CA2900858C - Formes pharmaceutiques en granules anti-abus a liberation immediate - Google Patents

Formes pharmaceutiques en granules anti-abus a liberation immediate Download PDF

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Publication number
CA2900858C
CA2900858C CA2900858A CA2900858A CA2900858C CA 2900858 C CA2900858 C CA 2900858C CA 2900858 A CA2900858 A CA 2900858A CA 2900858 A CA2900858 A CA 2900858A CA 2900858 C CA2900858 C CA 2900858C
Authority
CA
Canada
Prior art keywords
dosage form
core
form according
cellulose
granules
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.)
Active
Application number
CA2900858A
Other languages
English (en)
Other versions
CA2900858A1 (fr
Inventor
Dinesh K. Haswani
Derek V. Moe
Victoria A. O'neill
Manuel A. Vega Zepeda
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.)
Clexio Bioscience Ltd
Original Assignee
Cima Labs Inc
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 US14/333,986 external-priority patent/US20150118300A1/en
Application filed by Cima Labs Inc filed Critical Cima Labs Inc
Publication of CA2900858A1 publication Critical patent/CA2900858A1/fr
Application granted granted Critical
Publication of CA2900858C publication Critical patent/CA2900858C/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/20—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
    • 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
    • A61K31/16—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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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

Landscapes

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

Abstract

L'invention concerne des formes pharmaceutiques orales à libération immédiate qui possèdent des propriétés anti-abus. Plus précisément, les formes pharmaceutiques selon l'invention dissuadent de tout abus par l'ingestion de multiples doses individuelles. En outre, les formes pharmaceutiques selon l'invention protègent contre toute overdose cas d'ingestion accidentelle ou intentionnelle de multiples doses individuelles.
CA2900858A 2013-10-31 2014-10-29 Formes pharmaceutiques en granules anti-abus a liberation immediate Active CA2900858C (fr)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201361898207P 2013-10-31 2013-10-31
US61/898,207 2013-10-31
USPCT/US2014/047014 2014-07-17
US14/333,986 US20150118300A1 (en) 2013-10-31 2014-07-17 Immediate Release Abuse-Deterrent Granulated Dosage Forms
PCT/US2014/047014 WO2015065547A1 (fr) 2013-10-31 2014-07-17 Formes pharmaceutiques en granulés anti-abus à libération immédiate
US14/333,986 2014-07-17
US14/477,354 2014-09-04
USPCT/US2014/054061 2014-09-04
US14/477,354 US20150118301A1 (en) 2013-10-31 2014-09-04 Immediate Release Abuse-Deterrent Granulated Dosage Forms
PCT/US2014/054061 WO2015065586A1 (fr) 2013-10-31 2014-09-04 Formes pharmaceutiques en granulés anti-abus à libération immédiate
US14/484,793 US20150118295A1 (en) 2013-10-31 2014-09-12 Immediate Release Abuse-Deterrent Granulated Dosage Forms
US14/484,793 2014-09-12
PCT/US2014/062887 WO2015066172A1 (fr) 2013-10-31 2014-10-29 Formes pharmaceutiques en granulés anti-abus à libération immédiate

Publications (2)

Publication Number Publication Date
CA2900858A1 CA2900858A1 (fr) 2015-05-07
CA2900858C true CA2900858C (fr) 2017-05-02

Family

ID=53005066

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2900858A Active CA2900858C (fr) 2013-10-31 2014-10-29 Formes pharmaceutiques en granules anti-abus a liberation immediate

Country Status (5)

Country Link
EP (1) EP3062778A4 (fr)
CA (1) CA2900858C (fr)
EA (1) EA032013B1 (fr)
IL (1) IL245125B (fr)
WO (1) WO2015066172A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015065547A1 (fr) 2013-10-31 2015-05-07 Cima Labs Inc. Formes pharmaceutiques en granulés anti-abus à libération immédiate
CA2970065A1 (fr) 2014-12-08 2016-06-16 Cima Labs Inc. Formes galeniques en granules a liberation immediate, a effet anti-abus
WO2018044895A1 (fr) * 2016-08-29 2018-03-08 Cima Labs Inc. Formes posologiques à libération immédiate permettant la dissuasion des abus et présentant une résistance à l'alcool
AU2019352028A1 (en) 2018-10-05 2021-03-11 Clexio Biosciences Ltd. Dosage regime of esketamine for treating major depressive disorder
US20220062200A1 (en) 2019-05-07 2022-03-03 Clexio Biosciences Ltd. Abuse-deterrent dosage forms containing esketamine
US11324707B2 (en) 2019-05-07 2022-05-10 Clexio Biosciences Ltd. Abuse-deterrent dosage forms containing esketamine

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9401894D0 (en) * 1994-02-01 1994-03-30 Rhone Poulenc Rorer Ltd New compositions of matter
DK1276470T3 (da) * 2000-04-20 2007-06-18 Novartis Ag Smagskaskerende overtrækssammensætning
ES2361148T3 (es) * 2001-05-11 2011-06-14 Endo Pharmaceuticals Inc. Forma de dosificación de opioides de liberación controlada resistente al abuso.
US9125833B2 (en) * 2005-11-02 2015-09-08 Relmada Therapeutics, Inc. Multimodal abuse resistant and extended release opioid formulations
US20090022798A1 (en) * 2007-07-20 2009-01-22 Abbott Gmbh & Co. Kg Formulations of nonopioid and confined opioid analgesics
ES2692437T3 (es) * 2007-08-13 2018-12-03 Abuse Deterrent Pharmaceutical Llc Fármacos resistentes al abuso, método de uso y método de preparación
US20100099696A1 (en) * 2008-10-16 2010-04-22 Anthony Edward Soscia Tamper resistant oral dosage forms containing an embolizing agent
WO2012061779A1 (fr) * 2010-11-04 2012-05-10 Abbott Gmbh & Co. Kg Formulations de médicaments
AR090218A1 (es) * 2012-03-02 2014-10-29 Rhodes Pharmaceuticals Lp Formulaciones de liberacion inmediata resistentes a la manipulacion

Also Published As

Publication number Publication date
EA201690874A1 (ru) 2016-08-31
IL245125A0 (en) 2016-06-30
IL245125B (en) 2021-06-30
EA032013B1 (ru) 2019-03-29
EP3062778A1 (fr) 2016-09-07
WO2015066172A1 (fr) 2015-05-07
EP3062778A4 (fr) 2017-07-19
CA2900858A1 (fr) 2015-05-07

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Effective date: 20150810