Drug Information for DURAGESIC (fentanyl transdermal system) (Janssen, division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.): DESCRIPTION

  • DURAGESIC® (fentanyl transdermal system) is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is:

    The molecular weight of fentanyl base is 336.5, and the empirical formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4.

  • System Components and Structure

  • The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/h per 10 cm2). The composition per unit area of all system sizes is identical. Each system also contains 0.1 mL of alcohol USP per 10 cm2.

    *Nominal delivery rate per hour

    ** Nominal delivery rate is 12.5 mcg/hr

    Dose*(mcg/h)Size(cm2)Fentanyl Content(mg)
    12** 5 1.25
    25 10 2.5
    50 20 5
    75 30 7.5
    100 40 10

    DURAGESIC® is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:

    1) a backing layer of polyester film; 2) a drug reservoir of fentanyl and alcohol USP gelled with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer membrane that controls the rate of fentanyl delivery to the skin surface; and 4) a fentanyl containing silicone adhesive. Before use, a protective liner covering the adhesive layer is removed and discarded.

    The active component of the system is fentanyl. The remaining components are pharmacologically inactive. Less than 0.2 mL of alcohol is also released from the system during use.

  • Drug Information Provided by National Library of Medicine (NLM).