CA2446550A1 - Abuse-resistant controlled-release opioid dosage form - Google Patents

Abuse-resistant controlled-release opioid dosage form Download PDF

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Publication number
CA2446550A1
CA2446550A1 CA002446550A CA2446550A CA2446550A1 CA 2446550 A1 CA2446550 A1 CA 2446550A1 CA 002446550 A CA002446550 A CA 002446550A CA 2446550 A CA2446550 A CA 2446550A CA 2446550 A1 CA2446550 A1 CA 2446550A1
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Canada
Prior art keywords
opioid
antagonist
pharmaceutical composition
composition according
blocking
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Granted
Application number
CA002446550A
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French (fr)
Other versions
CA2446550C (en
Inventor
Frank S. Caruso
Huai-Hung Kao
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Endo Pharmaceuticals Inc
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Individual
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Expired - Lifetime legal-status Critical Current

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    • 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
    • A61K31/33—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
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/20—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
    • A61K9/2013—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
    • A61K9/205—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
    • 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
    • A61K9/4858—Organic 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
    • A61K9/48—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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Abuse-resistant, controlled release opioid tablets in combination containing an opioid antagonist such as naloxone at a level above that needed to suppre ss the euphoric effect of the opioid, if the combination were crushed to break the controlled release properties causing the opioid and opioid antagonist t o be released as a immediate release product as a single dose. The controlled release nature of the table prevents the accumulation of orally effective amounts of opioid antagonist when taken normally. The opioid antagonist is contained in a controlled-release matrix and released, over time, with the opioid.

Claims (20)

1. An oral pharmaceutical composition comprising:
a controlled release matrix;
an opioid agonist;
an opioid antagonist having greater antagonistic effect when administered parenterally than when administered orally;
wherein said opioid antagonist is present in the composition in an orally effective amount for blocking the opioid effect and/or inducing withdrawal when the controlled release matrix is defeated and the composition improperly administered for immediate release;
wherein said controlled release matrix is selected and incorporated for controlling the release rate of the opioid antagonist such that antagonist levels are not effective for blocking the opioid effect by blocking both the inhibitory and excitatory receptors or for attenuating opioid side effects by selectively blocking the excitatory receptors under proper oral administration regimes.
2. The pharmaceutical composition according to claim 1 wherein the release rate of the opioid antagonist is approximately 100 to approximately 25 percent of the release rate of the opioid agonist.
3. The pharmaceutical composition according to claim 1 wherein the release rate of the opioid antagonist is approximately 100 percent of the release rate of the opioid agonist.
4. The pharmaceutical composition according to claim 1 wherein the release rate of the opioid antagonist is approximately 50 percent of the release rate of the opioid agonist.
5. The pharmaceutical composition according to claim 1 wherein the release rate of the opioid antagonist is approximately 25 percent of the release rate of the opioid agonist.
6. The pharmaceutical composition according to claim 1 wherein the oral:parenteral potency ratio of the opioid antagonist is at least about 10:1.
7. The pharmaceutical composition according to claim 1 wherein the oral:parenteral potency ratio of the opioid antagonist is at least about 25:1.
8. The pharmaceutical composition according to claim 1 wherein the oral:parenteral potency ratio of the opioid antagonist is at least about 100:1.
9. The pharmaceutical composition according to claim 1, wherein said opioid agonist is selected from the group consisting of morphine, oxycodone, levorphenol, meperdine, hydrocodone, codeine, dihydrocodeine, hydromorphone, propoxyphene, methadone, and oxymorphone.
10. The pharmaceutical composition according to claim 1 wherein the opioid antagonist is selected from the group consisting of naloxone; naltrexone; N - cyclo propylmethyl - 7,8 -dihydro - 14- hydroxynormorphinone; and 21 - cyclopropyl z, - (1 - hydroxy - 1 - methylethyl) -6,14- endo - ethano - tetrahydrooripavine (or diphenorphine) and the pharmaceutically-acceptable salts thereof.
11. The pharmaceutical composition according to claim 1 wherein said opioid antagonist is naloxone.
12. The pharmaceutical composition according to claim 1 wherein said opioid agonist is oxycodone.
13. The pharmaceutical composition according to claim 1 wherein said opioid agonist is present in concentration pharmaceutically equivalent to oxycodone doses of approximately 10-160mg.
14. The pharmaceutical composition according to Claim 1, wherein the release rate of the antagonist is such that a single dose of the composition does not render available an orally effective amount of antagonist, yet when two or more doses of the composition are combined -with or without crushing - to achieve an abusive dose of the opioid agonist, the opioid antagonist is available at orally effective blocking levels.
15. A pharmaceutical composition comprising:
a controlled release matrix;
an opioid agonist;
an opioid antagonist having greater antagonistic effect when administered parenterally than when administered orally;
16 wherein said opioid antagonist is present in the composition in an amount proportional to the number of abusive doses of the opioid agonist in the composition such that if the CR matrix is defeated and two or more doses of the composition are combined to yield an abusive dose of the opioid agonist, the amount of opioid antagonist will suffice to block the opioid effect and/or induce withdrawal when taken orally;
wherein said controlled release matrix is selected and incorporated for controlling the release rate of the opioid antagonist such that antagonist levels are not effective for blocking the opioid effect by blocking the inhibitory and excitatory receptors or attenuating opioid side effects by selectively blocking the excitatory receptors under proper oral administration regimes.

16. The pharmaceutical composition according to Claim 15, wherein the release rate of the antagonist is such that a single dose of the composition does not render available an orally effective amount of antagonist, yet when two or more doses of the composition are combined -with or without crushing - to achieve an abusive dose of the opioid agonist, the opioid antagonist is available at orally effective blocking levels.
17. An oral pharmaceutical composition comprising:
a controlled release matrix;
approximately 10-160 mg oxycodone;
approximately 2-160 mg naloxone;
wherein the ratio of oxycodone to naloxone is approximately 4-5:1 to 1:1;
wherein said controlled release matrix is selected and incorporated for controlling the release rate of the oxycodone for maintaining pharmaceutical effectiveness for a period up to 12 hours and for controlling the release rate of the naloxone such that naloxone levels are not effective for blocking the opioid effect by blocking both the inhibitory and excitatory receptors or for attenuating opioid side effects by selectively blocking the excitatory receptors under proper oral administration regimes.
18. An oral pharmaceutical composition comprising, in % by weight:
about 3-35% opioid agonist;
about 2-20% opioid antagonist;
about 10-50% microcrystalline cellulose, NF;
about 30-70% ammonio methacrylate copolymer, NF; and at least one excipient selected from the group consisting of:
up to about 5% colloidal silicon dioxide, NF;

up to about 5% sodium lauryl sulfate, NF;
up to about 2% magnesium hydroxide, USP;
up to about 15% povidone, USP;
up to about 5% stearic acid, NF; and up to about 5% magnesium stearate, NF;

wherein said composition is a controlled release formulation adapted to release the oxycodone at a therapeutically effective rate, and to release said naloxone at a rate ineffective for blocking the opioid effect and/or inducing withdrawal when the controlled release formulation is taken orally in intact form.
19. The oral pharmaceutical composition according to claim 18, wherein said opioid agonist is selected from the group consisting of morphine, oxycodone, levorphenol, meperdine, hydrocodone, codeine, dihydrocodeine, hydromorphone, propoxyphene, methadone, and oxymorphone and the opioid antagonist is selected from the group consisting of naloxone;
naltrexone; N - cyclo propylmethyl - 7,8 - dihydro - 14- hydroxynormorphinone;
and 21 -cyclopropyl z, - (1 - hydroxy - 1 - methylethyl) - 6,14- endo - ethano -tetrahydrooripavine (or diphenorphine) and the pharmaceutically-acceptable salts thereof.
20. The oral pharmaceutical composition according to claim 18 wherein said opioid agonist is oxycodone hydrochloride and said opioid antagonist is naloxone.
CA2446550A 2001-05-11 2002-05-10 Abuse-resistant controlled-release opioid dosage form Expired - Lifetime CA2446550C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US29043901P 2001-05-11 2001-05-11
US60/290,439 2001-05-11
PCT/US2002/015022 WO2002092060A1 (en) 2001-05-11 2002-05-10 Abuse-resistant controlled-release opioid dosage form

Publications (2)

Publication Number Publication Date
CA2446550A1 true CA2446550A1 (en) 2002-11-21
CA2446550C CA2446550C (en) 2012-03-06

Family

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Family Applications (1)

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CA2446550A Expired - Lifetime CA2446550C (en) 2001-05-11 2002-05-10 Abuse-resistant controlled-release opioid dosage form

Country Status (10)

Country Link
US (20) US20030065002A1 (en)
EP (1) EP1387673B1 (en)
JP (7) JP4522652B2 (en)
CN (1) CN1525851A (en)
AT (1) ATE493130T1 (en)
AU (2) AU2002305559B2 (en)
CA (1) CA2446550C (en)
DE (1) DE60238756D1 (en)
ES (1) ES2361148T3 (en)
WO (1) WO2002092060A1 (en)

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