Artículos de revistas
Bioequivalence Study And Pharmacokinetic Evaluation Of Two Quetiapine Formulations In Healthy Volunteers After A Single Dose Administration [estudo De Bioequivalência E Avaliação Farmacocinética De Duas Formulações De Quetiapina Em Voluntários Sadios Após Administração De Dose única]
Registro en:
Revista Brasileira De Medicina. , v. 68, n. 9, p. 269 - 273, 2011.
347264
2-s2.0-80055119456
Autor
Abib Jr. E.
Duarte L.F.
Pereira R.
Savio D.
Pengo S.
Morais D.C.
De Lima L.G.
Institución
Resumen
The study was performed to compare the bioavailability/bioequivalence of two Quetiapine 25 mg tablet formulations (Quetiapine from Aché Laboratórios Farmacêuticos S/A as test formulation and Seroquel® from Astrazeneca Ltda, Brazil, as reference formulation) in 48 volunteers of both sexes. The study was conducted as an open randomized two periods cross-over design with a wash out phase of one week. Plasma samples were obtained over a 36 hour interval. Plasma concentrations of Quetiapine were determined by LC-MS-MS equipment using Clozapine as internal standard. From the data obtained, the following pharmacokinetics parameters were calculated: AUC0-t′, AUC0-∞ and Cmax′ Geometric mean of Quetiapine/Seroquel® 25 mg was 99.96% for AUC 0-t′ 100.12% for AUC0-8 and 92.59% for C max′ the 90% confidence intervals were 93.58-106.77%, 93.88-106.78% and 83.22-103.01%, respectively. Since the 90% confidence intervals for Cmax′ AUC0-t and AUC 0-∞ were within the range of 80-125% proposed by Food and Drug Administration and ANVISA (the National Health Surveillance Agency of Brasil), it was concluded that Quetiapine 25 mg Tablet was bioequivalent to Seroquel® 25 mg tablet, and so the test product can be considered interchangeable in normal medical practice. © Copyright Moreira Jr. Editora. Todos os direitos reservados. 68 9 269 273 Abi-Dargham, A., Laruelle, M., Aghajanian, G.K., Charney, D., Krystal, J., The role of serotonin in the pathophysiology and treatment of schizophrenia (1997) Journal of Neuropsychiatry and Clinical Neurosciences, 9 (1), pp. 1-17 Barrett, B., Holcapek, M., Huclova, J., Borek-Dohalsky, V., Fejt, P., Nemec, B., Jelinek, I., Validated HPLC-MS/MS method for determination of quetiapine in human plasma (2007) Journal of Pharmaceutical and Biomedical Analysis, 44 (2), pp. 498-505. , DOI 10.1016/j.jpba.2007.03.034, PII S0731708507002051, Hyphenated Techniques in Pharmaceutical and Biomedical Analysis 2006 Borkar, B.H., Vidhate, S., Lohiya, R.T., Umekar, M.J., Spectrophotometric Determination of an Atypical Antipsychotic Compound in Pharmaceutical Formulation (2009) International Journal of ChemTech Research, 1, pp. 1153-1161 Calabrese, J.R., Keck Jr., P.E., Macfadden, W., Minkwitz, M., Ketter, T.A., Weisler, R.H., Cutler, A.J., Mullen, J., A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression (2005) American Journal of Psychiatry, 162 (7), pp. 1351-1360. , DOI 10.1176/appi.ajp.162.7.1351 Copolov, D.L., Link, C.G.G., Kowalcyk, B., A multicentre, double-blind, randomized comparison of quetiapine (ICI 204,636, 'Seroquel') and haloperidol in schizophrenia (2000) Psychological Medicine, 30 (1), pp. 95-105. , DOI 10.1017/S0033291799001476 DeVane, C.L., Nemeroff, C.B., Clinical Pharmacokinetics of Quetiapine: An Atypical Antipsychotic (2001) Clinical Pharmacokinet, 40, pp. 509-522 Figueroa, C., Brecher, M., Hamer-Maansson, J., Pharmacokinetic profiles of extended release quetiapine fumarate compared with quetiapine inmediate release (2009) Prog Neuropsychopharmacol Biol Psychiatry, 33, pp. 199-204 Goldstein, J.M., Atypical antipsychotic drugs: Beyond acute psychosis, new directions (1999) Emerging Drugs, 4, pp. 127-151 Judd, L.L., Akiskal, H.S., Schettler, P.J., Endicott, J., Maser, J., Solomon, D.A., Leon, A.C., Keller, M.B., The long-term natural history of the weekly symptomatic status of bipolar I disorder (2002) Archives of General Psychiatry, 59 (6), pp. 530-537 Kapur, S., Remington, G., Serotonin-dopamine interaction and its relevance to schizophrenia (1996) American Journal of Psychiatry, 153 (4), pp. 466-476 Keck, P., McIntyre, R., Shelton, R., Bipolar depression: Best practices for the outpatient (2007) CNS Spectr, 12, pp. 1-16 Mahatthanatrakul, W., Rattana, S., Sriwiriyajan, S., Wongnawa, M., Ridtitid, W., Bioequivalence study of a generic quetiapine in healthy male volunteers (2008) International Journal of Clinical Pharmacology and Therapeutics, 46, pp. 489-496 Mario, A., Michael, E., The Role of Quetiapine Extended Release in the Treatment of Bipolar Depression (2010) Adv Ther, 27, pp. 1-11 Peuskens, J., A comparison of quetiapine and chlorpromazine in the treatment of schizophrenia (1997) Acta Psychiatr Scand, 96, pp. 265-273 Rayan, J., Lena, D., Martha, S., Role of extended release quetiapine in the management of bipolar disorders (2010) Neuropsychiatr Dis Treat, 6, pp. 29-35 Thase, M.E., Macfadden, W., Weisler, R.H., Chang, W., Paulsson, B., Khan, A., Calabrese, J.R., Efficacy of quetiapine monotherapy in bipolar I and II depression: A double-blind, placebo-controlled study (the BOLDER II study) (2006) Journal of Clinical Psychopharmacology, 26 (6), pp. 600-609. , DOI 10.1097/01.jcp.0000248603.76231.b7, PII 0000471420061200000009 Vieta, E., Mullen, J., Brecher, M., Paulsson, B., Jones, M., Quetiapine monotherapy for mania associated with bipolar disorder: Combined analysis of two international, double-blind, randomised, placebo-controlled studies (2005) Current Medical Research and Opinion, 21 (6), pp. 923-934. , DOI 10.1185/030079905X46340, 2971