AU2012280198B2 - Darunavir combination formulations - Google Patents

Darunavir combination formulations Download PDF

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Publication number
AU2012280198B2
AU2012280198B2 AU2012280198A AU2012280198A AU2012280198B2 AU 2012280198 B2 AU2012280198 B2 AU 2012280198B2 AU 2012280198 A AU2012280198 A AU 2012280198A AU 2012280198 A AU2012280198 A AU 2012280198A AU 2012280198 B2 AU2012280198 B2 AU 2012280198B2
Authority
AU
Australia
Prior art keywords
darunavir
dosage form
oral dosage
form according
silicon dioxide
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2012280198A
Other languages
English (en)
Other versions
AU2012280198A1 (en
AU2012280198A8 (en
Inventor
Urbain Alfons C. DELAET
Philip Erna H. HEYNS
Eugeen Maria Jozef Jans
Roel Jos M. Mertens
Geert VAN DER AVOORT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Janssen Sciences Ireland ULC
Gilead Sciences Inc
Original Assignee
Janssen Sciences Ireland ULC
Gilead Sciences Inc
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 Janssen Sciences Ireland ULC, Gilead Sciences Inc filed Critical Janssen Sciences Ireland ULC
Publication of AU2012280198A1 publication Critical patent/AU2012280198A1/en
Publication of AU2012280198A8 publication Critical patent/AU2012280198A8/en
Assigned to JANSSEN SCIENCES IRELAND UC, GILEAD SCIENCES, INC. reassignment JANSSEN SCIENCES IRELAND UC Request for Assignment Assignors: GILEAD SCIENCES, INC., JANSSEN R&D IRELAND
Application granted granted Critical
Publication of AU2012280198B2 publication Critical patent/AU2012280198B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Oncology (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)
AU2012280198A 2011-07-07 2012-07-06 Darunavir combination formulations Active AU2012280198B2 (en)

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 (3)

Publication Number Publication Date
AU2012280198A1 AU2012280198A1 (en) 2014-01-09
AU2012280198A8 AU2012280198A8 (en) 2014-01-16
AU2012280198B2 true AU2012280198B2 (en) 2016-12-22

Family

ID=46551505

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2012280198A Active AU2012280198B2 (en) 2011-07-07 2012-07-06 Darunavir combination formulations

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)

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PL2729130T3 (pl) 2011-07-07 2018-02-28 Janssen Sciences Ireland Uc Preparaty kombinowane darunawiru
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
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
BR112019002125A2 (pt) * 2016-08-08 2019-05-14 Hetero Labs Limited composição de comprimidos de alta carga de fármacos para o tratamento do hiv
US11045423B2 (en) 2016-08-08 2021-06-29 Hetero Labs Limited Anti-retroviral compositions
WO2018029565A1 (en) 2016-08-08 2018-02-15 Hetero Labs Limited A multi-class anti-retroviral composition
US20180085387A1 (en) * 2016-09-27 2018-03-29 Gilead Sciences, Inc. Therapeutic compositions for treatment of human immunodeficiency virus
MX2020000694A (es) 2017-07-20 2020-07-29 Janssen Sciences Ireland Unlimited Co Composiciones que comprenden darunavir, cobicistat, emtricitabine y alafenamida de tenofovir para usar en el tratamiento del vih.
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
WO2021180963A1 (en) 2020-03-13 2021-09-16 Janssen Sciences Ireland Unlimited Company A protease inhibitor regimen for 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

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ES2127938T3 (es) 1993-08-24 1999-05-01 Searle & Co Hidroxietilamino sulfonamidas utiles como inhibidores de proteasas retroviricas.
PT2336134T (pt) 1998-06-23 2016-10-19 The Board Of Trustees Of The Univ Of Illionis Ensaio de aptidão e métodos para reduzir a resistência do hiv à terapia
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TWI471145B (zh) 2005-06-13 2015-02-01 Bristol Myers Squibb & Gilead Sciences Llc 單一式藥學劑量型
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US20080039428A1 (en) * 2006-06-29 2008-02-14 Panacos Pharmaceuticals, Inc. Antiretroviral combination therapy
KR101477822B1 (ko) 2006-07-07 2015-01-02 길리애드 사이언시즈, 인코포레이티드 치료제의 약동학 특성의 모듈레이터
MX2009004439A (es) * 2006-10-25 2009-05-11 Mcneil Ppc Inc Composicion de ibuprofeno.
PT3150586T (pt) 2007-02-23 2020-03-31 Gilead Sciences Inc Moduladores de propriedades farmacocinéticas de agentes terapêuticos
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
CN105712977B (zh) 2007-11-20 2021-06-29 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
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PL2393485T3 (pl) * 2009-02-06 2015-12-31 Gilead Sciences Inc Dwuwarstwowe tabletki zawierające elwitegrawir, kobicystat, emtrycytabinę i tenofowir
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Also Published As

Publication number Publication date
CY1121999T1 (el) 2020-07-31
CA2838659C (en) 2020-02-18
DK2729130T3 (en) 2017-12-11
KR20140068845A (ko) 2014-06-09
PT2729130T (pt) 2017-12-13
KR102058097B1 (ko) 2019-12-20
US20230302024A1 (en) 2023-09-28
CA2838659A1 (en) 2013-01-10
MX2013015199A (es) 2014-09-01
BR112014000290A2 (pt) 2017-02-07
JP2014520787A (ja) 2014-08-25
ES2651212T3 (es) 2018-01-25
AU2012280198A1 (en) 2014-01-09
EP2729130A1 (en) 2014-05-14
SI2729130T1 (en) 2018-03-30
US11654150B2 (en) 2023-05-23
WO2013004818A1 (en) 2013-01-10
HRP20171889T1 (hr) 2018-01-12
US20200093840A1 (en) 2020-03-26
PL2729130T3 (pl) 2018-02-28
EA026587B1 (ru) 2017-04-28
BR112014000290B1 (pt) 2022-05-10
CN103826616B (zh) 2016-08-10
EA201490222A1 (ru) 2014-04-30
EP2729130B1 (en) 2017-09-06
RS56667B1 (sr) 2018-03-30
AU2012280198A8 (en) 2014-01-16
LT2729130T (lt) 2018-01-10
NO2729130T3 (enExample) 2018-02-03
IL229933A (en) 2017-09-28
US20140142070A1 (en) 2014-05-22
CN103826616A (zh) 2014-05-28
HUE035241T2 (en) 2018-05-02
MX343689B (es) 2016-11-16
JP6122427B2 (ja) 2017-04-26
SMT201700574T1 (it) 2018-01-11

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Legal Events

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TH Corrigenda

Free format text: IN VOL 28 , NO 1 , PAGE(S) 74 UNDER THE HEADING PCT APPLICATIONS THAT HAVE ENTERED THE NATIONAL PHASE - NAME INDEX UNDER THE NAME JANSSEN R&D IRELAND, APPLICATION NO. 2012280198, UNDER INID (71) ADD CO-APPLICANT GILEAD SCIENCES, INC.

PC1 Assignment before grant (sect. 113)

Owner name: GILEAD SCIENCES, INC.; JANSSEN SCIENCES IRELAND UC

Free format text: FORMER APPLICANT(S): GILEAD SCIENCES, INC.; JANSSEN R&D IRELAND

FGA Letters patent sealed or granted (standard patent)