Abstract
Sustained release suppositories of sodium diclofenac (SR-Supp) were evaluated in 8 patients who were in pain. In terms of the study of plasma diclofenac concentration profiles in 4 healthy male humans, plasma diclofenac concentrations of more than 50 ng/ml were maintained for 8 h in one subject, for 9 h in another, and for more than 12 h in two others after administration of a Sr-Supp containing 50 mg sodium diclofenac. In the clinical investigations of SR-Supp, 8 patients having chronic rheumatoid arthritis with severe pain were treated with SR-Supp. Plasma diclofenac concentrations in patients were determined only at 4 h after administration of SR-Supp, but in all cases, they correlated well with the values obtained in healthy subjects. The effect of SR-Supp in alleviating pain was sustained for 10 h or more, and allowed the patients to sleep comfortably through the night.
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