WO2007106550A3 - Methods and compositions for deterring abuse of orally administered pharmaceutical products - Google Patents

Methods and compositions for deterring abuse of orally administered pharmaceutical products Download PDF

Info

Publication number
WO2007106550A3
WO2007106550A3 PCT/US2007/006519 US2007006519W WO2007106550A3 WO 2007106550 A3 WO2007106550 A3 WO 2007106550A3 US 2007006519 W US2007006519 W US 2007006519W WO 2007106550 A3 WO2007106550 A3 WO 2007106550A3
Authority
WO
WIPO (PCT)
Prior art keywords
abuse
compositions
methods
orally administered
pharmaceutical products
Prior art date
Application number
PCT/US2007/006519
Other languages
French (fr)
Other versions
WO2007106550A2 (en
Inventor
James F Emigh
Andrew D Reddick
Ron J Spivey
Ronald L Leech Jr
Original Assignee
Acura Pharmaceuticals Inc
James F Emigh
Andrew D Reddick
Ron J Spivey
Ronald L Leech Jr
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 Acura Pharmaceuticals Inc, James F Emigh, Andrew D Reddick, Ron J Spivey, Ronald L Leech Jr filed Critical Acura Pharmaceuticals Inc
Priority to CA2647360A priority Critical patent/CA2647360C/en
Priority to EP07753168A priority patent/EP1993519A4/en
Priority to AU2007225101A priority patent/AU2007225101A1/en
Publication of WO2007106550A2 publication Critical patent/WO2007106550A2/en
Publication of WO2007106550A3 publication Critical patent/WO2007106550A3/en
Priority to IL193766A priority patent/IL193766A0/en

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
    • A61K31/74—Synthetic polymeric materials
    • 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
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/1664—Compounds of unknown constitution, e.g. material from plants or 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2027—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
    • 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
    • A61K9/48—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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

This invention relates to an abuse deterrent formulation of an oral dosage form of a therapeutically effective amount of any active drug substance that can be subject to abuse combined with a gel forming polymer, a nasal mucosal irritating surfactant and a flushing agent. Such a dosage form is intended to deter abuse of the active drug substance via injection, nasal inhalation or consumption of quantities of the dosage unit exceeding the usual therapeutically effective dose.
PCT/US2007/006519 2006-03-15 2007-03-14 Methods and compositions for deterring abuse of orally administered pharmaceutical products WO2007106550A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA2647360A CA2647360C (en) 2006-03-15 2007-03-14 Methods and compositions for deterring abuse of orally administered pharmaceutical products
EP07753168A EP1993519A4 (en) 2006-03-15 2007-03-14 Methods and compositions for deterring abuse of orally administered pharmaceutical products
AU2007225101A AU2007225101A1 (en) 2006-03-15 2007-03-14 Methods and compositions for deterring abuse of orally administered pharmaceutical products
IL193766A IL193766A0 (en) 2006-03-15 2008-08-28 Method and compositions for deterring abuse of orally administered pharmaceutical products

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US78244806P 2006-03-15 2006-03-15
US60/782,448 2006-03-15

Publications (2)

Publication Number Publication Date
WO2007106550A2 WO2007106550A2 (en) 2007-09-20
WO2007106550A3 true WO2007106550A3 (en) 2008-06-12

Family

ID=38510088

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/006519 WO2007106550A2 (en) 2006-03-15 2007-03-14 Methods and compositions for deterring abuse of orally administered pharmaceutical products

Country Status (5)

Country Link
EP (1) EP1993519A4 (en)
AU (1) AU2007225101A1 (en)
CA (1) CA2647360C (en)
IL (1) IL193766A0 (en)
WO (1) WO2007106550A2 (en)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1429739A1 (en) 2001-09-21 2004-06-23 Egalet A/S Polymer release system
WO2003024430A1 (en) 2001-09-21 2003-03-27 Egalet A/S Morphine polymer release system
ATE495732T1 (en) 2003-03-26 2011-02-15 Egalet As CONTROLLED RELEASE MORPHINE SYSTEM
AU2008258596B2 (en) 2007-06-04 2013-02-14 Egalet Ltd Controlled release pharmaceutical compositions for prolonged effect
US8486448B2 (en) 2007-12-17 2013-07-16 Paladin Labs Inc. Misuse preventative, controlled release formulation
AU2015200313B2 (en) * 2007-12-17 2016-12-01 Alpharma Pharmaceuticals, Llc Pharmaceutical composition
WO2009079521A1 (en) * 2007-12-17 2009-06-25 Alpharma Pharmaceuticals, Llc Pharmaceutical composition
JP5667575B2 (en) * 2008-12-16 2015-02-12 パラディン ラブス インコーポレーテッド Controlled release formulation to prevent misuse
AU2010211220B2 (en) 2009-02-06 2013-08-01 Egalet Ltd. Immediate release composition resistant to abuse by intake of alcohol
NZ603579A (en) 2009-06-24 2014-02-28 Egalet Ltd Controlled release formulations
KR20150059167A (en) 2012-07-06 2015-05-29 에갈렛 리미티드 Abuse deterrent pharmaceutical compositions for controlled release
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9707184B2 (en) 2014-07-17 2017-07-18 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
CA2964628A1 (en) 2014-10-20 2016-04-28 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050112067A1 (en) * 2003-11-26 2005-05-26 Vijai Kumar Methods and compositions for deterring abuse of opioid containing dosage forms
US20060110327A1 (en) * 2004-11-24 2006-05-25 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of orally administered pharmaceutical products
US20060177380A1 (en) * 2004-11-24 2006-08-10 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of orally administered pharmaceutical products

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10250084A1 (en) * 2002-10-25 2004-05-06 Grünenthal GmbH Dosage form protected against abuse

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050112067A1 (en) * 2003-11-26 2005-05-26 Vijai Kumar Methods and compositions for deterring abuse of opioid containing dosage forms
US20060110327A1 (en) * 2004-11-24 2006-05-25 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of orally administered pharmaceutical products
US20060177380A1 (en) * 2004-11-24 2006-08-10 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of orally administered pharmaceutical products

Also Published As

Publication number Publication date
IL193766A0 (en) 2011-08-01
CA2647360C (en) 2012-05-15
CA2647360A1 (en) 2007-09-20
WO2007106550A2 (en) 2007-09-20
AU2007225101A1 (en) 2007-09-20
EP1993519A2 (en) 2008-11-26
EP1993519A4 (en) 2011-12-21

Similar Documents

Publication Publication Date Title
WO2006058249A3 (en) Methods and compositions for deterring abuse of orally administered pharmaceutical products
WO2007106550A3 (en) Methods and compositions for deterring abuse of orally administered pharmaceutical products
CA2845634C (en) Abuse-resistant mucoadhesive devices for delivery of buprenorphine
WO2008069941A3 (en) Modified release ibuprofen solid oral dosage form
WO2007112274A3 (en) Formulations of low dose non-steroidal anti-inflammatory drugs and beta-cyclodextrin
WO2010103544A3 (en) A novel sustained release composition of compounds selected from the class of centrally acting muscle relaxants
WO2008023016A3 (en) Galenic formulations of aliskiren
JP2009536147A5 (en)
WO2006056711A3 (en) Oral medicament for the modified release of at least one active principle, in multimicrocapsule form
WO2007012019A3 (en) Medicaments containing famotidine and ibuprofen and administration of same
CA2661759A1 (en) Buprenophine-wafer for drug substitution therapy
WO2008011595A3 (en) Hydrophobic abuse deterrent delivery system
HK1139871A1 (en) Improvements in and relating to medicinal compositions
HRP20140592T1 (en) Improved medicinal compositions comprising buprenorphine and naltrexone
RU2007127999A (en) ORAL DISINFECTING PHARMACEUTICAL COMPOSITIONS WITH SENSOR SIGNAL AGENTS
WO2007121913A3 (en) Pharmaceutical solution formulations for pressurised metered dose inhalers
CA2762107A1 (en) Sublingual dexmedetomidine compositions and methods of use thereof
WO2013183062A3 (en) Palatable formulations of ibuprofen
WO2008085765A3 (en) Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
WO2008027350A3 (en) Acetaminophen pharmaceutical compositions
JP2007536311A5 (en)
MX2010006284A (en) Phenylephrine pharmaceutical formulations and compositions for transmucosal absorption.
BRPI0513455A (en) flavor masking formulation comprising the drug in a delayed dissolution form and / or cyclodextrin in an improved dissolution form
WO2007143155A3 (en) Sustained release pharmaceutical dosage form containing phenylephrine
WO2005055921A3 (en) Compositions for treatment of ear disorders and methods of use thereof

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 07753168

Country of ref document: EP

Kind code of ref document: A2

WWE Wipo information: entry into national phase

Ref document number: 193766

Country of ref document: IL

Ref document number: 2007225101

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 2647360

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2007753168

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 2007225101

Country of ref document: AU

Date of ref document: 20070314

Kind code of ref document: A