DE602006004731D1 - Trockengranulierungzusammensetzung enthaltend Emtricitabine und Tenofovir DF - Google Patents

Trockengranulierungzusammensetzung enthaltend Emtricitabine und Tenofovir DF

Info

Publication number
DE602006004731D1
DE602006004731D1 DE602006004731T DE602006004731T DE602006004731D1 DE 602006004731 D1 DE602006004731 D1 DE 602006004731D1 DE 602006004731 T DE602006004731 T DE 602006004731T DE 602006004731 T DE602006004731 T DE 602006004731T DE 602006004731 D1 DE602006004731 D1 DE 602006004731D1
Authority
DE
Germany
Prior art keywords
tenofovir
composition containing
dry granulation
granulation composition
containing emtricitabine
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
DE602006004731T
Other languages
English (en)
Inventor
Terrence C Dahl
Mark M Menning
Reza Oliyai
Taiyin Yang
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.)
Gilead Sciences Inc
Original Assignee
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37532912&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE602006004731(D1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gilead Sciences Inc filed Critical Gilead Sciences Inc
Publication of DE602006004731D1 publication Critical patent/DE602006004731D1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002Compounding apparatus specially for enteral or parenteral nutritive solutions
    • 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
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic 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
    • 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
    • A61K31/66Phosphorus compounds
    • A61K31/683Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • 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
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DE602006004731T 2005-06-13 2006-06-13 Trockengranulierungzusammensetzung enthaltend Emtricitabine und Tenofovir DF Active DE602006004731D1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US69001005P 2005-06-13 2005-06-13
US77135306P 2006-02-07 2006-02-07
PCT/US2006/023222 WO2006135932A2 (en) 2005-06-13 2006-06-13 Stable fixed-dose formulations containing a combination of antivirals, method for producing thereof using dry granulation

Publications (1)

Publication Number Publication Date
DE602006004731D1 true DE602006004731D1 (de) 2009-02-26

Family

ID=37532912

Family Applications (1)

Application Number Title Priority Date Filing Date
DE602006004731T Active DE602006004731D1 (de) 2005-06-13 2006-06-13 Trockengranulierungzusammensetzung enthaltend Emtricitabine und Tenofovir DF

Country Status (22)

Country Link
US (3) US20070077295A1 (de)
EP (1) EP1890681B1 (de)
JP (3) JP5409001B2 (de)
CN (2) CN101222914B (de)
AR (1) AR054511A1 (de)
AT (1) ATE419839T1 (de)
AU (1) AU2006257794B2 (de)
CA (1) CA2611520C (de)
CY (1) CY1108973T1 (de)
DE (1) DE602006004731D1 (de)
DK (1) DK1890681T3 (de)
ES (1) ES2320039T3 (de)
HK (1) HK1109861A1 (de)
HR (1) HRP20090194T1 (de)
MX (1) MX2007015764A (de)
NZ (1) NZ564045A (de)
PL (1) PL1890681T3 (de)
PT (1) PT1890681E (de)
RS (1) RS50812B (de)
SI (1) SI1890681T1 (de)
TW (1) TWI375560B (de)
WO (1) WO2006135932A2 (de)

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EP3025718A1 (de) 2003-01-14 2016-06-01 Gilead Sciences, Inc. Zusammensetzungen und verfahren für antivirale kombinationstherapie
TWI471145B (zh) 2005-06-13 2015-02-01 Bristol Myers Squibb & Gilead Sciences Llc 單一式藥學劑量型
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
TWI411613B (zh) 2006-07-07 2013-10-11 Gilead Sciences Inc 用於改善被細胞色素p450單氧合酶所代謝之治療劑的藥物動力性質之調節劑
MX2009008935A (es) 2007-02-23 2009-11-02 Gilead Sciences Inc Moduladores de las propiedades farmacocineticas de productos terapeuticos.
EA201591353A1 (ru) 2008-05-02 2016-01-29 Джилид Сайэнс, Инк. Применение частиц твердого носителя для улучшения технологических характеристик фармацевтического агента
US8173621B2 (en) 2008-06-11 2012-05-08 Gilead Pharmasset Llc Nucleoside cyclicphosphates
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CN105125511A (zh) * 2014-05-30 2015-12-09 北京星昊医药股份有限公司 一种富马酸替诺福韦酯片及其制备方法
PT3607939T (pt) 2015-06-30 2022-09-12 Gilead Sciences Inc Formulações farmacêuticas compreendendo tenofovir e emtricitabina
CN106539807B (zh) * 2015-09-21 2020-06-26 四川海思科制药有限公司 一种稳定的药物组合物及其制备方法
CN106749409A (zh) * 2016-11-30 2017-05-31 宁波美诺华药业股份有限公司 一种替诺福韦酯富马酸盐二聚体杂质的合成方法
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EP1890681A2 (de) 2008-02-27
CN101222914B (zh) 2015-10-07
HRP20090194T1 (en) 2009-07-31
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JP2015007137A (ja) 2015-01-15
HK1109861A1 (en) 2008-06-27
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DK1890681T3 (da) 2009-04-20
CA2611520C (en) 2011-11-29
ATE419839T1 (de) 2009-01-15
CN101222914A (zh) 2008-07-16
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US8871271B2 (en) 2014-10-28
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AU2006257794A1 (en) 2006-12-21
CA2611520A1 (en) 2006-12-21
EP1890681B1 (de) 2009-01-07
SI1890681T1 (sl) 2009-06-30
JP5409001B2 (ja) 2014-02-05
US20140370102A1 (en) 2014-12-18
US20140037732A1 (en) 2014-02-06
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