CA2918707A1 - Forme pharmaceutique unitaire comprenant de l'emtricitabine, du tenofovir, du darunavir et du ritonavir et un comprime monolithique comprenant du darunavir et du ritonavir - Google Patents

Forme pharmaceutique unitaire comprenant de l'emtricitabine, du tenofovir, du darunavir et du ritonavir et un comprime monolithique comprenant du darunavir et du ritonavir Download PDF

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Publication number
CA2918707A1
CA2918707A1 CA2918707A CA2918707A CA2918707A1 CA 2918707 A1 CA2918707 A1 CA 2918707A1 CA 2918707 A CA2918707 A CA 2918707A CA 2918707 A CA2918707 A CA 2918707A CA 2918707 A1 CA2918707 A1 CA 2918707A1
Authority
CA
Canada
Prior art keywords
ritonavir
darunavir
tablet
pharmaceutical formulation
weight
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.)
Abandoned
Application number
CA2918707A
Other languages
English (en)
Inventor
Nitzan SHAHAR
Elina HARONSKY
Julia Hrakovsky
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.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries 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 Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of CA2918707A1 publication Critical patent/CA2918707A1/fr
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/675Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/427Thiazoles not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/63Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • AIDS & HIV (AREA)
  • Molecular Biology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA2918707A 2013-08-29 2014-08-28 Forme pharmaceutique unitaire comprenant de l'emtricitabine, du tenofovir, du darunavir et du ritonavir et un comprime monolithique comprenant du darunavir et du ritonavir Abandoned CA2918707A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361871674P 2013-08-29 2013-08-29
US61/871,674 2013-08-29
PCT/IB2014/001637 WO2015028875A2 (fr) 2013-08-29 2014-08-28 Forme pharmaceutique unitaire comprenant de l'emtricitabine, du ténofovir, du darunavir et du ritonavir et un comprimé monolithique comprenant du darunavir et du ritonavir

Publications (1)

Publication Number Publication Date
CA2918707A1 true CA2918707A1 (fr) 2015-03-05

Family

ID=51830545

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2918707A Abandoned CA2918707A1 (fr) 2013-08-29 2014-08-28 Forme pharmaceutique unitaire comprenant de l'emtricitabine, du tenofovir, du darunavir et du ritonavir et un comprime monolithique comprenant du darunavir et du ritonavir

Country Status (8)

Country Link
EP (1) EP3038607A2 (fr)
AR (1) AR097512A1 (fr)
CA (1) CA2918707A1 (fr)
HK (1) HK1220390A1 (fr)
IL (1) IL244107A0 (fr)
MX (1) MX2016002560A (fr)
TW (1) TW201542212A (fr)
WO (1) WO2015028875A2 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015155673A1 (fr) * 2014-04-08 2015-10-15 Teva Pharmaceutical Industries Ltd Forme pharmaceutique unitaire comprenant de l'emtricitabine, du ténofovir, du darunavir et du ritonavir
CA2937365C (fr) 2016-03-29 2018-09-18 F. Hoffmann-La Roche Ag Formulation en granules de 5-methyl-1-phenyl-2-(1h)-pyridone et methode de fabrication associee
KR101777564B1 (ko) 2016-05-30 2017-09-12 영남대학교 산학협력단 테노포비어 디소프록실 유리염기를 함유한 정제 조성물 및 이의 제조방법
WO2018153977A1 (fr) * 2017-02-24 2018-08-30 Hexal Ag Composition stable de ténofovir alafénamide
CN108727401A (zh) * 2017-04-20 2018-11-02 盐城迪赛诺制药有限公司 达鲁那韦新晶型及其制备方法和应用

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US5539122A (en) 1989-05-23 1996-07-23 Abbott Laboratories Retroviral protease inhibiting compounds
US5354866A (en) 1989-05-23 1994-10-11 Abbott Laboratories Retroviral protease inhibiting compounds
US5914331A (en) 1990-02-01 1999-06-22 Emory University Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
US5204466A (en) 1990-02-01 1993-04-20 Emory University Method and compositions for the synthesis of bch-189 and related compounds
US5968942A (en) 1992-08-25 1999-10-19 G. D. Searle & Co. α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
PT810209E (pt) 1992-08-25 2002-09-30 Searle & Co Hidroxietilamino-sulfonamidas de alfa- e beta-aminoacidos uteis como inibidores de protease retroviral
MY115461A (en) 1995-03-30 2003-06-30 Wellcome Found Synergistic combinations of zidovudine, 1592u89 and 3tc
US6037157A (en) 1995-06-29 2000-03-14 Abbott Laboratories Method for improving pharmacokinetics
US5922695A (en) 1996-07-26 1999-07-13 Gilead Sciences, Inc. Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
US5935946A (en) 1997-07-25 1999-08-10 Gilead Sciences, Inc. Nucleotide analog composition and synthesis method
CO5090830A1 (es) 1998-07-20 2001-10-30 Abbott Lab Poliformo de un agente farmaceutico
US7364752B1 (en) 1999-11-12 2008-04-29 Abbott Laboratories Solid dispersion pharamaceutical formulations
ES2308136T3 (es) 2003-01-14 2008-12-01 Gilead Sciences, Inc. Composiciones y procedimientos para la politerapia antiviral.
US8025899B2 (en) 2003-08-28 2011-09-27 Abbott Laboratories Solid pharmaceutical dosage form
WO2006005720A1 (fr) * 2004-07-08 2006-01-19 Tibotec Pharmaceuticals Ltd. Combinaison d'inhibiteurs de protease et de tanscriptase inverse anti-vih
AR045841A1 (es) * 2004-09-28 2005-11-16 Richmond Sa Com Ind Y Financie Una composicion farmaceutica solida que comprende al tiazolil metil ester del acido [5s-(5r*, 8r*, 10r*,11r*)] -10- hidroxi-2- metil-5-(1-metiletil)-1-[2-(1-metiletil)-4-tiazolil]-3,6-dioxo-8,11-bis(fenilmetil)-2,4,7,12- tetraazatridecan-13-oico y un procedimiento para prepararla.
TWI375560B (en) 2005-06-13 2012-11-01 Gilead Sciences Inc Composition comprising dry granulated emtricitabine and tenofovir df and method for making the same
TWI471145B (zh) 2005-06-13 2015-02-01 Bristol Myers Squibb & Gilead Sciences Llc 單一式藥學劑量型
AU2008268537B2 (en) * 2007-06-22 2012-11-01 Bristol-Myers Squibb Holdings Ireland Tableted compositions containing atazanavir
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JP2012509320A (ja) * 2008-11-21 2012-04-19 ウルティモルフィクス・テクノロジーズ・ベー・フェー テノフォビル、エムトリシタビン及びエファビレンツの湿式造粒法
WO2011013110A1 (fr) * 2009-07-31 2011-02-03 Ranbaxy Laboratories Limited Formes posologiques unitaires d'inhibiteurs de protéase du vih
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EP2332544A1 (fr) 2009-11-20 2011-06-15 Assistance Publique, Hopitaux De Paris Nouvelle composition pharmaceutique utile pour le traitement des personnes atteintes du virus de l'immunodéficience humaine (VIH)
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Also Published As

Publication number Publication date
IL244107A0 (en) 2016-04-21
WO2015028875A3 (fr) 2015-11-19
MX2016002560A (es) 2016-10-26
AR097512A1 (es) 2016-03-23
TW201542212A (zh) 2015-11-16
WO2015028875A2 (fr) 2015-03-05
WO2015028875A8 (fr) 2016-09-01
EP3038607A2 (fr) 2016-07-06
HK1220390A1 (zh) 2017-05-05

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Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20180828