DK2729130T3 - Darunavir-kombinationsformuleringer - Google Patents
Darunavir-kombinationsformuleringer Download PDFInfo
- Publication number
- DK2729130T3 DK2729130T3 DK12738060.8T DK12738060T DK2729130T3 DK 2729130 T3 DK2729130 T3 DK 2729130T3 DK 12738060 T DK12738060 T DK 12738060T DK 2729130 T3 DK2729130 T3 DK 2729130T3
- Authority
- DK
- Denmark
- Prior art keywords
- darunavir
- dosage form
- oral dosage
- hypromellose
- granulate
- Prior art date
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; 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)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Virology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Molecular Biology (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 (10)
1. Oral doseringsform, der omfatter 0,4 til 0,6 vægt-% (vægt/vægt) af et smøremiddel, 3 vægt-% (vægt/vægt) af et disintegreringsmiddel, 17 til 20 vægt-% (vægt/vægt) siliciumdioxid ladet med GS-9350 (Cobicistat) svarende til en samlet mængde på 150 mg fri form ækvivalent af GS-9350 og 50 til 60 vægt-% (vægt/vægt) darunavirgranulat, hvilket darunavirgranulat består af darunavir og/eller et farmaceutisk acceptabelt salt eller solvat deraf, hypromellose og eventuelt restvand fra granuleringen.
2. Oral doseringsform ifølge krav 1, hvor siliciumdioxiden ladet med GS-9350 er kolloid siliciumdioxid.
3. Oral doseringsform ifølge krav 1 eller 2, hvor hypromellosen er hypromellose 2910 15 mPa.s.
4. Oral doseringsform ifølge krav 1, 2 eller 3, der omfatter 0,5 vægt-% (vægt/vægt) af et smøremiddel.
5. Oral doseringsform ifølge et hvilket som helst af ovennævnte krav, hvor disintegreringsmidlet er polyplasdon XL-10, og smøremidlet er magnesiumstearat.
6. Oral doseringsform ifølge et hvilket som helst af ovennævnte krav, der omfatter 800 mg fri form ækvivalent af darunavir.
7. Fremgangsmåde til fremstilling af en oral doseringsform ifølge et hvilket som helst af ovennævnte krav, som omfatter trinene: - tilvejebringelse af granuleret darunavir ved: blanding af vand og hypromellose, sprøjtning af denne første blanding på et pulver af darunavir og/eller et farmaceutisk acceptabelt salt eller solvat deraf og tørring af det således opnåede darunavirgranulat tilvejebringelse af en anden blanding, der omfatter mikrokrystallinsk cellulose, siliciumdioxid ladet med GS-9350, et disintegreringsmiddel, tilsætning af granuleret darunavir til blandingen og efterfølgende tørblanding, - tilsætning af et smøremiddel og blanding indtil homogenitet, - presning af blandingen til tilvejebringelse af den orale doseringsform, hvilken orale doseringsform herefter eventuelt filmovertrækkes.
8. Fremgangsmåde til fremstilling af en oral doseringsform ifølge krav 7, hvor siliciumdioxiden ladet med GS-9350 er kolloid siliciumdioxid.
9. Oral doseringsform ifølge et hvilket som helst af kravene 1 til 6 til anvendelse i medicin.
10. Oral doseringsform ifølge et hvilket som helst af kravene 1 til 6 til anvendelse til behandling af HIV-infektion.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11173067 | 2011-07-07 | ||
PCT/EP2012/063249 WO2013004818A1 (en) | 2011-07-07 | 2012-07-06 | Darunavir combination formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2729130T3 true DK2729130T3 (da) | 2017-12-11 |
Family
ID=46551505
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12738060.8T DK2729130T3 (da) | 2011-07-07 | 2012-07-06 | Darunavir-kombinationsformuleringer |
Country Status (23)
Country | Link |
---|---|
US (3) | US20140142070A1 (da) |
EP (1) | EP2729130B1 (da) |
JP (1) | JP6122427B2 (da) |
KR (1) | KR102058097B1 (da) |
CN (1) | CN103826616B (da) |
AU (1) | AU2012280198B2 (da) |
BR (1) | BR112014000290B1 (da) |
CA (1) | CA2838659C (da) |
CY (1) | CY1121999T1 (da) |
DK (1) | DK2729130T3 (da) |
EA (1) | EA026587B1 (da) |
ES (1) | ES2651212T3 (da) |
HR (1) | HRP20171889T1 (da) |
HU (1) | HUE035241T2 (da) |
IL (1) | IL229933A (da) |
LT (1) | LT2729130T (da) |
MX (1) | MX343689B (da) |
NO (1) | NO2729130T3 (da) |
PL (1) | PL2729130T3 (da) |
PT (1) | PT2729130T (da) |
RS (1) | RS56667B1 (da) |
SI (1) | SI2729130T1 (da) |
WO (1) | WO2013004818A1 (da) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RS56667B1 (sr) | 2011-07-07 | 2018-03-30 | Janssen Sciences Ireland Uc | Kombinovane formulacije darunavira |
JP2015508822A (ja) * | 2012-03-01 | 2015-03-23 | ギリアード サイエンシーズ, インコーポレイテッド | 噴霧乾燥製剤 |
KR102527797B1 (ko) | 2012-12-21 | 2023-05-03 | 길리애드 사이언시즈, 인코포레이티드 | 폴리시클릭-카르바모일피리돈 화합물 및 그의 제약 용도 |
TWI737647B (zh) | 2015-11-09 | 2021-09-01 | 美商基利科學股份有限公司 | 用於治療人類免疫缺乏病毒之治療組合物 |
US20190175509A1 (en) * | 2016-08-08 | 2019-06-13 | Hetero Labs Limited | High Drug Loaded Tablet Composition for Treating HIV |
US11045423B2 (en) | 2016-08-08 | 2021-06-29 | Hetero Labs Limited | Anti-retroviral compositions |
US20190175511A1 (en) * | 2016-08-08 | 2019-06-13 | Hetero Labs Limited | A Multi-Class Anti-Retroviral Composition |
US20180085387A1 (en) * | 2016-09-27 | 2018-03-29 | Gilead Sciences, Inc. | Therapeutic compositions for treatment of human immunodeficiency virus |
MA49635A (fr) | 2017-07-20 | 2020-05-27 | Gilead Sciences Inc | Compositions comprenant du darunavir, du cobicistat, de l'emtricitabine et du ténofovir alafénamide pour une utilisation dans le traitement du vih |
US20200101093A1 (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 |
Family Cites Families (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995006030A1 (en) | 1993-08-24 | 1995-03-02 | G.D. Searle & Co. | Hydroxyethylamino sulphonamides useful as retroviral protease inhibitors |
US5968942A (en) | 1992-08-25 | 1999-10-19 | G. D. Searle & Co. | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
CA2336160C (en) | 1998-06-23 | 2015-02-17 | The United States Of America, Represented By The Secretary, Department Of Health And Human Services | Use of compounds for treating hiv |
AR037797A1 (es) | 2001-12-12 | 2004-12-01 | Tibotec Pharm Ltd | Combinacion de inhibidores de proteasa dependientes del citocromo p450 |
EA007120B8 (ru) | 2002-05-16 | 2012-03-30 | Тиботек Фармасьютикалз Лтд. | Псевдополиморфные формы ингибитора вич-протеазы |
TWI471145B (zh) | 2005-06-13 | 2015-02-01 | Bristol Myers Squibb & Gilead Sciences Llc | 單一式藥學劑量型 |
AU2007256931B2 (en) | 2006-05-30 | 2013-01-24 | 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 |
EP3696171A1 (en) | 2006-07-07 | 2020-08-19 | Gilead Sciences, Inc. | Modulators of pharmacokinetic properties of therapeutics |
CN101528205A (zh) * | 2006-10-25 | 2009-09-09 | 麦克内尔-Ppc股份有限公司 | 布洛芬组合物 |
ES2603617T3 (es) | 2007-02-23 | 2017-02-28 | Gilead Sciences, Inc. | Moduladores de propiedades farmacocinéticas de la terapéutica |
BRPI0812964A2 (pt) * | 2007-06-25 | 2014-12-16 | Tibotec Pharm Ltd | Forma de dosagem farmacêutica oral sólida |
AR069539A1 (es) * | 2007-07-25 | 2010-02-03 | Tibotec Pharm Ltd | Avances respecto de las formulaciones de comprimidos contra el vih |
NZ584998A (en) | 2007-11-20 | 2012-08-31 | Janssen Pharmaceutica Nv | Cycloalkyloxy-and heterocycloalkyloxypyridine compounds as modulators of the histamine h3 receptor |
GT200800303A (es) * | 2007-12-24 | 2009-09-18 | Combinacion anti-retroviral | |
KR101784647B1 (ko) * | 2008-05-02 | 2017-10-11 | 길리애드 사이언시즈, 인코포레이티드 | 제약 제제의 가공성 향상을 위한 고체 담체 입자의 용도 |
AP3250A (en) * | 2009-02-06 | 2015-05-31 | Gilead Sciences Inc | Tablets for combination therapy |
ES2619562T3 (es) * | 2009-09-17 | 2017-06-26 | Mylan Laboratories Limited | Procesos para la preparación de darunavir y su forma amorfa |
WO2011141921A1 (en) | 2010-05-10 | 2011-11-17 | Hetero Research Foundation | Darunavir compositions |
US20140142174A1 (en) | 2011-07-07 | 2014-05-22 | Urbain Alfons C. Delaet | Darunavir formulations |
RS56667B1 (sr) | 2011-07-07 | 2018-03-30 | Janssen Sciences Ireland Uc | Kombinovane formulacije darunavira |
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 |
EP3240793A1 (en) | 2015-01-03 | 2017-11-08 | Mylan Laboratories Ltd. | Processes for the preparation of amorphous tenofovir alafenamide hemifumarate and a premix thereof |
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2012
- 2012-07-06 RS RS20171244A patent/RS56667B1/sr unknown
- 2012-07-06 CA CA2838659A patent/CA2838659C/en active Active
- 2012-07-06 WO PCT/EP2012/063249 patent/WO2013004818A1/en active Application Filing
- 2012-07-06 NO NO12738060A patent/NO2729130T3/no unknown
- 2012-07-06 EA EA201490222A patent/EA026587B1/ru unknown
- 2012-07-06 DK DK12738060.8T patent/DK2729130T3/da active
- 2012-07-06 MX MX2013015199A patent/MX343689B/es active IP Right Grant
- 2012-07-06 JP JP2014517822A patent/JP6122427B2/ja active Active
- 2012-07-06 ES ES12738060.8T patent/ES2651212T3/es active Active
- 2012-07-06 PL PL12738060T patent/PL2729130T3/pl unknown
- 2012-07-06 BR BR112014000290-8A patent/BR112014000290B1/pt active IP Right Grant
- 2012-07-06 EP EP12738060.8A patent/EP2729130B1/en active Active
- 2012-07-06 KR KR1020147000092A patent/KR102058097B1/ko active IP Right Grant
- 2012-07-06 LT LTEP12738060.8T patent/LT2729130T/lt unknown
- 2012-07-06 HU HUE12738060A patent/HUE035241T2/en unknown
- 2012-07-06 CN CN201280033554.0A patent/CN103826616B/zh active Active
- 2012-07-06 AU AU2012280198A patent/AU2012280198B2/en active Active
- 2012-07-06 US US14/131,282 patent/US20140142070A1/en not_active Abandoned
- 2012-07-06 SI SI201231141T patent/SI2729130T1/en unknown
- 2012-07-06 PT PT127380608T patent/PT2729130T/pt unknown
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2013
- 2013-12-17 IL IL229933A patent/IL229933A/en active IP Right Grant
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2017
- 2017-12-05 CY CY20171101267T patent/CY1121999T1/el unknown
- 2017-12-05 HR HRP20171889TT patent/HRP20171889T1/hr unknown
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2019
- 2019-11-27 US US16/697,888 patent/US11654150B2/en active Active
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2023
- 2023-05-05 US US18/313,266 patent/US20230302024A1/en active Pending
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