KR102058097B1 - 다루나비어 복합 제제 - Google Patents

다루나비어 복합 제제 Download PDF

Info

Publication number
KR102058097B1
KR102058097B1 KR1020147000092A KR20147000092A KR102058097B1 KR 102058097 B1 KR102058097 B1 KR 102058097B1 KR 1020147000092 A KR1020147000092 A KR 1020147000092A KR 20147000092 A KR20147000092 A KR 20147000092A KR 102058097 B1 KR102058097 B1 KR 102058097B1
Authority
KR
South Korea
Prior art keywords
darunavir
silicon dioxide
granules
formulation
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
KR1020147000092A
Other languages
English (en)
Korean (ko)
Other versions
KR20140068845A (ko
Inventor
우르바인 알퐁스 체. 델라에트
필립 에르나 에이치. 헤인스
오이겐 마리아 요제프 얀스
로얼 요스 엠. 메르텐스
데르 아보르트 게르트 판
Original Assignee
얀센 사이언시즈 아일랜드 언리미티드 컴퍼니
길리애드 사이언시즈, 인코포레이티드
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 언리미티드 컴퍼니, 길리애드 사이언시즈, 인코포레이티드 filed Critical 얀센 사이언시즈 아일랜드 언리미티드 컴퍼니
Publication of KR20140068845A publication Critical patent/KR20140068845A/ko
Application granted granted Critical
Publication of KR102058097B1 publication Critical patent/KR102058097B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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)
KR1020147000092A 2011-07-07 2012-07-06 다루나비어 복합 제제 Active KR102058097B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11173067 2011-07-07
EP11173067.7 2011-07-07
PCT/EP2012/063249 WO2013004818A1 (en) 2011-07-07 2012-07-06 Darunavir combination formulations

Publications (2)

Publication Number Publication Date
KR20140068845A KR20140068845A (ko) 2014-06-09
KR102058097B1 true KR102058097B1 (ko) 2019-12-20

Family

ID=46551505

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020147000092A Active KR102058097B1 (ko) 2011-07-07 2012-07-06 다루나비어 복합 제제

Country Status (24)

Country Link
US (3) US20140142070A1 (enExample)
EP (1) EP2729130B1 (enExample)
JP (1) JP6122427B2 (enExample)
KR (1) KR102058097B1 (enExample)
CN (1) CN103826616B (enExample)
AU (1) AU2012280198B2 (enExample)
BR (1) BR112014000290B1 (enExample)
CA (1) CA2838659C (enExample)
CY (1) CY1121999T1 (enExample)
DK (1) DK2729130T3 (enExample)
EA (1) EA026587B1 (enExample)
ES (1) ES2651212T3 (enExample)
HR (1) HRP20171889T1 (enExample)
HU (1) HUE035241T2 (enExample)
IL (1) IL229933A (enExample)
LT (1) LT2729130T (enExample)
MX (1) MX343689B (enExample)
NO (1) NO2729130T3 (enExample)
PL (1) PL2729130T3 (enExample)
PT (1) PT2729130T (enExample)
RS (1) RS56667B1 (enExample)
SI (1) SI2729130T1 (enExample)
SM (1) SMT201700574T1 (enExample)
WO (1) WO2013004818A1 (enExample)

Families Citing this family (12)

* 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
WO2013130766A1 (en) * 2012-03-01 2013-09-06 Gilead Sciences, Inc. Spray dried formulations
SI2822954T1 (sl) 2012-12-21 2016-07-29 Gilead Sciences, Inc. Policiklične karbamoilpiridonske spojine in njihova farmacevtska uporaba
PE20181207A1 (es) 2015-11-09 2018-07-23 Gilead Sciences Inc Composiciones terapeuticas para el tratamiento del virus de inmunodeficiencia humana
EP3496718A4 (en) 2016-08-08 2020-01-22 Hetero Labs Limited ANTIRETROVIRAL COMPOSITIONS
ES2952878T3 (es) 2016-08-08 2023-11-06 Hetero Labs Ltd Una composición antirretroviral multiclase
US20190175509A1 (en) * 2016-08-08 2019-06-13 Hetero Labs Limited High Drug Loaded Tablet Composition for Treating HIV
US20180085387A1 (en) * 2016-09-27 2018-03-29 Gilead Sciences, Inc. Therapeutic compositions for treatment of human immunodeficiency virus
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
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
CN119700779B (zh) * 2024-11-28 2025-11-04 安徽贝克生物制药有限公司 一种达芦那韦和考比司他复合片剂及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009135179A2 (en) * 2008-05-02 2009-11-05 Gilead Sciences, Inc. The use of solid carrier particles to improve the processability of a pharmaceutical agent
WO2011048604A2 (en) * 2009-09-17 2011-04-28 Matrix Laboratories Limited An improved process for the preparation of darunavir

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5968942A (en) 1992-08-25 1999-10-19 G. D. Searle & Co. α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
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
EP2767539B1 (en) 2002-05-16 2017-07-12 Janssen Sciences Ireland UC Pseudopolymorphic forms of a HIV protease inhibitor
TWI471145B (zh) 2005-06-13 2015-02-01 Bristol Myers Squibb & Gilead Sciences Llc 單一式藥學劑量型
CA2653940C (en) 2006-05-30 2015-07-14 Janssen Pharmaceutica N.V. Substituted pyridyl amide compounds as modulators of the histamine h3 receptor
US20080039428A1 (en) * 2006-06-29 2008-02-14 Panacos Pharmaceuticals, Inc. Antiretroviral combination therapy
PT2049506E (pt) 2006-07-07 2015-10-09 Gilead Sciences Inc Moduladores de propriedades farmacocinéticas de agentes terapêuticos
CA2667207A1 (en) * 2006-10-25 2008-05-02 Mcneil-Ppc, Inc. Ibuprofen composition
BRPI0807581A2 (pt) 2007-02-23 2014-07-01 Gilead Science, Inc. Moduladores de propriedades farmacocinéticas de produtos terapêuticos
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
EA018582B1 (ru) 2007-11-20 2013-09-30 Янссен Фармацевтика Н.В. Соединения циклоалкилокси- и гетероциклоалкилоксипиридина как модуляторы гистаминового рецептора н
GT200800303A (es) * 2007-12-24 2009-09-18 Combinacion anti-retroviral
SG173544A1 (en) * 2009-02-06 2011-09-29 Gilead Sciences Inc Tablets for combination therapy
EP2568810B1 (en) 2010-05-10 2018-09-19 Hetero Research Foundation Darunavir compositions
US20140142174A1 (en) 2011-07-07 2014-05-22 Urbain Alfons C. Delaet Darunavir formulations
SMT201700574T1 (it) 2011-07-07 2018-01-11 Gilead Sciences Inc Formulazioni delle combinazioni di darunavir
WO2013115916A1 (en) 2012-02-03 2013-08-08 Gilead Sciences, Inc. Combination therapy comprising gs-7340 and cobicistat for use in the treatment of viral infections
WO2016108205A1 (en) 2015-01-03 2016-07-07 Mylan Laboratories Limited Processes for the preparation of amorphous tenofovir alafenamide hemifumarate and a premix thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009135179A2 (en) * 2008-05-02 2009-11-05 Gilead Sciences, Inc. The use of solid carrier particles to improve the processability of a pharmaceutical agent
WO2011048604A2 (en) * 2009-09-17 2011-04-28 Matrix Laboratories Limited An improved process for the preparation of darunavir

Also Published As

Publication number Publication date
JP2014520787A (ja) 2014-08-25
DK2729130T3 (en) 2017-12-11
LT2729130T (lt) 2018-01-10
BR112014000290A2 (pt) 2017-02-07
US20230302024A1 (en) 2023-09-28
EP2729130A1 (en) 2014-05-14
JP6122427B2 (ja) 2017-04-26
WO2013004818A1 (en) 2013-01-10
AU2012280198B2 (en) 2016-12-22
NO2729130T3 (enExample) 2018-02-03
MX2013015199A (es) 2014-09-01
MX343689B (es) 2016-11-16
CN103826616B (zh) 2016-08-10
SI2729130T1 (en) 2018-03-30
BR112014000290B1 (pt) 2022-05-10
CN103826616A (zh) 2014-05-28
PL2729130T3 (pl) 2018-02-28
HUE035241T2 (en) 2018-05-02
CY1121999T1 (el) 2020-07-31
AU2012280198A8 (en) 2014-01-16
AU2012280198A1 (en) 2014-01-09
ES2651212T3 (es) 2018-01-25
US11654150B2 (en) 2023-05-23
EP2729130B1 (en) 2017-09-06
EA026587B1 (ru) 2017-04-28
SMT201700574T1 (it) 2018-01-11
RS56667B1 (sr) 2018-03-30
US20200093840A1 (en) 2020-03-26
CA2838659C (en) 2020-02-18
KR20140068845A (ko) 2014-06-09
PT2729130T (pt) 2017-12-13
HRP20171889T1 (hr) 2018-01-12
CA2838659A1 (en) 2013-01-10
IL229933A (en) 2017-09-28
US20140142070A1 (en) 2014-05-22
EA201490222A1 (ru) 2014-04-30

Similar Documents

Publication Publication Date Title
KR102058097B1 (ko) 다루나비어 복합 제제
KR101817991B1 (ko) 다루나비어 제제
KR101923103B1 (ko) 릴피비린 hcl 및 테노포비어 디소프록실 푸마레이트를 포함하는 치료 조성물
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

PA0201 Request for examination

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

R18-X000 Changes to party contact information recorded

St.27 status event code: A-3-3-R10-R18-oth-X000

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

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

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

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

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: 7