In vitro release of nitroglycerin from topical products by use of artificial membranes.
An in vitro testing method for measuring the release of nitroglycerin from topical drug products was evaluated. The method involved measuring the amount of nitroglycerin that diffused from ointments and patches through various synthetic membranes into receptor fluid contained in a modified Franz diffusion cell. Plots of the amount of nitroglycerin released against the square root of time for all 10 synthetic membranes were linear. Five membranes (group I) were found to release nitroglycerin at similar rates (difference not significant; p > 0.05). Use of the other five membranes (group II) in diffusion cells resulted in release rates significantly slower than those of group I membranes (p < 0.05). Rapid permeation of nitroglycerin from a solution through a polysulfone membrane demonstrated a lack of significant diffusion barrier properties of this membrane. Rates of release of nitroglycerin from commercially available ointments were found to be similar. A comparison of three commercial nitroglycerin patches revealed that these products released nitroglycerin at different rates in vitro.
Wu
S T
ST
Biopharmaceutics Research Branch, Food and Drug Administration (FDA), Washington, D.C. 20204.
Shiu
G K
GK
Simmons
J E
JE
Bronaugh
R L
RL
Skelly
J P
JP
D000279:Administration, Cutaneous; D000287:Administration, Topical; D002626:Chemistry, Pharmaceutical / Q000379:methods; D016503:Drug Delivery Systems; D007700:Kinetics; D008567:Membranes, Artificial; D005996:Nitroglycerin / Q000008:administration & dosage / Q000737:chemistry*; D009823:Ointment Bases / Q000737:chemistry
D008567:Membranes, Artificial; D009823:Ointment Bases; D005996:Nitroglycerin