HUE035241T2 - Darunavir kombinációs készítmények - Google Patents

Darunavir kombinációs készítmények Download PDF

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Publication number
HUE035241T2
HUE035241T2 HUE12738060A HUE12738060A HUE035241T2 HU E035241 T2 HUE035241 T2 HU E035241T2 HU E12738060 A HUE12738060 A HU E12738060A HU E12738060 A HUE12738060 A HU E12738060A HU E035241 T2 HUE035241 T2 HU E035241T2
Authority
HU
Hungary
Prior art keywords
darunavir
amely amely
oral
weight
tablet
Prior art date
Application number
HUE12738060A
Other languages
English (en)
Inventor
Urbain Alfons C Delaet
Philip Erna H Heyns
Eugeen Maria Jozef Jans
Roel Mertens
Der Avoort Geert Van
Original Assignee
Janssen Sciences Ireland Uc
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 Uc, Gilead Sciences Inc filed Critical Janssen Sciences Ireland Uc
Publication of HUE035241T2 publication Critical patent/HUE035241T2/hu

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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)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (5)

  1. »Ä RÚNA VIR KOM »ÏNÂCIÔS KÉSZÍTMÉNYEK Szsdmdaled igénypoédsk î. Orális dőzisfonott. amely tartalmaz tká-Chó tömegéé sikoslidanyagot, 3 lbmeg% dezimegrákfezerE Π- -20 OlnisydE I50 mg szabad formájú ES-OlőO-oek i'€';>bîcisïsî} megfelelő összmsnoyiségS OS>935ö-et hordozó síibemm'dmxídm és 'Ό-οΟ tömegé<· das .mas'.? gramiianiin»»!. «nteh dartasnsirbnl ésísags <ο·ο,Κ g' éi.s.îS’.mlng elfogadható sójából vagy sznlvátjábói. hipromellőzbót és a graooiálásbóí megmaradt feä&amp;menny? maradék vízből áll.
  2. 2, Az !.. igdnypost.szériád orális dozisforma, amelyben a 03-9330^1 hordozó szilteibm-dioxid kolloid szilfcimn-dioxtd.
  3. 3. Az I. vagy 2 se.és'.ypom szerinti ooilís dsSzssfortna, amelyben a isiprosnelióz 1$ tnPa.s viszkozitású hipromellóz 291:0, 4x Az E. 2, vagy 3. igénypont szerinti orális dözisiorma, amely 0,5 tőmeg% slkositóanyago? tartalmaz. &amp; Az előző igénypontok bármelyike szedőt! orális dödsíótma, emalybéb a dezlhdgrálószér poly-pi&amp;sdoae Xk-10 és a slkosdöaoyág ras§náziom-szíe3té.i. Ο V 1' -> s«' \nnx 'to d\iv. s< am íí" ψη and, Hk s k>k < tr o ámno ! rei -ékvíválem datouat in. sortsimaz, ?. Eljárás az előző igéstyprastok bíhmmtyikébee igényelt orális-dőzísferma előáliitásdts, amely bntalotaz·' za a kővetkező lépéseket. - gs-ermláit dantoavir biztosítása viz és hipromdkv tWe*.e\ete<\s 1, erotak az első keveréknek por tormája danmavirmt és/vagy darusévá gyógy ás.'atdáv elbu ao\r<. so és<d vagy szolvétjávzt történő összekeverése vei. valarolot az így kapu-t rfarattavir-graaulátum szárításává?; - mikrokristályos eeiiuiőzt, OS-93SÖ-eí Imtdozo smlídum-dioxldoi és dezlotegrálószert íaítalmezO második .keverék biztosítása;. - granulál! daronava hozzáadása a kesma^K > es ret követő szárazkeverés; - síkos ítő&amp;oysg hozzáadá:»í és homo 'énre k< \ < rgse; - a kexeres poxv'es? ,s Így ídfe dór s e ,nr Ion eoa. .m.eE m dm de.mtorrosadod esetben. íítetns.1'bevont.
  4. 8. Eljárás a ?. Igénypont sr. na» meh- árforma előállítására, amelyben a <kfe9sSídne? töltött szilieE am-div\t<t k.vknd s. díen.m ?O\»d
  5. 9, Az dó. Igénypontok, bármelyike széfem igényelt orális dőzisibroíá. gyógyászátbas történő alkalmazás-fa. lő. Az l-ő. igénypontok bármelyike szériád orális dozislbr-fià ÍííV-fedözés kezetésétsen történő alkalmazásra.
HUE12738060A 2011-07-07 2012-07-06 Darunavir kombinációs készítmények HUE035241T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP11173067 2011-07-07

Publications (1)

Publication Number Publication Date
HUE035241T2 true HUE035241T2 (hu) 2018-05-02

Family

ID=46551505

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE12738060A HUE035241T2 (hu) 2011-07-07 2012-07-06 Darunavir kombinációs készítmények

Country Status (23)

Country Link
US (3) US20140142070A1 (hu)
EP (1) EP2729130B1 (hu)
JP (1) JP6122427B2 (hu)
KR (1) KR102058097B1 (hu)
CN (1) CN103826616B (hu)
AU (1) AU2012280198B2 (hu)
BR (1) BR112014000290B1 (hu)
CA (1) CA2838659C (hu)
CY (1) CY1121999T1 (hu)
DK (1) DK2729130T3 (hu)
EA (1) EA026587B1 (hu)
ES (1) ES2651212T3 (hu)
HR (1) HRP20171889T1 (hu)
HU (1) HUE035241T2 (hu)
IL (1) IL229933A (hu)
LT (1) LT2729130T (hu)
MX (1) MX343689B (hu)
NO (1) NO2729130T3 (hu)
PL (1) PL2729130T3 (hu)
PT (1) PT2729130T (hu)
RS (1) RS56667B1 (hu)
SI (1) SI2729130T1 (hu)
WO (1) WO2013004818A1 (hu)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2651212T3 (es) 2011-07-07 2018-01-25 Janssen Sciences Ireland Uc Formulaciones combinadas de darunavir
EP2819644A1 (en) * 2012-03-01 2015-01-07 Gilead Sciences, Inc. Spray dried formulations
ES2926068T3 (es) 2012-12-21 2022-10-21 Gilead Sciences Inc Compuestos de carbamoilpiridona policíclicos y su uso farmacéutico
SG11201802983TA (en) 2015-11-09 2018-05-30 Gilead Sciences Inc Therapeutic compositions for treatment of human immunodeficiency virus
WO2018029561A1 (en) 2016-08-08 2018-02-15 Hetero Labs Limited Anti-retroviral compositions
US20190175511A1 (en) * 2016-08-08 2019-06-13 Hetero Labs Limited A Multi-Class Anti-Retroviral Composition
US20190175509A1 (en) * 2016-08-08 2019-06-13 Hetero Labs Limited High Drug Loaded Tablet Composition for Treating HIV
EP3518935A1 (en) * 2016-09-27 2019-08-07 Gilead Sciences, Inc. Therapeutic compositions for treatment of human immunodeficiency virus
JP2020528409A (ja) 2017-07-20 2020-09-24 ヤンセン・サイエンシズ・アイルランド・アンリミテッド・カンパニー Ｈｉｖの処置における使用のための、ダルナビル、コビシスタット、エムトリシタビン、及びテノホビルアラフェナミドを含む組成物
WO2020064980A1 (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

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EP2568810B1 (en) 2010-05-10 2018-09-19 Hetero Research Foundation Darunavir compositions
ES2651212T3 (es) 2011-07-07 2018-01-25 Janssen Sciences Ireland Uc Formulaciones combinadas de darunavir
AU2012280277B2 (en) 2011-07-07 2017-02-09 Janssen Sciences Ireland Uc Darunavir formulations
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Also Published As

Publication number Publication date
US20230302024A1 (en) 2023-09-28
CA2838659A1 (en) 2013-01-10
LT2729130T (lt) 2018-01-10
EA201490222A1 (ru) 2014-04-30
ES2651212T3 (es) 2018-01-25
JP6122427B2 (ja) 2017-04-26
CY1121999T1 (el) 2020-07-31
SI2729130T1 (en) 2018-03-30
CN103826616B (zh) 2016-08-10
DK2729130T3 (en) 2017-12-11
BR112014000290A2 (pt) 2017-02-07
JP2014520787A (ja) 2014-08-25
KR20140068845A (ko) 2014-06-09
CN103826616A (zh) 2014-05-28
AU2012280198A8 (en) 2014-01-16
US20140142070A1 (en) 2014-05-22
IL229933A (en) 2017-09-28
EP2729130B1 (en) 2017-09-06
CA2838659C (en) 2020-02-18
WO2013004818A1 (en) 2013-01-10
NO2729130T3 (hu) 2018-02-03
US20200093840A1 (en) 2020-03-26
US11654150B2 (en) 2023-05-23
PL2729130T3 (pl) 2018-02-28
RS56667B1 (sr) 2018-03-30
PT2729130T (pt) 2017-12-13
AU2012280198A1 (en) 2014-01-09
EA026587B1 (ru) 2017-04-28
MX2013015199A (es) 2014-09-01
KR102058097B1 (ko) 2019-12-20
EP2729130A1 (en) 2014-05-14
AU2012280198B2 (en) 2016-12-22
BR112014000290B1 (pt) 2022-05-10
HRP20171889T1 (hr) 2018-01-12
MX343689B (es) 2016-11-16

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