DK2480220T3 - Behandling og forebyggelse af HIV-infektion - Google Patents

Behandling og forebyggelse af HIV-infektion Download PDF

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Publication number
DK2480220T3
DK2480220T3 DK10762626.9T DK10762626T DK2480220T3 DK 2480220 T3 DK2480220 T3 DK 2480220T3 DK 10762626 T DK10762626 T DK 10762626T DK 2480220 T3 DK2480220 T3 DK 2480220T3
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DK
Denmark
Prior art keywords
brecanavir
administration
hiv
formulation
months
Prior art date
Application number
DK10762626.9T
Other languages
English (en)
Inventor
Lieven Elvire Colette Baert
Guenter Kraus
Original Assignee
Janssen R & D Ireland
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.)
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Publication date
Application filed by Janssen R & D Ireland filed Critical Janssen R & D Ireland
Application granted granted Critical
Publication of DK2480220T3 publication Critical patent/DK2480220T3/da

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/18Antivirals for RNA viruses for HIV
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Optics & Photonics (AREA)
  • Nanotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (14)

1. Anvendelse af en parenteral formulering, der omfatter en antiviralt effektiv mængde af brecanavir eller et farmaceutisk acceptabelt syreadditionssalt deraf og et bæremateriale uden et yderligere middel, der har en positiv virkning på lægemiddelmetabolismen og/eller farmakokinetikken til forbedring af biotilgængeligheden, hvor det yderligere middel er ritonavir, til fremstilling af et medikament til behandling af et individ, der er inficeret med HIV, hvor formuleringen er til intermitterende administration ved hjælp af subkutan eller intramuskulær injektion med et tidsinterval fra to uger til ét år.
2. Anvendelse ifølge krav 1, hvor den parenterale formulering er en opløsning, der omfatter en effektiv mængde af brecanavir og et vandigt bæremateriale.
3. Anvendelse ifølge krav 2, hvor et opløsningsmiddel eller overfladeaktivt stof er tilsat til opløsningen.
4. Anvendelse ifølge et hvilket som helst af kravene 1-3, hvor formuleringen er til administration med et tidsinterval fra to uger til én måned.
5. Anvendelse ifølge et hvilket som helst af kravene 1-3, hvor formuleringen er til administration med et tidsinterval fra én måned til tre måneder.
6. Anvendelse ifølge et hvilket som helst af kravene 1-3, hvor formuleringen er til administration med et tidsinterval fra tre måneder til seks måneder.
7. Anvendelse ifølge et hvilket som helst af kravene 1-3, hvor formuleringen er til administration en gang hver måned.
8. Anvendelse ifølge et hvilket som helst af kravene 1-3, hvor formuleringen er til administration en gang hver 3. måned.
9. Anvendelse ifølge krav 1, hvor blodplasmaniveauet holdes på et niveau over 28 ng/ml.
10. Farmaceutisk præparat til administration ved hjælp af intramuskulær eller subkutan injektion, der omfatter en terapeutisk effektiv mængde af brecanavir eller et salt deraf, i form af en suspension af mikro- eller nanopartikler, der omfatter: (a) brecanavir eller et salt deraf i mikro- eller nanopartikelform, der har en overflademodulator adsorberet til overfladen deraf; og (b) et farmaceutisk acceptabelt, vandigt bæremateriale; hvori den aktive bestanddel brecanavir er suspenderet.
11. Præparat ifølge krav 10, hvor overflademodulatoren er udvalgt blandt poloxamerer, a- tocopherylpolyethylenglycolsuccinater, polyoxyethylensorbitanfedtsyreestere og salte af negativt ladede phospholipider.
12. Præparat ifølge krav 10 eller 11, hvor overflademodulatoren er udvalgt blandt poloxamer 338, Vitamin E-TGPS, polysorbat-80, polysorbat-20 og æg- phosphatidylglycerolnatrium.
13. Præparat ifølge et hvilket som helst af kravene 10 til 12, hvor den gennemsnitlige effektive partikelstørrelse af brecanavir-mikro- eller nanopartikler er under 200 nm.
14. Anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor den parenterale formulering er et farmaceutisk præparat ifølge et hvilket som helst af kravene 10 til 13.
DK10762626.9T 2009-09-22 2010-09-22 Behandling og forebyggelse af HIV-infektion DK2480220T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09170916 2009-09-22
PCT/EP2010/063930 WO2011036159A2 (en) 2009-09-22 2010-09-22 Treatment and prevention of hiv infection

Publications (1)

Publication Number Publication Date
DK2480220T3 true DK2480220T3 (da) 2015-02-23

Family

ID=41466671

Family Applications (1)

Application Number Title Priority Date Filing Date
DK10762626.9T DK2480220T3 (da) 2009-09-22 2010-09-22 Behandling og forebyggelse af HIV-infektion

Country Status (17)

Country Link
US (1) US20120201868A1 (da)
EP (1) EP2480220B1 (da)
JP (1) JP5897465B2 (da)
KR (2) KR101845811B1 (da)
CN (1) CN102573815B (da)
AU (1) AU2010299959B2 (da)
BR (1) BR112012006345A2 (da)
CA (1) CA2774750C (da)
DK (1) DK2480220T3 (da)
ES (1) ES2530941T3 (da)
HK (1) HK1174256A1 (da)
HR (1) HRP20150192T1 (da)
MX (1) MX2012003424A (da)
PL (1) PL2480220T3 (da)
RU (1) RU2569058C2 (da)
WO (1) WO2011036159A2 (da)
ZA (1) ZA201202070B (da)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4037661A1 (en) * 2019-10-01 2022-08-10 VIIV Healthcare Company Method for treating hiv with cabotegravir and rilpivirine

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6045829A (en) * 1997-02-13 2000-04-04 Elan Pharma International Limited Nanocrystalline formulations of human immunodeficiency virus (HIV) protease inhibitors using cellulosic surface stabilizers
AR031520A1 (es) 1999-06-11 2003-09-24 Vertex Pharma Un compuesto inhibidor de aspartilo proteasa, una composicion que lo comprende y un metodo para tratar un paciente con dicha composicion
US7220768B2 (en) * 2003-02-11 2007-05-22 Wyeth Holdings Corp. Isoxazole-containing thiourea inhibitors useful for treatment of varicella zoster virus
BRPI0707179A2 (pt) * 2006-01-20 2011-04-26 Tibotec Pharm Ltd tratamento de longo termo de infecção por hiv
AU2008274185B2 (en) * 2007-07-12 2014-07-03 Janssen Sciences Ireland Uc Crystalline form of (E) 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2 pyrimidinyl]amino]benzonitrile

Also Published As

Publication number Publication date
HK1174256A1 (en) 2013-06-07
CN102573815B (zh) 2015-09-30
RU2012116070A (ru) 2013-10-27
KR20120093850A (ko) 2012-08-23
WO2011036159A2 (en) 2011-03-31
US20120201868A1 (en) 2012-08-09
KR20170141825A (ko) 2017-12-26
EP2480220A2 (en) 2012-08-01
CA2774750A1 (en) 2011-03-31
MX2012003424A (es) 2012-05-08
RU2569058C2 (ru) 2015-11-20
KR101845811B1 (ko) 2018-05-18
AU2010299959B2 (en) 2016-07-21
ZA201202070B (en) 2013-08-28
JP2013505224A (ja) 2013-02-14
PL2480220T3 (pl) 2015-10-30
ES2530941T3 (es) 2015-03-09
WO2011036159A3 (en) 2011-11-24
AU2010299959A1 (en) 2012-03-01
CA2774750C (en) 2017-11-28
HRP20150192T1 (hr) 2015-04-10
EP2480220B1 (en) 2014-11-19
JP5897465B2 (ja) 2016-03-30
KR101811314B1 (ko) 2017-12-26
CN102573815A (zh) 2012-07-11
BR112012006345A2 (pt) 2020-08-11

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