DK2426132T3 - Fremgangsmåde til fremstilling af oxycodonhydrochlorid-sammensætninger med mindre end 25 ppm 14-hydroxycodeinon - Google Patents
Fremgangsmåde til fremstilling af oxycodonhydrochlorid-sammensætninger med mindre end 25 ppm 14-hydroxycodeinon Download PDFInfo
- Publication number
- DK2426132T3 DK2426132T3 DK11186168.8T DK11186168T DK2426132T3 DK 2426132 T3 DK2426132 T3 DK 2426132T3 DK 11186168 T DK11186168 T DK 11186168T DK 2426132 T3 DK2426132 T3 DK 2426132T3
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- DK
- Denmark
- Prior art keywords
- hydroxycodeinone
- ppm
- oxycodone
- solution
- water
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/06—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with a hetero atom directly attached in position 14
- C07D489/08—Oxygen atom
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
-
- 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
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- 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]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/02—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/02—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone
- C07D489/04—Salts; Organic complexes
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Pain & Pain Management (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Rheumatology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Medicinal Preparation (AREA)
- Low-Molecular Organic Synthesis Reactions Using Catalysts (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Saccharide Compounds (AREA)
Claims (7)
1. Fremgangsmåde til fremstilling af en oxycodonhydrochlorid-sammensætning, der har et 14-hydroxycodeinon-niveau i en mængde på mindre end 25 ppm som bestemt ved HPLC-fremgangsmåden i eksempel 6, omfattende omsætning, i et egnet opløsningsmiddel, af en oxycodonbase-sammensætning, der indeholder en mængde af 8,14-dihydroxy-7,8-dihydrocodeinon med saltsyre i en mængde, der er større end 1,0 molækvivalent sammenlignet med oxycodonbase-sammensætningen, hvorved 8,14-dihydroxy-7,8-dihydrocodeinon dehydreres til 14-hydroxycodeinon, og under reduceringsbetingelser tilvejebragt af en katalysator og en hydrogendonor, hvorved 14-hydroxycodeinon omdannes til oxycodon, hvor opløsningsmidlet er udvalgt fra gruppen bestående af vand, en alkohol, en ether, en amid, N-methylpyrrolidon, en carboxylsyre og en passende blanding af to eller flere af de førnævnte opløsningsmidler.
2. Fremgangsmåde ifølge krav 1, hvor opløsningsmidlet er udvalgt fra gruppen bestående af vand, en alkohol, en ether, N-methylpyrrolidon og en passende blanding af to eller flere af de førnævnte opløsningsmidler.
3. Fremgangsmåde ifølge krav 2, hvor opløsningsmidlet er udvalgt fra gruppen bestående af vand, isopropanol, methanol, ethanol, tetrahydrofuran, dio-xan, N-methylpyrrolidon og en passende blanding af to eller flere af de førnævnte opløsningsmidler.
4. Fremgangsmåde ifølge krav 3, hvor opløsningsmidlet er udvalgt fra gruppen bestående af vand, isopropanol, methanol, ethanol og en passende blanding af to eller flere af de førnævnte opløsningsmidler.
5. Fremgangsmåde ifølge krav 4, hvor opløsningsmidlet er en kombination af isopropanol og vand.
6.
Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor 8,14-dihydroxy-7,8-dihydrocodeinon er 8a,14-dihydroxy-7,8-dihydrocodeinon.
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US55749204P | 2004-03-30 | 2004-03-30 | |
US60153404P | 2004-08-13 | 2004-08-13 | |
US62007204P | 2004-10-18 | 2004-10-18 | |
US64862505P | 2005-01-31 | 2005-01-31 | |
US65177805P | 2005-02-10 | 2005-02-10 | |
EP10011787.8A EP2319846B1 (en) | 2004-03-30 | 2005-03-30 | Process for preparing oxycodone hydrochloride having less than 25ppm 14-hydroxycodeinone |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2426132T3 true DK2426132T3 (da) | 2016-04-04 |
Family
ID=35124996
Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10011787.8T DK2319846T3 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
DK05730345.5T DK1730151T4 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
DK11186168.8T DK2426132T3 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid-sammensætninger med mindre end 25 ppm 14-hydroxycodeinon |
DK10011792T DK2305683T3 (da) | 2004-03-30 | 2005-03-30 | Farmaceutisk doseringsform omfattende hydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
DK10011788.6T DK2316837T3 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid, der har mindre end 25ppm 14-hydroxycodeinon |
DK200700214U DK200700214U3 (da) | 2004-03-30 | 2007-08-02 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10011787.8T DK2319846T3 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
DK05730345.5T DK1730151T4 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
Family Applications After (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10011792T DK2305683T3 (da) | 2004-03-30 | 2005-03-30 | Farmaceutisk doseringsform omfattende hydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
DK10011788.6T DK2316837T3 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid, der har mindre end 25ppm 14-hydroxycodeinon |
DK200700214U DK200700214U3 (da) | 2004-03-30 | 2007-08-02 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon |
Country Status (39)
Country | Link |
---|---|
US (35) | US7129248B2 (da) |
EP (7) | EP2319846B1 (da) |
JP (8) | JP4912294B2 (da) |
KR (12) | KR101200700B1 (da) |
CN (5) | CN102838607B (da) |
AP (1) | AP2232A (da) |
AR (1) | AR049012A1 (da) |
AT (2) | ATE501150T1 (da) |
AU (2) | AU2005230826C1 (da) |
BR (1) | BRPI0508758B8 (da) |
CA (3) | CA2913355C (da) |
CR (2) | CR8593A (da) |
CY (5) | CY1111487T1 (da) |
DE (2) | DE602005026786D1 (da) |
DK (6) | DK2319846T3 (da) |
EA (1) | EA013208B1 (da) |
EC (1) | ECSP066953A (da) |
ES (6) | ES2938727T3 (da) |
FI (1) | FI7843U1 (da) |
HK (3) | HK1098745A1 (da) |
HR (5) | HRP20110425T4 (da) |
HU (3) | HUE029913T2 (da) |
IL (8) | IL178038A (da) |
LT (2) | LT2316837T (da) |
MA (1) | MA28492B1 (da) |
ME (4) | ME03068B (da) |
MX (2) | MX363228B (da) |
MY (3) | MY154985A (da) |
NO (1) | NO337669B1 (da) |
NZ (3) | NZ601326A (da) |
PE (1) | PE20050880A1 (da) |
PL (5) | PL2316837T3 (da) |
PT (5) | PT2305683E (da) |
RS (5) | RS53891B1 (da) |
SG (3) | SG170736A1 (da) |
SI (5) | SI2319846T1 (da) |
TW (3) | TWI483944B (da) |
WO (1) | WO2005097801A1 (da) |
ZA (1) | ZA200607181B (da) |
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