ME02153B - Nove farmaceutske kompozicije, otporne na zloupotrebu, za tretman zavisnosti od opioida - Google Patents

Nove farmaceutske kompozicije, otporne na zloupotrebu, za tretman zavisnosti od opioida

Info

Publication number
ME02153B
ME02153B MEP-2015-71A MEP201571A ME02153B ME 02153 B ME02153 B ME 02153B ME P201571 A MEP201571 A ME P201571A ME 02153 B ME02153 B ME 02153B
Authority
ME
Montenegro
Prior art keywords
tablet
tablet according
buprenorphine
particle
mixing
Prior art date
Application number
MEP-2015-71A
Other languages
English (en)
Inventor
Andreas Fischer
Original Assignee
Orexo Ab
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=47046639&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME02153(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Orexo Ab filed Critical Orexo Ab
Publication of ME02153B publication Critical patent/ME02153B/me

Links

Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Addiction (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (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. Tableta pogodna za sublingvalnu administraciju koja sadrži:(a) mikročestice farmakološki efektivne količine buprenorfina ili njegove farmaceutski prihvatljive soli koje su u kontaktu su sa česticama koje sadrže limunsku kiselinu;(b) farmakološki efektivne količine naloksona ili njegove farmaceutski prihvatljive soli; i(c) dezintegrator izabran iz grupe natrijum karboksimetilceluloze, natrijum skrob glikolata, razgranatog polivinilpirolidona i njihove smeše
2. Tableta prema patentnom Zahtjevu 1, pri čemu mikročestice buprenorfina imaju maseni prečnik manji od oko 15 μm.
3. Tableta prema bilo kojem od prethodnih patentnih zahtjeva, koja je prisutna kao interaktivna smjesa i sadrži mikročestice buprenorfina ili njegove prihvatljive soli predstavljenim na površinama nosača čestica.
4. Tableta prema patentnom Zahtjevu 3, gde je nosač čestica veličine između oko 100 i 800 μm
5. Tableta prema patentnom Zahtjevu 3 ili Zahtjevu 4, pri čemu je nosač čestica rastvoran u vodi.
6. Tableta prema bilo kojem od patentnih Zahtjeva od 3 do 5, pri čemu nosač čestica sadrži manitol.
7. Tableta prema bilo kojem od patentnih Zahtjeva od 3 do 6, pri čemu su čestice limunske kiseline predstavljene i ponašaju se kao nosači čestica.
8. Tableta prema bilo kojem od prethodnih zahtjeva, pri čemu tableta sadrži čestice koje sadrže nalokson ili njegove soli i dezintegrator.
9. Proces za pripremu tablete definisane prema bilo kojem od prethodnih zahtjeva, gde mješanje uzima mesto između mikročestica buprenorfina ili njegove soli i čestice limunske kiseline, vraća ih u kontakt jedne s drugima.
10. Proces prema patentnom Zahtevu 9, gde mješanje sadrži prosto mješanje ili granulaciju.
11. Proces za pripremu tablete iz bilo kojeg od Zahtjeva od 3 do 8, što sadrži suvo mješanje nosača čestica sa buprenorfinom ili njegovom soli.
12. Proces za pripremu tablete prema patentnom Zahtjevu 8, koji sadrži proces prema patentnom Zahtjevu 11, praćen mješanjem sa česticama koji sadrže nalokson ili njegove soli i dezintegrator.
13. Tableta prema bilo kojem od Zahtjeva od 1 do 8, za upotrebu u metodu tretmana potrebe i/ili zavisnosti od opioida.
14. Tableta prema bilo kojem od patentnih Zahtjeva od 1 do 8, za upotrebu u metodu tretmana bola.
MEP-2015-71A 2011-09-19 2012-09-18 Nove farmaceutske kompozicije, otporne na zloupotrebu, za tretman zavisnosti od opioida ME02153B (me)

Applications Claiming Priority (3)

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
EP12775283.0A EP2706986B1 (en) 2011-09-19 2012-09-18 New abuse-resistant pharmaceutical composition for the treatment of opioid dependence

Publications (1)

Publication Number Publication Date
ME02153B true ME02153B (me) 2015-10-20

Family

ID=47046639

Family Applications (1)

Application Number Title Priority Date Filing Date
MEP-2015-71A ME02153B (me) 2011-09-19 2012-09-18 Nove farmaceutske kompozicije, otporne na zloupotrebu, za tretman zavisnosti od opioida

Country Status (31)

Country Link
US (16) US8940330B2 (me)
EP (3) EP2915525B1 (me)
JP (2) JP6210988B2 (me)
KR (1) KR102078044B1 (me)
CN (1) CN103813785B (me)
AU (1) AU2012311293B2 (me)
BR (1) BR112014006356B1 (me)
CA (1) CA2834327C (me)
CL (1) CL2014000575A1 (me)
CO (1) CO6960541A2 (me)
CY (2) CY1116270T1 (me)
DK (2) DK2915525T3 (me)
EA (1) EA029507B1 (me)
ES (2) ES2538460T3 (me)
HR (2) HRP20150369T1 (me)
HU (1) HUE056309T2 (me)
IL (1) IL230528B (me)
LT (1) LT2915525T (me)
ME (1) ME02153B (me)
MX (1) MX361757B (me)
MY (1) MY185284A (me)
PE (1) PE20141198A1 (me)
PH (1) PH12014500316B1 (me)
PL (2) PL2915525T3 (me)
PT (2) PT2706986E (me)
RS (2) RS53995B1 (me)
SG (1) SG2014009401A (me)
SI (2) SI2706986T1 (me)
SM (2) SMT202100546T1 (me)
WO (1) WO2013041851A1 (me)
ZA (1) ZA201400501B (me)

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