In vitro determination of verapamil hydrochloride tablet dissolution

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


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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Pharmacy Clinical pharmacology
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