Development of extemporaneous preparation for pediatric use containing furosemide

• Autor(a) principal: Silva dos Santos, Taianne
• Data de Publicação: 2020
• Outros Autores: Rocha Cordeiro, Mariane, Neves Fonseca, Leandro, Pardócimo Vaz, Urias, Pinto Vilela , Fernanda Maria, Diniz Tavares, Guilherme
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: HU Revista (Online)
• DOI: 10.34019/1982-8047.2020.v46.28850
• Texto Completo: https://periodicos.ufjf.br/index.php/hurevista/article/view/28850
• topic: Pediatrics; Quality control; Pediatria; Controle de qualidade

Introduction:Due to the characteristics of the human organism during childhood, the drugs used by this public need to be adequate in dosage and pharmaceutical form, ensuring correct treatment and patient compliance. However, the commercial scarcity of these drugs leads to the off-label use of formulations intended for the treatment of adult individuals, which may be inappropriate for pediatric therapy. In this sense, furosemide is a loop diuretic used off-label in children and is not commercially available in Brazil in liquid form, which is more suitable for pediatric audiences.Objective:To develop and evaluate the quality of a pediatric oral oral preparation containing 10 mg / mL furosemide.Material and Methods:An active suspension was prepared and the physicochemical and microbiological quality control of the formulation was performed. From the physicochemical point of view, the following parameters were evaluated: appearance, pH, viscosity and drug content. Regarding microbiological analysis, the visible growth of total mesophilic microorganisms (fungi and bacteria) was evaluated after incubation of the product in culture medium specific for these microorganisms.Results:An off-white, odorless formulation with sediment formation was obtained after rest and easily resuspended after agitation. The drug had an average pH of 7.16 ± 0.138, average viscosity of 40.79 cP ± 0.100 and an average active content of 108.7% ± 0.075. In addition, there was no visible growth of mesophilic microorganisms in the developed product.Conclusion:The suspension presented satisfactory results in relation to the evaluated parameters, with characteristics similar to those found in the literature for other furosemide suspensions. Thus, it is a formulation option that can be manipulated in an extemporaneous form and administered to pediatric patients.