KR101817991B1 - 다루나비어 제제 - Google Patents

다루나비어 제제 Download PDF

Info

Publication number
KR101817991B1
KR101817991B1 KR1020147000084A KR20147000084A KR101817991B1 KR 101817991 B1 KR101817991 B1 KR 101817991B1 KR 1020147000084 A KR1020147000084 A KR 1020147000084A KR 20147000084 A KR20147000084 A KR 20147000084A KR 101817991 B1 KR101817991 B1 KR 101817991B1
Authority
KR
South Korea
Prior art keywords
darunavir
dosage form
formulation
oral dosage
mixture
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
KR1020147000084A
Other languages
English (en)
Korean (ko)
Other versions
KR20140068844A (ko
Inventor
우르바인 알퐁스 체 델라에트
필립 에르나 에이치 헤인스
오이겐 마리아 요제프 얀스
Original Assignee
얀센 사이언시즈 아일랜드 유씨
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 얀센 사이언시즈 아일랜드 유씨 filed Critical 얀센 사이언시즈 아일랜드 유씨
Publication of KR20140068844A publication Critical patent/KR20140068844A/ko
Application granted granted Critical
Publication of KR101817991B1 publication Critical patent/KR101817991B1/ko
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
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/145Intimate 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 compounds
    • 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
    • A61K9/14Particulate 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • 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
    • A61K9/2095Tabletting processes
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • AIDS & HIV (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
KR1020147000084A 2011-07-07 2012-07-06 다루나비어 제제 Active KR101817991B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11173066.9 2011-07-07
EP11173066 2011-07-07
PCT/EP2012/063242 WO2013004816A1 (en) 2011-07-07 2012-07-06 Darunavir formulations

Publications (2)

Publication Number Publication Date
KR20140068844A KR20140068844A (ko) 2014-06-09
KR101817991B1 true KR101817991B1 (ko) 2018-01-12

Family

ID=46458539

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020147000084A Active KR101817991B1 (ko) 2011-07-07 2012-07-06 다루나비어 제제

Country Status (23)

Country Link
US (3) US20140142174A1 (enExample)
EP (1) EP2729128B1 (enExample)
JP (1) JP6101260B2 (enExample)
KR (1) KR101817991B1 (enExample)
CN (1) CN103841962B (enExample)
AU (1) AU2012280277B2 (enExample)
BR (1) BR112014000195A2 (enExample)
CA (1) CA2837539C (enExample)
CY (1) CY1119446T1 (enExample)
DK (1) DK2729128T3 (enExample)
EA (1) EA026588B1 (enExample)
ES (1) ES2598823T3 (enExample)
HR (1) HRP20161340T1 (enExample)
HU (1) HUE030341T2 (enExample)
IL (1) IL229700B (enExample)
LT (1) LT2729128T (enExample)
MX (1) MX341976B (enExample)
PL (1) PL2729128T3 (enExample)
PT (1) PT2729128T (enExample)
RS (1) RS55236B1 (enExample)
SI (1) SI2729128T1 (enExample)
SM (1) SMT201600380B (enExample)
WO (1) WO2013004816A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SMT201700574T1 (it) 2011-07-07 2018-01-11 Gilead Sciences Inc Formulazioni delle combinazioni di darunavir
MX2016002560A (es) 2013-08-29 2016-10-26 Teva Pharma Forma de dosificacion unitaria que comprende emtricitabina, tenofovir, darunavir y ritonavir y un comprimido monolitico que comprende darunavir y ritonavir.
JP5843986B2 (ja) * 2014-03-25 2016-01-13 アステラス製薬株式会社 粒状医薬組成物
EP3129009A1 (en) 2014-04-08 2017-02-15 Teva Pharmaceutical Industries Ltd Unit dosage form comprising emtricitabine, tenofovir, darunavir and ritonavir
EP3210017B1 (en) 2014-10-26 2021-10-06 King Abdullah University Of Science And Technology Alkaloids from sponge, scaffolds for the inhibition of human immunodeficiency virus (hiv)
EP4696309A2 (en) 2017-07-20 2026-02-18 Janssen Sciences Ireland Unlimited Company Compositions comprising darunavir, cobicistat, emtricitabine and tenofovir alafenamide for use in the treatment of hiv
JP7469293B2 (ja) 2018-08-17 2024-04-16 エイドス セラピューティクス,インコーポレイティド Ag10の製剤
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
US20210290590A1 (en) 2020-03-13 2021-09-23 Janssen Sciences Ireland Unlimited Company Methods of treating subjects infected with hiv
MX2022013090A (es) * 2020-04-20 2022-11-14 Poviva Corp Composiciones y metodos para el suministro mejorado de agentes antivirales.

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6248775B1 (en) 1992-08-25 2001-06-19 G. D. Searle & Co. α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU7669794A (en) 1993-08-24 1995-03-21 G.D. Searle & Co. Hydroxyethylamino sulphonamides useful as retroviral protease inhibitors
ES2604662T3 (es) 1998-06-23 2017-03-08 The United States Of America, Represented By The Secretary, Department Of Health And Human Services Ensayo de acondicionamiento físico y métodos para reducir la resistencia del VIH a la terapia
TWI286476B (en) 2001-12-12 2007-09-11 Tibotec Pharm Ltd Combination of cytochrome P450 dependent protease inhibitors
CA2689330A1 (en) * 2007-06-25 2008-12-31 Tibotec Pharmaceuticals Combination formulations
AR069539A1 (es) * 2007-07-25 2010-02-03 Tibotec Pharm Ltd Avances respecto de las formulaciones de comprimidos contra el vih
GT200800303A (es) * 2007-12-24 2009-09-18 Combinacion anti-retroviral
US8703980B2 (en) * 2009-09-17 2014-04-22 Siva Rama Prasad Vellanki Process for the preparation of darunavir

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6248775B1 (en) 1992-08-25 2001-06-19 G. D. Searle & Co. α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors

Also Published As

Publication number Publication date
CN103841962B (zh) 2016-08-17
JP2014520786A (ja) 2014-08-25
US20160113949A1 (en) 2016-04-28
US20210244749A1 (en) 2021-08-12
JP6101260B2 (ja) 2017-03-22
WO2013004816A1 (en) 2013-01-10
HUE030341T2 (en) 2017-05-29
PL2729128T3 (pl) 2017-05-31
RS55236B1 (sr) 2017-02-28
CY1119446T1 (el) 2018-04-04
CA2837539C (en) 2021-08-10
AU2012280277A1 (en) 2013-12-19
DK2729128T3 (en) 2016-11-21
MX341976B (es) 2016-09-07
CA2837539A1 (en) 2013-01-10
PT2729128T (pt) 2016-09-21
CN103841962A (zh) 2014-06-04
LT2729128T (lt) 2016-11-10
ES2598823T3 (es) 2017-01-30
EA201490223A1 (ru) 2014-06-30
MX2013015196A (es) 2014-08-18
HRP20161340T1 (hr) 2016-12-02
SI2729128T1 (sl) 2016-11-30
KR20140068844A (ko) 2014-06-09
EA026588B1 (ru) 2017-04-28
EP2729128A1 (en) 2014-05-14
BR112014000195A2 (pt) 2017-02-21
US20140142174A1 (en) 2014-05-22
IL229700A0 (en) 2014-01-30
EP2729128B1 (en) 2016-07-27
AU2012280277B2 (en) 2017-02-09
SMT201600380B (it) 2017-01-10
IL229700B (en) 2018-04-30

Similar Documents

Publication Publication Date Title
KR101817991B1 (ko) 다루나비어 제제
US11654150B2 (en) Darunavir combination formulations
CN104363896A (zh) 恩替卡韦的药物组合物及制造方法
EP3383402B1 (en) Pharmaceutical composition comprising darunavir and method for the preparation thereof

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

N231 Notification of change of applicant
PN2301 Change of applicant

St.27 status event code: A-3-3-R10-R13-asn-PN2301

St.27 status event code: A-3-3-R10-R11-asn-PN2301

R17-X000 Change to representative recorded

St.27 status event code: A-3-3-R10-R17-oth-X000

A201 Request for examination
A302 Request for accelerated examination
E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

PA0302 Request for accelerated examination

St.27 status event code: A-1-2-D10-D17-exm-PA0302

St.27 status event code: A-1-2-D10-D16-exm-PA0302

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

St.27 status event code: A-1-2-D10-D22-exm-PE0701

GRNT Written decision to grant
PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

R18-X000 Changes to party contact information recorded

St.27 status event code: A-5-5-R10-R18-oth-X000

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 4

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 5

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 6

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 7

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 8

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 9

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-OTH-PR1001 (AS PROVIDED BY THE NATIONAL OFFICE)

Year of fee payment: 9