ES2331046T1 - Formulacion de liberacion controlada. - Google Patents

Formulacion de liberacion controlada. Download PDF

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Publication number
ES2331046T1
ES2331046T1 ES09004973T ES09004973T ES2331046T1 ES 2331046 T1 ES2331046 T1 ES 2331046T1 ES 09004973 T ES09004973 T ES 09004973T ES 09004973 T ES09004973 T ES 09004973T ES 2331046 T1 ES2331046 T1 ES 2331046T1
Authority
ES
Spain
Prior art keywords
controlled release
dosage form
alcohol
baselineskip
tramadol
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
ES09004973T
Other languages
English (en)
Inventor
Ronald Brown Miller
Stuart Thomas Leslie
Sandra Therese Antoinette Malkowska
Kevin John Smith
Walter Wimmer
Horst Winkler
Udo Hahn
Derek Allan Prater
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=ES2331046(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 ES2331046T1 publication Critical patent/ES2331046T1/es
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)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Preparación de liberación controlada que comprende tramadol o una sal farmacéuticamente aceptable del mismo para administración oral.

Claims (15)

1. Preparación de liberación controlada que comprende tramadol o una sal farmacéuticamente aceptable del mismo para administración oral.
2. Preparación de liberación controlada como la reivindicada en la reivindicación 1, que contiene de 50 a 800 mg de tramadol (calculados como tramadol clorhidrato).
3. Preparación de liberación controlada como la reivindicada en la reivindicación 1 o 2, que tiene una velocidad de disolución in vitro (medida como aquí se ha definido) como la que se indica a continuación:
\vskip1.000000\baselineskip
2 
\vskip1.000000\baselineskip
4. Preparación de liberación controlada como la reivindicada en la reivindicación 1 o 2, que tiene una velocidad de disolución in vitro (medida como aquí se ha definido) como la que se indica a continuación:
\vskip1.000000\baselineskip
3 
\vskip1.000000\baselineskip
5. Preparación de liberación controlada como la reivindicada en la reivindicación 1 o 2, que tiene una velocidad de disolución in vitro (medida como aquí se ha definido anteriormente) como la que se indica a continuación:
\vskip1.000000\baselineskip
4
6. Preparación de liberación controlada como la reivindicada en la reivindicación 1 o 2, que tiene una velocidad de disolución in vitro (medida como aquí se ha definido) como la que se indica a continuación:
5
7. Forma posológica oral sólida de liberación controlada según cualquiera de las reivindicaciones 1 a 6, que comprende una cantidad terapéuticamente eficaz de tramadol o de una sal del mismo en una matriz adaptada para proporcionar una liberación controlada del tramadol o de la sal del mismo tras administración oral.
8. Forma posológica según la reivindicación 7, caracterizada por el hecho de que la matriz comprende una matriz de liberación controlada que comprende al menos un alquilo, y preferiblemente un alquilo de C_{1} a C_{6}, celulosa, al menos un alcohol alifático de C_{12} a C_{36}, y preferiblemente de C_{14} a C_{22}, y opcionalmente al menos un polialquilglicol, y preferiblemente polietilenglicol.
9. Forma posológica según la reivindicación 8, caracterizada por el hecho de que la alquilcelulosa que es al menos una es etilcelulosa.
10. Forma posológica según la reivindicación 8 o 9, caracterizada por el hecho de que la forma posológica contiene de un 1 a un 20% en peso, y preferiblemente de un 2 a un 15% en peso, de una o varias alquilcelulosas.
11. Forma posológica según cualquiera de las reivindicaciones 8 a 10, caracterizada por el hecho de que el alcohol alifático comprende alcohol laurílico, alcohol miristílico, alcohol estearílico, o preferiblemente alcohol cetílico o alcohol cetoestearílico.
12. Proceso según cualquiera de las reivindicaciones 8 a 11, caracterizado por el hecho de que la forma posológica contiene de un 5 a un 30% en peso de alcohol alifático, y preferiblemente de un 10 a un 25% en peso de alcohol alifático.
13. Forma posológica según cualquiera de las reivindicaciones 1 a 6, en forma de esferoides con recubrimiento pelicular, caracterizada por el hecho de que la matriz esferoidal comprende un agente esferonizante, y preferiblemente celulosa microcristalina.
14. Forma posológica según cualquiera de las reivindicaciones 1 a 6, en forma de multiparticulados, donde la matriz comprende un diluyente o soporte fusible hidrofóbico que tiene un punto de fusión de 35 a 140ºC y opcionalmente un componente de control de liberación que comprende un material fusible hidrosoluble, o un material orgánico o inorgánico soluble o insoluble particulado.
15. Forma posológica según cualquiera de las reivindicaciones 1 a 6, que comprende una tableta hecha comprimiendo un multiparticulado según la reivindicación 14.
ES09004973T 1993-05-10 1994-04-29 Formulacion de liberacion controlada. Pending ES2331046T1 (es)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
DE4315525 1993-05-10
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
GB9324045 1993-11-23
GB9404544A GB9404544D0 (en) 1994-03-09 1994-03-09 Controlled release formulation
GB9404544 1994-03-09
GB9404928 1994-03-14
GB9404928A GB2287880A (en) 1994-03-14 1994-03-14 Production of sustained release compositions

Publications (1)

Publication Number Publication Date
ES2331046T1 true ES2331046T1 (es) 2009-12-21

Family

ID=27435744

Family Applications (5)

Application Number Title Priority Date Filing Date
ES04030658T Expired - Lifetime ES2346651T3 (es) 1993-05-10 1994-04-29 Formulacion de liberacion controlada que tramadol formulacion de liberacion controlada que contiene tramadol.
ES95114527T Expired - Lifetime ES2159591T5 (es) 1993-05-10 1994-04-29 Formulación de liberación controlada
ES94303128T Expired - Lifetime ES2088312T3 (es) 1993-05-10 1994-04-29 Formulacion de liberacion controlada que contiene tramadol.
ES09004973T Pending ES2331046T1 (es) 1993-05-10 1994-04-29 Formulacion de liberacion controlada.
ES04014719T Expired - Lifetime ES2247574T3 (es) 1993-05-10 1994-04-29 Formulacion de liberacion controlada que comprende tramadol.

Family Applications Before (3)

Application Number Title Priority Date Filing Date
ES04030658T Expired - Lifetime ES2346651T3 (es) 1993-05-10 1994-04-29 Formulacion de liberacion controlada que tramadol formulacion de liberacion controlada que contiene tramadol.
ES95114527T Expired - Lifetime ES2159591T5 (es) 1993-05-10 1994-04-29 Formulación de liberación controlada
ES94303128T Expired - Lifetime ES2088312T3 (es) 1993-05-10 1994-04-29 Formulacion de liberacion controlada que contiene tramadol.

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES04014719T Expired - Lifetime ES2247574T3 (es) 1993-05-10 1994-04-29 Formulacion de liberacion controlada que comprende tramadol.

Country Status (22)

Country Link
US (6) US5591452A (es)
EP (6) EP2103303B1 (es)
JP (3) JP3045924B2 (es)
CN (2) CN1094755C (es)
AT (5) ATE138566T1 (es)
AU (2) AU6196394A (es)
CA (1) CA2123160C (es)
CZ (1) CZ288517B6 (es)
DE (8) DE69434479T2 (es)
DK (4) DK1527775T3 (es)
ES (5) ES2346651T3 (es)
FI (3) FI942092A7 (es)
GR (2) GR3020084T3 (es)
HU (1) HU228177B1 (es)
ID (1) ID25988A (es)
IL (3) IL109460A (es)
NO (3) NO306446B1 (es)
NZ (1) NZ260408A (es)
PT (3) PT699436E (es)
SG (1) SG67347A1 (es)
SK (2) SK279971B6 (es)
TW (1) TW496736B (es)

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