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Wafer formulation

  • US 8,623,401 B2
  • Filed: 03/27/2008
  • Issued: 01/07/2014
  • Est. Priority Date: 03/27/2008
  • Status: Active Grant
First Claim
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1. An orally administrable wafer comprising at least about 30 to about 80 wt % pullulan, PEG in an amount of less than about 5 wt % and a pharmaceutical agent selected from the group consisting of morphine, heroin, hydromorphone, metophon, oxymorphone, levorphanol, codeine, hydrocodone, oxycodone, nalorphine, naloxone, naltrexone and fentanyl, wherein the wafer is prepared by dissolving the film forming agent in an aqueous solution to form a gel that is treated with a plurality of heating and cooling cycles for a total time period of no more than about 3 minutes and the wafer exhibits a dissolution rate of at least about 2 milligrams/sec in an aqueous environment and a Tmax of no more than about 10 minutes.

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