Drug development and industrial pharmacy · 2026
Polysaccharide-based suspensions: a novel pediatric-friendly formulation for administering furosemide through nasogastric tubes.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Soutier Luiza Gonçalves, Gurski Carla Suellen, Ribeiro Felipe Neme, Trindade Giovanna Araujo de Morais, Sari Marcel Henrique Marcondes, Guimarães Thais Martins, Pontarolo Roberto, Ferreira Luana Mota
Аннотация
OBJECTIVE: Our study aimed to develop extemporaneous furosemide suspensions using a polysaccharide as the suspensor agent and to evaluate their stability and drug loss during tube administration.
SIGNIFICANCE: Extemporaneous oral furosemide liquid formulations are often necessary for managing neonatal cardiovascular disorders, as commercial formulations are typically limited to solid preparations. However, the practice involves syrup as the vehicle, and data on the stability of these formulations are missing.
METHODS: Suspensions were prepared by crushing tablets and using xanthan gum as a thickening agent, without the addition of sugar or preservatives. Samples were stored at room temperature, under refrigeration, and at 40 °C. Physicochemical stability was evaluated on days 0, 3, 5, and 7, assessing pH, density, sedimentation volume, redispersion time, and drug content. Drug quantification was performed using an adapted UV spectrophotometric method. Microbiological stability was evaluated on the same days following standard procedures for nonsterile preparations. In vitro simulations of nasogastric tube administration were conducted to determine potential drug loss.
RESULTS: The formulation maintained stable physicochemical properties over 7 days, with no sedimentation and a density of 1.2 g/mL. Drug content remained near 100%, and pH was around 6.0, with non-Newtonian behavior. Microbiological assessments confirmed conformity with microbial count limits and the absence of pathogens for seven days under refrigeration, at room temperature, and at 40 °C. After nasogastric tube administration, the losses were 13% and 14%.
CONCLUSIONS: Oral furosemide suspensions prepared with xanthan gum exhibited satisfactory physicochemical and microbiological stability. These neonatal formulations show potential for the safe management of pediatric cardiovascular disorders.
SIGNIFICANCE: Extemporaneous oral furosemide liquid formulations are often necessary for managing neonatal cardiovascular disorders, as commercial formulations are typically limited to solid preparations. However, the practice involves syrup as the vehicle, and data on the stability of these formulations are missing.
METHODS: Suspensions were prepared by crushing tablets and using xanthan gum as a thickening agent, without the addition of sugar or preservatives. Samples were stored at room temperature, under refrigeration, and at 40 °C. Physicochemical stability was evaluated on days 0, 3, 5, and 7, assessing pH, density, sedimentation volume, redispersion time, and drug content. Drug quantification was performed using an adapted UV spectrophotometric method. Microbiological stability was evaluated on the same days following standard procedures for nonsterile preparations. In vitro simulations of nasogastric tube administration were conducted to determine potential drug loss.
RESULTS: The formulation maintained stable physicochemical properties over 7 days, with no sedimentation and a density of 1.2 g/mL. Drug content remained near 100%, and pH was around 6.0, with non-Newtonian behavior. Microbiological assessments confirmed conformity with microbial count limits and the absence of pathogens for seven days under refrigeration, at room temperature, and at 40 °C. After nasogastric tube administration, the losses were 13% and 14%.
CONCLUSIONS: Oral furosemide suspensions prepared with xanthan gum exhibited satisfactory physicochemical and microbiological stability. These neonatal formulations show potential for the safe management of pediatric cardiovascular disorders.