There is provided pharmaceutical compositions for the treatment of pain comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic. The compositions are also useful in prevention of opioid abuse by addicts.

Claims

35 · 1 independent · depth 3

35 granted claims

›1.independentA method of treating pain in a subject in need thereof comprising transmucosally administering a particulate transmucosal pharmaceutical composition i…+34

›2.↳ 1The method of claim 1, wherein said pain is selected from the group consisting of severe pain, acute pain and breakthrough pain.d2

›3.↳ 1The method of claim 1, wherein the opioid analgesic is fentanyl.d2

›4.↳ 1The method of claim 1, wherein the opioid analgesic is in the form of microparticles.d2+1

›6.↳ 1The method of claim 1, wherein the total amount of opioid analgesic that is employed is in the range of about 0.0005% to about 20% by weight based upo…d2+1

›8.↳ 1The method of claim 1, wherein the amount of opioid analgesic that is present is sufficient to provide a dose per unit dosage form of between about 1 …d2+1

›10.↳ 1The method of claim 1, wherein the opioid antagonist is naloxone.d2

›11.↳ 1The method or claim 1, wherein the total amount of opioid antagonist that is employed is in the range of about 1% to about 99.9995% by weight based up…d2+1

›13.↳ 1The method of claim 1, wherein the amount of opioid antagonist that is present is sufficient to provide a dose per unit dosage form of between about 0…d2+1

›15.↳ 1The method of claim 1, wherein the carrier particles are of a size that is between about 50 and about 1,000 μm.d2+1

›17.↳ 1The method of claim 1, which further comprises a bioadhesion or a mucoadhesion promoting agent, which agent is, at least in part, presented on the sur…d2+7

›18.↳ 17The method of claim 17, wherein the bioadhesion or mucoadhesion promoting agent is a polymeric substance with a weight average molecular weight above …d3

›19.↳ 17The method of claim 17, wherein the hioadhesion or mucoadhesion promoting agent is selected from a cellulose derivative, a starch derivative, an acryl…d3

›20.↳ 17The method of claim 17, wherein the hioadhesion or mucoadhesion promoting agent is selected from hydroxypropylmethyl cellulose, hydroxyethyl cellulose…d3

›21.↳ 17The method of claim 17, wherein the bioadhesion or mucoadhesion promoting agent is crosscarmellose sodium or crosslinked polyvinylpyrrolidone.d3

›22.↳ 17The method of claim 17, wherein the amount of bioadhesion or mucoadhesion promoting agent present is in the range of about 0.1 to about 25% by weight …d3

›23.↳ 17The method of claim 17, wherein the amount of bioadhesion or mucoadhesion promoting agent present is in the range of about 1 to about 15% by weight ba…d3

›24.↳ 17The method of claim 17, wherein the bioadhesion or mucoadhesion promoting agent has a particle size in the range of about 1 to about 100 μm.d3

›25.↳ 1The method of claim 1, wherein the carrier particles further comprise a pharmaceutically-acceptable substance selected from a carbohydrate, a pharmace…d2+2

›28.↳ 1The method of claim 1, wherein the composition further comprises a disintegrating agent, which is capable of accelerating to a measurable degree the d…d2+5

›34.↳ 1The method of claim 1, wherein said composition is resistant to abuse by an opioid dependent individual.d2

›35.↳ 1The method of claim 1, wherein said patient is an opioid dependent individual.d2

Classifications

14 codes

IPC · International Patent Classification

Section A — Human necessities

A61F13/00
A61K31/485
A61K9/20
A61K31/4468
A61K9/50
A61K9/16
A61K9/00

USPC · US Patent Classification

424/435514/282424/489514/329424/490424/465424/464

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Pendency

1.5 y

538 days filing → grant

Office actions

non-final + final

Responses

2 RCE

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Examiner

Hasan Ahmed

art unit 1615 · TC 1600

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Citations: 30 back · 0 forward

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Priority chain

2 priority documents

Priority

4 Dec 2006

earliest claimed

›Priority documents — 2

Type	Document	Date
provisional	US 60872496	4 Dec 2006
related publication	US 20130195982 A1	1 Aug 2013

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