DE729751T1 - Tramadolhaltiges Arzneimittel mit verzögerter Wirkstoffabgabe - Google Patents

Tramadolhaltiges Arzneimittel mit verzögerter Wirkstoffabgabe

Info

Publication number
DE729751T1
DE729751T1 DE0729751T DE96101147T DE729751T1 DE 729751 T1 DE729751 T1 DE 729751T1 DE 0729751 T DE0729751 T DE 0729751T DE 96101147 T DE96101147 T DE 96101147T DE 729751 T1 DE729751 T1 DE 729751T1
Authority
DE
Germany
Prior art keywords
dosage form
controlled release
alcohol
tramadol
pharmaceutical composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
DE0729751T
Other languages
English (en)
Inventor
Udo D-56412 Nentershausen Hahn
Stewart Thomas Cambridge Leslie
Sandra Therese Antoinette Ely Cambridgeshire Malkowska
Ronald Brown Ch-4051 Basle Miller
Derek Allan Milton Cambridge Prater
Kevin John Histon Cambridge Smith
Walter D-65549 Limburg Wimmer
Horst D-65550 Linter Winkler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Euro Celtique SA
Original Assignee
Euro Celtique SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27435744&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE729751(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE4315525A external-priority patent/DE4315525B4/de
Priority claimed from GB9324045A external-priority patent/GB2284760B/en
Priority claimed from GB9404544A external-priority patent/GB9404544D0/en
Priority claimed from GB9404928A external-priority patent/GB2287880A/en
Application filed by Euro Celtique SA filed Critical Euro Celtique SA
Publication of DE729751T1 publication Critical patent/DE729751T1/de
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2004—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
    • A61K9/2072—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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • 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]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (15)

10 15 25 PATENTANSPRÜCHE
1. Arzneimittel mit kontrollierter Wirkstoffabgabe, das Tramadol oder ein pharmazeutisch annehmbares Salz davon zur oralen Verabreichung enthält.
2. Arzneimittel mit kontrollierter Wirkstoff abgabe nach Anspruch 1, das 50 bis 800 mg Tramadol (berechnet als Tramadolhydrochlorid) enthält.
3. Arzneimittel mit kontrollierter Wirkstoffabgabe nach Anspruch 1 oder 2, mit der unten dargestellten /n-Wtro-Auflösungsgeschwindigkeit (gemessen gemäß der hier gegebenen Definition):
ZEIT (St.) ABGABE IN % 1 0-50 2 0-75 4 3-95 8 10-100 12 20-100 16 30-100 24 50-100 36 >80
4. Arzneimittel mit kontrollierter Wirkstoff abgabe nach Anspruch 1 oder 2, mit der unten dargestellten /n-i/Ztro-Auflösungsgeschwindigkeit (gemessen gemäß der hier gegebenen Definition):
ZEIT (St.) ABGABE IN % 1 20-50 CNJ 40-75 4 60-95 8 80-100 12 90-100
5. Arzneimittel mit kontrollierter Wirkstoff abgabe nach Anspruch 1 oder 2, mit der unten dargestellten /n-Wtro-Auflösungsgeschwindigkeit (gemessen gemäß der hier gegebenen Definition):
15
25
30
C.
ZEIT (St.) ABGABE IN % 1 0-50 CNJ 0-75 4 10-95 8 35-100 12 55-100 16 70-100 24 >90
6. Arzneimittel mit kontrollierter Wirkstoff abgabe nach Anspruch 1 oder 2, mit der unten dargestellten 7/7-WtroAuflösungsgeschwindigkeit (gemessen gemäß der hier gegebenen Definition):
ZEIT (St.) ABGABE IN % 1 0-30 2 0-40 4 3-55 CX) 10-65 12 20-75 16 30-88 24 50-100 36 >80
7. Feste orale Dosierungsform mit kontrollierter Wirkstoffabgabe nach einem der Ansprüche 1 bis 6, mit einer therapeutisch wirksamen Menge Tramadol oder eines Salzes davon in einer Matrix, die für eine kontrollierte Abgabe bzw. Freisetzung des Tramadols oder dessen Salzes bei oraler Verabreichung angepaßt ist.
8. Dosierungsform nach einem des Anspruches 7, dadurch gekennzeichnet, daß die Matrix eine Matrix mit kontrollierter Abgabe aufweist, die mindestens eine Alkyl-, vorzugsweise C1- bis C6-AlkyleelIuIöse, mindestens einen aliphatischen C12- bis C35-, vorzugsweise C14- bis C22-AIkOhOl, sowie wahl weise mindestens ein Polyalkylenglycol, vorzugsweise Polyethylenglycoi, aufweist.
r> rj
9. Dosierungsform nach Anspruch 8, dadurch gekennzeichnet, daß mindestens eine Alkyl eel IuI öse Ethyl eel IuI öse ist.
10. Dosierungsform nach Anspruch 8 oder 9, dadurch gekennzeichnet, daß die Dosierungsform 1 bis 20 Gew. -%, vorzugsweise 2 bis 15 Gew. -% einer oder mehrerer Alkyl eel IuI ösen enthält.
11. Dosierungsform nach einem der Ansprüche 8 bis 10, dadurch gekennzeichnet, daß der aliphatische Alkohol Laurylalkohol, Myristyl alkohol, Stearylalkohol oder vorzugsweise Cetylalkohol oder Cetostearylalkohol aufweist.
12. Verfahren nach einem der Ansprüche 8 bis 11, dadurch gekennzeichnet, daß die Dosierungsform 5 bis 30 Gew. -% aliphatischen Alkohol, vorzugsweise 10 bis 25 Gew.-% aliphatischen Alkohol enthält.
13. Dosierungsform nach einem der Ansprüche 1 bis 6 in Form von befilmten Kugelchen, dadurch gekennzeichnet, daß die Matrix der Kugelchen ein kugel bildendes Mittel. vorzugsweise mikrokristalline Cellulose, enthält.
14. Dosierungsform nach einem der Ansprüche 1 bis 6 in Form von Teilchengemengen, wobei die Matrix einen hydrophoben schmelzbaren Träger oder ein Verdünnungsmittel mit einem Schmelzpunkt von 35 bis 1400C und wahlweise eine Komponente zur Freisetzungskontrolle aufweist, die ein wasserlösliches schmelzbares Material oder ein aus Feststoffteilchen bestehendes lösliches oder unlösliches, organisches oder anorganisches Material aufweist.
15. Dosierungsform nach einem der Ansprüche 1 bis 6, die eine Tablette aufweist, die durch Pressen eines Teilchengemenges gemäß Anspruch 14 gebildet wird.
DE0729751T 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit verzögerter Wirkstoffabgabe Pending DE729751T1 (de)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE4315525A DE4315525B4 (de) 1993-05-10 1993-05-10 Pharmazeutische Zusammensetzung
GB9324045A GB2284760B (en) 1993-11-23 1993-11-23 A method of preparing pharmaceutical compositions by melt pelletisation
GB9404544A GB9404544D0 (en) 1994-03-09 1994-03-09 Controlled release formulation
GB9404928A GB2287880A (en) 1994-03-14 1994-03-14 Production of sustained release compositions

Publications (1)

Publication Number Publication Date
DE729751T1 true DE729751T1 (de) 1997-03-13

Family

ID=27435744

Family Applications (8)

Application Number Title Priority Date Filing Date
DE69435295T Expired - Lifetime DE69435295D1 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit gesteuerter Wirkstoffabgabe
DE69434479T Expired - Lifetime DE69434479T2 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit gesteuerter Wirkstoffabgabe
DE0699436T Pending DE699436T1 (de) 1993-05-10 1994-04-29 Arzneimittel mit kontrollierter Wirkstoffabgabe
DE69400215T Revoked DE69400215T2 (de) 1993-05-10 1994-04-29 Tramadol enthaltendes Arzneimittel mit verzögerter Wirkstoffabgabe
DE09004973T Active DE09004973T8 (de) 1993-05-10 1994-04-29 Formulierung mit gesteuerter Freisetzung
DE69427472T Expired - Lifetime DE69427472T3 (de) 1993-05-10 1994-04-29 Arzneimittel mit kontrollierter Wirkstoffabgabe
DE0729751T Pending DE729751T1 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit verzögerter Wirkstoffabgabe
DE9422335U Expired - Lifetime DE9422335U1 (de) 1993-05-10 1994-04-29 Formulierung mit kontrollierter Freisetzung

Family Applications Before (6)

Application Number Title Priority Date Filing Date
DE69435295T Expired - Lifetime DE69435295D1 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit gesteuerter Wirkstoffabgabe
DE69434479T Expired - Lifetime DE69434479T2 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit gesteuerter Wirkstoffabgabe
DE0699436T Pending DE699436T1 (de) 1993-05-10 1994-04-29 Arzneimittel mit kontrollierter Wirkstoffabgabe
DE69400215T Revoked DE69400215T2 (de) 1993-05-10 1994-04-29 Tramadol enthaltendes Arzneimittel mit verzögerter Wirkstoffabgabe
DE09004973T Active DE09004973T8 (de) 1993-05-10 1994-04-29 Formulierung mit gesteuerter Freisetzung
DE69427472T Expired - Lifetime DE69427472T3 (de) 1993-05-10 1994-04-29 Arzneimittel mit kontrollierter Wirkstoffabgabe

Family Applications After (1)

Application Number Title Priority Date Filing Date
DE9422335U Expired - Lifetime DE9422335U1 (de) 1993-05-10 1994-04-29 Formulierung mit kontrollierter Freisetzung

Country Status (22)

Country Link
US (6) US5591452A (de)
EP (6) EP0729751A1 (de)
JP (3) JP3045924B2 (de)
CN (2) CN1094755C (de)
AT (5) ATE468850T1 (de)
AU (2) AU6196394A (de)
CA (1) CA2123160C (de)
CZ (1) CZ288517B6 (de)
DE (8) DE69435295D1 (de)
DK (4) DK1527775T3 (de)
ES (5) ES2088312T3 (de)
FI (3) FI942092L (de)
GR (2) GR3020084T3 (de)
HU (1) HU228177B1 (de)
ID (1) ID25988A (de)
IL (3) IL109460A (de)
NO (3) NO306446B1 (de)
NZ (1) NZ260408A (de)
PT (3) PT1527775E (de)
SG (1) SG67347A1 (de)
SK (2) SK279971B6 (de)
TW (1) TW496736B (de)

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