BRPI0507897A - formulação de droga sólida - Google Patents

formulação de droga sólida

Info

Publication number
BRPI0507897A
BRPI0507897A BRPI0507897-0A BRPI0507897A BRPI0507897A BR PI0507897 A BRPI0507897 A BR PI0507897A BR PI0507897 A BRPI0507897 A BR PI0507897A BR PI0507897 A BRPI0507897 A BR PI0507897A
Authority
BR
Brazil
Prior art keywords
drug formulation
solid drug
deaminoidoxy
toremifene
stereoisomer
Prior art date
Application number
BRPI0507897-0A
Other languages
English (en)
Inventor
Veli-Matti Lehtola
Kaija Halonen
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=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0507897(A) "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

    • 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
    • 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
    • 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
    • A61K9/1682Processes
    • 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)
  • 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 isómero geométrico, um estereoisómero, um sal farmaceuticamente aceitável, ou um éster do mesmo, ou um metabólito do mesmo, 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 true BRPI0507897A (pt) 2007-07-24
BRPI0507897B1 BRPI0507897B1 (pt) 2018-10-09
BRPI0507897B8 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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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
US8758821B2 (en) * 2004-05-04 2014-06-24 Hormos Medical Ltd. Oral formulations of ospemifene
PL2275098T3 (pl) 2004-05-04 2012-12-31 Hormos Medical Ltd Nowe doustne preparaty ospemifenu
NZ591443A (en) * 2005-09-22 2013-04-26 Intermune Inc Granule formation of pirfenidone and pharmaceutically acceptable excipients
US20070104743A1 (en) * 2005-11-09 2007-05-10 Hormos Medical Ltd. Formulations of fispemifene
CA2563690C (en) * 2006-10-12 2014-10-07 Pharmascience Inc. Pharmaceutical compositions comprising intra- and extra- granular fractions
EP2518039B8 (en) 2007-02-14 2014-12-17 Forendo Pharma Ltd. Method for the preparation of therapeutically valuable triphenylbutene derivatives
WO2008099060A2 (en) 2007-02-14 2008-08-21 Hormos Medical Ltd Methods for the preparation of fispemifene from ospemifene
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
US10596118B2 (en) * 2015-03-10 2020-03-24 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
CA3047601A1 (en) * 2017-01-24 2018-08-02 OmniGen Research, L.L.C. Granulated feed supplement and methods for making and using
CN115666513A (zh) 2020-05-18 2023-01-31 奥瑞克索股份公司 用于药物递送的新颖药物组合物
KR20240103005A (ko) 2021-11-25 2024-07-03 오렉쏘 에이비 아드레날린을 포함하는 약학적 조성물

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Also Published As

Publication number Publication date
WO2005079777A1 (en) 2005-09-01
EP2286806A1 (en) 2011-02-23
NO20064262L (no) 2006-09-20
CA2554695A1 (en) 2005-09-01
MXPA06009546A (es) 2007-04-10
RU2006133902A (ru) 2008-03-27
SI1718288T1 (sl) 2011-09-30
RU2423113C2 (ru) 2011-07-10
PL1718288T3 (pl) 2011-10-31
NO341573B1 (no) 2017-12-04
CN1953741A (zh) 2007-04-25
EP1718288B1 (en) 2011-04-20
CA2554695C (en) 2013-03-05
EP1718288A1 (en) 2006-11-08
CY1111689T1 (el) 2015-10-07
RU2675624C2 (ru) 2018-12-21
US8642079B2 (en) 2014-02-04
BRPI0507897B8 (pt) 2021-05-25
DE602005027540D1 (de) 2011-06-01
ATE506054T1 (de) 2011-05-15
CN1953741B (zh) 2011-03-30
BRPI0507897B1 (pt) 2018-10-09
AU2005215174B2 (en) 2010-06-03
JP2007523210A (ja) 2007-08-16
PT1718288E (pt) 2011-07-25
AU2005215174A1 (en) 2005-09-01
JP4993203B2 (ja) 2012-08-08
ES2364970T3 (es) 2011-09-19
US20140220118A1 (en) 2014-08-07
DK1718288T3 (da) 2011-08-01
RU2011112362A (ru) 2012-10-10
US20050187301A1 (en) 2005-08-25

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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]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 09/10/2018, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/01/2005 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

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B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2758 DE 14-11-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.