FI121588B - Förfarande för framställning av opioidformulation - Google Patents

Förfarande för framställning av opioidformulation Download PDF

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Publication number
FI121588B
FI121588B FI955782A FI955782A FI121588B FI 121588 B FI121588 B FI 121588B FI 955782 A FI955782 A FI 955782A FI 955782 A FI955782 A FI 955782A FI 121588 B FI121588 B FI 121588B
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FI
Finland
Prior art keywords
opioid
hours
release
formulation
analgesic
Prior art date
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FI955782A
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English (en)
Finnish (fi)
Other versions
FI955782A0 (sv
FI955782A (sv
Inventor
Paul Goldenheim
Richard Sackler
Robert Kaiko
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Euro Celtique Sa
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Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
Publication of FI955782A0 publication Critical patent/FI955782A0/sv
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    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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]

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Dental Preparations (AREA)
  • Inorganic Compounds Of Heavy Metals (AREA)
  • Medicines Containing Plant Substances (AREA)

Claims (12)

1. Förfarande för tillverkning av en opioidformulering med fordröjd frigöring som ges oralt en gang per dygn, vilken opioidformulering omfattar flera substrat, som 5 innehaller en dos av en opioidanalget och en effektiv mängd av ätminstone ett retarderande material, kännetecknat därav, att förfarandet omfattar steg, i vilka: A) flera substrat med fordröjd frigöring tillverkas genom beläggning av flera inerta pärlor med en del av nämnda opioidanalgetdos och genom beläggning av nämnda belagda inerta pärlor med nämnda retarderande material, och 10 B) nämnda substrat med fordröjd frigöring förenas med en form med omedelbar frigöring av den äterstäende nämnda opioidanalgetdosen i en proportion som ästadkommer frigöring av nämnda opioidanalget frän den sälunda erhällna formuleringen med effektiv hastighet för ästadkommande av en analgetisk effekt efter oral administrering tili en människopatient för ätminstone cirka 24 timmar 15 och initialt en snabb ökning av plasmakoncentrationen av nämnda opioid sä att det ästadkoms en absorptionshalveringstid frän 1 tili cirka 8 timmar vid administrering tili en patient i fastetillständ.
2. Förfarande enligt patentkravet 1, kännetecknat därav, att nämnda opioid är 20 tramadol eller ett sait därav.
3. Förfarande enligt patentkravet 1 eller 2, kännetecknat därav, att nämnda retarderande material väljs frän en grupp som bestär av en akrylpolymer, en alkylcellulosa, shellack, zein, hydrogenerad vegetabilisk olja, hydrogenerad 25 ricinolja och blandningar av nägon av ovannämnda.
4. Förfarande enligt nägot av patentkraven 13, kännetecknat därav, att nämnda formulering med fördröjd frigöring som ges oralt ästadkommer en absorptionshalveringstid pä cirka 1-6 timmar. 30
5. Förfarande enligt nägot av patentkraven 1-3, kännetecknat därav, att nämnda formulering med fordröjd frigöring som ges oralt ästadkommer en absorptionshalveringstid pä cirka 1-3 timmar. 5
6. Förfarande enligt nägot av patentkraven 1-5, kännetecknat därav, att en topplasmanivä av nämnda opioid in vivo ästadkoms 2 cirka 10 timmar efter administrering.
7. Förfarande enligt nägot av patentkraven 1-6, kännetecknat därav, att nämnda 10 formulering med fordröjd frigöring omfattar flera substrat, nämnda opioid medräknad, varvid var och en av nämnda substrat har en diameter pä 0,1 - 3 mm.
8. Förfarande enligt nägot av patentkraven 1-7, kännetecknat därav, att fonnen med omedelbar frigöring av opioidanalget beläggs pä substraten med fordröjd 15 frigöring.
9. Förfarande enligt nägot av patentkraven 1-8, kännetecknat därav, att nämnda substrat inncsluts i en kapscl. 20
10. Förfarande enligt nägot av patentkraven 1-9, kännetecknat därav, att nämnda substrat tillverkas i en form som väljs bland sfaroider, pärlor, mikrokulor, kom, pelletter, jonbytarhartspärlor, gryn och blandningar av dessa.
11. Förfarande enligt nägot av patentkraven 18, kännetecknat därav, att 25 nämnda formulering med fordröjd frigöring tillverkas som en tablett.
12. Förfarande enligt nägot av patentkraven 17, kännetecknat därav, att formen med omedelbar frigöring innesluts i form av pulver eller gryn i en kapsel med substraten med fordröjd frigivning.
FI955782A 1993-11-23 1995-12-01 Förfarande för framställning av opioidformulation FI121588B (sv)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US15646893 1993-11-23
US08/156,468 US5478577A (en) 1993-11-23 1993-11-23 Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasma drug level
US9413606 1994-11-22
PCT/US1994/013606 WO1995014460A1 (en) 1993-11-23 1994-11-22 Opioid formulations for treating pain

Publications (3)

Publication Number Publication Date
FI955782A0 FI955782A0 (sv) 1995-12-01
FI955782A FI955782A (sv) 1996-01-30
FI121588B true FI121588B (sv) 2011-01-31

Family

ID=22559696

Family Applications (1)

Application Number Title Priority Date Filing Date
FI955782A FI121588B (sv) 1993-11-23 1995-12-01 Förfarande för framställning av opioidformulation

Country Status (23)

Country Link
US (10) US5478577A (sv)
EP (4) EP1023896B1 (sv)
JP (5) JPH09505602A (sv)
KR (1) KR100201767B1 (sv)
CN (1) CN1134253C (sv)
AT (3) ATE212831T1 (sv)
AU (1) AU693134B2 (sv)
BG (1) BG63269B1 (sv)
CZ (1) CZ292936B6 (sv)
DE (3) DE69434911T2 (sv)
DK (3) DK1470815T3 (sv)
ES (3) ES2170136T5 (sv)
FI (1) FI121588B (sv)
HK (1) HK1029927A1 (sv)
HU (1) HUT73976A (sv)
IL (1) IL111742A (sv)
NO (1) NO315147B1 (sv)
NZ (3) NZ508526A (sv)
PL (1) PL312587A1 (sv)
PT (3) PT1023896E (sv)
SK (1) SK283544B6 (sv)
TW (1) TW420617B (sv)
WO (1) WO1995014460A1 (sv)

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