Authors: A. Štambergová; Z. Ulbrichová; J. Šedivý; T. Sechser Authors‘ workplace: Pracoviště klinické farmakologie Institutu klinické a experimentální medicíny, Praha Published in: Čes. slov. Farm., 1999; , 214-217 Category:
Three different products containing 240 mg of verapamil hydrochloride in a coated tablet withsustained release were compared using the blinded dissolution test. The amount of the activesubstance released from the tablet and its dynamics differed significantly with all three productsafter 3 hours of dissolution. With product C (Isoptin SR, a proprietary product manufactured byKnoll), 92,2 % of the active substance was released after seven hours. With generic products A andB, the amounts were higher and lower, respectively. The dynamics of release of the active substancewas linear only with the proprietary product. Irregular and non-linear rates of active substancerelease from the tablet may result in clinically suboptimal efficacy and safety of generic products.
Key words: dissolution test – verapamil – sustained release – UV spectrophotometry
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