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Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain

  • US 8,778,393 B2
  • Filed: 07/23/2012
  • Issued: 07/15/2014
  • Est. Priority Date: 01/06/2006
  • Status: Active Grant
First Claim
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1. A method of treating pain in a subject, comprising administering a dosage form to the oral mucosa of a subject, wherein said dosage form comprises:

  • from about 5 to about 100 micrograms (mcg) of sufentanil, and a bioadhesive material, wherein;

    (i) said bioadhesive material adheres the dosage form to the oral mucosa of said subject during the period of drug delivery;

    (ii) said dosage form has a volume of less than 30 microliters or a mass of less than 30 mg; and

    (iii) after administration of said dosage form to said subject, said dosage form provides a minimal saliva response and minimal swallowing of sufentanil;

    at least 55% of drug delivery of sufentanil occurs via the oral transmucosal route;

    said dosage form provides a dose-normalized mean Cmax of 1.59-2.75 pg/mL per mcg dosed;

    said dosage form provides a Tmax of from about 19.8 minutes to about 60 minutes; and

    said dosage form provides a Tmax with a coefficient of variation of less than 40%.

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