DK2706986T3 - Ny misbrugsforhindrende farmaceutisk sammensætning til behandling af opioidafhængighed - Google Patents

Ny misbrugsforhindrende farmaceutisk sammensætning til behandling af opioidafhængighed Download PDF

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Publication number
DK2706986T3
DK2706986T3 DK12775283.0T DK12775283T DK2706986T3 DK 2706986 T3 DK2706986 T3 DK 2706986T3 DK 12775283 T DK12775283 T DK 12775283T DK 2706986 T3 DK2706986 T3 DK 2706986T3
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Denmark
Prior art keywords
buprenorphine
tablet
naloxone
particles
opioid
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Application number
DK12775283.0T
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English (en)
Inventor
Andreas Fischer
Original Assignee
Orexo Ab
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Publication of DK2706986T3 publication Critical patent/DK2706986T3/da

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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
    • A61K31/33—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
    • 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
    • A61K31/4748—Quinolines; Isoquinolines forming part of bridged ring systems
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/2004—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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Addiction (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Zoology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. Tablet, der er egnet til sublingual indgivelse, omfattende: (a) mikropartikler af en farmakologisk virksom mængde af buprenorphin eller et farmaceutisk acceptabelt salt deraf i kontakt med partikler omfattende citronsyre; (b) en farmakologisk virksom mængde af naloxon eller et farmaceutisk acceptabelt salt deraf; og (c) et sprængmiddel udvalgt fra gruppen croscarmellosenatrium, natriumstivelsesglycolat, tværbundet polyvinylpyrrolidon og blandinger deraf.
2. Tablet ifølge krav 1, hvor mikropartiklerne af buprenorphin har en vægtbaseret middeldiameter på mindre end ca. 15 pm.
3. Tablet ifølge et hvilket som helst af de foregående krav, der er præsenteret som en interaktiv blanding omfattende mikropartikler af buprenorphin eller et farmaceutisk acceptabelt salt deraf, præsenteret på overfladerne af bærerpartikler.
4. Tablet ifølge krav 3, hvor bærerpartiklerne har en størrelse, der er mellem ca. 100 og ca. 800 pm.
5. Tablet ifølge krav 3 eller krav 4, hvor bærerpartiklerne er vandopløselige.
6. Tablet ifølge et hvilket som helst af kravene 3 til 5, hvor bærerpartiklerne omfatter mannitol.
7. Tablet ifølge et hvilket som helst af kravene 3 til 6, hvor partiklerne af citronsyre er præsenteret og virker som bærerpartikler.
8. Tablet ifølge et hvilket som helst af de foregående krav, hvor tabletten omfatter partikler omfattende naloxon eller salt deraf og sprængmiddel.
9. Fremgangsmåde til fremstilling af en tablet som defineret i et hvilket som helst af de foregående krav, hvorved der sker blanding mellem mikro- partiklerne af buprenorphin eller salt deraf og partiklerne af citronsyre, hvorved de kommer i kontakt med hinanden.
10. Fremgangsmåde ifølge krav 9, hvorved blandingen omfatter simpel blanding eller granulering.
11. Fremgangsmåde til fremstilling af en tablet som defineret i et hvilket som helst af kravene 3 til 8, omfattende tørblanding af bærerpartikler med buprenorphin eller salt deraf.
12. Fremgangsmåde til fremstilling af en tablet som defineret i krav 8, omfattende en fremgangsmåde ifølge krav 11, efterfulgt af blanding med partikler omfattende naloxon eller salt deraf og sprængmiddel.
13. Tablet som defineret i et hvilket som helst af kravene 1 til 8 til anvendelse i en fremgangsmåde til behandling af opioidafhængighed og/eller opioidhang.
14. Tablet som defineret i et hvilket som helst af kravene 1 til 8 til anvendelse i en fremgangsmåde til behandling af smerte.
DK12775283.0T 2011-09-19 2012-09-18 Ny misbrugsforhindrende farmaceutisk sammensætning til behandling af opioidafhængighed DK2706986T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161536180P 2011-09-19 2011-09-19
PCT/GB2012/052303 WO2013041851A1 (en) 2011-09-19 2012-09-18 New abuse-resistant pharmaceutical composition for the treatment of opioid dependence

Publications (1)

Publication Number Publication Date
DK2706986T3 true DK2706986T3 (da) 2015-06-01

Family

ID=47046639

Family Applications (2)

Application Number Title Priority Date Filing Date
DK12775283.0T DK2706986T3 (da) 2011-09-19 2012-09-18 Ny misbrugsforhindrende farmaceutisk sammensætning til behandling af opioidafhængighed
DK15156024.0T DK2915525T3 (en) 2011-09-19 2012-09-18 Sublingual abuse-resistant tablets comprising buprenorphine and naloxone

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK15156024.0T DK2915525T3 (en) 2011-09-19 2012-09-18 Sublingual abuse-resistant tablets comprising buprenorphine and naloxone

Country Status (31)

Country Link
US (16) US20130071477A1 (da)
EP (3) EP2915525B1 (da)
JP (2) JP6210988B2 (da)
KR (1) KR102078044B1 (da)
CN (1) CN103813785B (da)
AU (1) AU2012311293B2 (da)
BR (1) BR112014006356B1 (da)
CA (1) CA2834327C (da)
CL (1) CL2014000575A1 (da)
CO (1) CO6960541A2 (da)
CY (2) CY1116270T1 (da)
DK (2) DK2706986T3 (da)
EA (1) EA029507B1 (da)
ES (2) ES2887104T3 (da)
HR (2) HRP20150369T1 (da)
HU (1) HUE056309T2 (da)
IL (1) IL230528B (da)
LT (1) LT2915525T (da)
ME (1) ME02153B (da)
MX (1) MX361757B (da)
MY (1) MY185284A (da)
PE (1) PE20141198A1 (da)
PH (1) PH12014500316B1 (da)
PL (2) PL2706986T3 (da)
PT (2) PT2706986E (da)
RS (2) RS53995B1 (da)
SG (1) SG2014009401A (da)
SI (2) SI2915525T1 (da)
SM (2) SMT202100546T1 (da)
WO (1) WO2013041851A1 (da)
ZA (1) ZA201400501B (da)

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