Pharmacokinetic evaluation
An open-label, randomized crossover study was conducted in
30 healthy adult subjects dosed with two separate single-dose
administrations of two pseudoephedrine HCl 30 mg tablets
(60 mg dose) following an overnight fast. There was a
minimum washout period of 7 days between treatments.
The two treatments were Sudafed (McNeil Laboratories,
Fort Washington, PA) and Nexafed Tablets (Acura
Pharmaceuticals Inc., Palatine, IL) which uses the Impede
technology. Nexafed tablets used in the pharmacokinetic
study were manufactured in a full-scale commercial batch,
whereas Impede technology tablets used in the aforementioned
extraction and one-pot evaluations were manufactured
on smaller scale R&D equipment.