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Acta pediátrica de México

versión On-line ISSN 2395-8235versión impresa ISSN 0186-2391

Resumen

GARCIA-ALVAREZ, Raquel et al. Physicochemical and microbiological stabilities of a captopril extemporaneous formulation. Acta pediatr. Méx [online]. 2014, vol.35, n.6, pp.459-468. ISSN 2395-8235.

Due to the large number of paediatric patients requiring treatment for hypertension (HT), to the seriousness of its consequences there is a need to prepare an extemporaneous oral captopril formulation suitable for administration to children. Objective. To develop a liquid formulation of captopril from innovative and generic drugs with a uniform content, cheapier and easier to prepare and with good palatability. Material and method. We have developed oral extemporaneous formulations of captopril stemming from generic brands, at concentrations of 1 and 5 mg/mL, with pleasant taste and odour. Its physicochemical stability and uniformity of content were determined by HPLC on a Waters™ analyser. Data were analysed with the Millennium software, version 32.0. Microbial growth was represented by colony forming units (CFU) in MacConkey, TSA and Sabouraud media, after 72 and 96 hours of incubation at 37°C. Physicochemical and microbiological stabilities of different extemporaneous formulations on days 1, 7, 14, 21 and 30 were determined. Comparative statistics were made by ANOVA test run in Microsoft Excel™. Results. Two generic captopril brands and innovative in formulations containing 1mg/mL and 5mg/mL were physicochemical stable at 30 and 21 days respectively, and no growth of bacteria or fungi common pathogens occurred when stored at 4°C for 30 days. Conclusion. Extemporaneous formulations can be prepared with captopril innovative drug and some generic brands, which maintain their physical and chemical characteristics and are microbiologically stable when stored at 4°C.

Palabras llave : Captopril; Innovative Drug; Generic Drug; Extemporaneous Formulation; Arterial Hypertension; Physicochemical Stability; Chromatography; High Performance Liquid; HPLC.

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