Abstract
A dissolution test procedure using an adaptation of the FDA paddle method (USP Apparatus 2) has been developed for the purpose of assuring uniform batch to batch release. The patch is held in position in the dissolution vessel by sandwiching it between a watchglass and an aluminum wire screen. The dissolution profiles of the three marketed brands (10 dosage forms) of transdermal nitroglycerin patches were determined over a 24-h period. All samples, were analyzed by HPLC. The results of patches manufactured by each firm indicate dose proportional release. While there is a qualitative difference in the dissolution pattern among manufacturers, the dissolution procedure was found to be simple, reliable and reproducible, suggesting this technique can be used as a quality control tool for assuring product uniformity.
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