DK2319846T3 - Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon - Google Patents
Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 14-hydroxycodeinon Download PDFInfo
- Publication number
- DK2319846T3 DK2319846T3 DK10011787.8T DK10011787T DK2319846T3 DK 2319846 T3 DK2319846 T3 DK 2319846T3 DK 10011787 T DK10011787 T DK 10011787T DK 2319846 T3 DK2319846 T3 DK 2319846T3
- Authority
- DK
- Denmark
- Prior art keywords
- hydroxycodeinone
- ppm
- oxycodone hydrochloride
- less
- solution
- Prior art date
Links
Classifications
-
- 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
-
- 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
Claims (9)
1. Fremgangsmåde til fremstilling af en oxycodonhydrochlorid-sammensætning med mindre end 25 ppm 14-hydroxycodeinon som bestemt ved HPLC-metoden i eksempel 6, omfattende hydrogenering af en oxy-codonhydrochlorid-sammensætning med mindst 100 ppm 14-hydroxycodeinon som bestemt ved HPLC-metoden i eksempel 6 i et egnet opløsningsmiddel til fremstilling af en oxycodonhydrochlorid-sammensætning med mindre end 25 ppm 14-hydroxycodeinon, hvor det egnede opløsningsmiddel 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, yderligere omfattende genvinding af oxycodonhydrochlorid-sammensætningen, der har mindre end 25 ppm 14-hydroxycodeinon, fra opløsningsmidlet, hvor genvindingstrinnet omfatter at krystallisere oxycodonhy-drochlorid-sammensætningen med mindre end 25 ppm 14-hydroxycodeinon og at filtrere den krystalliserede sammensætning fra opløsningsmidlet.
2. Fremgangsmåde ifølge krav 1, hvor hydrogeneringen udføres med en katalysator og en hydrogendonor.
3. Fremgangsmåde ifølge krav 2, hvor katalysatoren er palladium på carbon.
4. Fremgangsmåde ifølge krav 3, hvor hydrogeneringen anvender hydrogengas og palladium på carbon-katalysatoren.
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 4, 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.
6. Fremgangsmåde ifølge krav 5, 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.
7. Fremgangsmåde ifølge krav 6, hvor opløsningsmidlet er udvalgt fra gruppen bestående af vand, isopropanol, methanol, ethanol og en passende blanding af to eller flere af de førnævnte opløsningsmidler.
8. Fremgangsmåde ifølge krav 5, hvor opløsningsmidlet er en kombination af isopropanol og vand.
9. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 8, hvor mindst en del af 14-hydroxycodeinonet stammer fra 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 | |
EP05730345.5A EP1730151B2 (en) | 2004-03-30 | 2005-03-30 | Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2319846T3 true DK2319846T3 (da) | 2016-08-15 |
Family
ID=35124996
Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
DK05730345.5T DK1730151T4 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid 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 |
DK10011787.8T DK2319846T3 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid med mindre end 25 ppm 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 (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
DK05730345.5T DK1730151T4 (da) | 2004-03-30 | 2005-03-30 | Fremgangsmåde til fremstilling af oxycodonhydrochlorid 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 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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) | EP2316837B1 (da) |
JP (8) | JP4912294B2 (da) |
KR (12) | KR20120106784A (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) | CA2557845C (da) |
CR (2) | CR8593A (da) |
CY (5) | CY1111487T1 (da) |
DE (2) | DE602005026786D1 (da) |
DK (6) | DK2426132T3 (da) |
EA (1) | EA013208B1 (da) |
EC (1) | ECSP066953A (da) |
ES (6) | ES2585576T3 (da) |
FI (1) | FI7843U1 (da) |
HK (3) | HK1098745A1 (da) |
HR (5) | HRP20110425T4 (da) |
HU (3) | HUE028233T2 (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) | NZ602862A (da) |
PE (1) | PE20050880A1 (da) |
PL (5) | PL2426132T3 (da) |
PT (5) | PT2426132E (da) |
RS (5) | RS57000B1 (da) |
SG (3) | SG170736A1 (da) |
SI (5) | SI2305683T1 (da) |
TW (3) | TW201509943A (da) |
WO (1) | WO2005097801A1 (da) |
ZA (1) | ZA200607181B (da) |
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