CA2983648A1 - Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix - Google Patents

Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix

Info

Publication number
CA2983648A1
CA2983648A1 CA2983648A CA2983648A CA2983648A1 CA 2983648 A1 CA2983648 A1 CA 2983648A1 CA 2983648 A CA2983648 A CA 2983648A CA 2983648 A CA2983648 A CA 2983648A CA 2983648 A1 CA2983648 A1 CA 2983648A1
Authority
CA
Canada
Prior art keywords
dosage form
particle
active ingredient
pharmacologically active
form according
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
CA2983648A
Other languages
English (en)
French (fr)
Inventor
Klaus WENING
Lutz Barnscheid
Anja Geissler
Jana Denker
Jessica Redmer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gruenenthal GmbH
Original Assignee
Gruenenthal GmbH
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 Gruenenthal GmbH filed Critical Gruenenthal GmbH
Publication of CA2983648A1 publication Critical patent/CA2983648A1/en
Abandoned legal-status Critical Current

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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • 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
    • A61K9/14—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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61K9/14—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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA2983648A 2015-04-24 2016-04-22 Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix Abandoned CA2983648A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15165070 2015-04-24
EP15165070.2 2015-04-24
PCT/EP2016/058977 WO2016170093A1 (en) 2015-04-24 2016-04-22 Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix

Publications (1)

Publication Number Publication Date
CA2983648A1 true CA2983648A1 (en) 2016-10-27

Family

ID=53015581

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2983648A Abandoned CA2983648A1 (en) 2015-04-24 2016-04-22 Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix

Country Status (8)

Country Link
US (1) US20160310486A1 (enExample)
EP (1) EP3285744A1 (enExample)
JP (1) JP2018513864A (enExample)
AU (1) AU2016251302A1 (enExample)
BR (1) BR112017022335A2 (enExample)
CA (1) CA2983648A1 (enExample)
MX (1) MX2017013643A (enExample)
WO (1) WO2016170093A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3473246A1 (en) 2017-10-19 2019-04-24 Capsugel Belgium NV Immediate release abuse deterrent formulations
EP3727384A4 (en) 2017-12-20 2021-11-03 Purdue Pharma L.P. ABUSE-DISSUASIVE MORPHINE SULPHATE FORMES
EP3679926A1 (en) * 2019-01-14 2020-07-15 APTYS Pharmaceuticals SAS A method of manufacturing a pharmaceutical composition comprising nefopam and acetaminophen, and the pharmaceutical composition obtained thereby

Family Cites Families (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7141250B2 (en) 2001-08-06 2006-11-28 Euro-Celtique S.A. Pharmaceutical formulation containing bittering agent
US20030092724A1 (en) 2001-09-18 2003-05-15 Huaihung Kao Combination sustained release-immediate release oral dosage forms with an opioid analgesic and a non-opioid analgesic
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
EP1658054B1 (de) 2003-08-06 2007-06-27 Grünenthal GmbH Gegen missbrauch gesicherte darreichungsform
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
US7201920B2 (en) 2003-11-26 2007-04-10 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of opioid containing dosage forms
PL1740156T3 (pl) 2004-04-22 2011-12-30 Gruenenthal Gmbh Sposób wytwarzania zabezpieczonej przed nadużyciem, stałej postaci aplikacyjnej
BRPI0513300B1 (pt) 2004-07-01 2018-11-06 Gruenenthal Gmbh forma farmacêutica oral, protegida frente ao abuso, contendo (1r, 2r)-3-(3-dimetilamino-1-etil-2- metil-lpropil)-fenol
AR049562A1 (es) 2004-07-01 2006-08-16 Gruenenthal Gmbh Formas farmaceuticas orales, con liberacion controlada de opioides, protegidas frente al abuso y procedimiento para su preparacion
PL1765298T3 (pl) 2004-07-01 2013-01-31 Gruenenthal Gmbh Sposób wytwarzania stałej postaci dawkowania, która jest zabezpieczona przez nadużywaniem, wykorzystujący wytłaczarkę z przekładnią planetarną
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
NZ562304A (en) 2005-05-10 2010-06-25 Novartis Ag Extrusion process for making compositions with poorly compressible therapeutic compounds e.g. metformin hydrochloride
US8652529B2 (en) 2005-11-10 2014-02-18 Flamel Technologies Anti-misuse microparticulate oral pharmaceutical form
US20070292508A1 (en) 2006-06-05 2007-12-20 Balchem Corporation Orally disintegrating dosage forms
US20080069891A1 (en) 2006-09-15 2008-03-20 Cima Labs, Inc. Abuse resistant drug formulation
SA07280459B1 (ar) 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
AU2009243681B2 (en) 2008-05-09 2013-12-19 Grunenthal Gmbh Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
GB0909680D0 (en) 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
CN102639118B (zh) 2009-07-22 2015-07-29 格吕伦塔尔有限公司 氧化稳定的抗干扰剂型
KR101738369B1 (ko) 2009-07-22 2017-05-22 그뤼넨탈 게엠베하 핫 멜트 압출된 제어 방출 투여형
ES2606227T3 (es) 2010-02-03 2017-03-23 Grünenthal GmbH Preparación de una composición farmacéutica en polvo mediante una extrusora
CN107308124A (zh) 2010-09-02 2017-11-03 格吕伦塔尔有限公司 包含阴离子聚合物的抗破碎剂型
BR112013005194A2 (pt) 2010-09-02 2016-05-03 Gruenenthal Gmbh forma de dosagem resistente à violação compreendendo sal inorgânico
TWI516286B (zh) 2010-09-02 2016-01-11 歌林達股份有限公司 含陰離子聚合物之抗破碎劑型
WO2012061779A1 (en) 2010-11-04 2012-05-10 Abbott Gmbh & Co. Kg Drug formulations
US8858963B1 (en) * 2011-05-17 2014-10-14 Mallinckrodt Llc Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
EA201400172A1 (ru) 2011-07-29 2014-06-30 Грюненталь Гмбх Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства
BR112014001091A2 (pt) 2011-07-29 2017-02-14 Gruenenthal Gmbh comprimido resistente à adulteração que fornece liberação imediata do fármaco
FR2979242A1 (fr) 2011-08-29 2013-03-01 Sanofi Sa Comprime contre l'usage abusif, a base de paracetamol et d'oxycodone
PE20141171A1 (es) 2011-10-06 2014-09-21 Gruenenthal Chemie Forma de dosificacion farmaceutica oral resistente a alteracion comprendiendo agonista opioide y antagonista opioide
PE20141671A1 (es) 2011-11-17 2014-11-22 Gruenenthal Chemie Forma de dosis farmaceutica oral a prueba de manipulacion que comprende un agente antagonista y/o repelente opioide, oxido de polialquileno y un polimero anionico
US20130225625A1 (en) 2012-02-28 2013-08-29 Grunenthal Gmbh Tamper-resistant pharmaceutical dosage form comprising nonionic surfactant
MX356421B (es) 2012-02-28 2018-05-29 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico.
CN109820830A (zh) * 2012-03-02 2019-05-31 罗德兹制药股份有限公司 抗破坏性立即释放型制剂类
EP2838512B1 (en) 2012-04-18 2018-08-22 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
SI2846835T1 (en) 2012-05-11 2018-01-31 Gruenenthal Gmbh Heat-formed pharmaceutical dosage form, resistant to abuse and containing zinc
US20140275143A1 (en) * 2013-03-15 2014-09-18 Mallinckrodt Llc Compositions Comprising An Opioid And An Additional Active Pharmaceutical Ingredient For Rapid Onset And Extended Duration Of Analgesia That May Be Administered Without Regard To Food
EP3003279A1 (en) 2013-05-29 2016-04-13 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US9737490B2 (en) * 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
CA2817728A1 (en) 2013-05-31 2014-11-30 Pharmascience Inc. Abuse deterrent immediate release formulation
BR112016000194A8 (pt) 2013-07-12 2019-12-31 Gruenenthal Gmbh forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila

Also Published As

Publication number Publication date
US20160310486A1 (en) 2016-10-27
WO2016170093A1 (en) 2016-10-27
BR112017022335A2 (en) 2018-07-10
EP3285744A1 (en) 2018-02-28
AU2016251302A1 (en) 2017-11-23
JP2018513864A (ja) 2018-05-31
MX2017013643A (es) 2018-03-08

Similar Documents

Publication Publication Date Title
US20200276188A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction
AU2012289764B2 (en) Tamper-resistant tablet providing immediate drug release
AU2012292418B2 (en) Tamper-resistant tablet providing immediate drug release
US20200009055A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US20160310428A1 (en) Tamper-resistant fixed dose combination providing fast release of two drugs from different particles
US20210046009A1 (en) Protecting oral overdose with abuse deterrent immediate release formulations
US20160310486A1 (en) Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix
US20160310427A1 (en) Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a powder
US20160310437A1 (en) Tamper-resistant fixed dose combination providing fast release of two drugs from particles
US20200268748A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US20200338069A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction

Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20220301