BR112017008033A2 - composição farmacêutica para administração oral e respectivo processo de preparação - Google Patents

composição farmacêutica para administração oral e respectivo processo de preparação

Info

Publication number
BR112017008033A2
BR112017008033A2 BR112017008033-8A BR112017008033A BR112017008033A2 BR 112017008033 A2 BR112017008033 A2 BR 112017008033A2 BR 112017008033 A BR112017008033 A BR 112017008033A BR 112017008033 A2 BR112017008033 A2 BR 112017008033A2
Authority
BR
Brazil
Prior art keywords
taxane
pharmaceutical composition
oral administration
weight
glycerol
Prior art date
Application number
BR112017008033-8A
Other languages
English (en)
Korean (ko)
Other versions
BR112017008033B1 (pt
Inventor
Lee In-Hyun
Son Min-Hee
Park Yeong-Taek
Lee Seul-Ae
Lee Han-Koo
Original Assignee
Dae Hwa Pharma. Co., 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
Application filed by Dae Hwa Pharma. Co., Ltd. filed Critical Dae Hwa Pharma. Co., Ltd.
Publication of BR112017008033A2 publication Critical patent/BR112017008033A2/pt
Publication of BR112017008033B1 publication Critical patent/BR112017008033B1/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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

a presente invenção propõe uma composição farmacêutica para administração oral, a qual compreende (a) um taxano, (b) um triglicerídeo de cadeia média, (c) um complexo de oleoil glicerol com 30% a 65% em peso de teor de mono-oleoil glicerol, 15% a 50% em peso de teor de dioleoil glicerol e 2% a 20% em peso de teor de trioleoil glicerol, (d) um surfactante e, como opção, (e) éster de ácido graxo de polioxil gliceril, e um processo para prepará-la.
BR112017008033-8A 2014-10-31 2015-07-30 Composição farmacêutica para administração oral e respectivo processo de preparação BR112017008033B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2014-0150173 2014-10-31
KR1020140150173A KR101542364B1 (ko) 2014-10-31 2014-10-31 탁산을 포함하는 경구 투여용 약학 조성물
PCT/KR2015/007987 WO2016068457A1 (ko) 2014-10-31 2015-07-30 탁산을 포함하는 경구 투여용 약학 조성물

Publications (2)

Publication Number Publication Date
BR112017008033A2 true BR112017008033A2 (pt) 2018-01-23
BR112017008033B1 BR112017008033B1 (pt) 2023-05-09

Family

ID=53886623

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017008033-8A BR112017008033B1 (pt) 2014-10-31 2015-07-30 Composição farmacêutica para administração oral e respectivo processo de preparação

Country Status (11)

Country Link
US (2) US10653663B2 (pt)
EP (1) EP3213746B1 (pt)
JP (1) JP6521274B2 (pt)
KR (1) KR101542364B1 (pt)
CN (2) CN112691078B (pt)
BR (1) BR112017008033B1 (pt)
CA (1) CA2966146C (pt)
ES (1) ES2971042T3 (pt)
RU (1) RU2683326C2 (pt)
WO (1) WO2016068457A1 (pt)
ZA (1) ZA201703562B (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101612257B1 (ko) 2015-07-30 2016-04-20 대화제약 주식회사 고농도의 탁산을 포함하는 경구 투여용 약학 조성물
KR101612255B1 (ko) 2015-07-30 2016-04-20 대화제약 주식회사 고농도의 탁산을 포함하는 경구 투여용 약학 조성물
KR20200005110A (ko) * 2018-07-05 2020-01-15 대화제약 주식회사 탁산-함유 약학 조성물을 함유하는 의약품의 안정성 개선방법
KR102093100B1 (ko) * 2018-07-11 2020-03-26 대화제약 주식회사 산화 안정성이 향상된 탁산을 포함하는 경구용 약학 조성물
EP3955894A1 (en) 2019-04-18 2022-02-23 Yissum Research Development Company of the Hebrew University of Jerusalem Ltd Self-emulsifying drug delivery systems for delivery of lipophilic compounds
KR102185475B1 (ko) 2019-06-20 2020-12-02 대화제약 주식회사 이리노테칸 자유 염기를 포함하는 경구투여용 약학 조성물
KR20240047637A (ko) * 2022-10-05 2024-04-12 한국과학기술연구원 탁산을 포함하는 경구 투여용 약학 조성물 및 이의 제조방법

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU756752B2 (en) * 1998-04-01 2003-01-23 Skyepharma Canada Inc. Anticancer compositions
EP1365759A2 (en) * 2001-01-18 2003-12-03 PHARMACIA & UPJOHN COMPANY Chemotherapeutic microemulsion compositions of paclitaxel with improved oral bioavailability
US20020192280A1 (en) * 2001-05-01 2002-12-19 Angiotech Pharmaceuticals, Inc. Compositions and methods for treating inflammatory conditions utilizing protein or polysaccharide containing anti-microtubule agents
HUP0501186A2 (en) * 2001-12-03 2006-05-29 Novacea Pharmaceutical compositions comprising active vitamin d compounds
KR100441167B1 (ko) * 2001-12-27 2004-07-21 씨제이 주식회사 마이크로에멀젼 예비 농축액 조성물
KR100573289B1 (ko) * 2002-07-20 2006-04-24 대화제약 주식회사 방광내 투여를 통한 방광암치료용 파클리탁셀 조성물 및그의 제조 방법
KR100533458B1 (ko) * 2002-07-20 2005-12-07 대화제약 주식회사 파클리탁셀의 가용화용 조성물 및 그의 제조 방법
EP1498120A1 (en) * 2003-07-18 2005-01-19 Aventis Pharma S.A. Semi-solid formulations for the oral administration of taxoids
EP1498143A1 (en) * 2003-07-18 2005-01-19 Aventis Pharma S.A. Self-emulsifying and self-microemulsifying formulations for the oral administration of taxoids
CA2537029C (en) * 2003-11-26 2013-03-12 Likan Liang Micellar systems useful for delivery of lipophilic or hydrophobic compounds
FR2873585B1 (fr) * 2004-07-27 2006-11-17 Aventis Pharma Sa Nouvelles formulations galeniques de principes actifs
KR100737742B1 (ko) 2005-12-05 2007-07-10 대화제약 주식회사 파클리탁셀 조성물의 제조 방법
JP5501224B2 (ja) 2007-05-25 2014-05-21 ザ・ユニバーシティ・オブ・ブリティッシュ・コロンビア 治療薬の経口投与のための製剤および関連する方法
DE102007063134A1 (de) * 2007-12-24 2009-06-25 Sasol Germany Gmbh Verfahren zur Herstellung von Öl in Wasser Emulsionen aus selbstemulgierenden Gelkonzentraten

Also Published As

Publication number Publication date
RU2017118733A (ru) 2018-11-30
US20170312244A1 (en) 2017-11-02
RU2017118733A3 (pt) 2018-11-30
EP3213746A1 (en) 2017-09-06
JP6521274B2 (ja) 2019-05-29
CN112691078A (zh) 2021-04-23
US11116744B2 (en) 2021-09-14
US10653663B2 (en) 2020-05-19
US20200237707A1 (en) 2020-07-30
CA2966146C (en) 2022-04-26
CN106999440A (zh) 2017-08-01
EP3213746B1 (en) 2023-12-27
BR112017008033B1 (pt) 2023-05-09
EP3213746C0 (en) 2023-12-27
JP2017537976A (ja) 2017-12-21
ES2971042T3 (es) 2024-06-03
WO2016068457A1 (ko) 2016-05-06
CN106999440B (zh) 2021-02-12
CN112691078B (zh) 2023-03-10
KR101542364B1 (ko) 2015-08-07
EP3213746A4 (en) 2018-06-27
ZA201703562B (en) 2018-11-28
RU2683326C2 (ru) 2019-03-28
CA2966146A1 (en) 2016-05-06

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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.

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 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 30/07/2015, OBSERVADAS AS CONDICOES LEGAIS