DK2273983T3 - Fremgangsmåde til fremstilling af en pulverformig mellemproduktformulering og en fast slutdoseringsform under anvendelse af et sprøjtestørkningstrin - Google Patents
Fremgangsmåde til fremstilling af en pulverformig mellemproduktformulering og en fast slutdoseringsform under anvendelse af et sprøjtestørkningstrin Download PDFInfo
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- DK2273983T3 DK2273983T3 DK09741898.2T DK09741898T DK2273983T3 DK 2273983 T3 DK2273983 T3 DK 2273983T3 DK 09741898 T DK09741898 T DK 09741898T DK 2273983 T3 DK2273983 T3 DK 2273983T3
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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
- A61K9/14—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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/14—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
- A61K9/145—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 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
- A61K9/14—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
- A61K9/14—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
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (15)
1. Fremgangsmåde til fremstilling af et pulver, hvilken fremgangsmåde omfatter trinnene i) at tilvejebringe mindst en første bestanddel, hvor den mindst ene første bestanddel omfatter eller repræsenterer vitaminolie, lecitin eller simeticon, ii) at tilvejebringe mindst en anden bestanddel med et smeltepunkt eller smelteområde over omgivelsernes temperatur, hvor den mindste ene anden bestanddel omfatter eller består af polyalkylenglykol, iii) at danne en homogen væskeblanding omfattende den mindst ene første bestanddel og den mindst ene anden bestanddel ved at omrøre og opvarme blandingen til eller holde blandingen på en temperatur i området fra over smeltepunktet eller smelteområdet for den anden bestanddel og op til 120 °C, hvor den homogene væskeblanding omfatter fra 92 % efter vægt til 99,9 % efter vægt af den mindst ene anden bestanddel og fra 0,1 % efter vægt til 8 % efter vægt af den mindst ene første bestanddel, iv) at overføre væskeblandingen til mindst en sprøjtestørkningsenhed ved hjælp af mindst en overførselsenhed, som er tilpasset til at holde blandingen på flydende form under overførsel deraf, v) at sprøjtestørkne blandingen og vi) at isolere pulveret opnået efter sprøjtestørkning.
2. Fremgangsmåde ifølge krav 1, hvor den mindst ene første bestanddel omfatter eller består af tokoferol og/eller tokoferolderivater.
3. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor den mindst ene anden bestanddel omfatter eller består af polyethylenglykol.
4. Fremgangsmåde ifølge krav 3, hvor polyethylenglykolen er polyethylenglykol 6000 (PEG 6000).
5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor overførselsenheden omfatter mindst en fødelinje og mindst en pumpe, hvor i det mindste fødelin-jen er tilpasset til at kunne varmes op.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor smeltepunktet eller smelteområdet for den anden bestanddel er i området fra >40 °C til 120 °C.
7. Pulver, som kan opnås ved fremgangsmåden ifølge et hvilket som helst af de foregående krav.
8. Pulver ifølge krav 7 omfattende eller bestående af fra 92 % efter vægt til 99,9 % efter vægt polyalkylenglykol som den mindst ene anden bestanddel og fra 0,1 % efter vægt til 8 % efter vægt tokoferol som den mindst ene første bestanddel.
9. Pulver ifølge krav 7 eller 8 med en partikelstørrelsesfordeling d50 i området fra 40 pm til 300 pm.
10. Anvendelse af et pulver ifølge et hvilket som helst af kravene 7 til 9 til fremstil- ling af en fast doseringsform indeholdende mindst en farmaceutisk virksom bestanddel.
11. Anvendelse ifølge krav 10, hvor den faste doseringsform omfatter mindst en farmaceutisk aktiv bestanddel, mindst en poly(alkylenoxid), mindst et celluloseetherderi-vat, mindst en polyalkylenglykol og mindst en vitaminolie.
12. Anvendelse ifølge krav 11, hvor vitaminolien er til stede i en mængde på under 1 % efter vægt baseret på den faste doseringsforms samlede vægt.
13. Fremgangsmåde til fremstilling af en fast doseringsform, hvilken fremgangsmåde omfatter trinnene a) at tilvejebringe et pulver ifølge fremgangsmåden ifølge et hvilket som helst af kravene 1 til 6 (bestanddel a), b) at tilvejebringe mindst en farmaceutisk virksom bestanddel (bestanddel b), c) at tilvejebringe mindst en tredje bestanddel (bestanddel c), d) at danne en blanding omfattende bestanddelene a, b og c, e) at omdanne blandingen til en fast doseringsform.
14. Fremgangsmåde ifølge krav 13, hvor den mindst ene tredje bestanddel (bestanddel c) er udvalgt fra gruppen bestående af poly(alkylenoxid), poly(vinylalkohol), hy-droxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropyl-methylcellulose og carboxymethylcellulose.
15. Fremgangsmåde til fremstilling af en tablet ifølge krav 13 eller 14, hvilken fremgangsmåde omfatter trinnene a) at tilvejebringe pulveret ifølge fremgangsmåden ifølge et hvilket som helst af kravene 1 til 6 (bestanddel a), b) at tilvejebringe den mindst ene farmaceutisk aktive bestanddel (bestanddel b), c) at tilvejebringe den mindst ene tredje bestanddel (bestanddel c), d) at danne en blanding omfattende bestanddelene a, b og c, e) at smelteekstrudere blandingen, f) at indvinde det ekstruderede produkt, og g) at komprimere det ekstruderede produkt til en tablet.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08008749 | 2008-05-09 | ||
PCT/EP2009/003290 WO2009135680A1 (en) | 2008-05-09 | 2009-05-08 | Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step |
Publications (1)
Publication Number | Publication Date |
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DK2273983T3 true DK2273983T3 (da) | 2016-09-19 |
Family
ID=40050124
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK09741898.2T DK2273983T3 (da) | 2008-05-09 | 2009-05-08 | Fremgangsmåde til fremstilling af en pulverformig mellemproduktformulering og en fast slutdoseringsform under anvendelse af et sprøjtestørkningstrin |
Country Status (26)
Country | Link |
---|---|
US (1) | US9161917B2 (da) |
EP (1) | EP2273983B1 (da) |
JP (1) | JP5674641B2 (da) |
KR (1) | KR101690094B1 (da) |
CN (1) | CN102123701B (da) |
AU (1) | AU2009243681B2 (da) |
BR (1) | BRPI0912014A2 (da) |
CA (1) | CA2723438C (da) |
CO (1) | CO6341546A2 (da) |
CY (1) | CY1118085T1 (da) |
DK (1) | DK2273983T3 (da) |
EC (1) | ECSP10010613A (da) |
ES (1) | ES2599031T3 (da) |
HR (1) | HRP20161307T1 (da) |
HU (1) | HUE030803T2 (da) |
IL (1) | IL209044A (da) |
LT (1) | LT2273983T (da) |
MX (1) | MX2010012039A (da) |
NZ (1) | NZ588863A (da) |
PL (1) | PL2273983T3 (da) |
PT (1) | PT2273983T (da) |
RU (1) | RU2508092C2 (da) |
SI (1) | SI2273983T1 (da) |
TW (1) | TWI524904B (da) |
WO (1) | WO2009135680A1 (da) |
ZA (1) | ZA201007818B (da) |
Families Citing this family (40)
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DE10336400A1 (de) * | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
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DE102004032103A1 (de) * | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
DE102004032049A1 (de) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
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SI2273983T1 (sl) | 2008-05-09 | 2016-11-30 | Gruenenthal Gmbh | Postopek za pripravo intermediatne praškaste formulacije in končne trdne odmerne oblike z uporabo stopnje strjevanja z razprševanjem |
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