DK2258345T3 - Fast farmaceutisk doseringsform omfattende en fast dispersion af en HIV-proteaseinhibitor - Google Patents
Fast farmaceutisk doseringsform omfattende en fast dispersion af en HIV-proteaseinhibitor Download PDFInfo
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- DK2258345T3 DK2258345T3 DK10181264.2T DK10181264T DK2258345T3 DK 2258345 T3 DK2258345 T3 DK 2258345T3 DK 10181264 T DK10181264 T DK 10181264T DK 2258345 T3 DK2258345 T3 DK 2258345T3
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- dosage form
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- hiv protease
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Classifications
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- 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
- A61K9/2072—Pills, 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
-
- 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
- A61K9/141—Intimate 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
- A61K9/146—Intimate 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
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Virology (AREA)
- Oncology (AREA)
- Communicable Diseases (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 (24)
1. Fast farmaceutisk doseringsform, der omfatter en fast dispersion af mindst en HIV-proteaseinhibitor i mindst én farmaceutisk acceptabel vandopløselig polymer og mindst et farmaceutisk acceptabelt overfladeaktivt middel, hvor doseringsformen omfatter ritonavir og et overfladeaktivt middel med en HLB-værdi på fra 4 til 10.
2. Fast doseringsform ifølge krav 1, hvor den faste dispersion omfatter en vandopløselig polymer med en Tg på mindst 50° C.
3. Fast doseringsform ifølge krav 1 eller 2, hvor den faste dispersion er en glasagtig opløsning eller en fast opløsning.
4. Fast doseringsform ifølge krav 1, hvor doseringsformen omfatter et farmaceutisk acceptabelt overfladeaktivt middel ud over det overfladeaktive middel med en HLB-værdi på fra 4 til 10.
5. Fast doseringsform ifølge krav 4, hvor det overfladeaktive middel, der har en HLB-værdi på fra 4 til 10, udgør mindst 50 vægt-% af den samlede mængde overfladeaktivt middel, der anvendes.
6. Fast doseringsform ifølge krav 1, hvor det overfladeaktive middel, der har en HLB-værdi på fra 4 til 10, er en sorbitanfedtsyreester.
7. Fast doseringsform ifølge krav 6, hvor det overfladeaktive middel, der har en HLB-værdi på fra 4 til 10, er valgt blandt sorbitanmonolaurat og sorbitan-monopalmitat.
8. Fast doseringsform ifølge krav 1, hvor doseringsformen omfatter, i forhold til doseringsformens vægt, fra 5 til 30 vægt-% af en HIV-proteaseinhibitor eller en kombination af HIV-proteaseinhibitorer, fra 50 til 85 vægt-% af en vandopløselig polymer eller en kombination af vandopløselige polymerer, fra 2 til 20 vægt-% af et overfladeaktivt middel eller en kombination af overfladeaktive midler og fra 0 til 15 vægt-% additiver.
9. Fast doseringsform ifølge krav 1, hvor den mindst ene HIV- proteaseinhibitor er en kombination af ritonavir og mindst en anden HIV-proteaseinhibitor, hvor doseringsformen udviser en doseringstilpasset AUC af ritonavirplasmakoncentration hos hunde på mindst 9 pg.h/ml/100 mg.
10. Fast doseringsform ifølge krav 2, hvor den mindst ene HIV- proteaseinhibitor er en kombination af ritonavir og lopinavir.
11. Fast doseringsform ifølge krav 1, hvor den faste dispersion omfatter en vandopløselig polymer med en Tg på fra 80 til 180° C.
12. Fast doseringsform ifølge krav 1, hvor doseringsformen omfatter en homopolymer eller copolymer af N-vinylpyrrolidon.
13. Fast doseringsform ifølge krav 1, hvor doseringsformen omfatter en copolymer af N-vinylpyrrolidon og vinylacetat.
14. Fast doseringsform ifølge krav 13, hvor doseringsformen omfatter en copolymer på 60 vægt-% af copolymeren, N-vinylpyrrolidon, og 40 vægt-% af copolymeren, vinylacetat.
15. Fast doseringsform ifølge krav 1, hvor doseringsformen indeholder mindst et additiv, der er valgt blandt strømningsregulatorer, sprængmidler, bulkmidler og smøremidler.
16. Fast doseringsform ifølge krav 1, hvor doseringsformen omfatter vandop-løselig(e) polymer(er), der er valgt blandt homopolymerer og copolymerer af N-vinyllactamer, celluloseestere og celluloseethere, højmolekylære polyalky-lenoxider, polyacrylater og polymethacrylater, polyacrylamider, vinylacetatpo-lymerer, delvist hydrolyseret polyvinylacetat, polyvinylalkohol, oligo- og po-lysaccharider og blandinger deraf.
17. Fast doseringsform ifølge krav 1, der kan opnås ved hjælp af en fremgangsmåde, der omfatter (i) at fremstille en homogen smelte af HIV-proteaseinhibitoren eller HIV-proteaseinhibitorerne, den eller de vandopløselige polymerer og det eller de overfaldeaktive midler, og (ii) at lade smelten stivne til opnåelse af et fast dispersionsprodukt.
18. Fast doseringsform ifølge krav 17, hvor et additiv, der er valgt blandt strømningsregulatorer, smøremidler, fyldstoffer, sprængmidler, blødgørere og stabilisatorer, er indbefattet i smelten.
19. Fast doseringsform ifølge krav 1, hvor den faste dispersion er en glasagtig opløsning eller en fast opløsning, der omfatter ritonavir og det overfladeaktive middel med en FILB-værdi på fra 4 til 10.
20. Fast doseringsform ifølge krav 1, hvor den faste dispersion er en glasagtig opløsning eller en fast opløsning, der omfatter ritonavir, en vandopløselig polymer med en Tg på mindst 50° C og det overfladeaktive middel med en HLB-værdi på fra 4 til 10.
21. Fast farmaceutisk doseringsform ifølge krav 1, omfattende en fast dispersion af ritonavir og lopinavir; en copolymer af N-vinylpyrrolidon og vinylacetat; og en sorbitanfedtsyreester.
22. Fast doseringsform ifølge krav 21, hvor doseringsformen indeholder mindst et additiv, der er valgt blandt strømningsregulatorer, sprængmidler, bulkmidler og smøremidler.
23. Fast farmaceutisk doseringsform ifølge krav 1, omfattende en fast dispersion af ritonavir og lopinavir, der forekommer i en mængde på fra 5 til 30 vægt-% af doseringsformen; en copolymer af N-vinylpyrrolidon og vinylacetat fra 50 til 85 vægt-% af doseringsformen; og en sorbitanfedtsyreester fra 2 til 20 vægt-% af doseringsformen.
24. Fast doseringsform ifølge et hvilket som helst af kravene 1 til 23 til anvendelse ved behandling af en HIV-infektion hos et pattedyr.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/650,178 US20050048112A1 (en) | 2003-08-28 | 2003-08-28 | Solid pharmaceutical dosage form |
| EP04816820A EP1663183B9 (en) | 2003-08-28 | 2004-08-23 | Solid pharmaceutical dosage form comprising ritonavir |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2258345T3 true DK2258345T3 (da) | 2017-01-16 |
Family
ID=34217089
Family Applications (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10181250.1T DK2258344T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform omfattende en fast dispersion af ritonavir og lopinavir |
| DK10181264.2T DK2258345T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform omfattende en fast dispersion af en HIV-proteaseinhibitor |
| DK04816820.7T DK1663183T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform omfattende ritonavir |
| DK15169378.5T DK2942051T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform der omfatter en fast dispersion af hiv-protease-inhibitor |
| DK10181268.3T DK2258346T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform omfattende en fast dispersion af en hiv-proteaseinhibitor |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10181250.1T DK2258344T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform omfattende en fast dispersion af ritonavir og lopinavir |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK04816820.7T DK1663183T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform omfattende ritonavir |
| DK15169378.5T DK2942051T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform der omfatter en fast dispersion af hiv-protease-inhibitor |
| DK10181268.3T DK2258346T3 (da) | 2003-08-28 | 2004-08-23 | Fast farmaceutisk doseringsform omfattende en fast dispersion af en hiv-proteaseinhibitor |
Country Status (31)
| Country | Link |
|---|---|
| US (1) | US20050048112A1 (da) |
| EP (6) | EP1663183B9 (da) |
| JP (6) | JP4815348B2 (da) |
| KR (5) | KR101563222B1 (da) |
| CN (5) | CN101919858B (da) |
| AT (1) | ATE516017T1 (da) |
| AU (3) | AU2004283087C1 (da) |
| CA (2) | CA2536638C (da) |
| CR (3) | CR8256A (da) |
| CY (5) | CY1111981T1 (da) |
| DK (5) | DK2258344T3 (da) |
| EA (4) | EA020992B1 (da) |
| EC (1) | ECSP066397A (da) |
| ES (5) | ES2653762T3 (da) |
| HK (4) | HK1094766A1 (da) |
| HR (1) | HRP20110555T1 (da) |
| HU (3) | HUE031153T2 (da) |
| IL (3) | IL173939A (da) |
| ME (2) | MEP17608A (da) |
| MX (2) | MX358033B (da) |
| NO (3) | NO330282B1 (da) |
| NZ (2) | NZ579622A (da) |
| PL (5) | PL2258346T3 (da) |
| PT (5) | PT2258344E (da) |
| RS (2) | RS59969B1 (da) |
| SG (3) | SG145690A1 (da) |
| SI (5) | SI1663183T1 (da) |
| TW (1) | TWI342221B (da) |
| UA (1) | UA85564C2 (da) |
| WO (1) | WO2005039551A2 (da) |
| ZA (3) | ZA200801362B (da) |
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| US8025899B2 (en) | 2003-08-28 | 2011-09-27 | Abbott Laboratories | Solid pharmaceutical dosage form |
| AU2012202831B2 (en) * | 2005-02-23 | 2015-01-22 | Abbvie Inc. | A solid pharmaceutical dosage formulation |
| KR20070025070A (ko) * | 2005-08-31 | 2007-03-08 | 주식회사 대웅제약 | 시부트라민 및 계면활성제를 함유하는 고체분산체 및 그의제조방법 |
| AU2006325404B2 (en) * | 2005-12-14 | 2012-03-01 | Cipla Limited | Pharmaceutical combination comprising nucleotide and nucleoside reverse transcriptase inhibitors (such as tenofovir and lamivudine) in different parts of the dosage unit |
| EP1962808B1 (en) * | 2005-12-14 | 2010-09-29 | F. Hoffmann-La Roche AG | Hcv prodrug formulation |
| US20090136570A1 (en) * | 2006-01-20 | 2009-05-28 | Bhagwant Rege | Taste-Masked Tablets and Granules |
| EP1832281A1 (en) * | 2006-03-10 | 2007-09-12 | Abbott GmbH & Co. KG | Process for producing a solid dispersion of an active ingredient |
| EP1880715A1 (en) * | 2006-07-19 | 2008-01-23 | Abbott GmbH & Co. KG | Pharmaceutically acceptable solubilizing composition and pharmaceutical dosage form containing same |
| US20100173921A1 (en) * | 2006-08-10 | 2010-07-08 | Cipla Limited | Antiretroviral Solid Oral Composition |
| US20080181948A1 (en) | 2006-11-15 | 2008-07-31 | Abbott Laboratories | Solid pharmaceutical dosage formulations |
| ES2603617T3 (es) | 2007-02-23 | 2017-02-28 | Gilead Sciences, Inc. | Moduladores de propiedades farmacocinéticas de la terapéutica |
| GT200800303A (es) * | 2007-12-24 | 2009-09-18 | Combinacion anti-retroviral | |
| ES2607814T3 (es) * | 2008-02-28 | 2017-04-04 | Abbvie Inc. | Preparación de tabletas |
| WO2009153654A1 (en) * | 2008-06-17 | 2009-12-23 | Aurobindo Pharma Limited | Solid dosage forms of antiretrovirals |
| EP2346495B2 (en) * | 2008-10-07 | 2023-05-24 | Kudos Pharmaceuticals Limited | Pharmaceutical formulation 514 |
| WO2010070611A1 (en) | 2008-12-18 | 2010-06-24 | Ranbaxy Laboratories Limited | Atazanavir formulations |
| TW201043269A (en) * | 2009-04-14 | 2010-12-16 | Bristol Myers Squibb Co | Bioavailable compositions of amorphous alpha-(N-sulfonamido)acetamide compound |
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| UA113500C2 (xx) | 2010-10-29 | 2017-02-10 | Одержані екструзією розплаву тверді дисперсії, що містять індукуючий апоптоз засіб | |
| CA2829186A1 (en) * | 2011-03-07 | 2012-09-13 | Bandi Parthasaradhi Reddy | Amorphous form of lopinavir and ritonavir mixture |
| WO2012164575A2 (en) | 2011-05-27 | 2012-12-06 | Hetero Research Foundation | Amorphous ritonavir co-precipitated |
| IN2014CN00827A (da) * | 2011-08-16 | 2015-04-03 | Merck Sharp & Dohme | |
| EP2564832A1 (en) | 2011-08-29 | 2013-03-06 | Hexal AG | Solid dosage form of HIV protease inhibitors |
| KR101794032B1 (ko) * | 2011-09-21 | 2017-11-07 | (주)바이오시네틱스 | 나노입자 제조방법 |
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| WO2013131645A1 (en) | 2012-03-07 | 2013-09-12 | Ratiopharm Gmbh | Dosage form comprising non-crystalline lopinavir and crystalline ritonavir |
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2003
- 2003-08-28 US US10/650,178 patent/US20050048112A1/en not_active Abandoned
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2004
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2006
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2007
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2008
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2010
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2012
- 2012-12-21 CR CR20120661A patent/CR20120661A/es unknown
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2013
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- 2013-12-27 NO NO20131743A patent/NO335326B1/no not_active Application Discontinuation
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2015
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2016
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2018
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