DE09004973T1 - Formulierung mit gesteuerter Freisetzung - Google Patents

Formulierung mit gesteuerter Freisetzung Download PDF

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Publication number
DE09004973T1
DE09004973T1 DE09004973T DE09004973T DE09004973T1 DE 09004973 T1 DE09004973 T1 DE 09004973T1 DE 09004973 T DE09004973 T DE 09004973T DE 09004973 T DE09004973 T DE 09004973T DE 09004973 T1 DE09004973 T1 DE 09004973T1
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DE
Germany
Prior art keywords
dosage form
controlled release
tramadol
matrix
alcohol
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.)
Granted
Application number
DE09004973T
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English (en)
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DE09004973T8 (de
Inventor
Ronald Brown Harpenden Miller
Stuart Thomas Leslie
Sandra Therese Antoinette Wilburton Malkowska
Kevin John Histon Smith
Walter Wimmer
Horst Winkler
Udo Hahn
Derek Allan Milton Prater
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Euro Celtique SA
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Euro Celtique SA
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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=DE09004973(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 DE09004973T1 publication Critical patent/DE09004973T1/de
Application granted granted Critical
Publication of DE09004973T8 publication Critical patent/DE09004973T8/de
Active legal-status Critical Current

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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; 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
    • A61K9/20—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

Abstract

Präparat mit kontrollierter Freisetzung, umfassend Tramadol oder ein pharmazeutisch verträgliches Salz davon, zur oralen Verabreichung.

Claims (15)

  1. Präparat mit kontrollierter Freisetzung, umfassend Tramadol oder ein pharmazeutisch verträgliches Salz davon, zur oralen Verabreichung.
  2. Präparat mit kontrollierter Freisetzung gemäß Anspruch 1, enthaltend 50 bis 800 mg Tramadol (berechnet als Tramadol-Hydrochlorid).
  3. Präparat mit kontrollierter Freisetzung gemäß Anspruch 1 oder 2, folgende in-vitro-Auflösungsrate aufweist (gemessen wie hierin definiert): Zeit (h) % freigesetzt 1 0–50 2 0–75 4 3–95 8 10–100 12 20–100 16 30–100 24 50–100 36 > 80
  4. Präparat mit kontrollierter Freisetzung gemäß Anspruch 1 oder 2, welche folgende in-vitro-Auflösungsrate aufweist (gemessen wie hierin definiert): Zeit (h) % freigesetzt 1 20–50 2 40–75 4 60–95 8 80–100 12 90–100
  5. Präparat mit kontrollierter Freisetzung gemäß Anspruch 1 oder 2, welche folgende in-vitro-Auflösungsrate aufweist (gemessen wie vorstehend definiert): Zeit (h) % freigesetzt 1 0–50 2 0–75 4 10–95 8 35–100 12 55–100 16 70–100 24 > 90
  6. Präparat mit kontrollierter Freisetzung gemäß Anspruch 1 oder 2, welche folgende in-vitro-Auflösungsrate aufweist (gemessen wie hierin definiert): Zeit (h) % freigesetzt 1 0–30 2 0–40 4 3–55 8 10–65 12 20–75 16 30–88 24 50–100 36 > 80
  7. Eine feste, orale Dosierungsform mit kontrollierter Freisetzung gemäß einem der Ansprüche 1 bis 6, umfassend eine therapeutisch wirksame Menge Tramadol oder ein Salz davon in einer Matrix, welche geeignet ist, dass Tramadol oder Salz davon bei oraler Verabreichung kontrolliert freizusetzen.
  8. Eine Dosierungsform gemäß einem der Ansprüche 7, dadurch gekennzeichnet dass die Matrix eine kontrolliert freisetzende Matrix umfasst, welche mindestens ein Alkyl umfasst, bevorzugt C1 bis C6 Alkyl, Cellulose, mindestens einen C12 bis C36, bevorzugt C14 bis C22, aliphatischen Alkohol und optional mindestens ein Polyalkylglykol, bevorzugt Polyethylenglykol.
  9. Eine Dosierungsform gemäß Anspruch 8, dadurch gekennzeichnet dass die mindestens eine Alkylcellulose Ethylcellulose ist.
  10. Eine Dosierungsform gemäß Anspruch 8 oder 9, dadurch gekennzeichnet, dass die Dosierungsform von 1 bis 20% w/w, bevorzugt 2 bis 15% w/w einer oder mehrerer Akylcellulosen enthält.
  11. Eine Dosierungsform gemäß einem der Ansprüche 8 bis 10, dadurch gekennzeichnet, dass der aliphatische Alkohol Laurylalkohol, Myristylalkohol, Stearylalkohol, oder bevorzugt Cetylalkohol oder Cetostearylalkohol umfasst.
  12. Ein Prozess gemäß einem der Anspüche 8 bis 11, dadurch gekennzeichnet, dass die Dosierungsform von 5 bis 30% w/w aliphatischen Alkohol enthält, bevorzugt von 10 bis 25% w/w aliphatischen Alkohol.
  13. Eine Dosierungsform gemäß einem der Ansprüche 1 bis 6, in der Form von mit Film überzogenen Sphäroiden, dadurch gekennzeichnet, dass die Sphäroidmatrix ein sphäronisierendes Agenz umfasst, bevorzugt mikrokristalline Cellulose.
  14. Eine Dosierungsform gemäß einem der Ansprüche 1 bis 6, in der Form von Multipartikulaten, wobei die Matrix einen hydrophoben schmelzbaren Träger oder Weichmacher mit einem Schmelzpunkt von 35 bis 140°C umfasst und optional einen Bestandteil zur Kontrolle der Freisetzung welcher ein wasserlösliches schmelzbares Material, oder ein partikuläres lösliches oder unlösliches organisches oder anorganisches Material umfasst.
  15. Eine Dosierungsform gemäß einem der Ansprüche 1 bis 6, welche eine Tablette umfasst, geformt durch komprimieren eines Multipartikulats gemäß Anspruch 14.
DE09004973T 1993-05-10 1994-04-29 Formulierung mit gesteuerter Freisetzung Active DE09004973T8 (de)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
DE4315525 1993-05-10
DE4315525A DE4315525B4 (de) 1993-05-10 1993-05-10 Pharmazeutische Zusammensetzung
GB9324045 1993-11-23
GB9324045A GB2284760B (en) 1993-11-23 1993-11-23 A method of preparing pharmaceutical compositions by melt pelletisation
GB9404544 1994-03-09
GB9404544A GB9404544D0 (en) 1994-03-09 1994-03-09 Controlled release formulation
GB9404928 1994-03-14
GB9404928A GB2287880A (en) 1994-03-14 1994-03-14 Production of sustained release compositions
EP09004973.5A EP2103303B1 (de) 1993-05-10 1994-04-29 Tramadolhaltige formulierung mit gesteuerter freisetzung

Publications (2)

Publication Number Publication Date
DE09004973T1 true DE09004973T1 (de) 2010-01-14
DE09004973T8 DE09004973T8 (de) 2010-10-21

Family

ID=27435744

Family Applications (8)

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

Family Applications Before (4)

Application Number Title Priority Date Filing Date
DE69427472T Expired - Lifetime DE69427472T3 (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
DE69435295T Expired - Lifetime DE69435295D1 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit gesteuerter Wirkstoffabgabe
DE0729751T Pending DE729751T1 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit verzögerter Wirkstoffabgabe

Family Applications After (3)

Application Number Title Priority Date Filing Date
DE69434479T Expired - Lifetime DE69434479T2 (de) 1993-05-10 1994-04-29 Tramadolhaltiges Arzneimittel mit gesteuerter Wirkstoffabgabe
DE9422335U Expired - Lifetime DE9422335U1 (de) 1993-05-10 1994-04-29 Formulierung mit kontrollierter Freisetzung
DE0699436T Pending DE699436T1 (de) 1993-05-10 1994-04-29 Arzneimittel mit kontrollierter Wirkstoffabgabe

Country Status (22)

Country Link
US (6) US5591452A (de)
EP (6) EP0624366B1 (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) DE69427472T3 (de)
DK (4) DK0699436T4 (de)
ES (5) ES2247574T3 (de)
FI (3) FI942092A (de)
GR (2) GR3020084T3 (de)
HU (1) HU228177B1 (de)
ID (1) ID25988A (de)
IL (3) IL119660A (de)
NO (3) NO306446B1 (de)
NZ (1) NZ260408A (de)
PT (3) PT1468679E (de)
SG (1) SG67347A1 (de)
SK (2) SK283143B6 (de)
TW (1) TW496736B (de)

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