) MXPA06009546A (pt)
NO (1) NO341573B1 (pt)
PL (1) PL1718288T3 (pt)
PT (1) PT1718288E (pt)
RU (2) RU2423113C2 (pt)
SI (1) SI1718288T1 (pt)
WO (1) WO2005079777A1 (pt)

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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
CN1950071A (zh) 2004-05-04 2007-04-18 霍尔莫斯医疗有限公司 ospemifene的新口服制剂
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
JP2009514944A (ja) * 2005-11-09 2009-04-09 ホルモス メディカル リミテッド フィスペミフェン製剤
CA2563690C (en) * 2006-10-12 2014-10-07 Pharmascience Inc. Pharmaceutical compositions comprising intra- and extra- granular fractions
SI2121553T1 (sl) 2007-02-14 2012-11-30 Hormos Medical Ltd Postopek za pripravo terapevtsko uporabnih trifenilbutenskih derivatov
WO2008099060A2 (en) 2007-02-14 2008-08-21 Hormos Medical Ltd Methods for the preparation of fispemifene from ospemifene
CA2719608A1 (en) * 2008-04-01 2009-10-08 Ocean 1 806, Llc Orodispersable formulations of phosphodiesterase-5 (pde-5) inhibitors
US9321712B2 (en) 2012-10-19 2016-04-26 Fermion Oy 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
WO2016145138A1 (en) 2015-03-10 2016-09-15 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
WO2018140450A1 (en) * 2017-01-24 2018-08-02 Costigan Timothy E Granulated feed supplement and methods for making and using
RS63725B1 (sr) 2020-05-18 2022-12-30 Orexo Ab Nova farmaceutska kompozicija za davanje leka
AR127780A1 (es) 2021-11-25 2024-02-28 Orexo Ab Nueva composición farmacéutica que comprende adrenalina

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Also Published As

Publication number Publication date
JP4993203B2 (ja) 2012-08-08
SI1718288T1 (sl) 2011-09-30
AU2005215174A1 (en) 2005-09-01
NO20064262L (no) 2006-09-20
EP2286806A1 (en) 2011-02-23
NO341573B1 (no) 2017-12-04
EP1718288A1 (en) 2006-11-08
WO2005079777A1 (en) 2005-09-01
MXPA06009546A (es) 2007-04-10
US8642079B2 (en) 2014-02-04
AU2005215174B2 (en) 2010-06-03
CY1111689T1 (el) 2015-10-07
US20140220118A1 (en) 2014-08-07
PL1718288T3 (pl) 2011-10-31
BRPI0507897A (pt) 2007-07-24
US20050187301A1 (en) 2005-08-25
CN1953741A (zh) 2007-04-25
DK1718288T3 (da) 2011-08-01
CN1953741B (zh) 2011-03-30
JP2007523210A (ja) 2007-08-16
RU2675624C2 (ru) 2018-12-21
DE602005027540D1 (de) 2011-06-01
CA2554695C (en) 2013-03-05
RU2006133902A (ru) 2008-03-27
ES2364970T3 (es) 2011-09-19
ATE506054T1 (de) 2011-05-15
RU2423113C2 (ru) 2011-07-10
BRPI0507897B1 (pt) 2018-10-09
EP1718288B1 (en) 2011-04-20
CA2554695A1 (en) 2005-09-01
RU2011112362A (ru) 2012-10-10
PT1718288E (pt) 2011-07-25

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
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