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BR112016013502A2 - unidade de dosagem sólida que desintegra oralmente contendo um componente de estetrol. - Google Patents

unidade de dosagem sólida que desintegra oralmente contendo um componente de estetrol.

Info

Publication number
BR112016013502A2
BR112016013502A2 BR112016013502A BR112016013502A BR112016013502A2 BR 112016013502 A2 BR112016013502 A2 BR 112016013502A2 BR 112016013502 A BR112016013502 A BR 112016013502A BR 112016013502 A BR112016013502 A BR 112016013502A BR 112016013502 A2 BR112016013502 A2 BR 112016013502A2
Authority
BR
Brazil
Prior art keywords
dosage unit
solid dosage
unit containing
orally disintegrating
disintegrating solid
Prior art date
Application number
BR112016013502A
Other languages
English (en)
Other versions
BR112016013502B1 (pt
Inventor
Jan Tijmen Coelingh Bennink Herman
Jan Platteeuw Johannes
Original Assignee
Donesta Bioscience B V
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=49759137&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112016013502(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Donesta Bioscience B V filed Critical Donesta Bioscience B V
Publication of BR112016013502A2 publication Critical patent/BR112016013502A2/pt
Publication of BR112016013502B1 publication Critical patent/BR112016013502B1/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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • 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
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30Oestrogens

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BR112016013502-4A 2013-12-12 2014-12-10 unidade de dosagem farmacêutica sólida que desintegra oralmente contendo um componente de estetrol, método para a preparação da unidade de dosagem sólida e uso de grânulos consistindo em um componente de estetrol BR112016013502B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13196904.0 2013-12-12
EP13196904 2013-12-12
PCT/EP2014/077127 WO2015086643A1 (en) 2013-12-12 2014-12-10 Orally disintegrating solid dosage unit containing an estetrol component

Publications (2)

Publication Number Publication Date
BR112016013502A2 true BR112016013502A2 (pt) 2018-07-03
BR112016013502B1 BR112016013502B1 (pt) 2021-05-11

Family

ID=49759137

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016013502-4A BR112016013502B1 (pt) 2013-12-12 2014-12-10 unidade de dosagem farmacêutica sólida que desintegra oralmente contendo um componente de estetrol, método para a preparação da unidade de dosagem sólida e uso de grânulos consistindo em um componente de estetrol

Country Status (29)

Country Link
US (2) US9884064B2 (pt)
EP (1) EP3079671B1 (pt)
JP (1) JP6447931B2 (pt)
KR (1) KR102265150B1 (pt)
CN (1) CN105979935B (pt)
AU (1) AU2014363599B2 (pt)
BR (1) BR112016013502B1 (pt)
CA (1) CA2932855C (pt)
CL (1) CL2016001411A1 (pt)
CY (1) CY1119817T1 (pt)
DK (1) DK3079671T3 (pt)
EA (1) EA032306B1 (pt)
ES (1) ES2655076T3 (pt)
HR (1) HRP20180129T1 (pt)
HU (1) HUE035848T2 (pt)
IL (1) IL246082B (pt)
LT (1) LT3079671T (pt)
MA (1) MA39105B1 (pt)
MX (1) MX369035B (pt)
NO (1) NO3079671T3 (pt)
NZ (1) NZ720906A (pt)
PL (1) PL3079671T3 (pt)
PT (1) PT3079671T (pt)
RS (1) RS56738B1 (pt)
SG (1) SG11201604741UA (pt)
SI (1) SI3079671T1 (pt)
TN (1) TN2016000230A1 (pt)
WO (1) WO2015086643A1 (pt)
ZA (1) ZA201603903B (pt)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012164096A1 (en) 2011-06-01 2012-12-06 Estetra S.A. Process for the production of estetrol intermediates
US11053273B2 (en) 2011-06-01 2021-07-06 Estetra S.P.R.L. Process for the production of estetrol intermediates
EP2383279A1 (en) 2011-07-19 2011-11-02 Pantarhei Bioscience B.V. Process for the preparation of estetrol
AU2012293593B2 (en) * 2011-08-11 2017-03-23 Estetra Srl Use of estetrol as emergency contraceptive
DK3310345T3 (da) 2015-06-18 2021-05-25 Estetra Sprl Orodispersibel tablet indeholdende estetrol
CR20180041A (es) * 2015-06-18 2018-05-03 Mithra Pharmaceuticals S A Unidad de dosificación orodispersable que contiene un componente estetrol.
LT3310346T (lt) 2015-06-18 2021-06-10 Estetra Sprl Burnoje disperguojama tabletė, turinti estetrolio
JP6863547B2 (ja) 2015-06-18 2021-04-21 エステトラ ソシエテ プリーヴ ア レスポンサビリテ リミテ エステトロール成分を含有する口腔内崩壊性投与単位
US20200046729A1 (en) * 2016-08-05 2020-02-13 Estetra Sprl Methods using combined oral contraceptive compositions with reduced cardiovascular effects
CA3178291A1 (en) 2016-08-05 2018-04-12 Estetra Srl Method for the management of dysmenorrhea and menstrual pain
JP2021513507A (ja) * 2018-02-07 2021-05-27 エステトラ ソシエテ プリーヴ ア レスポンサビリテ リミテ 心臓血管系への影響を低減した避妊薬組成物
TWI801561B (zh) * 2018-04-19 2023-05-11 比利時商依思特拉私人有限責任公司 化合物及其用於緩解絕經相關症狀的用途
JOP20200260A1 (ar) 2018-04-19 2019-10-19 Estetra Sprl مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث
HU231240B1 (hu) 2019-09-03 2022-04-28 Richter Gedeon Nyrt. Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására
WO2024160373A1 (en) 2023-02-02 2024-08-08 Industriale Chimica S.R.L. PROCESS FOR PREPARING (15α,16α,17β)-ESTRA-1,3,5(10)-TRIENE-3,15,16,17-TETROL (ESTETROL) MONOHYDRATE

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997004752A1 (en) * 1995-07-26 1997-02-13 Duramed Pharmaceuticals, Inc. Pharmaceutical compositions of conjugated estrogens and methods for their use
US6117446A (en) 1999-01-26 2000-09-12 Place; Virgil A. Drug dosage unit for buccal administration of steroidal active agents
WO2002094276A1 (en) * 2001-05-18 2002-11-28 Pantarhei Bioscience B.V. Pharmaceutical composition for use in hormone replacement therapy
EP1260225A1 (en) 2001-05-18 2002-11-27 Pantarhei Bioscience B.V. A pharmaceutical composition for use in hormone replacement therapy
EP1390041B1 (en) * 2001-05-23 2009-11-25 Pantarhei Bioscience B.V. Drug delivery system comprising a tetrahydroxylated estrogen for use in hormonal contraception
WO2002094279A1 (en) 2001-05-23 2002-11-28 Pantarhei Bioscience B.V. Drug delivery system comprising a tetrahidroxilated estrogen for use in hormonal contraception
WO2003018026A1 (en) 2001-08-31 2003-03-06 Pantarhei Bioscience B.V. Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy
WO2003041718A1 (en) 2001-11-15 2003-05-22 Pantarhei Bioscience B.V. Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy
EA007599B1 (ru) * 2002-02-21 2006-12-29 Шеринг Акциенгезельшафт Фармацевтические композиции, содержащие один или несколько стероидов, один или несколько тетрагидрофолатных компонентов и витамин в
GB0410616D0 (en) 2004-05-13 2004-06-16 Unilever Plc Antiperspirant or deodorant compositions
US20070048369A1 (en) 2005-08-26 2007-03-01 National Starch And Chemical Investment Holding Corporation Mucosal delivery tablet
US20090221540A1 (en) 2006-01-09 2009-09-03 Pantarhei Bioscience B.V. Method of Treating An Acute Vascular Disorder
US20070286819A1 (en) 2006-06-08 2007-12-13 Warner Chilcott Company, Inc. Methods to administer ethinyl estradiol and prodrugs thereof with improved bioavailability
ES2659316T3 (es) * 2006-06-08 2018-03-14 Allergan Pharmaceuticals International Limited Procedimientos para administrar formas de dosificación sólidas de etinilestradiol y profármacos del mismo con biodisponibilidad mejorada
AR064014A1 (es) * 2006-11-29 2009-03-04 Wyeth Corp Tabletas bi-capa de estrogeno/moduladores selectivos de receptores de estrogeno (serm) y estrogeno/progestina
EP2124900B1 (en) * 2006-12-20 2014-12-03 Teva Women's Health, Inc. Orally disintegrating solid dosage forms comprising progestin and methods of making and use thereof
AR064875A1 (es) * 2007-01-12 2009-04-29 Wyeth Corp Composiciones de tableta en tableta
US8367647B2 (en) 2007-06-21 2013-02-05 Pantarhei Bioscience B.V. Treatment of meconium aspiration syndrome with estrogens
WO2010033832A2 (en) 2008-09-19 2010-03-25 Evestra, Inc. Estriol formulations
DE102009007771B4 (de) * 2009-02-05 2012-02-16 Bayer Schering Pharma Aktiengesellschaft Bukkales Applikationssystem, 17α-Estradiol enthaltend
CN102058604A (zh) * 2009-11-17 2011-05-18 北京万全阳光医学技术有限公司 一种含有地诺孕素和戊酸雌二醇的药物组合物及其制备方法
WO2014159377A1 (en) 2013-03-14 2014-10-02 Teva Women's Health, Inc. Compositions containing tanaproget and natural estrogens

Also Published As

Publication number Publication date
WO2015086643A1 (en) 2015-06-18
CY1119817T1 (el) 2018-06-27
HRP20180129T1 (hr) 2018-02-23
MA39105A1 (fr) 2017-04-28
JP2016540021A (ja) 2016-12-22
US9987287B2 (en) 2018-06-05
US9884064B2 (en) 2018-02-06
LT3079671T (lt) 2018-02-12
ES2655076T3 (es) 2018-02-16
KR20160102212A (ko) 2016-08-29
IL246082A0 (en) 2016-07-31
AU2014363599B2 (en) 2019-10-31
AU2014363599A1 (en) 2016-06-30
TN2016000230A1 (en) 2017-10-06
KR102265150B1 (ko) 2021-06-16
NO3079671T3 (pt) 2018-03-24
EP3079671A1 (en) 2016-10-19
PT3079671T (pt) 2017-11-24
MA39105B1 (fr) 2018-05-31
CA2932855A1 (en) 2015-06-18
RS56738B1 (sr) 2018-03-30
PL3079671T3 (pl) 2018-03-30
HUE035848T2 (en) 2018-05-28
BR112016013502B1 (pt) 2021-05-11
EA201691226A1 (ru) 2016-10-31
CN105979935B (zh) 2019-07-26
CL2016001411A1 (es) 2016-11-11
SI3079671T1 (en) 2018-04-30
US20180117063A1 (en) 2018-05-03
EA032306B1 (ru) 2019-05-31
IL246082B (en) 2018-03-29
JP6447931B2 (ja) 2019-01-09
MX369035B (es) 2019-10-25
ZA201603903B (en) 2018-07-25
US20160310506A1 (en) 2016-10-27
DK3079671T3 (en) 2017-12-11
NZ720906A (en) 2022-04-29
MX2016007595A (es) 2016-11-28
CN105979935A (zh) 2016-09-28
SG11201604741UA (en) 2016-07-28
CA2932855C (en) 2022-07-19
EP3079671B1 (en) 2017-10-25

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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]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B25A Requested transfer of rights approved

Owner name: ESTETRA SPRL (BE)

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: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/12/2014, OBSERVADAS AS CONDICOES LEGAIS.

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

Free format text: REFERENTE A 8A ANUIDADE.

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 2703 DE 25-10-2022 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.