THE CLINICAL EVALUATION OF SUSTAINED RELEASE ANTITUSSIVES

Abstract

The clinical evaluation of the effectiveness of a sustained acting drug can be achieved through statistical design and frequent visits on the part of an impartial observer who assigns a value to the clinical response observed. These values can be handled statistically to demonstrate the duration-effect of the drug. As an example of how such an evaluation may be accomplished utilizing a completely blind technique, a dihydrocodeinone-phenyltoloxamine-resin-complex (Tussionex) was evaluated as a long-acting antitussive. As a result of 8835 individual observations on groups of 67 and 60 patients, respectively, receiving different drugs for periods of 7 or 3 days each, statistical comparisons were made between resinated and nonresinated preparations. It was shown statistically that the ion exchange resin form of dihydrocodeinone and phenyltoloxamine produces an effective antitussive which acts for approximately 12 hours.