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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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
    • A61K31/63—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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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

Landscapes

  • 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)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • AIDS & HIV (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Molecular Biology (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 2011-07-07
EP11173067.7 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 (enExample)
EP (1) EP2729130B1 (enExample)
JP (1) JP6122427B2 (enExample)
KR (1) KR102058097B1 (enExample)
CN (1) CN103826616B (enExample)
AU (1) AU2012280198B2 (enExample)
BR (1) BR112014000290B1 (enExample)
CA (1) CA2838659C (enExample)
CY (1) CY1121999T1 (enExample)
DK (1) DK2729130T3 (enExample)
EA (1) EA026587B1 (enExample)
ES (1) ES2651212T3 (enExample)
HR (1) HRP20171889T1 (enExample)
HU (1) HUE035241T2 (enExample)
IL (1) IL229933A (enExample)
LT (1) LT2729130T (enExample)
MX (1) MX343689B (enExample)
NO (1) NO2729130T3 (enExample)
PL (1) PL2729130T3 (enExample)
PT (1) PT2729130T (enExample)
RS (1) RS56667B1 (enExample)
SI (1) SI2729130T1 (enExample)
SM (1) SMT201700574T1 (enExample)
WO (1) WO2013004818A1 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2729130T (pt) 2011-07-07 2017-12-13 Gilead Sciences Inc Formulações de combinação de darunavir
WO2013130766A1 (en) * 2012-03-01 2013-09-06 Gilead Sciences, Inc. Spray dried formulations
NZ709260A (en) 2012-12-21 2016-07-29 Gilead Sciences Inc Polycyclic-carbamoylpyridone compounds and their pharmaceutical use
CN113546052A (zh) 2015-11-09 2021-10-26 吉利德科学公司 治疗人免疫缺陷病毒的治疗组合物
BR112019002132A2 (pt) 2016-08-08 2019-05-14 Hetero Labs Limited composições anti-retrovirais
WO2018029566A1 (en) * 2016-08-08 2018-02-15 Hetero Labs Limited A high drug loaded tablet composition for treating hiv
BR112019002120A2 (pt) * 2016-08-08 2019-05-14 Hetero Labs Limited composição anti-retroviral de várias classes
EP3518935A1 (en) * 2016-09-27 2019-08-07 Gilead Sciences, Inc. Therapeutic compositions for treatment of human immunodeficiency virus
BR112020000842A2 (pt) 2017-07-20 2020-07-21 Janssen Sciences Ireland Unlimited Company composições e métodos para tratamento do hiv
US20200101093A1 (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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995006030A1 (en) 1993-08-24 1995-03-02 G.D. Searle & Co. Hydroxyethylamino sulphonamides useful as retroviral protease inhibitors
US5968942A (en) 1992-08-25 1999-10-19 G. D. Searle & Co. α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
AU771780B2 (en) 1998-06-23 2004-04-01 Board Of Trustees Of The University Of Illinois, The Fitness assay and associated methods
AR037797A1 (es) 2001-12-12 2004-12-01 Tibotec Pharm Ltd Combinacion de inhibidores de proteasa dependientes del citocromo p450
AU2003271740B2 (en) 2002-05-16 2010-05-13 Janssen R&D Ireland Pseudopolymorphic forms of a HIV protease inhibitor
TWI471145B (zh) 2005-06-13 2015-02-01 Bristol Myers Squibb & Gilead Sciences Llc 單一式藥學劑量型
MX339668B (es) 2006-05-30 2016-06-02 Janssen Pharmaceutica N V * Compuestos de piridil amida sustituidos como moduladores del receptor h3 de la histamina.
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
MX2009004439A (es) * 2006-10-25 2009-05-11 Mcneil Ppc Inc Composicion de ibuprofeno.
EP3150586B1 (en) 2007-02-23 2020-01-08 Gilead Sciences, Inc. Modulators of pharmacokinetic properties of therapeutics
RU2010102067A (ru) * 2007-06-25 2011-07-27 Тиботек Фармасьютикалз (Ie) Комбинированные композиции, включающие дарунавир и этравирин
AR069539A1 (es) * 2007-07-25 2010-02-03 Tibotec Pharm Ltd Avances respecto de las formulaciones de comprimidos contra el vih
CA2706328C (en) 2007-11-20 2016-04-19 Janssen Pharmaceutica N.V. Cycloalkyloxy- and heterocycloalkyloxypyridine compounds as modulators of the histamine h3 receptor
PA8809601A1 (es) * 2007-12-24 2009-07-23 Cipla Ltd Combinación anti-retroviral
NZ594214A (en) * 2009-02-06 2013-05-31 Gilead Sciences Inc Tablets comprising cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil fumarate for combination therapy
US20130195978A1 (en) 2010-05-10 2013-08-01 Hetero Research Foundation Darunavir Compositions
PT2729130T (pt) 2011-07-07 2017-12-13 Gilead Sciences Inc Formulações de combinação de darunavir
HUE030341T2 (en) 2011-07-07 2017-05-29 Janssen Sciences Ireland Uc Darunavir preparations
AU2012327170A1 (en) 2012-02-03 2013-08-22 Gilead Sciences, Inc. Therapeutic compounds
JP2018502118A (ja) 2015-01-03 2018-01-25 マイラン・ラボラトリーズ・リミテッドＭｙｌａｎ Ｌａｂｏｒａｔｏｒｉｅｓ Ｌｉｍｉｔｅｄ 非晶質ヘミフマル酸テノホビルアラフェナミドおよびその予備混合物を調製するプロセス

Patent Citations (2)

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

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