Summary:
Three different products containing 240 mg of verapamil hydrochloride in a coated tablet with
sustained release were compared using the blinded dissolution test. The amount of the active
substance released from the tablet and its dynamics differed significantly with all three products
after 3 hours of dissolution. With product C (Isoptin SR, a proprietary product manufactured by
Knoll), 92,2 % of the active substance was released after seven hours. With generic products A and
B, the amounts were higher and lower, respectively. The dynamics of release of the active substance
was linear only with the proprietary product. Irregular and non-linear rates of active substance
release 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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