Carbamazepine and carbamazepine-10, 11-epoxide therapeutic drug monitoring and biochemical and hematological evaluation in bipolar disorder outpatients
DOI:
https://doi.org/10.33448/rsd-v10i11.19640Keywords:
Therapeutic monitoring of drugs; Carbamazepine; Carbamazepine-10; 11-Epoxide; Hematological and biochemical parameters; HPLC-PDA validation; Bipolar disorder.Abstract
The objective of this study was to validate an analytical technique with HPLC-PDA for plasma measurement of carbamazepine (CBZ) and its metabolite carbamazepine-10, 11-epoxide (CBZ-E) for therapeutic monitoring (TM) of patients diagnosed with bipolar disorder (BD), as well as evaluating hematological and biochemical parameters of patients using CBZ. Sixteen patients registered with the Public Service of Psychiatry were selected. CBZ and CBZ-E measurements were performed with HPLC-PDA shimadzu LC-20 AT Prominence, under concentration gradient. Validation criteria: selectivity, linearity, precision, accuracy, recovery, stability. Hematological and biochemical tests were performed using conventional methods. As a result, it was obtained: accuracy >85% and precision <15%, good selectivity, robustness and stability, LOQ = 250 ng.mL-1 and HQL = 60,000 ng.mL-1. Among patients, 25% and 6.25% had CBZ and CBZ-E levels within the therapeutic range, respectively. There were hematological and biochemical changes related to the drug. The validated method is reliable for its intended purpose. TM proved to be extremely useful for detecting therapeutic failure.
References
Araújo, D. D., Silva, H. D., & Freitas, R. D. (2010). Carbamazepina: uma revisão de literatura. Revista eletrónica de farmácia, 7(4), 30-45.
Asadi-Pooya, A. A., & Sperling, M. R. (2009). Clinical features of sudden unexpected death in epilepsy. Journal of Clinical Neurophysiology, 26(5), 297–301.
Barrons, R., & Roberts, N. (2010). The role of carbamazepine and oxcarbazepine in alcohol withdrawal syndrome. Journal of Clinical Pharmacy and Therapeutics, 35(2), 153–167.
Bojic, S., & Becerra, R. (2017). Mindfulness-based treatment for bipolar disorder: A systematic review of the literature. Europe’s Journal of Psychology, 13(3), 573.
Brasil, R. R. (2003). nº 899, de 29 de maio de 2003, Guia para a validação de métodos analíticos e bioanalíticos. Diário Oficial União.
Centeno, A. J. (1990). Curso de estatística aplicada à biologia. Universidade Federal de Goiás.
Di Stefano, G., Truini, A., & Cruccu, G. (2018). Current and innovative pharmacological options to treat typical and atypical trigeminal neuralgia. Drugs, 78(14), 1433-1442.
Failace, R., & Fernandes, F. B. (2009). Hemograma: manual de interpretação. (5a ed.), Editora Artmed.
FDA. (2000). Guidance for Industry, Analytical Procedures and Methods Validation. Chemistry, Manufacturing, and Controls Docunmetation. https://www.gmp-compliance.org/guidelines/gmp-guideline/fda-analytical-procedures-and-methods-validation-issued-8-2000-posted-8-302000
França, F., & Korolkovas, A. (2010). Dicionário Terapêutico Guanabara. Editora.
Grande, I., Berk, M., Birmaher, B., & Vieta, E. (2016). Bipolar disorder. The Lancet, 387(10027), 1561-1572.
Jaworska-Andryszewska, P., & Rybakowski, J. K. (2019). Childhood trauma in mood disorders: neurobiological mechanisms and implications for treatment. Pharmacological Reports, 71(1), 112-120.
Leis, K., Mazur, E., Szyperski, P., Aleksiewicz, T., Jamrożek, T., Lipa, K., & Gałązka, P. (2018). Carbamazepine-hematologic effects of the use. Journal of Education, Health and Sport. 8(8), 51-60.
Martins, D. S. (2021). Memória verbal na esquizofrenia e no transtorno bipolar: aspectos longitudinais.
Matar, K. M., Nicholls, P. J., Tekle, A., Bawazir, S. A., & Al-Hassan, M. I. (1999). Liquid chromatographic determination of six antiepileptic drugs and two metabolites in microsamples of human plasma. Therapeutic drug monitoring, 21(5), 559.
Morales, Y. V., Fraguela, M. E. G., Chacón, L. M., Fuentes, N. P., Kessel, M. A. S., & Pedre, L. L. (2021). Toxicidad hepática y hematológica de la carbamazepina en la epilepsia farmacorresistente y su relación con variables clínicas. Panorama Cuba y Salud, 16(1), 41-49.
Narwat, A., Sharma, V., & Bala, K. (2018). Evaluation of Efficacy and Safety of Pregabalin as an Add on Therapy to Carbamazepine in Patients of Trigeminal Neuralgia. International Journal of Health Sciences and Research.
Navya, M. K., Sujatha, G. P., & Ashok, L. (2017). Physical and psychological distress-trigeminal neuralgia: A case report. Journal of Advanced Clinical and Research Insights, 4(2), 72-75.
Patil, K. M., & Bodhankar, S. L. (2005). Simultaneous determination of lamotrigine, phenobarbitone, carbamazepine and phenytoin in human serum by high-performance liquid chromatography. Journal of pharmaceutical and biomedical analysis, 39(1-2), 181-186.
Pereira, A. S., Shitsuka, D. M., Parreira, F. J., & Shitsuka, R. (2018). Metodologia da pesquisa científica.
Queiroz, R. H. C., Bertucci, C., Malfará, W. R., Dreossi, S. A. C., Chaves, A. R., Valério, D. A. R., & Queiroz, M. E. C. (2008). Quantification of carbamazepine, carbamazepine-10, 11-epoxide, phenytoin and phenobarbital in plasma samples by stir bar-sorptive extraction and liquid chromatography. Journal of pharmaceutical and biomedical analysis, 48(2), 428-434.
Ribani, M., Bottoli, C. B. G., Collins, C. H., Jardim, I. C. S. F., & Melo, L. F. C. (2004). Validação em métodos cromatográficos e eletroforéticos. Química nova, 27(5), 771-780.
Ribeiro, W. R. Apontamento de Hematologia Prática. Gráfica UFG, 1971.
Ruiz Domínguez, R., Andrade Anagua, A., & Medina Barrionuevo, R. (2010). Síndrome de secreción inadecuada de hormona antidiurética inducido por carbamazepina: presentación de un caso. Revista Médica La Paz, 16(1), 38-41.
Verrotti, A., Scaparrotta, A., Grosso, S., Chiarelli, F., & Coppola, G. (2014). Anticonvulsant drugs and hematological disease. Neurological Sciences, 35(7), 983-993.
Vieta, E., Berk, M., Schulze, T. G., Carvalho, A. F., Suppes, T., Calabrese, J. R., & Grande, I. (2018). Bipolar disorders. Nature reviews Disease primers, 4(1), 1-16.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2021 Luiz Carlos da Cunha; Ramias Vieira Calixto Freire; Carla Maria de Sousa Silva; Vania Cristina Rodriguez Salazar; Alessandro de Carvalho Cruz; Jerônimo Raimundo de Oliveira Neto; Renzo Freire de Almeida; Iuri Barbosa Pereira
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
1) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
2) Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
3) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.