African Journal of
Pharmacy and Pharmacology

  • Abbreviation: Afr. J. Pharm. Pharmacol.
  • Language: English
  • ISSN: 1996-0816
  • DOI: 10.5897/AJPP
  • Start Year: 2007
  • Published Articles: 2288

Full Length Research Paper

Steady-state bioequivalence study of clozapine psychotic patients in Brazil

Margareth de Oliveira Timóteo
  • Margareth de Oliveira Timóteo
  • Programa de Pós-Graduação em Ciências Médicas, Universidade Federal Fluminense, RJ, Brazil.
  • Google Scholar
Gutemberg Gomes Alves
  • Gutemberg Gomes Alves
  • Unidade de Pesquisa Clínica, Universidade Federal Fluminense, RJ, Brazil.
  • Google Scholar
Gilberto Perez Cardoso
  • Gilberto Perez Cardoso
  • Programa de Pós-Graduação em Ciências Médicas, Universidade Federal Fluminense, RJ, Brazil.
  • Google Scholar
Beni Olej
  • Beni Olej
  • Programa de Pós-Graduação em Ciências Médicas, Universidade Federal Fluminense, RJ, Brazil.
  • Google Scholar
Mauro Vitor Mendlowicz
  • Mauro Vitor Mendlowicz
  • Departamento de Saúde da Comunidade, Faculdade de Medicina, Universidade Federal Fluminense, RJ, Brazil.
  • Google Scholar
Luis Guillermo Coca Velarde
  • Luis Guillermo Coca Velarde
  • Programa de Pós-Graduação em Ciências Médicas, Universidade Federal Fluminense, RJ, Brazil.
  • Google Scholar
Luiz Querino de Araújo Caldas*
  • Luiz Querino de Araújo Caldas*
  • Programa de Pós-Graduação em Ciências Médicas, Universidade Federal Fluminense, RJ, Brazil.
  • Google Scholar


  •  Received: 03 January 2016
  •  Accepted: 11 March 2016
  •  Published: 15 April 2016

References

Agência Nacional de Vigilância Sanitária (ANVISA) (2002). Manual for Good Bioavailability and Bioequivalence Practices. 1(1).

 

Araújo LU, Albuquerque KT, Kato KC, Silveira GS, Maciel NR, Spósito PA Barcellos NMS Souza J, Bueno M, Storpirtis S (2010). Generic drugs in Brazil: Historical overview and legislation. Rev. Panam. Salud Publica. 28(6):480-492.
Crossref

 

Asenjo LC, Komossa K, Rummel-Kluge C, Hunger H, Schmid F, Schwarz S, Leucht S (2010). Clozapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst. Rev. 11:CD006633.
Crossref

 

Brazil (1999). Bill n° 9.787, 10 February 1999, provides for sanitary surveillance, establishes the concept of generic drug, provides for the use of generic names in pharmaceutical and other measures. Diário Oficial da União. 11(1):1.

 

Cohen D, Bogers JP, van Dijk D, Bakker B, Schulte PF (2012). Beyond white blood cell monitoring: Screening in the initial phase of clozapine therapy. J. Clin. Psychiatry 3(10):1307-1312.
Crossref

 

da Fonseca BM, Moreno IED, Barroso M, Costa S, Queiroz JA, Gallardo E (2013). Determination of seven selected antipsychotic drugs in human plasma using microextraction in packed sorbent and gas chromatography-tandem mass spectrometry. Anal. Bioanal. Chem. 405(12):3953-3963.
Crossref

 

do Carmo Borges NC, Astigarraga RB, Sverdloff CE, Galvinas PR, Borges BC, Moreno RA (2012). Comparative bioavailability of two oral formulations of clozapine in steady state administered in schizophrenic volunteers under individualized dose regime. Curr. Clin. Pharmacol. 7(4):241-253.
Crossref

 

Drew L (2013). Clozapine and agranulocytosis: Re-assessing the risks. Australas. Psychiatry 21(4):335-337.
Crossref

 

Golden G, Honigfeld G (2008). Bioequivalence of clozapine orally disintegrating 100-mg tablets compared with clozapine solid oral 100-mg tablets after multiple doses in patients with schizophrenia. Clin. Drug. Investig. 28(4):231-239.
Crossref

 

Herceg M, Muzinić L, Jukić V (2010). Can we prevent blood dyscrasia (leucopenia, thrombocytopenia) and epileptic seizures induced by clozapine. Psychiatr. Danub. 22(1):85-89.

 

Kane JM, Correll CU (2010). Past and present progress in the pharmacologic treatment of schizophrenia. J. Clin. Psychiatry 71(9):1115-1124.
Crossref

 

Lewis SW, Davies L, Jones PB, Barnes TR, Murray RM, Kerwin R, Taylor D, Hayhurst KP, Markwick A, Lloyd H, Dunn G (2006). Randomised controlled trials of conventional antipsychotic versus new atypical drugs, and new atypical drugs versus clozapine, in people with schizophrenia responding poorly to, or intolerant of current drug treatment. Health Technol. Assess. 10(17):1-165.
Crossref

 

Lucas C, Martin J (2013). Smoking and drug interactions. Aust. Prescr. 36:102-104.
Crossref

 

Meltzer HY (2012). Clozapine: Balancing safety with superior antipsychotic efficacy. Clin. Schizophr. Relat. Psychoses 6(3):134-144.
Crossref

 

Mercolini L, Bugamelli F, Kenndler E, Boncompagni G, Franchini L, Raggi MA (2007). Simultaneous determination of the antipsychotic drugs levomepromazine and clozapine and their main metabolites in human plasma by a HPLC-UV method with solid-phase extraction. J. Chrom. B Analyt. Technol. Biomed. Life Sci. 1:846(1-2):273-280.

 

Pokorny R, Finkel MJ, Robinson WT (1994). Normal volunteers should not be used for bioavailability or bioequivalence studies of clozapine. Pharm. Res. 11(8):1221.
Crossref

 

Rosland M, Szeto P, Procyshyn R, Barr AM, Wasan KM (2007). Determination of clozapine and its metabolite, norclozapine, in various biological matrices using high-performance liquid chromatography. Drug Dev. Ind. Pharm. 33(10):1158-66.
Crossref

 

Rumel D, Nishioka SDA, Santos AD (2006). Drug interchangeability: Clinical approach and consumer point of view. Rev. Saúde Pública. 40(5):921-927.
Crossref

 

Sarkar S, Grover S (2013). Antipsychotics in children and adolescents with schizophrenia: Asystematic review and meta-analysis. Indian J. Pharmacol. 145(5):439-446.

 

Suzuki T, Uchida H, Watanabe K, Kashima H (2011). Factors associated with response to Clozapine in schizophrenia: A review. Psychopharmacol. Bull. 44(1):32-60.

 

Tassaneeyakul W, Kittiwattanagul K, Vannaprasaht S, Kampan J, Tawalee A, Puapairoj P, Tiamkao S, Juthagridsada S, Kukongviriyapan V, Tassaneeyakul W (2005). Steady-state bioequivalence study of clozapine tablet in schizophrenic patients. J. Pharm. Pharm. Sci. 8(1):47-53.

 

Thomas AA, Friedman JH (2010). Current use of clozapine in Parkinson disease and related disorders. Clin. Neuropharmacol. 33(1):14-16.
Crossref

 

United States Food and Drug Administration, Center for Drug Evaluation and Research (US-FDA) (2014). Clozapine tablets: In vivo bioequivalence and in vitro dissolution testing. Guidance for Industry.

 

Warnez S, Alessi-Severini S (2014). Clozapine: A review of clinical practice guidelines and prescribing trends. BMC Psychiatry 14(1):102.
Crossref

 

Wohlfarth A, Toepfner N, Hermanns-Clausen M, Auwärter V (2011). Sensitive quantification of clozapine and its main metabolites norclozapine and clozapine-N-oxide in serum and urine using LC-MS/MS after simple liquid-liquid extraction work-up. Anal. Bioanal. Chem. 400(3):737-746.
Crossref