Sublingual fentanyl spray

  • US 8,486,972 B2
  • Filed: 01/25/2007
  • Issued: 07/16/2013
  • Est. Priority Date: 01/25/2006
  • Status: Active Grant
First Claim
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1. A unit dose of a non-propellant sublingual fentanyl formulation comprising discrete liquid droplets of an effective amount of fentanyl and a pharmaceutically acceptable liquid carrier, wherein the sublingual fentanyl formulation comprises:

  • from about 0.1% to about 0.8% by weight of fentanyl or a pharmaceutically acceptable salt thereof;

    from about 20% to about 60% by weight of ethanol; and

    from about 4% to about 6% by weight of propylene glycol;

    wherein after sublingual administration to a human, said sublingual fentanyl formulation provides a mean time to maximum plasma concentration (Tmax) of fentanyl of from about 5 to about 120 minutes.

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