BR112018072371A2 - uso de manitol, composição farmacêutica ou uso, método para preparar uma forma de dosagem sólida compreendendo tibolona - Google Patents

uso de manitol, composição farmacêutica ou uso, método para preparar uma forma de dosagem sólida compreendendo tibolona

Info

Publication number
BR112018072371A2
BR112018072371A2 BR112018072371A BR112018072371A BR112018072371A2 BR 112018072371 A2 BR112018072371 A2 BR 112018072371A2 BR 112018072371 A BR112018072371 A BR 112018072371A BR 112018072371 A BR112018072371 A BR 112018072371A BR 112018072371 A2 BR112018072371 A2 BR 112018072371A2
Authority
BR
Brazil
Prior art keywords
tibolone
dosage form
solid dosage
preparing
pharmaceutical composition
Prior art date
Application number
BR112018072371A
Other languages
English (en)
Inventor
Jaspart Séverine
Original Assignee
Mithra Pharmaceuticals S A
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
Application filed by Mithra Pharmaceuticals S A filed Critical Mithra Pharmaceuticals S A
Publication of BR112018072371A2 publication Critical patent/BR112018072371A2/pt

Links

Classifications

    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds 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
    • A61K31/567—Compounds 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 substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • 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

Abstract

a presente invenção se refere ao uso de um açúcar-álcool para estabilizar a tibolona em uma forma de dosagem sólida. a invenção também se refere a uma composição farmacêutica, em particular uma forma de dosagem sólida tal como um comprimido, compreendendo tibolona e um açúcar-álcool e um diluente não-açúcar-álcool, em que a razão em peso do açúcar-álcool para o diluente não-açúcar-álcool está compreendida entre 4:1 e 1:4, e um método para preparar a mesma.
BR112018072371A 2016-05-04 2017-05-04 uso de manitol, composição farmacêutica ou uso, método para preparar uma forma de dosagem sólida compreendendo tibolona BR112018072371A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16168390 2016-05-04
PCT/EP2017/060676 WO2017191266A1 (en) 2016-05-04 2017-05-04 Use of sugar-alcohols in tibolone compositions

Publications (1)

Publication Number Publication Date
BR112018072371A2 true BR112018072371A2 (pt) 2019-02-19

Family

ID=55919671

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018072371A BR112018072371A2 (pt) 2016-05-04 2017-05-04 uso de manitol, composição farmacêutica ou uso, método para preparar uma forma de dosagem sólida compreendendo tibolona

Country Status (13)

Country Link
US (1) US10736907B2 (pt)
EP (1) EP3452019B1 (pt)
AU (1) AU2017260799B2 (pt)
BR (1) BR112018072371A2 (pt)
CY (1) CY1124392T1 (pt)
DK (1) DK3452019T3 (pt)
ES (1) ES2889598T3 (pt)
HU (1) HUE055164T2 (pt)
MX (1) MX2018013274A (pt)
PL (1) PL3452019T3 (pt)
PT (1) PT3452019T (pt)
WO (1) WO2017191266A1 (pt)
ZA (1) ZA201807210B (pt)

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE665514A (pt) 1964-06-16
US4701450A (en) * 1984-03-21 1987-10-20 Akzo N.V. Steroids for use as immunomodulators
IE63051B1 (en) 1989-03-18 1995-03-22 Akzo Nv Pharmaceutical composition which contains a pharmaceutically suitable carrier and the compound having the structure (7alpha, 17alpha)-17-Hydroxy-7-methyl-19-nor-17-pregn-5(10)-en-20-yn- 3-one
IL123984A (en) 1997-04-22 2004-09-27 Akzo Nobel Nv Pharmacological dosage units containing tibolone and carrier pharmacy are acceptable
MXPA04003588A (es) 2001-10-18 2005-04-11 Norton Healthcare Ltd Nuevas formulaciones de tibolona.
TW200418525A (en) 2002-11-20 2004-10-01 Akzo Nobel Nv Coated pharmaceutical tablets containing Tibolone
EP1563833B1 (de) * 2004-02-06 2006-11-02 Helm AG Pharmazeutische Zubereitungen mit amorphem Tibolon
WO2005117899A1 (en) * 2004-06-02 2005-12-15 Cipla Limited Pharmaceutical composition comprising tibolone and process for procuding the same
CZ300465B6 (cs) 2007-07-25 2009-05-27 Zentiva, A. S. Zpusob výroby komprimované farmaceutické formulace s obsahem tibolonu
CN102085193B (zh) * 2009-12-08 2013-11-06 北京以岭生物工程技术有限公司 一种替勃龙口腔崩解片及其制备方法
JP6775155B2 (ja) 2015-09-14 2020-10-28 日本新薬株式会社 錠剤

Also Published As

Publication number Publication date
HUE055164T2 (hu) 2021-11-29
ES2889598T3 (es) 2022-01-12
MX2018013274A (es) 2019-03-06
US10736907B2 (en) 2020-08-11
WO2017191266A1 (en) 2017-11-09
ZA201807210B (en) 2022-04-28
CY1124392T1 (el) 2022-07-22
EP3452019B1 (en) 2021-06-23
PT3452019T (pt) 2021-07-28
US20190134058A1 (en) 2019-05-09
AU2017260799B2 (en) 2022-11-24
PL3452019T3 (pl) 2021-12-20
AU2017260799A1 (en) 2018-12-13
EP3452019A1 (en) 2019-03-13
DK3452019T3 (da) 2021-09-06

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Legal Events

Date Code Title Description
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.

B25A Requested transfer of rights approved

Owner name: NOVALON S.A. (BE)

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 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: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/05/2017, OBSERVADAS AS CONDICOES LEGAIS