Fentanyl – Novaplus Recall
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Fentanyl transdermal system is a transdermal system containing fentanyl. 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 molecular 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 10.5 cm2). The composition per unit area of all system sizes is identical.
*Nominal delivery rate per hour.
Fentanyl transdermal system 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.