Abstract
The study was performed to compare the bioavailability of two quetiapine 25 mg tablet formulations: the test formulation was quetiapine fumarate (kitapen®) manufactured by Cobalt Pharmaceuticals, Canada/ Arrow Farmaceutica Ltda* (Erowlabs). Seroquel® (quetiapine) from Astrazeneca Brazil was used as reference formulation. The study was conducted open with randomized two period crossover design and one week wash out period in 64 volunteers of both sexes. Plasma samples were obtained over a 48 hour interval. Quetiapine was analyzed by LC-MS-MS in the presence of quetiapine-D8 as internal standard. Plasma samples were obtained over a 48 hour interval. Quetiapine was analyzed by LC-MS-MS in the presence of quetiapine-D8 as internal standard. The mean ratio of parameters Cmax and AUC 0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC 0-t for test and reference formulation were 432.41 ng.h/mL and 412.20 ng.h/mL, for AUC 0-∞ were 440.06 ng.h/mL and 418.90 ng.h/mL and, for Cmax 126.94 ng/mL and 108.71 ng/mL, respectively. Geometric mean of quetiapine (kitapen®)/Seroquel® 25 mg individual percent ratio was 97.68% AUC 0-t , 97.47% for AUC 0-∞ and 90.68% for C max . The 90% confidence intervals were 92.67 – 102.96%, 92.53 – 102.67%, 83.37 – 98.64%, respectively. Since the 90% confidence intervals for C max , AUC 0-t and AUC 0-∞ were within the 80 – 125% interval proposed by Food and Drug Administration, it was concluded that quetiapine (kitapen®) 25 mg tablet was bioequivalent to Seroquel® 25 mg tablet according to both the rate and extent of absorption.
Highlights
Quetiapine is an antipsychotic drug with a unique receptor-binding profile belonging to the same chemical class of the antipsychotic clozapine, the dibenzothiazepine derivatives and classified as an atypical or second generation antipsychotic [1,2]
Bipolar affective disorder, including the more classic form defined by the occurrence of manic or mixed episodes and the form defined by less severe hypomanic episodes, is relatively common, typically begins early in life, is associated with high rates of recurrence and chronicity, and results in significant morbidity
The study was performed in accordance with the Helsinki Declaration and Good Clinical Practice Guideline, and informed consent was obtained from participants prior to study commencement
Summary
Quetiapine is an antipsychotic drug with a unique receptor-binding profile belonging to the same chemical class of the antipsychotic clozapine, the dibenzothiazepine derivatives and classified as an atypical or second generation antipsychotic [1,2]. Bipolar affective disorder, including the more classic form defined by the occurrence of manic or mixed episodes (bipolar I disorder) and the form defined by less severe hypomanic episodes (bipolar II disorder), is relatively common (combined lifetime incidence: approximately 3% to 5%), typically begins early in life (ie, before age 25), is associated with high rates of recurrence and chronicity, and results in significant morbidity. Due to these characteristics, bipolar affective disorder is one of the world’s greatest public health problems [5,6,7]
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