Bisoprolol, 1-(propan-2-ylamino)-3-[4-(2-propan-2-yloxyethoxymethyl)phenoxy]- propan-2-ol is a synthetic a highly selective beta1-adrenoceptor antagonist. Bisoprolol reduces the heart rate and is useful in treating abnormally rapid heart rhythms. It also reduces the force of contraction of the heart and lowers blood pressure.
The aim of the study was to compare pharmacokinetics of bisoprolol observed in two separate bioequivalence studies. The test products were Bisocard 10 mg and Bisocard 2.5 mg film-coated tablets, both manufactured by ICN Polfa Rzeszów S.A. The reference products were Concor 10^® and Concor COR 2.5 film-coated tablets, both manufactured by Merck KGaA, Beerse, Belgium. Bisoprolol concentration in plasma samples was determined using LC-MS/MS method at the Good Laboratory Practice certified laboratory of the Pharmacology Department, Pharmaceutical Research Institute.
The results indicated that generic and branded formulations were bioequivalent at both doses. In both studies the 90% CI for geometric mean test/reference-ratios for the primary pharmacokinetic parameters (AUC_(0-t), AUC_(0-∞) and C_max) were within acceptance limits of 80.00 – 125.00%. The secondary parameters (t_max, t_1/2, MRT) recorded in both studies were comparable.
The study was supported by ICN Polfa Rzeszów.

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