KR102058097B1 - 다루나비어 복합 제제 - Google Patents

다루나비어 복합 제제 Download PDF

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Publication number
KR102058097B1
KR102058097B1 KR1020147000092A KR20147000092A KR102058097B1 KR 102058097 B1 KR102058097 B1 KR 102058097B1 KR 1020147000092 A KR1020147000092 A KR 1020147000092A KR 20147000092 A KR20147000092 A KR 20147000092A KR 102058097 B1 KR102058097 B1 KR 102058097B1
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South Korea
Prior art keywords
darunavir
silicon dioxide
granules
formulation
mixture
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KR1020147000092A
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English (en)
Korean (ko)
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KR20140068845A (ko
Inventor
우르바인 알퐁스 체. 델라에트
필립 에르나 에이치. 헤인스
오이겐 마리아 요제프 얀스
로얼 요스 엠. 메르텐스
데르 아보르트 게르트 판
Original Assignee
얀센 사이언시즈 아일랜드 언리미티드 컴퍼니
길리애드 사이언시즈, 인코포레이티드
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Publication of KR20140068845A publication Critical patent/KR20140068845A/ko
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    • 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
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR1020147000092A 2011-07-07 2012-07-06 다루나비어 복합 제제 Active KR102058097B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11173067.7 2011-07-07
EP11173067 2011-07-07
PCT/EP2012/063249 WO2013004818A1 (en) 2011-07-07 2012-07-06 Darunavir combination formulations

Publications (2)

Publication Number Publication Date
KR20140068845A KR20140068845A (ko) 2014-06-09
KR102058097B1 true KR102058097B1 (ko) 2019-12-20

Family

ID=46551505

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020147000092A Active KR102058097B1 (ko) 2011-07-07 2012-07-06 다루나비어 복합 제제

Country Status (24)

Country Link
US (3) US20140142070A1 (https=)
EP (1) EP2729130B1 (https=)
JP (1) JP6122427B2 (https=)
KR (1) KR102058097B1 (https=)
CN (1) CN103826616B (https=)
AU (1) AU2012280198B2 (https=)
BR (1) BR112014000290B1 (https=)
CA (1) CA2838659C (https=)
CY (1) CY1121999T1 (https=)
DK (1) DK2729130T3 (https=)
EA (1) EA026587B1 (https=)
ES (1) ES2651212T3 (https=)
HR (1) HRP20171889T1 (https=)
HU (1) HUE035241T2 (https=)
IL (1) IL229933A (https=)
LT (1) LT2729130T (https=)
MX (1) MX343689B (https=)
NO (1) NO2729130T3 (https=)
PL (1) PL2729130T3 (https=)
PT (1) PT2729130T (https=)
RS (1) RS56667B1 (https=)
SI (1) SI2729130T1 (https=)
SM (1) SMT201700574T1 (https=)
WO (1) WO2013004818A1 (https=)

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EP2729130B1 (en) 2011-07-07 2017-09-06 Janssen Sciences Ireland UC Darunavir combination formulations
HK1204980A1 (en) * 2012-03-01 2015-12-11 Gilead Sciences, Inc. Spray dried formulations
EA030003B1 (ru) 2012-12-21 2018-06-29 Джилид Сайэнс, Инк. Полициклическое карбамоилпиридоновое соединение и его фармацевтическое применение для лечения вич-инфекции
WO2017083304A1 (en) 2015-11-09 2017-05-18 Gilead Sciences, Inc. Therapeutic compositions for treatment of human immunodeficiency virus
EP3496710A4 (en) * 2016-08-08 2020-03-18 Hetero Labs Limited TABLET COMPOSITION WITH A HIGH ACTIVE SUBSTANCE LOAD FOR TREATING HIV
ES2952878T3 (es) * 2016-08-08 2023-11-06 Hetero Labs Ltd Una composición antirretroviral multiclase
BR112019002132A2 (pt) 2016-08-08 2019-05-14 Hetero Labs Limited composições anti-retrovirais
WO2018064071A1 (en) * 2016-09-27 2018-04-05 Gilead Sciences, Inc. Therapeutic compositions for treatment of human immunodeficiency virus
EP3654951A1 (en) 2017-07-20 2020-05-27 Janssen Sciences Ireland Unlimited Company Compositions comprising darunavir, cobicistat, emtricitabine and tenofovir alafenamide for use in the treatment of hiv
WO2020064980A1 (en) 2018-09-28 2020-04-02 Janssen Sciences Ireland Unlimited Company Methods of treating and preventing neuropsychiatric and/or neurocognitive complications in patients infected with hiv
US20210290590A1 (en) 2020-03-13 2021-09-23 Janssen Sciences Ireland Unlimited Company Methods of treating subjects infected with hiv
CN119700779B (zh) * 2024-11-28 2025-11-04 安徽贝克生物制药有限公司 一种达芦那韦和考比司他复合片剂及其制备方法

Citations (2)

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WO2009135179A2 (en) * 2008-05-02 2009-11-05 Gilead Sciences, Inc. The use of solid carrier particles to improve the processability of a pharmaceutical agent
WO2011048604A2 (en) * 2009-09-17 2011-04-28 Matrix Laboratories Limited An improved process for the preparation of darunavir

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US5968942A (en) 1992-08-25 1999-10-19 G. D. Searle & Co. α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
EP0715618B1 (en) 1993-08-24 1998-12-16 G.D. Searle & Co. Hydroxyethylamino sulphonamides useful as retroviral protease inhibitors
CA2872424C (en) 1998-06-23 2017-03-07 The United States Of America, Represented By The Secretary, Department Of Health And Human Services Bisfuran derivatives useful in preventing the emergence of multidrug resistant hiv strains and treatment of hiv
TWI286476B (en) 2001-12-12 2007-09-11 Tibotec Pharm Ltd Combination of cytochrome P450 dependent protease inhibitors
BRPI0311176B8 (pt) 2002-05-16 2021-05-25 Janssen Sciences Ireland Uc pseudopolimorfo na forma de etanolato, seu uso, processo de preparação do mesmo e composição farmacêutica
TWI471145B (zh) 2005-06-13 2015-02-01 Bristol Myers Squibb & Gilead Sciences Llc 單一式藥學劑量型
WO2007143422A2 (en) 2006-05-30 2007-12-13 Janssen Pharmaceutica N.V. Substituted pyridyl amide compounds as modulators of the histamine h3 receptor
US20080039428A1 (en) * 2006-06-29 2008-02-14 Panacos Pharmaceuticals, Inc. Antiretroviral combination therapy
PL2049506T5 (pl) 2006-07-07 2024-09-09 Gilead Sciences, Inc. Modulatory farmakokinetycznych właściwości leków
CA2667207A1 (en) * 2006-10-25 2008-05-02 Mcneil-Ppc, Inc. Ibuprofen composition
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JP2010531301A (ja) * 2007-06-25 2010-09-24 テイボテク・フアーマシユーチカルズ ダルナビル及びエトラビリンを含んでなる組み合わせ調剤
AR069539A1 (es) 2007-07-25 2010-02-03 Tibotec Pharm Ltd Avances respecto de las formulaciones de comprimidos contra el vih
CN101868454A (zh) 2007-11-20 2010-10-20 詹森药业有限公司 作为组胺h3受体调节剂的环烷基氧基吡啶化合物和杂环烷基氧基吡啶化合物
GT200800303A (es) * 2007-12-24 2009-09-18 Combinacion anti-retroviral
EP2393485B1 (en) * 2009-02-06 2015-07-29 Gilead Sciences, Inc. Bilayer tablets comprising elvitegravir, cobicistat, emtricitabine and tenofovir
US20130195978A1 (en) 2010-05-10 2013-08-01 Hetero Research Foundation Darunavir Compositions
EP2729130B1 (en) 2011-07-07 2017-09-06 Janssen Sciences Ireland UC Darunavir combination formulations
SI2729128T1 (sl) 2011-07-07 2016-11-30 Janssen Sciences Ireland Uc Formulacije darunavirja
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WO2009135179A2 (en) * 2008-05-02 2009-11-05 Gilead Sciences, Inc. The use of solid carrier particles to improve the processability of a pharmaceutical agent
WO2011048604A2 (en) * 2009-09-17 2011-04-28 Matrix Laboratories Limited An improved process for the preparation of darunavir

Also Published As

Publication number Publication date
SI2729130T1 (en) 2018-03-30
US20200093840A1 (en) 2020-03-26
EA026587B1 (ru) 2017-04-28
EP2729130B1 (en) 2017-09-06
NO2729130T3 (https=) 2018-02-03
HRP20171889T1 (hr) 2018-01-12
JP2014520787A (ja) 2014-08-25
PT2729130T (pt) 2017-12-13
CY1121999T1 (el) 2020-07-31
WO2013004818A1 (en) 2013-01-10
IL229933A (en) 2017-09-28
RS56667B1 (sr) 2018-03-30
US20140142070A1 (en) 2014-05-22
EA201490222A1 (ru) 2014-04-30
BR112014000290A2 (pt) 2017-02-07
LT2729130T (lt) 2018-01-10
HUE035241T2 (en) 2018-05-02
CA2838659A1 (en) 2013-01-10
CN103826616B (zh) 2016-08-10
AU2012280198A8 (en) 2014-01-16
MX343689B (es) 2016-11-16
MX2013015199A (es) 2014-09-01
AU2012280198B2 (en) 2016-12-22
AU2012280198A1 (en) 2014-01-09
US20230302024A1 (en) 2023-09-28
CN103826616A (zh) 2014-05-28
EP2729130A1 (en) 2014-05-14
CA2838659C (en) 2020-02-18
JP6122427B2 (ja) 2017-04-26
DK2729130T3 (en) 2017-12-11
KR20140068845A (ko) 2014-06-09
PL2729130T3 (pl) 2018-02-28
US11654150B2 (en) 2023-05-23
SMT201700574T1 (it) 2018-01-11
BR112014000290B1 (pt) 2022-05-10
ES2651212T3 (es) 2018-01-25

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