SPL Set ID: 242759ef-cb6d-4e3e-9f8d-5e31efa1f289
1 drug(s) with this SPL Set ID
The system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 9.44 cm 2 ). The composition per unit area of all transdermal system sizes is identical. * Nominal delivery rate is 12.5 mcg/hour per hour ** Nominal delivery rate per hour Strength (mcg/hour) Size (cm²) Fentanyl Content (mg) 12* 4.72 1.33 25** 9.44 2.66 50** 18.88 5.32 75** 28.32 7.99 100** 37.76 10.65 The molecular weight of fentanyl base is 336.5, and the molecular formula is C 22 H 28 N 2 O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is: Fentanyl transdermal system is a rectangular translucent system with rounded corners. The product name, “FENTANYL” and dosage strength are printed in green on each system. Each system is comprised of a clear fluoropolymer coated polyethylene terephthalate (PET) release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these functional layers are: 1) a translucent backing layer of ethylene vinyl acetate/polyethylene terephthalate (EVA/PET) film with green print; 2) a drug-in-adhesive layer containing fentanyl, acrylate copolymer adhesive, and methyl laurate. Before use, a clear fluoropolymer coated PET release liner covering the drug-in-adhesive layer is removed and discarded. Structural Formula Parts of the Fentanyl Transdermal System Patch