Investigation of quality deviation in thiamine (vitamin B1) tablets due to suspect of therapeutic inefficacy in the treatment of neuropsychiatric conditions

• Autor(a) principal: Eserian, Jaqueline Kalleian
• Data de Publicação: 2019
• Outros Autores: Lombardo, Márcia
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1249
• topic: Tiamina; Análise Fiscal de Produtos; Controle de Qualidade; Alcoolismo; Doenças do Sistema Nervoso; Thiamine; Fiscal Analysis of Products; Quality Control; Alcoholism; Nervous System Diseases

Introduction: Thiamine supplementation for alcohol-dependent patients is one of the most important strategies for treating alcohol withdrawal syndrome and preventing and treating more serious neurological related complications. Also, it is used as adjuvant treatment for neurological conditions in geriatric patients. A municipal sanitary surveillance service from São Paulo requested the analysis of batches of thiamine hydrochloride tablets after complaints of therapeutic inefficacy during treatment of distinct neuropsychiatric conditions. Objective: To check if the thiamine therapeutic inefficacy complaints were associated to the medications’ quality. Method: Fiscal analyses were performed including aspect, weight variation, identification and potency of thiamine hydrochloride, uniformity of unitary doses and dissolution. Results: There was no quality deviation in the medications, as all performed assays presented satisfactory results. Conclusions: The administration of quality medications is essential for obtaining expected clinical effects. Other factors not associated to the medication quality such as patients’ adherence to the treatment and poor oral absorption might be associated to the complaints.