ME02687B - Dozni oblik otporan na promene - Google Patents

Dozni oblik otporan na promene

Info

Publication number
ME02687B
ME02687B MEP-2017-97A MEP9717A ME02687B ME 02687 B ME02687 B ME 02687B ME P9717 A MEP9717 A ME P9717A ME 02687 B ME02687 B ME 02687B
Authority
ME
Montenegro
Prior art keywords
dosage form
form according
particles
copolymer
matrix
Prior art date
Application number
MEP-2017-97A
Other languages
German (de)
English (en)
French (fr)
Inventor
Hassan Mohammad
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
Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
Publication of ME02687B publication Critical patent/ME02687B/me

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering 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
    • 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
    • A61K9/1635—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • 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
    • 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
    • A61K9/14—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
    • A61K9/14—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
    • A61K9/1682—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—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
    • 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
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
    • B29B9/00—Making granules
    • B29B9/12—Making granules characterised by structure or composition

Landscapes

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

Claims (18)

1. Dozni oblik koji sadrži: Nerastegnute, otopljene, ekstrudirane čestice koje sadrže Jek koji je opioidni agonist; i matriks; gde su pomenute otopljene, ekstrudirane čestice prisutne u isprekidanoj fazi u pomenutom matriksu; pomenuti matriks sadrži neprekidnu fazu koja sadrži agens koji formira gel; i pomenute čestice dalje sadrže kopolimer alkil estara akrilne kiseline i alkil estara metakrilne kiseline ili njihove smeše.
2. Dozni oblik prema patentnom zahtevu 1 , gde pomenute čestice sadrže 10 do 50 % mase pomenutog kopolimera, na osnovu ukupne mase čestice, gde pomenuti kopolimer daje otpornost na drobljenje.
3. Dozni oblik prema patentnom zahtevu 1 ili patentnom zahtevu 2, gde pomenute otopljene-ekstrudirane čestice imaju prečnik i/ili dužinu manju od oko 900 µm.
4. Dozni oblik prema bilo kom od patentnih zahteva 1 do 3, gde pomenute čestice dalje sadrže agens za kontrolisanje brzine ili modifikovanje.
5. Dozni oblik prema patentnom zahtevu 4, gde pomenuti agens za kontrolisanje brzine ili modifikovanje je alkil celuloza.
6. Dozni oblik prema patentnom zahtevu 5, gde pomenuta alkil celuloza je etilceluloza.
7. Dozni oblik prema bilo kom od patentnih zahteva 4 do 6, gde pomenute čestice sadrže 20 do 50 % mase agensa za kontrolisanje brzine ili modifikovanje, na osnovu ukupne mase čestice.
8. Dozni oblik prema bilo kom od patentnih zahteva 1 do 7, gde pomenuti agens za formiranje gela je odabran od polietilen oksida, polivinil akohola, hidroksipropil metil celuloze, karbomera, poli(uronske) kiseline ili njihovih smeša.
9. Dozni oblik prema bilo kom od patentnih zahteva 1 do 8, gde pomenuti agens za formiranje gela može da se podvrgne sušenju.
10. Dozni oblik prema bilo kom od patentnih zahteva 1 do 9, gde pomenuti opioidni agonist je odabran iz grupe koja se sastoji od oksikodona, oksimorfona, hidrokodona, hidromorfona, modina, kodeina, buprenorfina, fentanila, tramadola, tapentadola i njihovih farmaceutski prihvatljivih soli.
11. Dozni oblik prema bilo kom od patentnih zahteva 1 do 10, dalje sadrži jedan ili više dodatnih aktivnih sastojaka.
12. Dozni oblik prema patentnom zahtevu 1, gde pomenute čestice sadrže oksikodon ili hidromorfon, kopolimer etil akrilata i metil metakrilata, etil celulozu kao agens za kontrolisanje brzine ili modifikovanje, stearil alkohol i/ili trietil citrat kao plastifikator, gliceril dibehenat kao lubrikant i po izboru opioidni antagonist.
13. Dozni oblik prema patentnom zahtevu 12, gde pomenuti oksikodon ili hidromorfon je prisutan kao njegova hidrohloridna so.
14. Dozni oblik prema bilo kom od patentnih zahteva 1 do 13, gde pomenute čestice dalje sadrže opioidni antagonist.
15. Dozni oblik prema bilo kom od patentnih zahteva 1 do 14 za primenu kao lek.
16. Dozni oblik prema patentnom zahtevu 15, za primenu u lečenju ili kontrolisanju bola.
17. Postupak za pripremanje doznog oblika prema bilo kom od patentnih zahteva 1 do 14 koji sadrži:i) ekstrudiranje topljenjem kompozicije koja sadrži opioidni agonist i kopolimer alkil estara akrilne kiseline i alkil estara metakrilne kiseline ili njihovih smeša kroz otvore ekstruzione glave sa kalupom koji su manji od 1.0 mm u prečniku da se formira otopljeni ekstrudat koji ima prosečni prečnik manji od oko 1000µm;ii) sečenje otopljenog ekstrudata da se formiraju čestice koje imaju prosečan prečnik manji od oko 1 000 µm;iii) mešanje pomenutih č.estica sa matriksnim mate....rijalom tako da pomenute čestice formiraju isprekidanu fazu u pomenutom matriksu; iiv) formiranje pomenute smeše u dozni oblik.
18. Postupak prema patentnom zahtevu 17, gde pomenuti otvori ekstruzionih glava sa kalupima su 0,1 mm do 0,9 mm u prečniku.
MEP-2017-97A 2010-12-09 2011-12-09 Dozni oblik otporan na promene ME02687B (me)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1020895.7A GB201020895D0 (en) 2010-12-09 2010-12-09 Dosage form
PCT/GB2011/052455 WO2012076907A2 (en) 2010-12-09 2011-12-09 Dosage form
EP11808286.6A EP2648699B1 (en) 2010-12-09 2011-12-09 Tamper-resistant dosage form

Publications (1)

Publication Number Publication Date
ME02687B true ME02687B (me) 2017-06-20

Family

ID=43566928

Family Applications (1)

Application Number Title Priority Date Filing Date
MEP-2017-97A ME02687B (me) 2010-12-09 2011-12-09 Dozni oblik otporan na promene

Country Status (32)

Country Link
US (1) US20130330409A1 (me)
EP (1) EP2648699B1 (me)
JP (1) JP5926738B2 (me)
KR (1) KR101946037B1 (me)
CN (2) CN107397720A (me)
AU (1) AU2011340288B2 (me)
BR (1) BR112013014361A2 (me)
CA (1) CA2820431C (me)
CO (1) CO6751243A2 (me)
CY (1) CY1119050T1 (me)
DK (1) DK2648699T3 (me)
EA (1) EA024509B1 (me)
ES (1) ES2626676T3 (me)
GB (1) GB201020895D0 (me)
HR (1) HRP20170650T1 (me)
HU (1) HUE033340T2 (me)
IL (1) IL226437A0 (me)
LT (1) LT2648699T (me)
ME (1) ME02687B (me)
MX (1) MX347083B (me)
MY (1) MY161845A (me)
NZ (1) NZ610921A (me)
PH (1) PH12013501106A1 (me)
PL (1) PL2648699T3 (me)
PT (1) PT2648699T (me)
RS (1) RS55976B1 (me)
SG (1) SG190356A1 (me)
SI (1) SI2648699T1 (me)
SM (1) SMT201700233T1 (me)
UA (1) UA111834C2 (me)
WO (1) WO2012076907A2 (me)
ZA (1) ZA201304158B (me)

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