NZ590772A - Alcohol resistant dosage forms - Google Patents

Alcohol resistant dosage forms

Info

Publication number
NZ590772A
NZ590772A NZ590772A NZ59077206A NZ590772A NZ 590772 A NZ590772 A NZ 590772A NZ 590772 A NZ590772 A NZ 590772A NZ 59077206 A NZ59077206 A NZ 59077206A NZ 590772 A NZ590772 A NZ 590772A
Authority
NZ
New Zealand
Prior art keywords
opioid
dosage form
less
salt
controlled release
Prior art date
Application number
NZ590772A
Other languages
English (en)
Inventor
Richard O Mannion
William H Mckenna
Edward P O'donnell
Helen Kathleen Danagher
Geoffrey Gerard Hayes
Hassan Mohammad
Derek Allan Prater
Harjit Tamber
Malcolm Walden
Steve Whitelock
Wolfgang Fleischer
Udo Hahn
Christof Spitzley
Christian Leuner
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
Priority claimed from PCT/GB2005/050014 external-priority patent/WO2005079760A1/en
Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
Priority to NZ560669A priority Critical patent/NZ560669A/xx
Publication of NZ590772A publication Critical patent/NZ590772A/en

Links

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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/1635—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
    • 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
    • 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
    • A61K9/2027—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
    • A61K9/205—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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61P25/36—Opioid-abuse
    • 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]
    • 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
    • B29B9/02—Making granules by dividing preformed material
    • B29B9/06—Making granules by dividing preformed material in the form of filamentary material, e.g. combined with extrusion
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
    • B29K2033/04—Polymers of esters
    • B29K2033/12—Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0085—Copolymers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Addiction (AREA)
  • Mechanical Engineering (AREA)
  • Psychiatry (AREA)
  • Rheumatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
NZ590772A 2005-01-28 2006-01-27 Alcohol resistant dosage forms NZ590772A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
NZ560669A NZ560669A (en) 2005-01-28 2006-01-27 Use of alkyl cellulose as controlled release matrix material in alcohol resistant dosage forms

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB0501638.1A GB0501638D0 (en) 2005-01-28 2005-01-28 Particulates
PCT/GB2005/050014 WO2005079760A1 (en) 2004-02-12 2005-02-11 Particulates
US67050605P 2005-04-12 2005-04-12
US73033905P 2005-10-26 2005-10-26

Publications (1)

Publication Number Publication Date
NZ590772A true NZ590772A (en) 2012-05-25

Family

ID=34259727

Family Applications (2)

Application Number Title Priority Date Filing Date
NZ590772A NZ590772A (en) 2005-01-28 2006-01-27 Alcohol resistant dosage forms
NZ560669A NZ560669A (en) 2005-01-28 2006-01-27 Use of alkyl cellulose as controlled release matrix material in alcohol resistant dosage forms

Family Applications After (1)

Application Number Title Priority Date Filing Date
NZ560669A NZ560669A (en) 2005-01-28 2006-01-27 Use of alkyl cellulose as controlled release matrix material in alcohol resistant dosage forms

Country Status (11)

Country Link
EP (3) EP2319499A1 (https=)
JP (2) JP5704789B2 (https=)
CN (1) CN101132772B (https=)
AP (1) AP2274A (https=)
EA (1) EA015615B1 (https=)
GB (1) GB0501638D0 (https=)
IL (1) IL184858A (https=)
MA (1) MA29368B1 (https=)
NZ (2) NZ590772A (https=)
TN (1) TNSN07293A1 (https=)
ZA (1) ZA200705913B (https=)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090317355A1 (en) * 2006-01-21 2009-12-24 Abbott Gmbh & Co. Kg, Abuse resistant melt extruded formulation having reduced alcohol interaction
US20070212414A1 (en) * 2006-03-08 2007-09-13 Penwest Pharmaceuticals Co. Ethanol-resistant sustained release formulations
WO2010034342A1 (en) * 2008-09-24 2010-04-01 Evonik Röhm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
CA2755808C (en) * 2009-03-18 2016-01-19 Evonik Operations Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients
EP2408437A1 (en) * 2009-03-18 2012-01-25 Evonik Röhm GmbH Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising a polymer mixture and excipients
GB0909680D0 (en) * 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
PH12012502083A1 (en) * 2010-05-10 2017-07-26 Euro Celtique Sa Manufacturing of active-free granules and tablets comprising the same
US9700508B2 (en) * 2010-05-10 2017-07-11 Euro-Celtique S.A. Pharmaceutical compositions comprising hydromorphone and naloxone
EP2568965A1 (en) * 2010-05-10 2013-03-20 Euro-Celtique S.A. Combination of active loaded granules with additional actives
GB201020895D0 (en) * 2010-12-09 2011-01-26 Euro Celtique Sa Dosage form
ES2628303T3 (es) * 2011-06-01 2017-08-02 Fmc Corporation Formas de dosis sólidas de liberación controlada
WO2013057570A2 (en) * 2011-10-18 2013-04-25 Purdue Pharma L.P. Acrylic polymer formulations
EP2838512B1 (en) * 2012-04-18 2018-08-22 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
CA2881144A1 (en) * 2012-11-09 2014-05-09 Purdue Pharma Pharmaceutical compositions comprising hydromorphone and naloxone
MX2015010041A (es) 2013-02-05 2015-10-30 Purdue Pharma Lp Formulacion farmaceuticas resistentes a la alteracion.
RU2020117757A (ru) 2017-11-01 2021-11-29 Эджмонт Фармасьютикалс, Ллк Траст Оральные фармацевтические композиции лоразепама, устойчивые к спирту

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8626098D0 (en) * 1986-10-31 1986-12-03 Euro Celtique Sa Controlled release hydromorphone composition
US5266331A (en) 1991-11-27 1993-11-30 Euroceltique, S.A. Controlled release oxycodone compositions
US5656295A (en) 1991-11-27 1997-08-12 Euro-Celtique, S.A. Controlled release oxycodone compositions
US5968551A (en) 1991-12-24 1999-10-19 Purdue Pharma L.P. Orally administrable opioid formulations having extended duration of effect
NZ260408A (en) * 1993-05-10 1996-05-28 Euro Celtique Sa Controlled release preparation comprising tramadol
US5965161A (en) 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
DE19710008A1 (de) * 1997-03-12 1998-09-17 Basf Ag Feste, mindestens zweiphasige Zubereitungsformen eines Opioid-Analgeticums mit verzögerter Freisetzung
PT1009387E (pt) * 1997-07-02 2006-08-31 Euro Celtique Sa Formulacoes estabilizadas de libertacao controlada de tramadol
DE19901085C2 (de) * 1999-01-14 2003-12-18 Lohmann Therapie Syst Lts Transdermales therapeutisches System mit einer selbstklebenden Matrix, enthaltend organische Säure-Additionssalze von Alkaloiden des Morphin- bzw. Morphinantyps
US20030118641A1 (en) 2000-07-27 2003-06-26 Roxane Laboratories, Inc. Abuse-resistant sustained-release opioid formulation
HU229705B1 (en) 2000-02-08 2014-05-28 Euro Celtique Sa Tamper-resistant oral opioid agonist formulations
GB0026137D0 (en) * 2000-10-25 2000-12-13 Euro Celtique Sa Transdermal dosage form
WO2003004009A1 (en) * 2001-07-02 2003-01-16 Geneva Pharmaceuticals, Inc. Pharmaceutical composition
WO2003013476A1 (en) * 2001-08-06 2003-02-20 Euro-Celtique S.A. Compositions and methods to prevent abuse of opioids
CA2456322A1 (en) * 2001-08-06 2003-02-20 Euro-Celtique, S.A. Compositions and methods to prevent abuse of opioids
EP1492505B1 (en) * 2002-04-05 2015-06-03 Euro-Celtique S.A. Pharmaceutical preparation containing oxycodone and naloxone
US7399488B2 (en) 2002-07-05 2008-07-15 Collegium Pharmaceutical, Inc. Abuse-deterrent pharmaceutical compositions of opiods and other drugs
EP1551402A4 (en) * 2002-09-23 2009-05-27 Verion Inc PHARMACEUTICAL COMPOSITIONS NOT INDUCING ABUSE
ATE482695T1 (de) * 2002-12-13 2010-10-15 Durect Corp Orale darreichungsform mit flüssigen hochviskosen trägersystemen
US20060153915A1 (en) * 2003-01-23 2006-07-13 Amorepacific Corporation Sustained-release preparations and method for producing the same
TWI357815B (en) * 2003-06-27 2012-02-11 Euro Celtique Sa Multiparticulates
TWI350762B (en) * 2004-02-12 2011-10-21 Euro Celtique Sa Particulates

Also Published As

Publication number Publication date
JP2008528534A (ja) 2008-07-31
EP2319499A1 (en) 2011-05-11
IL184858A0 (en) 2007-12-03
CN101132772A (zh) 2008-02-27
JP5704789B2 (ja) 2015-04-22
NZ560669A (en) 2012-09-28
GB0501638D0 (en) 2005-03-02
MA29368B1 (fr) 2008-04-01
EP2289491A1 (en) 2011-03-02
TNSN07293A1 (fr) 2008-12-31
IL184858A (en) 2016-03-31
CN101132772B (zh) 2012-05-09
EP3228308A1 (en) 2017-10-11
ZA200705913B (en) 2008-08-27
AP2274A (en) 2011-08-19
EA200701595A1 (ru) 2008-02-28
AP2007004099A0 (en) 2007-08-31
JP2013100306A (ja) 2013-05-23
EA015615B1 (ru) 2011-10-31

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