Generic selection criteria for safety and patient benefit [VIII]: Comparing the physicochemical and pharmaceutical properties of brand-name and generic diclofenac sodium tapes.

ABSTRACT: With respect to diclofenac sodium-containing tape preparations of nonsteroidal antiphlogistic drug, we compared the pharmaceutical properties (pH, elongatedness, water-vapor permeability, adhesive force, and peeling-force) of 11 medicinal drugs (2 brand-name and 9 generic drugs) to obtain evidence for product selection in line with the needs of the patient. The elongatedness of the generic drugs Teikoku (1.39), Yutoku (1.40), and Nippon-zoki (1.43) were significantly higher than the brand-name drug Voltaren ？ (1.22). The adhesive force was measured using the probe tack test and the inclined ball tack test. The probe tack test results of Naboal ？ (6.8 N/cm 2), Teikoku (6.1 N/cm 2), Yutoku (5.9 N/cm 2), Nippon-zoki (6.2 N/cm 2), and Rakool (6.2 N/cm 2) were higher than that of Voltaren (2.0 N/cm 2). The inclined ball tack test results of Naboal (18.0), Teikoku (24.0), Yutoku (21.5), and Nippon-zoki (22.7) were also higher than that of Voltaren (7.2). Concerning peeling-force measurement, the 90° peeling-forces of Naboal (0.95 N), Teikoku (0.96 N), Yutoku (0.94 N), and Nippon-zoki (1.01 N) were higher than that of Voltaren (0.68 N). These results show that there were marked differences in the feeling of use of each product between the brand-name and generic drugs. The pharmacist indicates the basis for selection of a preparation according to the feeling of use desired by each patient. It has become possible to recommend products suitable for each patient, which will allow pharmacists to provide products according to the needs of each patient when a brand-name drug is changed to a generic one. Key Words: Transdermal therapeutic drug, brand-name drug, generic drug, diclofenac sodium tape Full Text: PDF(554KB