WO2004091512A3 - Abuse-resistant oral dosage forms and method of use thereof - Google Patents

Abuse-resistant oral dosage forms and method of use thereof Download PDF

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Publication number
WO2004091512A3
WO2004091512A3 PCT/US2004/011221 US2004011221W WO2004091512A3 WO 2004091512 A3 WO2004091512 A3 WO 2004091512A3 US 2004011221 W US2004011221 W US 2004011221W WO 2004091512 A3 WO2004091512 A3 WO 2004091512A3
Authority
WO
WIPO (PCT)
Prior art keywords
oral dosage
opioid
dosage form
antagonist
abuse
Prior art date
Application number
PCT/US2004/011221
Other languages
French (fr)
Other versions
WO2004091512A2 (en
Inventor
Atul M Mehta
Original Assignee
Atul M Mehta
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 Atul M Mehta filed Critical Atul M Mehta
Priority to ES04759447.8T priority Critical patent/ES2625092T3/en
Priority to CA2521655A priority patent/CA2521655C/en
Priority to EP04759447.8A priority patent/EP1615623B1/en
Publication of WO2004091512A2 publication Critical patent/WO2004091512A2/en
Publication of WO2004091512A3 publication Critical patent/WO2004091512A3/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
    • A61K9/48—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
    • A61K9/14—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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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
    • A61P25/30—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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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

Abstract

An opioid-antagonist oral dosage form which does not release a therapeutically effective amount of the opioid antagonist when the oral dosage form is orally administered to a human being, but whereby a physical alteration of the oral dosage form results in a release of the therapeutically effective amount of the opioid antagonist. An embodiment of the oral dosage form includes an opioid-antagonist layer coated onto a biologically inert pellet, and a non-releasing membrane coated onto the opioid-antagonist layer. Optionally, the oral dosage form can also include an opioid agonist, such that a method of preventing the abuse of an oral dosage form of an opioid agonist is provided by forming the oral dosage form including an opioid agonist and an opioid antagonist.
PCT/US2004/011221 2003-04-08 2004-04-08 Abuse-resistant oral dosage forms and method of use thereof WO2004091512A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
ES04759447.8T ES2625092T3 (en) 2003-04-08 2004-04-08 Oral dosage forms resistant to addiction and method of use thereof
CA2521655A CA2521655C (en) 2003-04-08 2004-04-08 Abuse-resistant oral dosage forms and method of use thereof
EP04759447.8A EP1615623B1 (en) 2003-04-08 2004-04-08 Abuse-resistant oral dosage forms and method of use thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/409,992 US20040202717A1 (en) 2003-04-08 2003-04-08 Abuse-resistant oral dosage forms and method of use thereof
US10/409,992 2003-04-08

Publications (2)

Publication Number Publication Date
WO2004091512A2 WO2004091512A2 (en) 2004-10-28
WO2004091512A3 true WO2004091512A3 (en) 2004-12-29

Family

ID=33130700

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/011221 WO2004091512A2 (en) 2003-04-08 2004-04-08 Abuse-resistant oral dosage forms and method of use thereof

Country Status (5)

Country Link
US (5) US20040202717A1 (en)
EP (2) EP1615623B1 (en)
CA (1) CA2521655C (en)
ES (1) ES2625092T3 (en)
WO (1) WO2004091512A2 (en)

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US20130230596A1 (en) 2013-09-05
US8425933B2 (en) 2013-04-23
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US20080166405A1 (en) 2008-07-10
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EP1615623A4 (en) 2012-02-22
CA2521655A1 (en) 2004-10-28
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CA2521655C (en) 2014-02-11
US20040202717A1 (en) 2004-10-14

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